A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Doses of MT-201 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Number of Participants with non-SAEs and SAES
研究概览
简要总结
First-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single and multiple doses of MT-201 in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-Blind
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male participant or female participant of nonchildbearing potential between 19 and 55 years of age (inclusive) at the time of signing informed consent.
- •Female participants must be of nonchildbearing potential, defined as postmenopausal or surgically sterile, and have official documentation, at least 6 months prior to the first dose.
- •Male participants with female partners of childbearing potential who are involved in heterosexual intercourse or activities that could lead to pregnancy must use barrier method of contraception (male condom) and refrain from sperm donation.
- •Good general health.
- •Able to provide written informed consent and understand and comply with the requirements of the study.
排除标准
- •History or presence of any clinically significant organ system disease.
- •Abnormal laboratory assessments, physical exam of ECG outside the normal range that is judged by the Investigator to be clinically significant.
- •History of alcohol or drug abuse within the past 24 months.
- •Current use or history of regular tobacco, or nicotine-containing products within 3 months prior to screening.
- •Administration or use of any investigational drug or device within 30 days preceding the first dose of study drug administration.
- •Blood donation within 60 days prior to dosing or plasma donation within 14 days prior to dosing.
研究组 & 干预措施
Single Ascending Dose of MT-201
To assess the safety and tolerability of single intravenous/subcutaneous doses of MT-201
干预措施: MT-201 (Drug)
Multiple Ascending Dose of MT-201
To assess the safety and tolerability of multiple intravenous/subcutaneous doses of MT-201
干预措施: MT-201 (Drug)
Single Ascending Dose Placebo Arm
To assess the safety and tolerability of single intravenous/subcutaneous doses of placebo
干预措施: Placebo (Drug)
Multiple Ascending Dose Placebo
To assess the safety and tolerability of multiple intravenous/subcutaneous doses of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with non-SAEs and SAES
时间窗: Up to 40 weeks
Incidence of adverse events, clinically significant laboratory abnormalities, clinically significant electrocardiogram, vital signs, and physical examination abnormalities.
次要结局
未报告次要终点