A Single-Center, Randomized, Double-blind, Placebo-controlled, Phase 1, Single Ascending Dose Safety, Tolerability, and Pharmacokinetic Study of TNX-201 Capsules in Healthy Volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 主要终点
- Plasma levels of isometheptene or metabolites.
研究概览
简要总结
Single-center, randomized, double-blind, placebo-controlled, single ascending dose, safety and tolerability study of TNX-201 capsules in healthy volunteers.
详细描述
Single-center, randomized, double-blind, placebo-controlled, single ascending dose, safety and tolerability study of TNX-201 capsules in healthy volunteers. Three successive cohorts are planned with doses of TNX-201 capsules, 35 mg, 70 mg, and 140 mg, respectively. Each cohort will consist of 15 subjects, and subjects will be randomly assigned to TNX-201, racemic isometheptene, or placebo capsules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- •Male or female, ≥ 18 and ≤ 55 years of age on the day of randomization. NOTE: At least 6 female subjects need to be randomized in each cohort.
- •Body mass index (BMI) ≥18.5 and ≤33.0
- •Non-tobacco users (no use of tobacco- or nicotine- containing products within 3 months prior to study drug administration)
排除标准
- •Any clinically significant abnormality or clinically significant abnormal laboratory test results found at Screening or Day -1, or a positive test for HBsAg, HCAb, or HIV found at Screening
- •Positive urine drug screen (including alcohol, tetrahydrocannabinol (THC), cocaine, amphetamines, and opiates) or urine cotinine test at Screening or on Day -1
- •Known or suspected hypersensitivity to isometheptene mucate or any excipients used in the formulations.
- •Positive serum pregnancy test at Screening or Day -1
- •Any reason, in the opinion of the Principal Investigator (PI) or the sponsor's Medical Monitor, to prevent the subject from participating in the study
- •Clinically significant ECG abnormalities
研究组 & 干预措施
TNX-201 35 mg
Drug: TNX-201 35 mg
干预措施: TNX-201 35 mg (Drug)
TNX-201 70 mg
Drug: TNX-201 70 mg
干预措施: TNX-201 70 mg (Drug)
TNX-201 140 mg
Drug: TNX-201 140 mg
干预措施: TNX-201 140 mg (Drug)
Racemic isometheptene 70 mg
Comparator: Racemic Isometheptene 70 mg
干预措施: Racemic isometheptene 70 mg (Drug)
Placebo
Drug: Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Plasma levels of isometheptene or metabolites.
时间窗: 60 minutes pre-dose and multiple timepoints up to 48 hours post-dose
Number of Adverse events
时间窗: 60 minutes pre-dose and multiple timepoints up to 48 hours post-dose
次要结局
未报告次要终点