A Phase 1, Randomized, Double-Blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Determine the Safety, Tolerability, Pharmacokinetics, and Food Effect of ANG-3070 in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Difference in Adverse Events
研究概览
简要总结
This is a Phase 1 study, to assess the safety, tolerability, pharmacokinetics, and food effect of single and multiple ascending doses of ANG-3070 in healthy adult participants.
This study is comprised of 12 cohorts. 5 single ascending dose (SAD) cohorts 6multiple ascending dose (MAD) cohorts, and 1 single dose food effect (FE) cross-over cohort Each cohort will have a total of 8 subjects: SAD and MAD (2 subjects receiving placebo and 6 subjects receiving active ANG-3070)
详细描述
This is a Phase 1 study, to assess the safety, tolerability, pharmacokinetics, and food effect of single and multiple ascending doses of ANG-3070 in healthy adult participants.
Each cohort will have a total of 8 subjects: SAD and MAD (2 subjects receiving placebo and 6 subjects receiving active ANG-3070). The study design employs sentinel dosing with 2 subjects (1 placebo, 1 active treatment) at least 24 hours prior to remainder of cohort for dose cohort 1.
SAD cohorts are defined as follows, with the FE crossover occurring for participants in cohort A3 on Day 15 and in cohort D1 on Day 5:
A1 ANG-3070 50 mg (n=6) / Placebo (n=2) A2 ANG-3070 100 mg (n=6) / Placebo (n=2) A3 ANG-3070 200 mg (n=6) / Placebo (n=2) A3 Day 15ANG-3070 200mg (n=6) / Placebo (n=2) A4 ANG-3070 400 mg (n=6) / Placebo (n=2) A5 Day 1 ANG-3070 600 mg (n=6) / Placebo (n=2) D1 Day 1 ANG-3070 600 mg Single Dose (n=6) / Placebo (n=2) D1 Day 5 (ANG-3070 600 mg Single Dose (n=6) / Placebo (n=2)
MAD cohorts will receive drug or placebo twice daily for 14 consecutive days (Day 1 to Day 14) or drug or placebo once daily for 14 consecutive days (Day 1 to Day 14) as follows:
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female volunteers, aged 18 to 65 years (inclusive at the time of informed consent);
- •Participants must be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at Screening and/or before administration of the initial dose of study drug; and
- •Participants must have a minimum body weight of 50 kg and a Body Mass Index (BMI) between ≥18.0 and ≤32.0 kg/m2 at Screening;
排除标准
- •Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period;
- •Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator's (or delegate's) opinion, could adversely affect the safety of the participant;
- •History of gastrointestinal (GI) disorders such as celiac disease, atrophic gastritis, lactose intolerance, and Helicobacter (H.) pylori infection;
- •Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the protocol or complete the study per protocol;
- •Any surgical or medical condition that could interfere with the absorption, distribution, metabolism, or excretion of the study drug;
研究组 & 干预措施
SAD
A1 Day 1 ANG-3070 50 mg (n=6) / Placebo (n=2) Oral
A2 Day 1 ANG-3070 100 mg (n=6) / Placebo (n=2) Oral
A3 Day 1 ANG-3070 200 mg (n=6) / Placebo (n=2) Oral
Day 15 ANG-3070 200mg (n=6) / Placebo (n=2) Oral
A4 Day 1 ANG-3070 400 mg (n=6) / Placebo (n=2) Oral
A5 Day 1 ANG-3070 600 mg (n=6) / Placebo (n=2) Oral
D1 Single Dose Food Effect: Day 1 ANG 3070 600 mg *with and without food* (n=6)/ Placebo (n=2) Oral
干预措施: ANG3070 (Drug)
SAD
A1 Day 1 ANG-3070 50 mg (n=6) / Placebo (n=2) Oral
A2 Day 1 ANG-3070 100 mg (n=6) / Placebo (n=2) Oral
A3 Day 1 ANG-3070 200 mg (n=6) / Placebo (n=2) Oral
Day 15 ANG-3070 200mg (n=6) / Placebo (n=2) Oral
A4 Day 1 ANG-3070 400 mg (n=6) / Placebo (n=2) Oral
A5 Day 1 ANG-3070 600 mg (n=6) / Placebo (n=2) Oral
D1 Single Dose Food Effect: Day 1 ANG 3070 600 mg *with and without food* (n=6)/ Placebo (n=2) Oral
干预措施: Placebo oral capsule (Drug)
MAD
B1 ANG-3070 50 mg BID (n=6) / Placebo (n=2)
B2 ANG-3070 100 mg BID (n=6) / Placebo (n=2)
B3 ANG-3070 250 mg BID (n=6) / Placebo (n=2)
B4 ANG-3070 500 mg, BID (n=6)/ Placebo (n=2)
C1 ANG-3070 400 mg, QD(n=6)/ Placebo (n=2)
C2 ANG-3070 600 mg, QD (n=6)/ Placebo (n=2)
干预措施: ANG3070 (Drug)
MAD
B1 ANG-3070 50 mg BID (n=6) / Placebo (n=2)
B2 ANG-3070 100 mg BID (n=6) / Placebo (n=2)
B3 ANG-3070 250 mg BID (n=6) / Placebo (n=2)
B4 ANG-3070 500 mg, BID (n=6)/ Placebo (n=2)
C1 ANG-3070 400 mg, QD(n=6)/ Placebo (n=2)
C2 ANG-3070 600 mg, QD (n=6)/ Placebo (n=2)
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Difference in Adverse Events
时间窗: Up to the Follow Up visit 8 days after the last study drug administration
Difference versus placebo in the number of subjects with adverse events to evaluate safety and tolerability of ANG3070.
Difference in Physical Exam
时间窗: Up to the Follow Up visit 8 days after the last study drug administration
Difference versus placebo in the number of subjects with abnormal Physical examination to evaluate safety and tolerability of ANG3070
Difference in Vital Signs
时间窗: Up to the Follow Up visit 8 days after the last study drug administration
Difference versus placebo in the number of subjects with abnormal vital signs to evaluate safety and tolerability of ANG3070.
Difference in Lab Values
时间窗: Up to the Follow Up visit 8 days after the last study drug administration
Difference versus placebo in the number of subjects with abnormal lab values to evaluate safety and tolerability of ANG3070.
Difference in ECG QT interval
时间窗: Up to the Follow Up visit 8 days after the last study drug administration
Difference versus placebo in the number of subjects with abnormal ECG QT interval to evaluate safety and tolerability of ANG3070
次要结局
- Assess PK(Up to the Follow Up visit 8 days after the last study drug administration)