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
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage of participants with adverse events (AEs) with onset after dose and until 15 days post-dose
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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;
排除标准
- •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;
研究组 & 干预措施
GenSci142
Single ascending dose levels，All subjects administered Single dose，Dose 1, Dose 2, Dose 3
干预措施: GenSci142 (Drug)
Placebo
All subjects administered Single dose
干预措施: Placebo GenSci142 (Drug)
结局指标
主要结局
Percentage of participants with adverse events (AEs) with onset after dose and until 15 days post-dose
时间窗: 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.
次要结局
- Apparent clearance (CL/F, mL/h)(Day1-Day3)
- Apparent volume of distribution (Vd/F, mL)(Day1-Day3)
- Serum concentration of GenSci142 (ng/mL)(Day1-Day3)
- Maximum serum concentration (Cmax, ng/mL)(Day1-Day3)
- Time to maximum serum concentration (Tmax, h)(Day1-Day3)
- Area under the concentration-time curve from the time zero to last measurable concentration (AUC0-t, h*ng/mL)(Day1-Day3)
- Area under concentration-time from time zero to infinity (AUC0-inf, h*ng/mL)(Day1-Day3)
- Anti-drug antibody (ADA) prevalence (%) or change of binding titers against GenSci142 in blood before administration and at the follow-up visit(Day1-Day15)
- Terminal half-life (t1/2, h)(Day1-Day3)