A Randomised, Double-Blind, Placebo-Controlled, First-in-Human Study of Orally Administered 83-0060 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of 83-0060 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Incidence of AEs
研究概览
简要总结
This is a clinical study aiming to assess pharmacokinetics, pharmacodynamics and preliminary efficacy of 83-0060 in Healthy Volunteers
详细描述
This is a Phase 1, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, PK, PD of orally administered 83-0060 in Healthy Volunteers. The study will be conducted in 2 parts: a single ascending dose (SAD) part at up to 5 dose levels and a multiple ascending dose (MAD) part at up to 3 dose levels. Evaluation of dose levels will be conducted in a sequential fashion with lower dose levels evaluated first in the sequence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-Blind, Placebo-Controlled
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
- •Adult males and females, 18 to 65 years of age (inclusive) at screening.
- •Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2, with a body weight (to 1 decimal place) ≥ 50.0 kg at screening.
排除标准
- •History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery within the past 3 months determined by the PI to be clinically significant.
- •History of surgery or hospitalisation within 30 days prior to screening, or surgery planned during the study.
- •Acute infections within 4 weeks prior to screening or current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications.
- •Presence or history of any abnormality or illness, including gastrointestinal surgery, which in the opinion of the PI may affect absorption, distribution, metabolism or elimination of the study drug.
- •Any history of malignant disease in the last 5 years (excludes surgically resected skin squamous cell or basal cell carcinoma).
- •Any screening laboratory result outside the normal laboratory reference range (as confirmed upon repeated testing) and deemed clinically significant by the PI.
研究组 & 干预措施
Single dose level 4 or placebo
Dose level 4. SAD study part.
干预措施: Placebo (Drug)
Multiple dose level 3 or placebo
Dose level 3. MAD study part.
干预措施: Placebo (Drug)
Single dose level 5 or placebo
Dose level 5. SAD study part.
干预措施: 83-0060 (Drug)
Single dose level 5 or placebo
Dose level 5. SAD study part.
干预措施: Placebo (Drug)
Multiple dose level 1 or placebo
Dose level 1. MAD study part.
干预措施: 83-0060 (Drug)
Multiple dose level 1 or placebo
Dose level 1. MAD study part.
干预措施: Placebo (Drug)
Multiple dose level 2 or placebo
Dose level 2. MAD study part.
干预措施: 83-0060 (Drug)
Multiple dose level 2 or placebo
Dose level 2. MAD study part.
干预措施: Placebo (Drug)
Multiple dose level 3 or placebo
Dose level 3. MAD study part.
干预措施: 83-0060 (Drug)
Single dose level 4 or placebo
Dose level 4. SAD study part.
干预措施: 83-0060 (Drug)
Single dose level 1 or placebo
Dose level 1. SAD study part.
干预措施: 83-0060 (Drug)
Single dose level 1 or placebo
Dose level 1. SAD study part.
干预措施: Placebo (Drug)
Single dose level 2 or placebo
Dose level 2. SAD study part.
干预措施: 83-0060 (Drug)
Single dose level 2 or placebo
Dose level 2. SAD study part.
干预措施: Placebo (Drug)
Single dose level 3 or placebo
Dose level 3. SAD study part.
干预措施: 83-0060 (Drug)
Single dose level 3 or placebo
Dose level 3. SAD study part.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of AEs
时间窗: 8 days in SAD part, 17 days for MAD part
Incidence of Adverse Events observed during the study
Incidence of drug-related AEs
时间窗: 8 days in SAD part, 17 days for MAD part
Incidence of Adverse Events observed during the study deemed related to the study drug by the Investigator
Incidence of SAEs
时间窗: 8 days in SAD part, 17 days for MAD part
Incidence of Serious Adverse Events observed during the study
Incidence of lab deviations
时间窗: 8 days in SAD part, 17 days for MAD part
Incidence of clinically relevant deviations in the clinical laboratory parameters
次要结局
- Plasma concentration(8 days in SAD part, 17 days for MAD part)