A First-In-Human, Phase 1, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GFB-887, a TRPC5 Channel Inhibitor, in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Urine PK parameters: CLR
研究概览
简要总结
The study will comprise primarily a single-ascending dose (SAD) escalation component.
详细描述
Double-blind, randomized, placebo-controlled, single-dose, sequential-group design in up to 7 cohorts of healthy participants.
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
- Double (Participant, Investigator)
盲法说明
Blinded
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
- •Males or females, of any race, between 18 and 55 years of age, inclusive, at Screening.
- •Body mass index between 18.0 and 32.0 kg/m^2, inclusive, at Screening.
- •Systolic blood pressure of between 90 and 140 mmHg, diastolic blood pressure between 60 and 90 mmHg, and heart rate between 40 and 100 bpm at Screening.
- •Female participants will be post-menopausal or surgically sterile (as confirmed by medical history).
- •Male participants will agree to use contraception while on study drug and for at least 90 days after the final follow-up visit.
- •Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.
- •Participants must be in good health.
- •Healthy Participant Cohorts - Key
排除标准
- •Females of childbearing potential.
- •Significant history or clinically significant manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- •History of alcoholism or drug/chemical abuse within 2 years prior to (first) Check-in.
- •Use of tobacco or nicotine-containing products within 60 days prior to (first) dosing, or positive cotinine at Screening or Check-in.
研究组 & 干预措施
GFB-887 SAD active
GFB-887 single dose active
干预措施: GFB-887 (Drug)
GFB-887 SAD placebo
GFB-887 single dose placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Urine PK parameters: CLR
时间窗: Approximately 5.5 weeks
PK
Plasma PK parameters: Tmax
时间窗: Approximately 5.5 weeks
PK
Incidence and severity of AEs
时间窗: Approximately 5.5 weeks
Safety and tolerability
Incidence of clinically significant changes in laboratory parameters, 12 lead ECG parameters, vital signs measurements, spirometry, and physical examinations
时间窗: Approximately 5.5 weeks
Safety and tolerability
Plasma PK parameters: Cmax
时间窗: Approximately 5.5 weeks
PK
Plasma PK parameters: AUC
时间窗: Approximately 5.5 weeks
PK
Urine PK parameters: Ae
时间窗: Approximately 5.5 weeks
PK
Urine PK parameters: Fe
时间窗: Approximately 5.5 weeks
PK
次要结局
未报告次要终点