Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-25 @ 7:39 PM
Study NCT ID:
NCT07302035
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A First-in-Human Safety and Pharmacokinetic Trial of GenSci142 Administered as Single Ascending Doses in Healthy Chinese Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016585', 'term': 'Vaginosis, Bacterial'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D014627', 'term': 'Vaginitis'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-11-27', 'studyFirstSubmitQcDate': '2025-12-10', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants with adverse events (AEs) with onset after dose and until 15 days post-dose', 'timeFrame': 'from first dose of study treatment up to 15 days post-dose', 'description': 'In participants who have received at least one dose of GenSci142 or placebo. For each dose level cohort of GenSci142 and for the placebo group.'}], 'secondaryOutcomes': [{'measure': 'Serum concentration of GenSci142 (ng/mL)', 'timeFrame': 'Day1-Day3', 'description': 'Concentrations of GenSci142 in serum samples at different time points are measured. Serum concentrations at different time points will be listed and summarized by descriptive statistics.'}, {'measure': 'Maximum serum concentration (Cmax, ng/mL)', 'timeFrame': 'Day1-Day3', 'description': 'PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above.'}, {'measure': 'Time to maximum serum concentration (Tmax, h)', 'timeFrame': 'Day1-Day3', 'description': 'PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above.'}, {'measure': 'Area under the concentration-time curve from the time zero to last measurable concentration (AUC0-t, h*ng/mL)', 'timeFrame': 'Day1-Day3', 'description': 'PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above.'}, {'measure': 'Area under concentration-time from time zero to infinity (AUC0-inf, h*ng/mL)', 'timeFrame': 'Day1-Day3', 'description': 'PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above.'}, {'measure': 'Terminal half-life (t1/2, h)', 'timeFrame': 'Day1-Day3', 'description': 'PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above.'}, {'measure': 'Apparent clearance (CL/F, mL/h)', 'timeFrame': 'Day1-Day3', 'description': 'PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above.'}, {'measure': 'Apparent volume of distribution (Vd/F, mL)', 'timeFrame': 'Day1-Day3', 'description': 'PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above.'}, {'measure': 'Anti-drug antibody (ADA) prevalence (%) or change of binding titers against GenSci142 in blood before administration and at the follow-up visit', 'timeFrame': 'Day1-Day15', 'description': 'For each dose level.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bacterial Infections', 'Vaginitis', 'Vaginal Diseases', 'Genital Diseases, Female', 'Female Urogenital Diseases', 'Gardnerella spp.', 'Gardnerella vaginalis', 'GenSci142'], 'conditions': ['Bacterial Vaginosis']}, 'descriptionModule': {'briefSummary': 'This is a Phase Ia single-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, Pharmacokinetic of GenSci142 in Chinese healthy women.', 'detailedDescription': 'This is a Phase 1a trial including single ascending dose levels and will assess the safety and tolerability of GenSci142 and describe the incidence of adverse events (AEs) for participants randomized at a ratio of 4:1 to GenSci142 or placebo within each cohort. Participants will receive one single dose of study treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy women of childbearing potential aged 18-55 years (inclusive) at the time of signing the Informed Consent Form (ICF);\n* Sexually active and willing to undergo vaginal administration of the study product；participants must agree to avoid the use of other intravaginal products (e.g., contraception ointments, gels, foams, sponges, lubricants, irrigation solutions, tampons, etc.) throughout the trial;\n* During the screening period, there are no clinically significant abnormalities in medical history, vital signs, physical examination, gynecological examination, laboratory test (hematology, routine urinalysis, clinical chemistry, coagulation function, vaginal microbiome test) and 12-lead ECG, or any out-of-range laboratory values or other findings must be assessed by the investigator as not clinically significant;\n\nExclusion Criteria:\n\n* Those experiencing stinging or burning sensation, hemorrhage, pruritus, erythema, edema, or increased discharge due to previous or current use of vaginal preparations, or those with any factors that possibly have an impact on evaluation of administration site irritation, or those with other factors that may have an impact on vaginal administration, such as genital malformation;\n* Serious infections, chronic infections, opportunistic infections, etc. within 3 months prior to screening, and infections treated with systemic antimicrobial drugs (including but not limited to viruses, bacteria, fungi, and parasitic infections) within 4 weeks prior to randomization;\n* Surgical history: a. vaginal, pelvic or cervical surgery within 90 days prior to screening or planning to undergo surgery during the study; b. hysterectomy; c. other major surgery within 30 days prior to screening or planning to undergo other surgeries during the study;'}, 'identificationModule': {'nctId': 'NCT07302035', 'briefTitle': 'A First-in-Human Safety and Pharmacokinetic Trial of GenSci142 Administered as Single Ascending Doses in Healthy Chinese Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Changchun GeneScience Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase Ia Single-Center, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetic Trial of GenSci142 Administered in Single Ascending Doses in Healthy Chinese Women', 'orgStudyIdInfo': {'id': 'GenSci142-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GenSci142', 'description': 'Single ascending dose levels，All subjects administered Single dose，Dose 1, Dose 2, Dose 3', 'interventionNames': ['Drug: GenSci142']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'All subjects administered Single dose', 'interventionNames': ['Drug: Placebo GenSci142']}], 'interventions': [{'name': 'GenSci142', 'type': 'DRUG', 'description': 'Vaginal insert', 'armGroupLabels': ['GenSci142']}, {'name': 'Placebo GenSci142', 'type': 'DRUG', 'description': 'Vaginal insert', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Jing ZHANG, Doctor', 'role': 'CONTACT', 'email': 'Zhangj_fudan@163.com', 'phone': '+86 02152887926'}], 'facility': 'Huashan Hospital Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Wei WANG', 'role': 'CONTACT', 'email': 'wangwei13@genscigroup.com', 'phone': '+86 18201085833'}], 'overallOfficials': [{'name': 'Jing ZHANG, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Huashan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changchun GeneScience Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Huashan Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}