A Phase 1, Partially Blind, Placebo Controlled, Randomized, Combined Single Ascending Dose With a Food Effect Cohort, Multiple Ascending Dose, and Relative Bioavailability Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBAJ-876 in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- Number of Participants with Treatment-Related Adverse Events in Part 1, Single Ascending Dose
研究概览
简要总结
A Phase 1, Partially Blind, Placebo Controlled, Randomized, Combined Single Ascending Dose (SAD) with a Food Effect Cohort (Part 1), Multiple Ascending Dose (MAD) (Part 2), and Relative Bioavailability (rBA) (Part 3) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBAJ-876 in Healthy Adult Subjects
详细描述
This study is a three-part, partially blinded, placebo controlled, combined single ascending dose with food-effect, multiple ascending dose study, and a single dose relative bioavailability study conducted at one study center in the United States.
Safety will be assessed throughout the study for all subjects. Safety assessments will include physical examinations, vital signs, serial ECGs, cardiac monitoring, adverse events (AEs), and clinical laboratory tests (including hematology, serum chemistry, coagulation, and urinalysis).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All volunteers must satisfy the following criteria to be considered for study participation:
- •Is a healthy adult male or female, 19 to 50 years of age (inclusive) at the time of screening.
- •Has a body mass index (BMI) ≥18.5 and ≤32.0 (kg/m2) and a body weight of no less than 50.0 kg.
- •Is medically healthy with no clinically significant screening results (e.g., laboratory profiles normal or up to Grade 1 per DMID Toxicity Tables), as deemed by the Investigator.
- •Has not used tobacco- or nicotine-containing products (including smoking cessation products), for a minimum of 6 months before dosing.
- •If assigned to receive study drug under fed conditions, is willing and able to consume the entire high-calorie, high-fat breakfast meal in the timeframe required.
排除标准
- •History or presence of clinically significant cardiovascular (heart murmur), pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
- •Any presence of musculoskeletal toxicity (severe tenderness with marked impairment of activity, or frank necrosis).
- •Has a positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV at screening.
- •Current or history of prolonged QT syndrome
- •Family history of long-QT syndrome or sudden death without a preceding diagnosis of a condition that could be causative of sudden death (such as known coronary artery disease, congestive heart failure, or terminal cancer).
- •If assigned to the fasted/fed cohort, is lactose intolerant.
研究组 & 干预措施
TBAJ-876 1x100 mg rBA fed
Single dose TBAJ-876 of 100 mg (1 x 100 mg tablet) (n=10) under fed conditions
干预措施: TBAJ-876 100 mg tablet (Drug)
TBAJ-876 10mg SAD
Cohort 1 single dose of 10 mg TBAJ-876 (n=6) under fasted conditions
干预措施: TBAJ-876 suspension (Drug)
TBAJ-876 25mg SAD
Cohort 2, Single dose of 25 mg TBAJ-876 (n=6) under fasted conditions
干预措施: TBAJ-876 suspension (Drug)
TBAJ-876 50mg SAD
Cohort 3 single dose of 50 mg TBAJ-876 (n=6) under fasted conditions
干预措施: TBAJ-876 suspension (Drug)
TBAJ-876 100mg fasted SAD
Cohort 4, single dose of 100 mg TBAJ-876 (n=9) under fasted conditions
干预措施: TBAJ-876 suspension (Drug)
TBAJ-876 100mg fed SAD
Cohort 4, dose of 100 mg TBAJ-876 (n=10) under fed conditions
干预措施: TBAJ-876 suspension (Drug)
TBAJ-876 200mg SAD
Cohort 5 single dose of 200 mg TBAJ-876 (n=6) under fasted conditions
干预措施: TBAJ-876 suspension (Drug)
TBAJ-876 400mg SAD
Cohort 6, single dose of 400 mg TBAJ-876) (n=6) under fasted conditions
干预措施: TBAJ-876 suspension (Drug)
TBAJ-876 800mg SAD
Cohort 7, Single dose of 800 mg TBAJ-876 (n=6) under fasted conditions
干预措施: TBAJ-876 suspension (Drug)
TBAJ-876 Placebo SAD
Single dose matching placebo for TBAJ-876 under fasted conditions (n=13)
干预措施: Placebo suspension (Drug)
TBAJ-876 25mg MAD
25 mg TBAJ-876 (n=9) for 14 days under fed conditions
干预措施: TBAJ-876 suspension (Drug)
TBAJ-876 75mg MAD
75 mg TBAJ-876) (n=9) for 14 days under fed conditions
干预措施: TBAJ-876 suspension (Drug)
TBAJ-876 200mg MAD
200 mg TBAJ-876 (n=9) for 14 days under fed conditions
干预措施: TBAJ-876 suspension (Drug)
TBAJ-876 Placebo MAD
Matching placebo for TBAJ-876 for 14 days under fed conditions (n=12)
干预措施: Placebo suspension (Drug)
TBAJ-876 1x100 mg rBA fasted
Single dose TBAJ-876 of 100 mg (1 x 100 mg tablet) (n=10) under fasted conditions
干预措施: TBAJ-876 100 mg tablet (Drug)
TBAJ-876 4x25 mg rBA fasted
Single dose TBAJ-876 of 100 mg (4 x 25 mg tablets) (n=10) under fasted conditions
干预措施: TBAJ-876 25 mg tablet (Drug)
结局指标
主要结局
Number of Participants with Treatment-Related Adverse Events in Part 1, Single Ascending Dose
时间窗: Day 1 to Day 28
Subjects will be monitored for any adverse events from the signing of the consent form until the end-of-study visit. The Investigator or a Sub-Investigator will assess its relationship to the study drug.
Number of Participants with Treatment-Related Adverse Events in Part 2, Multiple Ascending Dose
时间窗: Day 1 to Day 133
Subjects will be monitored for any adverse events from the signing of the consent form until the end-of-study visit. The Investigator or a Sub-Investigator will assess its relationship to the study drug.
Number of Participants with Treatment-Related Adverse Events in Part 3, Relative Bioavailability Study
时间窗: Day 1 to Day 21
Subjects will be monitored for any adverse events from the signing of the consent form until the end-of-study visit. The Investigator or a Sub-Investigator will assess its relationship to the study drug.
次要结局
- AUCExtrap [Pharmacokinetic Analysis](Days 1 - 28)
- AUCinf [Pharmacokinetic Analysis](Days 1 - 28)
- AUClast [Pharmacokinetic Analysis](Days 1 - 28)
- AUCtau [Pharmacokinetic Analysis](Days 1 - 28)
- Cavg [Pharmacokinetic Analysis](Days 1 - 28)
- Clast [Pharmacokinetic Analysis](Days 1 - 28)
- CL/F [Pharmacokinetic Analysis](Days 1 - 28)
- CLss/F [Pharmacokinetic Analysis](Days 1 - 28)
- Cmax [Pharmacokinetic Analysis](Days 1 - 28)
- RAUC [Pharmacokinetic Analysis](Days 1 - 28)
- RCmax [Pharmacokinetic Analysis](Days 1 - 28)
- Tlast [Pharmacokinetic Analysis](Days 1 - 28)
- Tmax [Pharmacokinetic Analysis](Days 1 - 28)
- T1/2 [Pharmacokinetic Analysis](Days 1 - 28)
- Vz/F [Pharmacokinetic Analysis](Days 1 - 28)
- λz [Pharmacokinetic Analysis](Days 1 - 28)