Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2026-03-06 @ 8:40 AM
Study NCT ID:
NCT03748758
Status:
COMPLETED
Last Update Posted:
2020-02-25
First Post:
2018-11-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Safety of Repeated Doses of OP0201 Metered Dose Inhaler Compared to Placebo in Healthy Adult Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'study002@novustherapeutics.com', 'phone': '949-679-1110', 'title': 'Clinical Director', 'organization': 'Novus Therapeutics'}, 'certainAgreement': {'otherDetails': 'No information, data or results shall be used by the Institution, Investigator or any other individual or entity other than the Sponsor. The use of Study Results by any party other than Sponsor requires prior written approval by the Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'End of study (Day 21)', 'eventGroups': [{'id': 'EG000', 'title': 'Drug: OP0201 Cohort A 30 mg Per Day', 'description': 'Cohort A- 30 mg per day X 14 days\n\nDrug: OP0201: Drug OP0201', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 5, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Drug: OP0201 Cohort B 60 mg Per Day', 'description': 'Cohort B-60 mg per day X 14 days\n\nDrug: OP0201: Drug OP0201', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 9, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Drug: Placebo', 'description': '0 mg per day X 14 days\n\nDrug: Placebo: Placebo', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Olfactory test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug: OP0201 Cohort A 30 mg Per Day', 'description': 'Cohort A- 30 mg per day X 14 days\n\nDrug: OP0201: Drug OP0201'}, {'id': 'OG001', 'title': 'Drug: OP0201 Cohort B 60 mg Per Day', 'description': 'Cohort B-60 mg per day X 14 days\n\nDrug: OP0201: Drug OP0201'}, {'id': 'OG002', 'title': 'Drug: Placebo', 'description': '0 mg per day X 14 days\n\nDrug: Placebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '21 Days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Evaluation of Systemic Exposure of DPPC: Observed DPPC Serum Concentration (µg/mL) by Nominal Timepoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug: OP0201 Cohort B 60 mg Per Day/ Day 1 Baseline', 'description': 'Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201'}, {'id': 'OG001', 'title': 'Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 30 Mins Predose', 'description': 'Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201'}, {'id': 'OG002', 'title': 'Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 5 Mins', 'description': 'Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201'}, {'id': 'OG003', 'title': 'Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 20 Mins', 'description': 'Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201'}, {'id': 'OG004', 'title': 'Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 35 Mins', 'description': 'Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201'}, {'id': 'OG005', 'title': 'Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 50 Mins', 'description': 'Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201'}, {'id': 'OG006', 'title': 'Drug: Placebo/ Day 1 Baseline', 'description': '0 mg per day X 14 days Drug: Placebo: Placebo'}, {'id': 'OG007', 'title': 'Drug: Placebo/ Day 14: 30 Mins Predose', 'description': '0 mg per day X 14 days Drug: Placebo: Placebo'}, {'id': 'OG008', 'title': 'Drug: Placebo/ Day 14: 5 Mins', 'description': '0 mg per day X 14 days Drug: Placebo: Placebo'}, {'id': 'OG009', 'title': 'Drug: Placebo/ Day 14: 20 Mins', 'description': '0 mg per day X 14 days Drug: Placebo: Placebo'}, {'id': 'OG010', 'title': 'Drug: Placebo/ Day 14: 35 Mins', 'description': '0 mg per day X 14 days Drug: Placebo: Placebo'}, {'id': 'OG011', 'title': 'Drug: Placebo/ Day 14: 50 Mins', 'description': '0 mg per day X 14 days Drug: Placebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '10.05', 'spread': '2.585', 'groupId': 'OG000'}, {'value': '10.18', 'spread': '2.703', 'groupId': 'OG001'}, {'value': '10.35', 'spread': '2.832', 'groupId': 'OG002'}, {'value': '9.954', 'spread': '2.475', 'groupId': 'OG003'}, {'value': '9.813', 'spread': '2.368', 'groupId': 'OG004'}, {'value': '10.04', 'spread': '2.564', 'groupId': 'OG005'}, {'value': '9.525', 'spread': '2.652', 'groupId': 'OG006'}, {'value': '12.86', 'spread': '6.145', 'groupId': 'OG007'}, {'value': '14.03', 'spread': '7.319', 'groupId': 'OG008'}, {'value': '13.20', 'spread': '6.505', 'groupId': 'OG009'}, {'value': '12.80', 'spread': '6.930', 'groupId': 'OG010'}, {'value': '13.39', 'spread': '6.668', 'groupId': 'OG011'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and Day 14', 'description': 'This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'It is pre-specified to collect and report data for only "Cohort B" and "Placebo" Arms/Groups per protocol. The Number of participants analyzed for Cohort B at Day 14, 30 mins pre-dose and 5 mins post-dose is one less compared to other timepoints due to exclusion of serum samples that had missing collection times.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Systemic Exposure of CP: Observed CP Serum Concentrations (µM) by Nominal Timepoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug: OP0201 Cohort B 60 mg Per Day/ Day 1 Baseline', 'description': 'Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201'}, {'id': 'OG001', 'title': 'Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 30 Mins Predose', 'description': 'Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201'}, {'id': 'OG002', 'title': 'Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 5 Mins', 'description': 'Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201'}, {'id': 'OG003', 'title': 'Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 20 Mins', 'description': 'Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201'}, {'id': 'OG004', 'title': 'Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 35 Mins', 'description': 'Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201'}, {'id': 'OG005', 'title': 'Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 50 Mins', 'description': 'Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201'}, {'id': 'OG006', 'title': 'Drug: Placebo/ Day 1 Baseline', 'description': '0 mg per day X 14 days Drug: Placebo: Placebo'}, {'id': 'OG007', 'title': 'Drug: Placebo/ Day 14: 30 Mins Predose', 'description': '0 mg per day X 14 days Drug: Placebo: Placebo'}, {'id': 'OG008', 'title': 'Drug: Placebo/ Day 14: 5 Mins', 'description': '0 mg per day X 14 days Drug: Placebo: Placebo'}, {'id': 'OG009', 'title': 'Drug: Placebo/ Day 14: 20 Mins', 'description': '0 mg per day X 14 days Drug: Placebo: Placebo'}, {'id': 'OG010', 'title': 'Drug: Placebo/ Day 14: 35 Mins', 'description': '0 mg per day X 14 days Drug: Placebo: Placebo'}, {'id': 'OG011', 'title': 'Drug: Placebo/ Day 14: 50 Mins', 'description': '0 mg per day X 14 days Drug: Placebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '299.503', 'spread': '61.999', 'groupId': 'OG000'}, {'value': '290.103', 'spread': '35.978', 'groupId': 'OG001'}, {'value': '293.473', 'spread': '56.417', 'groupId': 'OG002'}, {'value': '279.852', 'spread': '44.170', 'groupId': 'OG003'}, {'value': '279.289', 'spread': '44.424', 'groupId': 'OG004'}, {'value': '276.788', 'spread': '45.493', 'groupId': 'OG005'}, {'value': '298.519', 'spread': '126.157', 'groupId': 'OG006'}, {'value': '363.530', 'spread': '178.783', 'groupId': 'OG007'}, {'value': '387.945', 'spread': '200.583', 'groupId': 'OG008'}, {'value': '363.476', 'spread': '165.774', 'groupId': 'OG009'}, {'value': '366.353', 'spread': '195.732', 'groupId': 'OG010'}, {'value': '368.159', 'spread': '178.270', 'groupId': 'OG011'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and Day 14', 'description': 'This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day', 'unitOfMeasure': 'µM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'It is pre-specified to collect and report data for only "Cohort B" and "Placebo" Arms/Groups per protocol. The Number of participants analyzed for Cohort B at Day 14, 30 mins pre-dose and 5 mins post-dose is one less compared to other timepoints due to exclusion of serum samples that had missing collection times.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Systemic Exposure of DPPC: Baseline-corrected DPPC Serum Concentration (µg/mL) by Nominal Timepoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 30 Mins Predose', 'description': 'Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201'}, {'id': 'OG001', 'title': 'Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 5 Mins', 'description': 'Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201'}, {'id': 'OG002', 'title': 'Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 20 Mins', 'description': 'Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201'}, {'id': 'OG003', 'title': 'Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 35 Mins', 'description': 'Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201'}, {'id': 'OG004', 'title': 'Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 50 Mins', 'description': 'Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201'}, {'id': 'OG005', 'title': 'Drug: Placebo/ Day 14: 30 Mins Predose', 'description': '0 mg per day X 14 days Drug: Placebo: Placebo'}, {'id': 'OG006', 'title': 'Drug: Placebo/ Day 14: 5 Mins', 'description': '0 mg per day X 14 days Drug: Placebo: Placebo'}, {'id': 'OG007', 'title': 'Drug: Placebo/ Day 14: 20 Mins', 'description': '0 mg per day X 14 days Drug: Placebo: Placebo'}, {'id': 'OG008', 'title': 'Drug: Placebo/ Day 14: 35 Mins', 'description': '0 mg per day X 14 days Drug: Placebo: Placebo'}, {'id': 'OG009', 'title': 'Drug: Placebo/ Day 14: 50 Mins', 'description': '0 mg per day X 14 days Drug: Placebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.309', 'spread': '0.347', 'groupId': 'OG000'}, {'value': '0.871', 'spread': '0.787', 'groupId': 'OG001'}, {'value': '0.383', 'spread': '0.453', 'groupId': 'OG002'}, {'value': '0.300', 'spread': '0.407', 'groupId': 'OG003'}, {'value': '0.447', 'spread': '0.446', 'groupId': 'OG004'}, {'value': '3.333', 'spread': '3.490', 'groupId': 'OG005'}, {'value': '4.505', 'spread': '4.660', 'groupId': 'OG006'}, {'value': '3.678', 'spread': '3.850', 'groupId': 'OG007'}, {'value': '3.278', 'spread': '4.274', 'groupId': 'OG008'}, {'value': '3.865', 'spread': '4.009', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and Day 14', 'description': 'This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'It is pre-specified to collect and report data for only "Cohort B" and "Placebo" Arms/Groups per protocol. The Number of participants analyzed for Cohort B at Day 14, 30 mins pre-dose and 5 mins post-dose is one less compared to other timepoints due to exclusion of serum samples that had missing collection times.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Systemic Exposure of CP: Baseline-corrected CP Serum Concentrations (µM) by Nominal Timepoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 30 Mins Predose', 'description': 'Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201'}, {'id': 'OG001', 'title': 'Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 5 Mins', 'description': 'Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201'}, {'id': 'OG002', 'title': 'Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 20 Mins', 'description': 'Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201'}, {'id': 'OG003', 'title': 'Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 35 Mins', 'description': 'Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201'}, {'id': 'OG004', 'title': 'Drug: OP0201 Cohort B 60 mg Per Day/ Day 14: 50 Mins', 'description': 'Cohort B-60 mg per day X 14 days Drug: OP0201: Drug OP0201'}, {'id': 'OG005', 'title': 'Drug: Placebo/ Day 14: 30 Mins Predose', 'description': '0 mg per day X 14 days Drug: Placebo: Placebo'}, {'id': 'OG006', 'title': 'Drug: Placebo/ Day 14: 5 Mins', 'description': '0 mg per day X 14 days Drug: Placebo: Placebo'}, {'id': 'OG007', 'title': 'Drug: Placebo/ Day 14: 20 Mins', 'description': '0 mg per day X 14 days Drug: Placebo: Placebo'}, {'id': 'OG008', 'title': 'Drug: Placebo/ Day 14: 35 Mins', 'description': '0 mg per day X 14 days Drug: Placebo: Placebo'}, {'id': 'OG009', 'title': 'Drug: Placebo/ Day 14: 50 Mins', 'description': '0 mg per day X 14 days Drug: Placebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '8.341', 'spread': '15.478', 'groupId': 'OG000'}, {'value': '15.625', 'spread': '18.781', 'groupId': 'OG001'}, {'value': '6.697', 'spread': '14.869', 'groupId': 'OG002'}, {'value': '6.818', 'spread': '13.839', 'groupId': 'OG003'}, {'value': '5.699', 'spread': '10.410', 'groupId': 'OG004'}, {'value': '65.011', 'spread': '52.626', 'groupId': 'OG005'}, {'value': '89.426', 'spread': '74.425', 'groupId': 'OG006'}, {'value': '64.957', 'spread': '39.617', 'groupId': 'OG007'}, {'value': '67.834', 'spread': '69.575', 'groupId': 'OG008'}, {'value': '69.641', 'spread': '52.113', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and Day 14', 'description': 'This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day', 'unitOfMeasure': 'µM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'It is pre-specified to collect and report data for only "Cohort B" and "Placebo" Arms/Groups per protocol. The Number of participants analyzed for Cohort B at Day 14, 30 mins pre-dose and 5 mins post-dose is one less compared to other timepoints due to exclusion of serum samples that had missing collection times.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Drug: OP0201 Cohort A 30 mg Per Day', 'description': 'Cohort A- 30 mg per day X 14 days\n\nDrug: OP0201: Drug OP0201'}, {'id': 'FG001', 'title': 'Drug: OP0201 Cohort B 60 mg Per Day', 'description': 'Cohort B-60 mg per day X 14 days\n\nDrug: OP0201: Drug OP0201'}, {'id': 'FG002', 'title': 'Drug: Placebo', 'description': '0 mg per day X 14 days\n\nDrug: Placebo: Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Drug: OP0201 Cohort A 30 mg Per Day', 'description': 'Cohort A- 30 mg per day X 14 days\n\nDrug: OP0201: Drug OP0201'}, {'id': 'BG001', 'title': 'Drug: OP0201 Cohort B 60 mg Per Day', 'description': 'Cohort B-60 mg per day X 14 days\n\nDrug: OP0201: Drug OP0201'}, {'id': 'BG002', 'title': 'Drug: Placebo', 'description': '0 mg per day X 14 days\n\nDrug: Placebo: Placebo'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.9', 'spread': '7.2', 'groupId': 'BG000'}, {'value': '32.2', 'spread': '6.2', 'groupId': 'BG001'}, {'value': '35.3', 'spread': '10.4', 'groupId': 'BG002'}, {'value': '33.5', 'spread': '7.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-09', 'size': 4637268, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-01-13T16:10', 'hasProtocol': True}, {'date': '2019-04-03', 'size': 733252, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-01-13T16:11', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-11', 'studyFirstSubmitDate': '2018-11-13', 'resultsFirstSubmitDate': '2020-01-30', 'studyFirstSubmitQcDate': '2018-11-19', 'lastUpdatePostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-11', 'studyFirstPostDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With of Adverse Events', 'timeFrame': '21 Days'}], 'secondaryOutcomes': [{'measure': 'Evaluation of Systemic Exposure of DPPC: Observed DPPC Serum Concentration (µg/mL) by Nominal Timepoint', 'timeFrame': 'Day 1 and Day 14', 'description': 'This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day'}, {'measure': 'Evaluation of Systemic Exposure of CP: Observed CP Serum Concentrations (µM) by Nominal Timepoint', 'timeFrame': 'Day 1 and Day 14', 'description': 'This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day'}, {'measure': 'Evaluation of Systemic Exposure of DPPC: Baseline-corrected DPPC Serum Concentration (µg/mL) by Nominal Timepoint', 'timeFrame': 'Day 1 and Day 14', 'description': 'This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day'}, {'measure': 'Evaluation of Systemic Exposure of CP: Baseline-corrected CP Serum Concentrations (µM) by Nominal Timepoint', 'timeFrame': 'Day 1 and Day 14', 'description': 'This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Adult Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novustherapeutics.com/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and tolerability of two dose levels of OP0201 and placebo, when administered intranasally in healthy adults subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria includes but is not limited to:\n\n1. Body mass index of 18 to 30 kg/m2 (inclusive) and a minimum body weight of 50 kg at Screening.\n2. Able and willing to follow study instructions (including compliance with daily study treatment administration) and likely to complete all required study visits as assessed by the Investigator's judgement.\n3. Female subjects must agree to use an acceptable method of contraception (for pregnancy considerations and contraceptive requirements).\n4. Female subjects who are of childbearing potential must have a negative urine pregnancy test result at Screening and Day -1 prior to randomization.\n5. Male subjects must agree to use contraception\n6. Subjects must agree to refrain from immersing their head fully under water (eg, swimming, diving) from the time of signed informed consent until after the study exit visit.\n7. Physiologic tympanogram classified as Type A (normal) by the Investigator or designee.\n\nExclusion Criteria includes but is not limited to:\n\n1. History or presence of significant medical condition or a clinically significant abnormal finding, as determined by the Investigator.\n2. Presence of a clinically significant abnormal olfactory test finding at Screening defined as a total UPSIT score \\<35 (for females) and \\<34 (for males).\n3. Clinically significant ear disorder/disease currently or within 6 weeks prior to Screening.\n4. History of tympanostomy tubes in one or both ears within 1 year prior to Screening.\n5. Upper respiratory tract infection or pharyngitis currently or within 6 weeks prior to Screening.\n6. Allergy or sinus conditions (eg, sinusitis, non-specific nasal inflammation) currently or within 6 weeks prior to Screening.\n7. Clinically relevant blockage of one or both nasal passages, in the Investigator's opinion.\n8. Gastroesophageal reflux disease currently or within 6 weeks prior to Screening."}, 'identificationModule': {'nctId': 'NCT03748758', 'briefTitle': 'Evaluation of Safety of Repeated Doses of OP0201 Metered Dose Inhaler Compared to Placebo in Healthy Adult Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novus Therapeutics, Inc'}, 'officialTitle': 'Evaluation of Safety of Repeated Doses of OP0201 Metered Dose Inhaler Compared to Placebo in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'OP0201-C-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Drug: OP0201 (30 mg)', 'description': 'Cohort A- 30 mg per day X 14 days', 'interventionNames': ['Combination Product: Drug: OP0201']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Drug: Placebo', 'description': 'Cohort A- 0 mg per day X 14 days Cohort B- 0 mg per day X 14 days', 'interventionNames': ['Combination Product: Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Drug: OP0201 (60 mg)', 'description': 'Cohort B-60 mg per day X 14 days', 'interventionNames': ['Combination Product: Drug: OP0201']}], 'interventions': [{'name': 'Drug: OP0201', 'type': 'COMBINATION_PRODUCT', 'description': 'Drug OP0201', 'armGroupLabels': ['Drug: OP0201 (30 mg)', 'Drug: OP0201 (60 mg)']}, {'name': 'Drug: Placebo', 'type': 'COMBINATION_PRODUCT', 'description': 'Placebo', 'armGroupLabels': ['Drug: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66212', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Vince and Associates', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novus Therapeutics, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}