NCT06772870尚未招募1 期
A Phase 1, Double-Masked, Randomized, Placebo-Controlled, Single Ascending Dose Crossover Study to Assess the Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Intravenous DT-216P2 in Normal Healthy Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Frequency of treatment emergent adverse events (TEAEs)
研究概览
简要总结
This purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of DT-216P2 administered either subcutaneously (SC) and intravenously (IV) in normal healthy participants. Approximately 36 participants will be enrolled into this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be 18-45 years of age inclusive, at the time of signing the informed consent.
- •Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG.
- •Agree to abstain from strenuous physical activity outside of daily norm, until end of study.
- •Body mass index between 16 and 32 kg/m2 (inclusive) at screening; weight should be <= 100 kg at screening.
- •Male and/or female using protocol defined and regulatory approved contraception.
- •Capable of giving signed informed consent.
排除标准
- •Any concomitant medical condition that in the opinion of the investigator, puts the participant at risk or precludes participant from completing the study protocol.
- •Any clinically significant nonmedical conditions and psychiatric disorders that could put the participant at higher risk for participation in the study, influence the participant's ability to participate in the study, or interfere with interpretation of the participant's study results, in the opinion of the investigator.
- •Is not willing to comply with the contraceptive requirements during the study period, as per protocol.
研究组 & 干预措施
DT-216P2
Experimental
干预措施: DT-216P2 (Drug)
Placebo
Placebo Comparator
干预措施: Saline (Drug)
结局指标
主要结局
Frequency of treatment emergent adverse events (TEAEs)
时间窗: From first dose to end of study, Day 30 post first dose administration.
To evaluate the safety and tolerability of single ascending doses of DT-216P2 in normal healthy participants by frequency of treatment-emergent adverse events (TEAEs).
次要结局
- Maximum Plasma Concentration (Cmax) of DT-216P2(Pre-dose and up to 240 hours post first dose for both SC and IV infusion.)
- Area Under the Concentration-time Curve (AUC) of DT-216P2(Pre-dose and up to 240 hours post first dose for both SC and IV infusion.)
- Time to Maximum Plasma Concentration (Tmax) of DT-216P2(Pre-dose and up to 240 hours post first dose for both SC and IV infusion.)
研究者
研究点 (1)
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