A Phase I, First-in-human, Randomised, Double-blind, Placebo-controlled, Single Ascending Oral Dose, Safety, Tolerability and Pharmacokinetic Study to Investigate the Effects of OCT461201 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of Participants with Treatment Emergent Adverse Events during the study assessed as mild, moderate or severe
研究概览
简要总结
A study in healthy volunteers to evaluate the safety, tolerability and pharmacokinetics of OCT461201. The study included a screening period, a single dose of study treatment or placebo and a follow up period.
详细描述
A phase 1, randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of OCT461201 in healthy participants following ascending single doses.
The study comprised a screening period (Day -35 to Day -2), a treatment period (Day -1 to Day 3) and a post-study follow-up visit 4 - 8 days following administration of OCT461201 or placebo (i.e., Day 5 - 9). A dose leader design was implemented with 2 participants being dosed on the first dosing day (1 randomised to placebo, 1 to active drug) and the remainder of the cohort dosed at least 24 hours later pending an acceptable safety profile in the dose leader group. Safety and Pharmacokinetic data was reviewed by the Dose Escalation Review Committee before escalation to the next cohort/dose level.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind, randomised study
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female participant, between 15 and 55 years of age inclusive at screening
- •Body mass index (BMI) of 18-30 kg/m2
- •No clinically significant history of previous allergy/sensitivity to compounds similar to experimental drug or any of its excipients
- •No clinically significant results for serum biochemistry, haematology and/or urine analysis within 35 days before first dose of Investigational Medicinal Product (IMP)
- •No clinically significant abnormalities in 12-lead ECG within 35 days before dose of IMP
- •Available to complete the study including all follow up visits
排除标准
- •Clinically significant history of gastrointestinal disorder likely to influence IMP absorption
- •Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction
- •Participation in a new chemical entity clinical study within the previous 3 months or 5 half-lives, whichever was longer
研究组 & 干预措施
OCT461201 Dose Level 1
Single ascending dose of OCT461201 10 mg
干预措施: OCT461201 50 mg (Drug)
OCT461201 Dose Level 1
Single ascending dose of OCT461201 10 mg
干预措施: Placebo (Drug)
OCT461201 Dose Level 2
Single ascending dose of OCT461201 50 mg
干预措施: OCT461201 100 mg (Drug)
OCT461201 Dose Level 2
Single ascending dose of OCT461201 50 mg
干预措施: Placebo (Drug)
OCT461201 Dose Level 3
Single ascending dose of OCT461201 150 mg
干预措施: OCT461201 150 mg (Drug)
OCT461201 Dose Level 3
Single ascending dose of OCT461201 150 mg
干预措施: Placebo (Drug)
OCT461201 Dose Level 4
Single ascending dose of OCT461201 450 mg
干预措施: OCT461201 450 mg (Drug)
OCT461201 Dose Level 4
Single ascending dose of OCT461201 450 mg
干预措施: Placebo (Drug)
Placebo
Single dose of matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Treatment Emergent Adverse Events during the study assessed as mild, moderate or severe
时间窗: Day 1-9
次要结局
- Pharmacokinetic parameter: t1/2(Day 1-3)
- Pharmacokinetic parameter: Cmax(Day 1-3)
- Pharmacokinetic parameter: AUC(Day 1-3)