Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 8:51 PM
Study NCT ID:
NCT07459166
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009270', 'term': 'Naloxone'}, {'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-04', 'studyFirstSubmitDate': '2026-03-04', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with CS-1103-related adverse events (AEs) assessed by physical examinations', 'timeFrame': '3 days plus follow-up on Day 10', 'description': 'Physical examinations'}, {'measure': 'Number of participants with CS-1103-related adverse events (AEs) assessed by electrocardiograms (ECGs)', 'timeFrame': '3 days plus follow-up on Day 10', 'description': 'Digital 12-lead electrocardiograms (ECGs). Any correlation between CS-1103 plasma concentrations and changes in QT intervals will be noted'}, {'measure': 'Number of participants with CS-1103-related adverse events (AEs) assessed by vital signs', 'timeFrame': '3 days plus follow-up on Day 10', 'description': 'Blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature'}, {'measure': 'Number of participants with CS-1103-related adverse events (AEs) assessed by laboratory parameters', 'timeFrame': '3 days plus follow-up on Day 10', 'description': 'Clinical chemistry, hematology, coagulation, and urinalysis'}, {'measure': 'Time course of CS-1103 blood and urine concentrations', 'timeFrame': '48 hours', 'description': 'Measurement of plasma and urine concentrations of CS-1103'}, {'measure': 'Time course and magnitude of urine excretion of fentanyl', 'timeFrame': '48 hours', 'description': 'Measurement of concentration of fentanyl in urine'}], 'secondaryOutcomes': [{'measure': 'Effect of CS-1103 and fentanyl on QT interval', 'timeFrame': '48 hours', 'description': 'Concentration-QT correlation performed on baseline-corrected QTcF time-matched with PK for fentanyl and CS-1103 in plasma'}, {'measure': 'Effect of CS-1103 on the naloxone plasma and urine PK, if any', 'timeFrame': '48 hours', 'description': 'Measurement of standard urine and plasma PK parameters between placebo and CS-1103 treated participants'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fentanyl Overdose', 'Fentanyl Poisoning']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CS-1103 (1,000 mg), given by intravenous (IV) infusion in healthy participants in the presence of a clinically relevant dose of fentanyl (200 μg, IV), with naloxone blockade (400 μg, IV).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Major Inclusion Criteria:\n\n1. Healthy participants aged 18 to 55 years, inclusive;\n2. Have prior experience with opioids, such as from a dental procedure, chronic pain management, or previous inpatient surgical procedure;\n3. A body mass index between 18.0 to 30.0 kg/m2, inclusive, and a minimum body weight of 56 kg;\n4. Females must not be lactating and must have a negative pregnancy test during screening and admission.\n\nMajor Exclusion Criteria:\n\n1. Estimated glomerular filtration rate \\<60 mL/min/1.73 m2;\n2. History of cardiovascular disease;\n3. History of any clinically important disease or disorder which, in the opinion of the Investigator, may interfere with safe study participation.'}, 'identificationModule': {'nctId': 'NCT07459166', 'briefTitle': 'A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade', 'organization': {'class': 'INDUSTRY', 'fullName': 'Clear Scientific, Inc.'}, 'officialTitle': 'A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of a Single Dose of Intravenous CS 1103 Following a Single Intravenous Dose of Fentanyl in Healthy Subjects With Naloxone Blockade', 'orgStudyIdInfo': {'id': 'CS-1103-03'}, 'secondaryIdInfos': [{'id': '5UG3DA059286', 'link': 'https://reporter.nih.gov/quickSearch/5UG3DA059286', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants receive naloxone blockade (400 μg, IV), followed by fentanyl (200 μg, IV), followed by placebo (saline).', 'interventionNames': ['Drug: Naloxone Hydrochloride', 'Drug: Fentanyl', 'Drug: Sterile Saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active', 'description': 'Participants receive naloxone blockade (400 μg, IV), followed by fentanyl (200 μg, IV), followed by CS-1103 (1,000 mg, IV).', 'interventionNames': ['Drug: Naloxone Hydrochloride', 'Drug: Fentanyl', 'Drug: CS-1103']}], 'interventions': [{'name': 'Naloxone Hydrochloride', 'type': 'DRUG', 'description': 'Naloxone for intravenous administration', 'armGroupLabels': ['Active', 'Placebo']}, {'name': 'Fentanyl', 'type': 'DRUG', 'description': 'Fentanyl for intravenous administration', 'armGroupLabels': ['Active', 'Placebo']}, {'name': 'Sterile Saline', 'type': 'DRUG', 'description': 'Sterile Saline for intravenous administration', 'armGroupLabels': ['Placebo']}, {'name': 'CS-1103', 'type': 'DRUG', 'description': 'CS-1103 for intravenous administration', 'armGroupLabels': ['Active']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Lev Gertsik, M.D.', 'role': 'CONTACT', 'email': 'study.losangeles@parexel.com', 'phone': '888-228-7425'}], 'facility': 'California Clinical Trials Medical Group', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}], 'centralContacts': [{'name': 'Anna Del Rosario, B.S.', 'role': 'CONTACT', 'email': 'adelrosario@clearsci.com', 'phone': '617-621-8500'}, {'name': 'Piercen Oliver, Ph.D.', 'role': 'CONTACT', 'email': 'poliver@clearsci.com', 'phone': '617-621-8500'}], 'overallOfficials': [{'name': 'Xinhua Li, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clear Scientific, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clear Scientific, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}