Safety, Tolerability and Pharmacokinetic Characteristics of Singletine(DC407) in Healthy Adult Subjects After Single and Multiple Doses: a Single-center, Randomized, Double-blind, Placebo-controlled, Phase 1 Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety, tolerability and pharmacokinetic characteristics of Singletine in healthy adult subjects. The main questions it aims to answer are: safety and tolerability of Singletine in healthy subjects, the pharmacokinetic characteristics after single and multiple doses and the effect of food on the pharmacokinetic characteristics. Participants will be treated with Singletine orally and safety and pharmacokinetic evaluations will be conducted according to the protocol.
详细描述
This study will be an double-blinded, single-center phase I clinical trial. After being informed about the study and potential risks, all subjects giving written informed consent will undergo a 2-week screening period to determine eligibility for study entry. And then subjects will be administered for single-dose treatment or 7-day multiple-dose treatment and 9-day safety follow up after the last dose of treatment. The safety and pharmacokinetic measures will be conducted according to the protocol.
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
- 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
- •Age 18-45 years old (including both endpoints), healthy males or females;
- •Male weight ≥50 kg, female weight ≥45 kg, body mass index (BMI) between 19-28 kg/m2 (including both endpoints);
- •No significant abnormal clinical symptoms, normal physical examination, vital signs, 12-lead electrocardiogram (ECG), chest CT, ultrasound, and important indicators in laboratory tests show no clinically significant abnormalities;
- •Subjects (including partners) have no parenting plans within 90 days from screening to the last administration of the study drug and voluntarily adopt appropriate and effective contraceptive measures (non-oral contraceptives);
- •Have a full understanding of this study, voluntarily participate in the trial, and voluntarily sign the written informed consent form.
排除标准
- •Pregnant or lactating women;
- •Subjects with special dietary requirements who cannot adhere to a uniform diet;
- •Subjects suspected or confirmed to be allergic to any component similar to the study drug or any ingredient in the study drug, or individuals with an allergic constitution;
- •Subjects with past or present severe diseases/abnormalities (including but not limited to cardiac/cerebrovascular, respiratory, endocrine, metabolic, renal, hepatic, gastrointestinal, dermatologic, malignant tumors, hematological, immunological, rheumatic, neurological or psychiatric diseases), or any acute or chronic disease or physiological condition that could interfere with the trial results;
- •Subjects with severe infectious diseases within six months prior to screening, or a history of herpes zoster, disseminated herpes zoster, any infectious history judged by the investigator to likely worsen due to participation in the study, or any infectious history requiring antimicrobial treatment within two weeks after screening; or the presence of active infections, including acute and chronic infections as well as localized infections;
- •Subjects with active or latent tuberculosis, or with a history of tuberculosis.
研究组 & 干预措施
Singletine（DC407） ascending dose
Single ascending dose
干预措施: Singletine (Drug)
Singletine（DC407）food influence group
Food influence group
干预措施: Singletine (Drug)
Singletine placebo comparator(Single ascending dose)
Single ascending dose
干预措施: Placebo (Drug)
Singletine placebo comparator(food influence group)
Food influence group
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
时间窗: First dose of study drug up to 31 days after last dose of study drug
Assessment by adverse event monitoring CTCAE 5.0
次要结局
- Area Under the Curve（AUC） From Time Zero to Last Quantifiable Concentration(Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72 hours following single dose administration;)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72 hours following single dose administration;)