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

NCT07302035 | Not Yet Recruiting Phase 1

• 1 other identifier: GenSci142-101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Vaginosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with adverse events (AEs) with onset after dose and until 15 days post-dose

  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.

  from first dose of study treatment up to 15 days post-dose

Secondary Outcomes (9)

• Serum concentration of GenSci142 (ng/mL)

  Day1-Day3

• Maximum serum concentration (Cmax, ng/mL)

  Day1-Day3

• Time to maximum serum concentration (Tmax, h)

  Day1-Day3

• Area under the concentration-time curve from the time zero to last measurable concentration (AUC0-t, h*ng/mL)

  Day1-Day3

• Area under concentration-time from time zero to infinity (AUC0-inf, h*ng/mL)

  Day1-Day3

Study Arms (2)

GenSci142

EXPERIMENTAL

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

Drug: GenSci142

Placebo

PLACEBO COMPARATOR

All subjects administered Single dose

Drug: Placebo GenSci142

Interventions

GenSci142 DRUG

Vaginal insert

GenSci142

Placebo GenSci142 DRUG

Vaginal insert

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead
• Huashan Hospital: collaborator

Study Sites (1)

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

Vaginosis, Bacterial; Bacterial Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Jing ZHANG, Doctor

  Huashan Hospital

  STUDY CHAIR

Central Study Contacts

Wei WANG

CONTACT

+86 18201085833; wangwei13@genscigroup.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 24, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

CN (1)