Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2026-01-27 @ 3:22 AM
Study NCT ID:
NCT06530966
Status:
RECRUITING
Last Update Posted:
2024-08-02
First Post:
2024-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Study of ICP-332 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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-12-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-31', 'studyFirstSubmitDate': '2024-07-28', 'studyFirstSubmitQcDate': '2024-07-28', 'lastUpdatePostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Adverse Events (AEs)', 'timeFrame': 'Up to Day 28'}, {'measure': 'Number of Participants With Clinically Significant Change in Vital Signs', 'timeFrame': 'Up to Day 28'}, {'measure': 'Number of Participants With Clinically Significant Change in Electrocardiogram (ECG)', 'timeFrame': 'Up to Day 28'}, {'measure': 'Number of Participants With Clinically Significant Change in Physical Examination', 'timeFrame': 'Up to Day 28'}, {'measure': 'Number of Participants With Clinically Significant Change in Clinical Laboratory Values', 'timeFrame': 'Up to Day 28'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'A multiple ascending dose phase I study of ICP-332 in healthy subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form\n2. Body mass index (BMI) of ≥ 18.5 kg/m2 and \\< 30 kg/m2\n3. Male or infertile female subjects who are between 18-55 years old (inclusive)\n\nExclusion Criteria:\n\n1. Significant current or past acute or chronic disease or condition.\n2. A history of tuberculosis or current active/latent infection.\n3. With a history of drug or food allergy, or allergy to any of the composition components of the study drug, or allergic disease.\n4. Subjects with clinically significant abnormalities in the screening examinations.'}, 'identificationModule': {'nctId': 'NCT06530966', 'briefTitle': 'Phase I Study of ICP-332 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'InnoCare Pharma Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-332 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'ICP-CL-00605'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ICP-332', 'interventionNames': ['Drug: ICP-332 Tablets']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: ICP-332 Placebo Tablets']}], 'interventions': [{'name': 'ICP-332 Tablets', 'type': 'DRUG', 'description': 'Eligible patients will receive ICP-332 tablets orally as per the protocol', 'armGroupLabels': ['ICP-332']}, {'name': 'ICP-332 Placebo Tablets', 'type': 'DRUG', 'description': 'Eligible patients will receive ICP-332 placebo tablets orally as per the protocol', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kristin Satterfield, MD, PhD', 'role': 'CONTACT', 'email': 'kristin.satterfield@pharmaron.com', 'phone': '240-673-0500', 'phoneExt': '1734'}], 'facility': 'Pharmaron CPC Inc.', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'centralContacts': [{'name': 'Alexia Lu', 'role': 'CONTACT', 'email': 'CO_HGRAC@innocarepharma.com', 'phone': '010-66609745'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InnoCare Pharma Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}