Single-center, Double-blind, Placebo-controlled, Randomized, Single-ascending Dose Study to Investigate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of AC-076 in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events (AEs)
研究概览
简要总结
The main objective of the study is to investigate the safety and tolerability of single ascending doses of AC-076 administered as subcutaneous injection
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent
- •Body mass index (BMI) of 18.0 to 31.0 kg/m2 (inclusive) at screening
- •Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate 45-90 beats per minute (inclusive) at screening
- •Healthy on the basis of physical examination, electrocardiogram and laboratory tests
- •Maximum (at peak) platelet aggregation ≥ 40%
- •Values of closure time tested with the Platelet Function Analyzer (PFA) equipment, for both cartridges of collagen/epinephrine and collagen/ADP below the upper limit of normal range at screening
排除标准
- •Known hypersensitivity to AC-076 or drugs of the same class, or any of their excipients
- •Family or personal history of prolonged bleeding or bleeding disorders, intracranial vascular diseases, stroke, reasonable suspicion of vascular malformations, or peptic ulcers
- •Platelet count < 120 × 109 L-1 at screening
- •Known platelet disorders
- •Orthostatic hypotension at screening (i.e., decrease from supine to standing BP of > 20 mmHg in SBP or > 10 mmHg in DBP after being in standing position for 3 min)
- •Previous treatment with acetylsalicylate, non-steroidal anti-inflammatory drugs or any medication with blood thinning activity within 3 weeks prior to study drug administration; or with any other prescribed medications (including vaccines) or over the counter medications within 2 weeks prior to study drug administration
- •Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
研究组 & 干预措施
AC-076 sc administration - single ascending dose
On Day 1, 48 subjects will receive AC-076 at different single dose levels in a sequential manner and in a maximum of 6 dose levels, starting from 1 mg. Subjects will be followed by an observation period of 48 h. Each dose level will be investigated in a new group of 8 healthy male subjects (6 on active drug and 2 on placebo)
干预措施: AC-076 for s.c. administration (Drug)
Placebo
For each AC-076 dose level tested, 2 healthy male subjects will receive matching placebo in the same condition
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with adverse events (AEs)
时间窗: From study treatment administration up to day 3
Treatment-emergent AEs and treatment-emergent serious AEs
Changes from baseline in electrocardiogram (ECG) variables
时间窗: From study treatment administration up to day 3
ECG variables are to be recorded at rest using a standard 12-lead ECG
Changes from baseline in supine blood pressure
时间窗: From study treatment administration up to day 3
Supine blood pressure (mmHg)
Changes from baseline in pulse rate
时间窗: From study treatment administration up to day 3
Pulse rate (bpm)
次要结局
- Maximum plasma concentration (Cmax) of AC-076(From baseline up to day 3)
- time to reach Cmax (tmax)(From baseline up to day 3)
- Measurement of inhibition of platelet aggregation (IPA) using anticoagulant assays(From baseline up to day 3)
- Area under the plasma concentration-time curves from time 0 to inf [AUC(0-inf)](From baseline up to day 3)
- Area under the plasma concentration-time curves during a dosing interval [AUC(0-t)] of(From baseline up to day 3)
- terminal half-life (t1/2)(From baseline up to day 3)