Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-01-06 @ 7:45 AM
Study NCT ID:
NCT06721494
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-22
First Post:
2024-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single-Dose Study to Evaluate Safety and Efficacy of CS-1103 in Participants Receiving a Single Dose of Methamphetamine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008694', 'term': 'Methamphetamine'}], 'ancestors': [{'id': 'D000662', 'term': 'Amphetamines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-09-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2024-12-03', 'studyFirstSubmitQcDate': '2024-12-03', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-04', '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 and magnitude of urine excretion of methamphetamine', 'timeFrame': '48 hours', 'description': 'Measurement of concentration of methamphetamine in urine'}], 'secondaryOutcomes': [{'measure': 'Time course of CS-1103 blood and urine concentrations', 'timeFrame': '48 hours', 'description': 'Measurement of plasma and urine concentrations of CS-1103'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Methamphetamine Intoxication', 'Methamphetamine Disorders', 'Methamphetamine Abuse']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the safety, efficacy, and pharmacokinetics of four single, increasing doses of CS-1103, given by intravenous (IV) infusion in otherwise healthy, non-treatment seeking participants with methamphetamine use disorder in the presence of a clinically relevant dose of methamphetamine HCl (30 mg IV).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Major Inclusion Criteria:\n\n1. Healthy participants aged 18 to 55 years, inclusive;\n2. Meets DSM-5 criteria for methamphetamine use disorder;\n3. Not seeking treatment for methamphetamine use disorder;\n4. Primary route of methamphetamine self-administration must be intravenous or smoking;\n5. Able to abstain from methamphetamine without experiencing severe withdrawal;\n6. A body mass index between 18 to 30 kg/m2, inclusive and a minimum body weight of 50 kg;\n7. 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. Current moderate to severe use disorder for alcohol, cannabis, cocaine, opioids, or benzodiazepines;\n4. History of any clinically important disease or disorder which, in the opinion of the Investigator, may interfere with safe study participation.'}, 'identificationModule': {'nctId': 'NCT06721494', 'briefTitle': 'A Single-Dose Study to Evaluate Safety and Efficacy of CS-1103 in Participants Receiving a Single Dose of Methamphetamine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Clear Scientific, Inc.'}, 'officialTitle': 'A Phase 2 Single-Dose Study to Evaluate Safety and Efficacy of CS-1103 in Participants With Methamphetamine Use Disorder Not Seeking Treatment Receiving a Single Dose of Methamphetamine', 'orgStudyIdInfo': {'id': 'CS-1103-02'}, 'secondaryIdInfos': [{'id': '5U01DA058548-02', 'link': 'https://reporter.nih.gov/quickSearch/5U01DA058548-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants receive methamphetamine HCl (30 mg) followed by placebo (saline).', 'interventionNames': ['Drug: Methamphetamine', 'Drug: Sterile Saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active', 'description': 'Participants receive methamphetamine HCl (30 mg) followed by one of four doses of CS-1103', 'interventionNames': ['Drug: Methamphetamine', 'Drug: CS-1103']}], 'interventions': [{'name': 'Methamphetamine', 'type': 'DRUG', 'description': 'Methamphetamine HCl 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'}}}}