NCT05604287终止1 期
A Placebo-controlled, Randomized, Double-blind, Single and Multiple Dose-escalation Study to Evaluate Safety, Tolerability, and Pharmacokinetics of ID119031166M With the Exploration of Pharmacodynamic Effects in Healthy Participants
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Number of participants with Serious Adverse Events (SAEs) and Adverse Events (AEs)
研究概览
简要总结
This study will evaluate safety, tolerability, and Pharmacokinetics (PK) of ID119031166M with the Exploration of Pharmacodynamic (PD) effects in Healthy Participants.
详细描述
This is a Phase 1, randomized, double-blind, placebo-controlled, sequential single/repeated-dose study. This study is a dose-escalation study with healthy participants in single ascending dose (SAD) including food-effect and multiple ascending dose (MAD) cohorts to determine the highest allowable dose (HAD).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be Caucasian (White American of European or Latin American descent).
- •Healthy participants of Japanese origin are allowed up to 50% in each MAD cohort.
- •Body mass index (BMI) within the range of 18.5 to 30 kg/m^2 (inclusive) at the time of Screening.
- •No congenital or chronic diseases that require treatment and without pathologic symptoms or signs on medical examinations.
- •Participants with normal renal function.
- •Women are eligible to participate if not pregnant, not breastfeeding. Male subjects should be willing to use 'highly effective' or 'applicable' contraceptive methods.
排除标准
- •Currently have an acute disease with active symptoms.
- •History of melanoma or other skin issues (including, but not limited to pre-cancerous areas, atopic dermatitis, psoriasis, rosacea, excessive moles etc.).
- •History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, musculoskeletal, or cardiovascular disease and/or arrhythmias.
- •History of clinically significant hypersensitivity reaction to any drugs or additives.
- •History of any gastrointestinal disease.
- •History of substance use disorder including history of drug abuse disorder or history of alcohol use disorder, or tobacco use disorder or excessive caffeine intake.
- •Evidence of moderate or excessive alcohol consumption.
- •Tested positive in viral serology tests (hepatitis B virus [HBV], hepatitis C virus [HCV], and human immunodeficiency virus [HIV]).
- •Known family history or known presence of long QT syndrome.
- •A history of hypokalemia.
- •Use of concomitant medicines that prolong QT/QTc (QT Interval Corrected for Heart Rate).
- •History of active viral hepatitis (hepatitis A, B, C, and E), or autoimmune hepatitis.
- •History of Multiple Endocrine Neoplasia type
- •Solid organ transplantation, except corneal transplants.
- •History or presence of neutropenia which is defined as absolute neutrophil count (ANC) < 1.5 at Screening and admission.
- •Participants with a microalbuminuria.
- •Hemoglobin levels below 12.0 g/dL at Screening or Baseline.
- •White Blood Cell levels below 3.5 × 109/L at Screening or Baseline.
- •Platelet count < 150,000/µL, international normalized ratio (INR) > 1.5, albumin < 3.5 g/dL
研究组 & 干预措施
SAD: ID119031166M
Experimental
干预措施: ID119031166M (Drug)
MAD: ID119031166M
Experimental
干预措施: ID119031166M (Drug)
SAD: Placebo
Placebo Comparator
干预措施: Placebo (Drug)
MAD: Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with Serious Adverse Events (SAEs) and Adverse Events (AEs)
时间窗: From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 22 for MAD)
To evaluate the safety and tolerability of single and multiple ascending doses of ID119031166M in healthy participants.
次要结局
- Time of maximum plasma concentration determined directly from the concentration-time profile (Tmax)(Day 1-4 for SAD and Day 1-17 for MAD)
- Area under curve from pre-dose (time 0) to the time of the last quantifiable concentration (tlast) (AUC0-last)(Day 1-4 for SAD and Day 1-17 for MAD)
- Dose-normalized AUC0-last(Day 1-4 for SAD and Day 1-17 for MAD)
- Dose-normalized Cmax(Day 1-4 for SAD and Day 1-17 for MAD)
- Dose-normalized AUC from pre-dose (time 0) extrapolated to 24 hours (AUC0-24)(Day 1-4 for SAD and Day 1-17 for MAD)
- Maximum plasma concentration determined directly from the concentration- time profile (Cmax)(Day 1-4 for SAD and Day 1-17 for MAD)
研究者
研究点 (1)
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