A Phase 1 interventional study of GenSci142 and Placebo GenSci142 in Bacterial Vaginosis, sponsored by Changchun GeneScience Pharmaceutical Co., Ltd.. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-24.
Sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment
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.
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.
240 studies on the registry are indexed under Vaginosis, Bacterial; 39 are open to participants now.
This study's planned enrollment of 30 is below the median of 100 across 203 interventional studies indexed under Vaginosis, Bacterial.
Browse Vaginosis, Bacterial studies →Changchun GeneScience Pharmaceutical Co., Ltd. is the lead sponsor of 111 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single ascending dose levels，All subjects administered Single dose，Dose 1, Dose 2, Dose 3
Drug: GenSci142
All subjects administered Single dose
Drug: Placebo GenSci142
Vaginal insert
Vaginal insert
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.
Time frame: from first dose of study treatment up to 15 days post-dose
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.
Time frame: Day1-Day3
Maximum serum concentration (Cmax, ng/mL)
PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day1-Day3
Terminal half-life (t1/2, h)
PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above.
Time frame: Day1-Day3
Apparent clearance (CL/F, mL/h)
PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above.
Time frame: 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.
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
For each dose level.
Time frame: Day1-Day15
Start is estimated for Dec 2025; primary completion for Sep 2026, 9 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Changchun GeneScience Pharmaceutical Co., Ltd. →