A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single And Multiple Ascending Dose, First-Time-In-Human Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Ecc0509 In Healthy Volunteers
试验速览
- 阶段
- 1 期
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations
研究概览
简要总结
A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single And Multiple Ascending Dose, First-Time-In-Human Study to Assess The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ECC0509 in Healthy Volunteers.
详细描述
This study will be conducted in up to seven cohorts of Single Ascending Dose (SAD) & 3 cohorts of Multiple Ascending Dose (MAD). SAD will consist of a staggered dosing approach with a dose range from 1mg to 80mg. Staggered dosing approach will not be deployed for MAD cohorts with a dose range of 8mg to 40mg. In the MAD cohort, the effect of food will also be assessed by comparing the PK profile of Day 10 fed conditions against Day 14 fasted conditions.
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
- Triple (Participant, Care Provider, 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 non-childbearing potential female
- •Age ≥18 and ≤65 years old
- •BMI ≥18.0 and ≤32.0 kg/m2
- •Male participants agree to use contraception
- •No clinically significant abnormal findings in physical examination, 12-lead electrocardiogram (ECG), laboratory tests, or medical history
- •Able to understand and sign informed consent
排除标准
- •Significant allergic reactions to any drug.
- •History of significant drug abuse or alcohol abuse within 1 year prior to screening
- •Concomitant participation in any investigational study of any nature
- •Use of any concomitant medication except for the occasional use of acetaminophen (up to 2 g daily)
- •Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to dosing.
- •Any clinically significant abnormal findings in the participant's physical examination, laboratory tests, pregnancy test, urine drug screen, alcohol breath test, or medical history which, in the opinion of the Investigator, would prevent the subject from participating in the study.
研究组 & 干预措施
SAD Cohorts 1 to 6: Participants Receiving Placebo
Participants in each SAD cohort will be randomized to receive placebo.
干预措施: Placebo (Drug)
MAD Cohorts 1 to 4: Participants receiving Placebo
Participants will be randomized to receive a once-daily dose of placebo for 14 days.
干预措施: Placebo (Drug)
MAD Cohorts 1 to 4: Participants receiving ECC0509
Participants will be randomized to receive a once-daily dose of 1 of 4 escalating doses (3 mg, 10 mg, 30 mg, 60 mg) for 14 days.
干预措施: ECC0509 (Drug)
SAD Cohorts 1 to 6: Participants receiving ECC0509
Participants in each SAD cohort will be randomized to receive 1 of 6 escalating doses (1 mg, 4 mg, 10 mg, 20 mg, 40 mg, or 60 mg).
干预措施: ECC0509 (Drug)
结局指标
主要结局
Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations
时间窗: SAD: Up to Day 8. MAD: Up to Day 21.
Safety Assessment evaluated through adverse events, laboratory evaluations, vital signs, ECGs, and physical examination.
次要结局
- ECC0509 PK parameter: AUC0-τ(MAD: Up to Day 21)
- ECC0509 PK parameters: Cl/F(SAD: Up to Day 8.)
- ECC0509 PK parameters: Vz/F(SAD: Up to Day 8.)
- ECC0509 PK parameter: AUC0-24(MAD: Up to Day 21)
- ECC0509 PK parameter: Cmax ss(MAD: Up to Day 21)
- ECC0509 PK parameter: Tmax ss(MAD: Up to Day 21)
- ECC0509 PK parameter: Tlag ss(MAD: Up to Day 21)
- ECC0509 PK parameters: Cmax(SAD: Up to Day 8. MAD: Up to Day 21)
- ECC0509 PK parameter: Tmax(SAD: Up to Day 8. MAD: Up to Day 21)
- ECC0509 PK parameter: AUC0-t(SAD: Up to Day 8. MAD: Up to Day 21)
- ECC0509 PK parameter: Cmin ss(MAD: Up to Day 21)
- ECC0509 PK parameter: T½ el(SAD: Up to Day 8. MAD: Up to Day 21)
- ECC0509 PK parameter: Kel(SAD: Up to Day 8. MAD: Up to Day 21)
- ECC0509 PK parameter: Clss/F(MAD: Up to Day 21)
- ECC0509 PK parameter: Vz ss/F(MAD: Up to Day 21)
- ECC0509 PK parameters: AUC0-inf(SAD: Up to Day 8. MAD: Up to Day 21)
- ECC0509 PK parameters: Residual area(SAD: Up to Day 8. MAD: Up to Day 21)
- PD Parameter: SSAO(SAD: Up to Day 8. MAD: Up to Day 21.)