NCT04878705Unknown1 期
A Randomized, Double-blind, Placebo-controlled, Single Dose, Escalation, Phase I Clinical Trial to Evaluate the Safety and Tolerability of TWP-201 in Healthy Female Subjects
Shandong TheraWisdom Biopharma Co., Ltd.1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2021年5月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Incidence of adverse events, serious adverse and abnormal laboratory values event (defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)).
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled, single dose, escalation, phase I clinical trial to evaluate the safety and tolerability of recombinant human follicle stimulating hormone Fc fusion protein injection (TWP-201) in healthy female subjects. The objective of the trial is to evaluate the safety and tolerability of TWP-201 in healthy female subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Body weight ≥ 45 kg, 19 ≤ body mass index (BMI) ≤ 28 kg /m2;
- •Women with sexual experience, potential fertility and regular menstrual cycle (25-34 days) (including boundary value);
- •The levels of sex hormones were normal or abnormal without clinical significance at the time of screening;
- •The physiological structure of uterus and bilateral ovaries was normal or abnormal by ultrasound examination, without clinical significance;
排除标准
- •Known the history of stage III / IV endometriosis, submucosal myoma and endocrine abnormality within 6 months before enrollment;
- •Known the history of ovarian hyperstimulation syndrome (OHSS);
- •Premature ovarian failure, decreased ovarian reserve function (Antral Follicle Counting < 3), high ovarian response, polycystic ovary syndrome, unexplained vaginal bleeding or endometrial hyperplasia;
- •Any FSH or HMG preparations were used within 3 months before the first study;
- •Pregnancy or lactating women.
研究组 & 干预措施
TWP-201
Experimental
干预措施: TWP-201 (Drug)
placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Incidence of adverse events, serious adverse and abnormal laboratory values event (defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)).
时间窗: An average of 1 year
次要结局
- Pharmacodynamics(PD).(28 days)
- Maximum measured plasma concentration (Cmax) of TWP-201;(28 days)
- Time to maximum plasma concentration (Tmax) of TWP-201;(28 days)
- Half-life (T1/2) of TWP-201.(28 days)
- Immunogenicity profile of TWP-201.(28 days)
研究者
研究点 (1)
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