A Phase I, Double-Blind, Placebo-controlled, Randomized Study to Evaluate the Effects of Single Ascending Oral Doses of ACD856 on Safety, Tolerability and Pharmacokinetics in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Frequency of adverse events (AEs)
研究概览
简要总结
The SAD design of the study is based on the aim to study safety, tolerability and PK of selected doses of ACD856 in a limited number of healthy volunteers. ACD856 will be administered orally.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed and dated informed consent prior to any study-mandated procedure.´
- •Willing and able to comply with study requirements.
- •Healthy males and healthy women of non-childbearing potential aged ≥18 and <65 years at screening.
- •BMI ≥18.0 and ≤30.0 kg/m2 at screening.
- •Males and females of non-childbearing potential may be included in the study. Male subjects must be willing to use condom or be vasectomized or practice sexual abstinence to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the date of dosing until 3 months after dosing with the IMP.
- •Clinically acceptable medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator.
排除标准
- •Planned treatment or treatment with another investigational drug within 3 months prior to randomization.
- •Positive screen for drugs of abuse or a positive alcohol result at screening or admission to the clinic.
- •Clinically relevant findings in laboratory parameters, ECG or vital signs at screening
- •Current smokers or users of nicotine products.
- •History of alcohol abuse or excessive intake of alcohol.
- •Presence or history of drug abuse.
- •History of, or current use of, anabolic steroids.
- •Excessive caffeine consumption.
- •Plasma donation within one month of screening or blood donation prior to screening.
研究组 & 干预措施
ACD856
干预措施: ACD856 (fed cohort) (Drug)
ACD856
干预措施: ACD856 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Frequency of adverse events (AEs)
时间窗: 8 days
Number of subjects and percentage of subjects with AEs
Clinically significant changes in 12-lead ECGs
时间窗: 8 days
Number of subjects and percentage of subjects with clinically significant changes in 12-lead ECGs
Clinically significant changes in vital signs
时间窗: 8 days
Number of subjects and percentage of subjects with clinically significant changes in vital signs or stool frequency
Clinically significant changes in hematology, clinical chemistry, coagulation and/or urinalysis parameters
时间窗: 8 days
Number of subjects and percentage of subjects with clinically significant changes in any safety laboratory assessments.
Clinically significant changes in physical examinations
时间窗: 8 days
Number of subjects and percentage of subjects with clinically significant changes in physical examinations
次要结局
未报告次要终点