A First-in-Human Safety and Pharmacokinetic Trial of GenSci142 Administered as Single Ascending D… (NCT07302035) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A First-in-Human Safety and Pharmacokinetic Trial of GenSci142 Administered as Single Ascending Doses in Healthy Chinese Women
China30 participantsStarted 2025-12
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexFEMALE
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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 productï¼›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 infection…
What they're measuring
1
Percentage of participants with adverse events (AEs) with onset after dose and until 15 days post-dose
Timeframe: from first dose of study treatment up to 15 days post-dose