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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bacterial Vaginosis
• Intervention / Treatment: Drug: GenSci142; Drug: Placebo GenSci142

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Wei WANG; Phone Number: +86 18201085833; Email: wangwei13@genscigroup.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200040
      • Huashan Hospital Fudan University
      • Contact: Jing ZHANG, Doctor; Phone Number: +86 02152887926; Email: Zhangj_fudan@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GenSci142; Single ascending dose levels，All subjects administered Single dose，Dose 1, Dose 2, Dose 3	Drug: GenSci142; Vaginal insert
Placebo Comparator: Placebo; All subjects administered Single dose	Drug: Placebo GenSci142; Vaginal insert

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum concentration of GenSci142 (ng/mL)	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.	Day1-Day3
Maximum serum concentration (Cmax, ng/mL)	PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above.	Day1-Day3
Time to maximum serum concentration (Tmax, h)	PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above.	Day1-Day3
Area under the concentration-time curve from the time zero to last measurable concentration (AUC0-t, h*ng/mL)	PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above.	Day1-Day3
Area under concentration-time from time zero to infinity (AUC0-inf, h*ng/mL)	PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above.	Day1-Day3
Terminal half-life (t1/2, h)	PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above.	Day1-Day3
Apparent clearance (CL/F, mL/h)	PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above.	Day1-Day3
Apparent volume of distribution (Vd/F, mL)	PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above.	Day1-Day3
Anti-drug antibody (ADA) prevalence (%) or change of binding titers against GenSci142 in blood before administration and at the follow-up visit	For each dose level.	Day1-Day15

Collaborators and Investigators

• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
• Collaborators: Huashan Hospital
• Investigators: Study Chair: Jing ZHANG, Doctor, Huashan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 27, 2025
• First Submitted That Met QC Criteria: December 10, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Bacterial Infections; Vaginitis; Female Urogenital Diseases; Genital Diseases, Female; Gardnerella vaginalis; Vaginal Diseases; Gardnerella spp.; GenSci142
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Bacterial Infections and Mycoses; Vaginosis, Bacterial; Vaginal Diseases; Bacterial Infections; Genital Diseases, Female; Female Urogenital Diseases; Vaginitis
• Other Study ID Numbers: GenSci142-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No