A Prospective, Phase I, Double-blind, Parallel-group, Placebo-controlled, Randomised Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Oral Doses of ACD856 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Frequency of adverse events (AEs)
研究概览
简要总结
The multiple ascending dose (MAD) design of the study is based on the aim to study safety, tolerability, PK and pharmacodynamics 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 male or female adults of non-childbearing potential aged ≥ 18 and ≤ 65 years at screening.
- •Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2 at screening.
- •Only subjects of non-childbearing potential may be included in the study. Male subjects with partners of childbearing potential must be willing to use condoms, be vasectomised or practice sexual abstinence to prevent pregnancy and drug exposure of a partner, as well as 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
- •Any exposure to ACD856 in the past.
- •Treatment with another investigational drug within 3 months prior to or during the study.
- •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 subjects who use nicotine products.
- •History of alcohol abuse or excessive intake of alcohol.
- •History of, or current use of, anabolic steroids.
- •Excessive caffeine consumption.
- •Plasma donation or blood donation prior to screening.
- •Any planned night shift work within the duration of the study, from 48 h prior to randomisation until follow-up.
- •Any planned major surgery within the duration of the study.
- •Evidence of an active infection that requires treatment with antibiotics within 2 weeks of planned dosing.
研究组 & 干预措施
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: 16 days
Number and percentage of subjects with adverse events (AEs).
Clinically significant changes in 12-lead ECGs
时间窗: 16 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: 16 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: 16 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: 16 days
Number of subjects and percentage of subjects with clinically significant changes in physical examinations
GAD-7
时间窗: 16 days
Change from baseline of GAD-7
PHQ-9
时间窗: 16 days
Change from baseline of PHQ-9
C-SSRS
时间窗: 16 days
Change from baseline of C-SSRS
Prolactin
时间窗: 10 days
Change from baseline of prolactin levels
次要结局
未报告次要终点