Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2025-12-30 @ 12:03 PM
Study NCT ID:
NCT06912295
Status:
RECRUITING
Last Update Posted:
2025-08-24
First Post:
2025-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assess the Safety, Tolerability, and Pharmacokinetics of HL-1186 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2025-03-24', 'studyFirstSubmitQcDate': '2025-03-30', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the safety and tolerability of single and multiple doses of HL-1186 in healthy participants', 'timeFrame': 'Single ascending dose(SAD): day1 to day14; Food effect(FE): day1 to day21; Multiple ascending dose(MAD): day1 to day27', 'description': 'Number of participants with adverse events, with abnormal physical examination finding, with abnormal vital signs, abnormal 12-lead electrocardiograms and abnormal laboratory tests results (hematology, urinalysis, clinical chemistry, coagulation function'}], 'secondaryOutcomes': [{'measure': 'To assess the pharmacokinetic parameters of HL-1186 in healthy participants', 'timeFrame': 'Single ascending dose(SAD): day1 to day7; Food effect(FE): day1 to day14; Multiple ascending dose(MAD): day1 to day20', 'description': 'Time to reach maximum concentration (Tmax)'}, {'measure': 'To assess the pharmacokinetic parameters of HL-1186 in healthy participants', 'timeFrame': 'Single ascending dose(SAD): day1 to day7; Food effect(FE): day1 to day14; Multiple ascending dose(MAD): day1 to day20', 'description': 'Maximum concentration (Cmax)'}, {'measure': 'To assess the pharmacokinetic parameters of HL-1186 in healthy participants', 'timeFrame': 'Single ascending dose(SAD): day1 to day7; Food effect(FE): day1 to day14; Multiple ascending dose(MAD): day1 to day20', 'description': 'Area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration (AUC0-t)'}, {'measure': 'To assess the pharmacokinetic parameters of HL-1186 in healthy participants', 'timeFrame': 'Single ascending dose(SAD): day1 to day7; Food effect(FE): day1 to day14; Multiple ascending dose(MAD): day1 to day20', 'description': 'Elimination half time (T1/2)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Participants']}, 'descriptionModule': {'briefSummary': 'This single-center, randomized, double-blind, placebo-controlled, two-part study is designed to assess the safety, tolerability and PK of oral HL-1186 Tablet in healthy participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy participants, males and females.\n2. Between the ages of 18 and 45 years old (inclusive).\n3. Weighs no less than 50 kg (for males) or 45 kg (for females) and body mass index (BMI) within 19.0 to 26.0 kg/m2 (inclusive).\n4. During the screening period, vital signs, physical examination, blood routine, blood biochemistry, coagulation function, urine routine, virology examination, chest X-ray, and pregnancy blood test (female) were examined, and the results did not show abnormalities or abnormalities without clinical significance.\n\nExclusion Criteria:\n\n1. Females who are pregnant or breastfeeding; females/males who are prepared for having children.\n2. History or presence of neurological, cardiovascular, renal, hepatic, gastrointestinal, respiratory, hematological, endocrine, or osteoarticular disorders, or any laboratory abnormalities that pose a potential danger to constitute a risk when taking the study intervention or interfere with the interpretation of data.\n3. Active infectious diseases which need anti-infection treatment.\n4. Significant surgery within three months and not fully recovered per investigator's judgments.\n5. Significant allergies per investigator's judgments, e.g., food allergies, allergies, or atopic reactions to any components of the investigational drug or placebo, asthma attacks, etc.\n6. Immunosuppressive diseases, e.g., immunodeficiency, etc."}, 'identificationModule': {'nctId': 'NCT06912295', 'briefTitle': 'Assess the Safety, Tolerability, and Pharmacokinetics of HL-1186 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Huilun Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of HL-1186 in Healthy Participants', 'orgStudyIdInfo': {'id': 'PY-HL-1186-I-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HL-1186', 'description': 'Single dose ascending(SAD): participants will be randomized to receive a single dose of HL-1186 or placebo,dose ascending will be conducted sequentially from the low-dose cohort to the high-dose cohort Food effect(FE): participants will be randomized to group A or group B, to evaluate different fed conditions on the PK of HL-1186 Multiple ascending dose(MAD): participants will be randomized to receive Muliple doses of HL-1186 or placebo, dose ascending will be conducted sequentially from the low-dose cohort to the high-dose cohort', 'interventionNames': ['Drug: HL-1186']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'HL-1186 placebo', 'description': 'Single dose ascending(SAD): participants will be randomized to receive a single dose of HL-1186 or placebo,dose ascending will be conducted sequentially from the low-dose cohort to the high-dose cohort Food effect(FE): participants will be randomized to group A or group B, to evaluate different fed conditions on the PK of HL-1186 Multiple ascending dose(MAD): participants will be randomized to receive Muliple doses of HL-1186 or placebo, dose ascending will be conducted sequentially from the low-dose cohort to the high-dose cohort', 'interventionNames': ['Drug: HL-1186 placebo']}], 'interventions': [{'name': 'HL-1186', 'type': 'DRUG', 'description': 'HL-1186 tablet for oral administration.', 'armGroupLabels': ['HL-1186']}, {'name': 'HL-1186 placebo', 'type': 'DRUG', 'description': 'HL-1186 placebo tablet for oral administration.', 'armGroupLabels': ['HL-1186 placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wuxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiangnan University Affiliated Hospital', 'role': 'CONTACT', 'email': '13358100007@126.com', 'phone': '13358100007'}], 'facility': 'Jiangnan University Affiliated Hospital', 'geoPoint': {'lat': 31.56887, 'lon': 120.28857}}], 'centralContacts': [{'name': 'Kangli Ma', 'role': 'CONTACT', 'email': 'clinical_trial@hllife.com.cn', 'phone': '021-64311017'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}