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Not yet recruiting NCT07302035

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

Phase I Interventional Bacterial Vaginosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GenSci142, Placebo GenSci142.
Who it may be relevant to
Registry conditions: Bacterial Vaginosis. Basic parameters: 18 years — 55 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug GenSci142
    Vaginal insert
  • Drug Placebo GenSci142
    Vaginal insert

Primary outcome measures

  • Percentage of participants with adverse events (AEs) with onset after dose and until 15 days post-dose [Time frame: from first dose of study treatment up to 15 days post-dose]
Secondary outcome measures (9)
  • Serum concentration of GenSci142 (ng/mL) [Time frame: Day1-Day3]
  • Maximum serum concentration (Cmax, ng/mL) [Time frame: Day1-Day3]
  • Time to maximum serum concentration (Tmax, h) [Time frame: Day1-Day3]
  • Area under the concentration-time curve from the time zero to last measurable concentration (AUC0-t, h*ng/mL) [Time frame: Day1-Day3]
  • Area under concentration-time from time zero to infinity (AUC0-inf, h*ng/mL) [Time frame: Day1-Day3]
  • Terminal half-life (t1/2, h) [Time frame: Day1-Day3]
  • Apparent clearance (CL/F, mL/h) [Time frame: Day1-Day3]
  • Apparent volume of distribution (Vd/F, mL) [Time frame: Day1-Day3]
  • Anti-drug antibody (ADA) prevalence (%) or change of binding titers against GenSci142 in blood before administration and at the follow-up visit [Time frame: Day1-Day15]

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Huashan Hospital Fudan University — Shanghai

Identifiers

NCT: NCT07302035 · GenSci142-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗