Bacterial VaginosisPhase 1NCT07302035
A First-in-Human Safety and Pharmacokinetic Trial of GenSci142 Administered as Single Ascending Doses in Healthy Chinese Women
A Phase 1 study testing GenSci142 in people with Bacterial Vaginosis, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- GenSci142
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Dec 2025to Dec 2026
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040
Jing ZHANG, Doctor, +86 02152887926, Zhangj_fudan@163.com
About this study
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
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.
Read the 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.
- Conditions
- Bacterial Vaginosis
- Being tested
- GenSci142, Placebo GenSci142
- Keywords
- Bacterial Infections, Vaginitis, Vaginal Diseases, Genital Diseases, Female, Female Urogenital Diseases, Gardnerella spp., Gardnerella vaginalis, GenSci142
- Medical subject headings
- Vaginosis, Bacterial, Bacterial Infections, Vaginitis, Vaginal Diseases, Genital Diseases, Female, Female Urogenital Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenSci142Drug
Vaginal insert
Placebo GenSci142Drug
Vaginal insert
| Study group | Role | What they receive |
|---|---|---|
| GenSci142 | Experimental | Single ascending dose levels，All subjects administered Single dose，Dose 1, Dose 2, Dose 3 Receives: Drug: GenSci142 |
| Placebo | Placebo comparator | All subjects administered Single dose Receives: Drug: Placebo GenSci142 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from first dose of study treatment up to 15 days post-dose
Secondary outcomes (9)
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.
Measured: Day1-Day3
Maximum serum concentration (Cmax, ng/mL)
PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day1-Day3
Terminal half-life (t1/2, h)
PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above.
Measured: Day1-Day3
Apparent clearance (CL/F, mL/h)
PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above.
Measured: 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.
Measured: 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.
Measured: Day1-Day15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Huashan Hospital
- Responsible party
- Sponsor
- Investigators
- Jing ZHANG, Doctor, Study chair, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302035
- Sponsor's protocol ID
- GenSci142-101
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07302035
- Acronym / sponsor ID
- GenSci142-101
- Conditions
- Bacterial Vaginosis
- Keywords
- Bacterial Infections, Vaginitis, Vaginal Diseases, Genital Diseases, Female, Female Urogenital Diseases, Gardnerella spp., Gardnerella vaginalis, GenSci142
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Huashan Hospital
- Study start
- Dec 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Dec 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GenSci142 | Experimental | Drug: GenSci142Single ascending dose levels，All subjects administered Single dose，Dose 1, Dose 2, Dose 3 |
| Placebo | Placebo comparator | Drug: Placebo GenSci142All subjects administered Single dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (3 listed)
- 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;
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 |
|---|---|---|
| GenSci142Vaginal insert | Drug | GenSci142 |
| Placebo GenSci142Vaginal insert | Drug | Placebo |
Primary outcome
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
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.
9 secondary outcomes
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
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 24 Dec 2025.
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Enrolling by invitationObservational study
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WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
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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)
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A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
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Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
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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.
Jing ZHANG, Doctor study chair
Huashan Hospital
1 site 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 in people with Bacterial Vaginosis, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site 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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 Wei WANG (+86 18201085833, wangwei13@genscigroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 24 Dec 2025.