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.
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;
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;
Sequential
GenSci142
DrugVaginal insert
Placebo GenSci142
DrugVaginal 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.
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.
Maximum serum concentration (Cmax, ng/mL)
PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above.
Time to maximum serum concentration (Tmax, h)
PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above.
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.
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Changchun GeneScience Pharmaceutical Co., Ltd.
Lead sponsor
Huashan Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
