A First-in-Human Safety and Pharmacokinetic Trial of GenSci142 Administered as Single Ascending Doses in Healthy Chinese Women

NCT ID: NCT07302035

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Bacterial Vaginosis

Keywords

Bacterial Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Gardnerella spp.; Gardnerella vaginalis; GenSci142

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

GenSci142

Single ascending dose levels，All subjects administered Single dose，Dose 1, Dose 2, Dose 3

Group Type: EXPERIMENTAL

GenSci142

Intervention Type: DRUG

Vaginal insert

Placebo

All subjects administered Single dose

Group Type: PLACEBO_COMPARATOR

Placebo GenSci142

Intervention Type: DRUG

Vaginal insert

Interventions

GenSci142

Vaginal insert

Intervention Type: DRUG

Placebo GenSci142

Vaginal insert

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy women of childbearing potential aged 18-55 years (inclusive) at the time of signing the Informed Consent Form (ICF);
• 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;
• 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;

Exclusion Criteria

• 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;
• 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;
• 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Huashan Hospital

OTHER

Sponsor Role: collaborator

Changchun GeneScience Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jing ZHANG, Doctor

Role: STUDY_CHAIR

Huashan Hospital

Locations

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Wei WANG

Role: CONTACT

Phone: +86 18201085833

Email: wangwei13@genscigroup.com

Facility Contacts

Jing ZHANG, Doctor

Role: primary

Other Identifiers

GenSci142-101

Identifier Type: -

Identifier Source: org_study_id