A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Doses of MT-701 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Number of Subjects 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-701 in healthy participants.
详细描述
This is a first-in-human study of MT-701, a biologic therapy. The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single and multiple doses of MT-701 in healthy participants. The data obtained from this study will inform further development of MT-701.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, 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 or female (of non-childbearing potential only) participants 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 must use highly effective forms of contraception during sexual intercourse with female partners of childbearing potential. A non-vasectomized, male subject must agree to use a condom with a chemical barrier method.
- •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 of any prescription drug within 21 days of study drug administration; or over-the-counter drug within 7 days of study drug administration.
- •Administration or use of any investigational drug or device within 30 days preceding the first does of study drug administration.
- •Blood donation within 60 days prior to dosing or plasma donation within 14 days prior to dosing.
- •Sensitivity to any of the study drugs, or components thereof, or drug or other allergy that in the opinion of the Investigator or Sponsor Medical Monitor, contraindicates participation in the study.
研究组 & 干预措施
Part 1- Single Ascending Dose
To assess the safety and tolerability of single intravenous/subcutaneous dose of MT-701.
干预措施: MT-701 (Drug)
Part 2- Multiple Ascending Dose
To assess the safety and tolerability of multiple intravenous/subcutaneous doses of MT-701.
干预措施: MT-701 (Drug)
结局指标
主要结局
Number of Subjects with non-SAEs and SAES
时间窗: Up to 14 days post dose
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