Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2025-12-26 @ 3:06 AM
Study NCT ID:
NCT06722820
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-09
First Post:
2024-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate LPH-5 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2024-11-19', 'studyFirstSubmitQcDate': '2024-12-03', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of adverse events (AEs)', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'Incidence of abnormal clinical laboratory findings in 12-lead ECG parameters, vital signs, and physical examination', 'timeFrame': 'Through study completion, an average of 1 year'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics parameters - Cmax', 'timeFrame': 'Time Frame: 0-48 hours', 'description': 'Plasma PK concentrations including but not limited to: maximum plasma concentration (Cmax) (ng/ml)'}, {'measure': 'Pharmacokinetics parameters - tmax', 'timeFrame': 'Time Frame: 0-48 hours', 'description': 'Plasma PK concentrations including but not limited to: time to reach Cmax (tmax) (minutes)'}, {'measure': 'Pharmacokinetics parameters - AUC0-t', 'timeFrame': 'Time Frame: 0-48 hours', 'description': 'Plasma PK concentrations including but not limited to: area under the plasma concentration-time curve (AUC) from zero to the last quantifiable concentration (AUC0-t) (ng/ml x hours)'}, {'measure': 'Pharmacokinetics parameters - AUC0-∞', 'timeFrame': 'Time Frame: 0-48 hours', 'description': 'Plasma PK concentrations including but not limited to: AUC from zero to infinity (AUC0-∞)(ng/ml x hours)'}, {'measure': 'Pharmacokinetics parameters - AUC0-24h', 'timeFrame': 'Time Frame: 0-48 hours', 'description': 'Plasma PK concentrations including but not limited to: AUC from zero to 24 hours (AUC0-24h) (ng/ml x hours)'}, {'measure': 'Pharmacokinetics parameters - AUC0-48h', 'timeFrame': 'Time Frame: 0-48 hours', 'description': 'Plasma PK concentrations including but not limited to: AUC from zero to 48 hours (AUC0-48h) (ng/ml x hours)'}, {'measure': 'Pharmacokinetics parameters - half life', 'timeFrame': 'Time Frame: 0-48 hours', 'description': 'Plasma PK concentrations including but not limited to: half life (t1/2) (hours)'}, {'measure': 'Pharmacodynamic parameter - assessing the mood and subjective effects of single ascending doses of LPH-5 in healthy participants in questionnaires', 'timeFrame': 'Time Frame: 0-48 hours'}, {'measure': 'Pharmacodynamic parameter - Pharmaco-EEG (qEEG)', 'timeFrame': 'Time Frame: 0-48 hours', 'description': 'Power spectral analysis of absolute and/or relative amplitude in the various frequency bands.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Safety Issues', 'Tolerance']}, 'descriptionModule': {'briefSummary': 'This study will explore the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of LPH-5.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy as determined by a responsible physician, based on medical evaluation including medical history, physical examination, concomitant medication, vital signs, 12-lead ECG, and clinical laboratory evaluations.\n\nExclusion Criteria:\n\n* Any condition or disease detected during the medical interview/physical examination that could relapse during or immediately after the study, or would render the participant unsuitable for the study, place the participant at undue risk, or interfere with the ability of the participant to complete the clinical study, as determined by the Investigator.\n* Have a history of and/or current clinically significant determined by the Investigator\n* Consumes cannabis or cannabis-derived compounds more than 3 times per month or has substantial changes in cannabis consumption in the 21 days prior to screening.'}, 'identificationModule': {'nctId': 'NCT06722820', 'briefTitle': 'Study to Evaluate LPH-5 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lophora'}, 'officialTitle': 'Phase I, First-in-man, Randomised, Placebo-controlled, Single Dose Escalation Study to Investigate the Effects of LPH-5 on Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Parameters in Healthy Participants', 'orgStudyIdInfo': {'id': 'LPH-5CS01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'LPH-5\\_dose 1, single dose', 'interventionNames': ['Drug: LPH-5', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'LPH-5\\_dose 2, single dose', 'interventionNames': ['Drug: LPH-5', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': 'LPH-5\\_dose 3, single dose', 'interventionNames': ['Drug: LPH-5', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4', 'description': 'LPH-5\\_dose 4, single dose', 'interventionNames': ['Drug: LPH-5', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 5', 'description': 'LPH-5\\_dose 5, single dose', 'interventionNames': ['Drug: LPH-5', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 6', 'description': 'LPH-5\\_dose 6, single dose', 'interventionNames': ['Drug: LPH-5', 'Drug: Placebo']}], 'interventions': [{'name': 'LPH-5', 'type': 'DRUG', 'description': 'LPH-5', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4', 'Cohort 5', 'Cohort 6']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4', 'Cohort 5', 'Cohort 6']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mikael Thomsen, PhD', 'role': 'CONTACT', 'email': 'mik.thomsen@gmail.com', 'phone': '23276134'}, {'name': 'Jesper Kristensen, PhD', 'role': 'CONTACT', 'email': 'jk@lophora.com', 'phone': '25709521'}], 'overallOfficials': [{'name': 'Sophie Hays, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Biotrial'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lophora', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Biotrial', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}