A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)

NCT07663838 | Not Yet Recruiting Phase 1

• 1 other identifier: GenSci142-102
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 7

Brief Summary

A randomized, multicenter, open-label, active-controlled Phase Ib study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of multiple intravaginal doses of GenSci142 in patients with bacterial vaginosis (BV).

Conditions

Randomized; Open-label; Safety; Tolerability; Pharmacokinetics; Bacterial Vaginosis

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of treatment-emergent adverse events

  From the first dose to Day 30

Secondary Outcomes (12)

• Clinical cure rate base on Amsel assessment

  from first dose of study treatment up to 21~30 days after first dose

• Change of Nugent score from baseline

  from first dose of study treatment up to 2 days after first dose

• Microbiological cure rate base on Nugent score of <4

  from first dose of study treatment up to 21~30 days after first dose

• Clinical cure rate base on Amsel assessment

  from first dose of study treatment up to 8~14 days after first dose

• Microbiological cure rate base on Nugent score of <4

  from first dose of study treatment up to 8~14 days after first dose

Study Arms (2)

GenSci142 capsule

EXPERIMENTAL

Drug: GenSci142 capsule

clindamycin phosphate vaginal cream

ACTIVE COMPARATOR

Drug: clindamycin phosphate vaginal cream

Interventions

GenSci142 capsule DRUG

Vaginal administration

GenSci142 capsule

clindamycin phosphate vaginal cream DRUG

Clindamycin ointment, 5 grams, once daily for 7 days

clindamycin phosphate vaginal cream

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women of childbearing age aged 18-50 years (inclusive of the cut-off values, as of the date of signing the informed consent form), with a history of sexual activity and a regular menstrual cycle (21-35 days, inclusive of the cut-off values);
• Screening visits were conducted for women clinically diagnosed with bacterial vaginosis who had not received any treatment for bacterial vaginosis since the onset of their current symptoms. The clinical diagnostic criteria for bacterial vaginosis are as follows:
• At least one clinical symptom (itching, odour, abnormal vaginal discharge),
• and at least three positive findings on the Amsel clinical assessment (with clue cells constituting more than 20% of the total vaginal epithelial cells being a mandatory criterion),
• and a Nugent score of ≥7;
• Trial participants must agree to abstain from sexual intercourse for 48 hours prior to the first administration of the investigational medicinal product, throughout the treatment period, and for 48 hours prior to each return visit;
• be willing to use vaginal administration and agree to avoid the use of any vaginal products not specified in the trial protocol (such as contraceptive creams, gels, foams, sponges, lubricants, douches, tampons, etc.) throughout the trial period;
• Trial participants must voluntarily sign a written informed consent form prior to the trial;
• Trial participants must be able to understand the procedures and methods of this trial and be willing to strictly adhere to the clinical trial protocol to complete the trial.

You may not qualify if:

• Medical History
• Those currently suffering from any acute infection of the urinary or reproductive system, including but not limited to pelvic inflammatory disease, cervicitis, endometritis, and adnexitis;
• Those currently suffering from vulvovaginitis caused by other pathogens, including but not limited to Aerobic vaginitis, vulvovaginal candidiasis, trichomoniasis, gonorrhoea, genital herpes, and genital warts;
• Current presence of other vaginal or vulvar conditions, or being in the recovery phase following reproductive system surgery, where the investigator considers this to affect the trial evaluation;
• Patients currently receiving, or who will require during the trial, medications that reduce or antagonise oestrogen levels, such as gonadotropin-releasing hormoneagonists, high-potency progestogens and combined oral contraceptives;
• Women who are pregnant, breastfeeding, or have tested positive for pregnancy; or those planning to become pregnant during the trial; or those unable to use reliable contraception during the study;
• Individuals with impaired immunity or immune dysfunction, including but not limited to those currently undergoing treatment for malignant tumours, those with autoimmune diseases, or those currently using immunosuppressants;
• Participants with abnormal uterine bleeding, including prolonged menstrual periods (\>7 days);
• Those who are menstruating at the time of the screening visit or who are expected to commence menstruation within 14 days;
• Participants who have received treatment with inhalational anaesthetics, antispasmodic anti-diarrhoeal agents, kaolin-containing anti-diarrhoeal agents, muscle relaxants, chloramphenicol or erythromycin, or opioid analgesics within 7 days prior to screening;
• Participants who had received treatment with topical or systemic broad-spectrum antibiotics (excluding nitroimidazole antibiotics that do not affect Lactobacillus) within 1 month prior to screening;
• Those who have undergone vaginal douching or other vaginal procedures involving antiseptic treatment within 1 month prior to screening;
• A history of severe allergy to the investigational medicinal product, any of its excipients, or vaginal effervescent preparations; or a predisposition to allergies (e.g. allergy to two or more medicines or foods); Diet and lifestyle
• Those with an average daily cigarette consumption of ≥5 cigarettes in the 30 days prior to screening;
• Those who have consumed more than 5 litres of beer, 600 ml of spirits with an alcohol content of 40%, or 2 litres of wine per week within the 6 months prior to screening; History of substance abuse or dependence

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (7)

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 102218, China

Location

Nanjing Maternity and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Location

Jiangxi Provincial Women and Children's Medical Center

Nanchang, Jiangxi, 330006, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Shandong Provincial Hospital

Jinan, Shandong, 250001, China

Location

The Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Liao Qinping

CONTACT

+86 13701124527; 13701124527@163.com

Zhang Lei

CONTACT

+86 18601130459; 18601130459@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 23, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): January 5, 2027
• Study Completion (Estimated): May 5, 2027
• Last Updated: June 23, 2026

Record last verified: 2026-06

Locations

CN (7)