RandomizedPhase 1NCT07663838
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)
A Phase 1 study testing GenSci142 capsule and clindamycin phosphate vaginal cream in people with Randomized and Open-label, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 9 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Randomized, Open-label, Safety
- What is being tested?
- GenSci142 capsule and clindamycin phosphate vaginal cream
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 9 sitesChina
- Study dates
- 15 Aug 2026to 5 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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 (BV) who had not received any treatment for BV since the onset of their current symptoms. The clinical diagnostic criteria for BV are as follows:
- At least one clinical symptom (itching, odour, abnormal vaginal discharge),
- and at least three positive findings on the Amsel clinical assessment (positivity for clue cells is 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;
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- 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.
Who cannot join
- 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 VVC, trichomoniasis, genital herpes, and genital warts (CA), and only moderate-to-severe AV (AV score ≥5 by vaginal microecology assessment) is excluded;
- 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 hormone (GnRH) agonists, high-potency progestogens and combined oral contraceptives (COCs);
- Patients with a history of or currently suffering from major diseases such as cardiovascular, hepatic, renal, pulmonary, gastrointestinal, neurological, metabolic, urogenital, endocrine or psychiatric disorders, where the investigator considers inclusion inappropriate;
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- 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 (AUB) in whom malignancy cannot be ruled out, or who require a transvaginal surgical procedure within 90 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
- History of substance abuse within the past year (e.g. cannabis, benzodiazepines, ketamine, morphine, cocaine, methamphetamine); Screening examinations
- Participants with clinically significant abnormalities or vaginal mucosal lesions (e.g. mucosal oedema, congestion, ulcers, erosions) identified during the screening colposcopy, as judged by the investigator, which may affect drug administration;
- During the screening period, based on an assessment of medical history, vital signs, physical examination, clinical laboratory tests and ancillary investigations, the investigator considers the subject's general health status unsuitable for inclusion (see Section 10.2.2 for details regarding laboratory test exclusion criteria);
- Participants with positive results in infectious disease screening [Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV-Ab), Human Immunodeficiency Virus antibody (HIV-Ab), or positive syphilis serology]; Other
- Participants who have participated in other clinical trials of medicinal products or medical devices within the 3 months prior to screening and have used the investigational medicinal product or device; or who participated in a clinical study 3 months prior but are still within the follow-up period of that study or within 5 half-lives of the investigational medicinal product (whichever is longer) at the time of screening; The investigator considers that the trial participant has any other condition rendering them unsuitable for participation in the trial, or any other medical condition that may impair the participant's ability to tolerate the investigational medicinal product or to continue with the procedures specified in this study.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130021
- Recruiting
Affiliated Hangzhou First People's hospital
Hangzhou, Zhejiang, 310006
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong, 250001
- Recruiting
Jiangxi Provincial Women and Children's Medical Center
Nanchang, Jiangxi, 330006
- Recruiting
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, 210004
- Recruiting
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
- Recruiting
The first Affiliated hospital of Henan Medical University
Xinxiang, Henan, 453100
About this study
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).
Read the detailed description
This study aims to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of multiple intravaginal doses of GenSci142 in patients with bacterial vaginosis (BV) or BV combined mild aerobic vaginitis aged 18 to 50 years, providing a basis for subsequent clinical development. This is a randomized, multicenter, open-label, active-controlled clinical trial. A total of approximately 30 to 42 subjects are planned for enrollment and will be randomized in a 2:1 ratio to either the treatment group or the control group. Treatment group: GenSci142,.Control group: 2% clindamycin phosphate vaginal cream (referred to as clindamycin cream),.The study consists of a screening period (approximately 3 days), a treatment period (7 days), and a efficacy evaluation period (approximately 90 days), with a total of 7 scheduled visits.
- Conditions
- Randomized, Open-label, Safety, Tolerability, Pharmacokinetics, Bacterial Vaginosis
- Being tested
- GenSci142 capsule, clindamycin phosphate vaginal cream
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenSci142 capsuleDrug
Vaginal administration
clindamycin phosphate vaginal creamDrug
Clindamycin ointment, 5 grams, once daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| GenSci142 capsule | Experimental | Not described Receives: Drug: GenSci142 capsule |
| clindamycin phosphate vaginal cream | Active comparator | Not described Receives: Drug: clindamycin phosphate vaginal cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events
Measured: From the first dose to Day 30
Secondary outcomes (12)
Clinical cure rate base on Amsel assessment
Measured: from first dose of study treatment up to 21~30 days after first dose
Change of Nugent score from baseline
Measured: from first dose of study treatment up to 2 days after first dose
Microbiological cure rate base on Nugent score of <4
Measured: from first dose of study treatment up to 21~30 days after first dose
Clinical cure rate base on Amsel assessment
Measured: from first dose of study treatment up to 8~14 days after first dose
Microbiological cure rate base on Nugent score of <4
Measured: from first dose of study treatment up to 8~14 days after first dose
Rrecurrence rate (recurrence as assessed by either Amsel or Nugent score)
Measured: from first dose of study treatment up to 90 days after first dose
Clinical recurrence rate base on Amsel assessment
Measured: from first dose of study treatment up to 90 days after first dose
Microbiological recurrence rate base on score of >7
Measured: from first dose of study treatment up to 90 days after first dose
Time to clinical symptoms disappear
Measured: from first dose of study treatment up to 30 days
Time to recurrence
Measured: from first dose of study treatment up to 90 days after first dose
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.
Only for GenSci142 dose group
Measured: from pre-dose up to 2 days after first dose
Anti-drug antibody prevalence (%) or change of binding titers against GenSci142 in blood before administration and at the follow-up visit
For each group
Measured: from pre-dose up to 90 days after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start15 Aug 2026
- Primary completion5 Jan 2027 (estimated)
- Study completion5 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RandomizedStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663838
- Sponsor's protocol ID
- GenSci142-102
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07663838
- Acronym / sponsor ID
- GenSci142-102
- Conditions
- Randomized, Open-label, Safety, Tolerability, Pharmacokinetics, Bacterial Vaginosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Aug 2026 (actual)
- Primary completion
- 5 Jan 2027 (estimated)
- Study completion
- 5 May 2027 (estimated)
- First posted
- 23 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This study aims to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of multiple intravaginal doses of GenSci142 in patients with bacterial vaginosis (BV) or BV combined mild aerobic vaginitis aged 18 to 50 years, providing a basis for subsequent clinical development. This is a randomized, multicenter, open-label, active-controlled clinical trial. A total of approximately 30 to 42 subjects are planned for enrollment and will be randomized in a 2:1 ratio to either the treatment group or the control group. Treatment group: GenSci142,.Control group: 2% clindamycin phosphate vaginal cream (referred to as clindamycin cream),.The study consists of a screening period (approximately 3 days), a treatment period (7 days), and a efficacy evaluation period (approximately 90 days), with a total of 7 scheduled visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GenSci142 capsule | Experimental | Drug: GenSci142 capsule |
| clindamycin phosphate vaginal cream | Active comparator | Drug: clindamycin phosphate vaginal cream |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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 (BV) who had not received any treatment for BV since the onset of their current symptoms. The clinical diagnostic criteria for BV are as follows:
- 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;
Key exclusion criteria (21 listed)
- 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 VVC, trichomoniasis, genital herpes, and genital warts (CA), and only moderate-to-severe AV (AV score ≥5 by vaginal microecology assessment) is excluded;
- 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 hormone (GnRH) agonists, high-potency progestogens and combined oral contraceptives (COCs);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GenSci142 capsuleVaginal administration | Drug | GenSci142 capsule |
| clindamycin phosphate vaginal creamClindamycin ointment, 5 grams, once daily for 7 days | Drug | clindamycin phosphate vaginal cream |
Primary outcome
Incidence and severity of treatment-emergent adverse events
Time frame: From the first dose to Day 30
12 secondary outcomes
Clinical cure rate base on Amsel assessment
Time frame: from first dose of study treatment up to 21~30 days after first dose
Change of Nugent score from baseline
Time frame: from first dose of study treatment up to 2 days after first dose
Microbiological cure rate base on Nugent score of <4
Time frame: from first dose of study treatment up to 21~30 days after first dose
Clinical cure rate base on Amsel assessment
Time frame: from first dose of study treatment up to 8~14 days after first dose
Microbiological cure rate base on Nugent score of <4
Time frame: from first dose of study treatment up to 8~14 days after first dose
Rrecurrence rate (recurrence as assessed by either Amsel or Nugent score)
Time frame: from first dose of study treatment up to 90 days after first dose
Clinical recurrence rate base on Amsel assessment
Time frame: from first dose of study treatment up to 90 days after first dose
Microbiological recurrence rate base on score of >7
Time frame: from first dose of study treatment up to 90 days after first dose
Time to clinical symptoms disappear
Time frame: from first dose of study treatment up to 30 days
Time to recurrence
Time frame: from first dose of study treatment up to 90 days after first dose
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.
Time frame: from pre-dose up to 2 days after first dose
Anti-drug antibody prevalence (%) or change of binding titers against GenSci142 in blood before administration and at the follow-up visit
Time frame: from pre-dose up to 90 days after first dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GenSci142 capsule and clindamycin phosphate vaginal cream in people with Randomized and Open-label, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liao Qinping (+86 13701124527, 13701124527@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment-emergent adverse events (time frame: From the first dose to Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.