Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Study to Assess the Tolerability and Pharmacokinetics of APD916 Administered to Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- To evaluate the safety and tolerability of single, escalating doses of APD916 when administered to healthy adult subjects
研究概览
简要总结
The APD916-001 study is designed primarily to evaluate the safety and tolerability of APD916 when administered as a single dose
详细描述
This is a Phase 1, randomized, double-blind, placebo-controlled, single-dose escalation study of up to 9 dose cohorts (1, 2, 5, 10, 20, 30, 45, 70 and 90 mg) each comprising 8 subjects (2 to receive placebo, 6 to receive APD916). Each cohort will be assigned to receive a single dose of APD916. After dosing within the first cohort has been completed and safety data review identifies no tolerability issues, and the principal investigator (PI) and Sponsor have agreed that it is safe to proceed, then subjects in the next cohort may be dosed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or females ages 18-45 years
- •Body weight of 50-100 kg (110-220 pounds)
- •Eligible female subjects will be non-pregnant, evidenced by a negative serum pregnancy test at Screening and a urine dipstick pregnancy test on Day -1 (Check-In); non-lactating; surgically sterile, postmenopausal, or agree to continue to use a medically accepted method of birth control during and for at least 1 month after last study medication administration.
- •Eligible male subjects will either be surgically sterile (i.e., vasectomy), for at least 3 months prior to screening, or agree to use a condom with spermicide when sexually active with a female partner who is not using an acceptable method of birth control during the study and for 1 month after.
- •Exclusion Criteria
- •Subject who has donated any blood, or had significant blood loss within 56 days of dosing
- •History of smoking or tobacco use within 3 months prior to dosing
- •History of epilepsy or other seizure disorder
- •Recent history (within 2 years prior to the screening visit) of sleep disorders
- •History (within 2 years prior to the screening visit) of ADD or ADHD
- •Traveled across more than 3 time zones within 2 weeks prior to dosing
排除标准
- 未提供
结局指标
主要结局
To evaluate the safety and tolerability of single, escalating doses of APD916 when administered to healthy adult subjects
时间窗: Single dose
Safety measures to include adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical lab parameters.
次要结局
- To assess the pharmacokinetic properties of single, escalating doses of APD916(Single dose)