A Three-part, Phase 1, Single and Multiple Ascending Dose Escalation and Food Effect Study in Healthy Participants to Assess the Safety, Tolerability, and Pharmacokinetics of QX-4533
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Number of Participants with Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
The primary purpose of this study is to evaluate the safety and tolerability of QX-4533 following oral administration of single and multiple ascending doses in healthy participants.
详细描述
This study will consist of 3 parts: Part 1: A randomized, double-blind, placebo-controlled single ascending dose (SAD) evaluation, including an open-label crossover food effect (FE) assessment in 1 cohort.
Part 2: A 14-day randomized, double-blind, placebo-controlled multiple ascending dose (MAD) evaluation.
Part 3: An open-label, 2-period crossover FE assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
FE study will be open label.
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
- •Male or female between 18 and 55 years of age (inclusive) at screening.
- •Understands the study procedures and is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •Willing and able to comply with this protocol and be available for the entire duration of the study.
- •In good general health, determined by no clinically significant findings in the opinion of the Investigator from medical history, physical examination, 12-lead electrocardiogram (ECG), clinical laboratory findings, and vital signs at screening and Day -
- •Has body mass index of 18 to 32 kilograms per meter square (kg/m^2) inclusive.
排除标准
- •History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease according to the Investigator.
- •History of any Gastrointestinal (GI) procedures (e.g., bariatric surgery) that could impair gastrointestinal absorption.
- •History of any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the participant.
- •Clinically significant abnormalities on pre-study clinical examination or laboratory safety tests. Laboratory safety assessments (e.g., serum chemistry, hematology, coagulation) will be performed at screening and on Day -1 (if screening is prior to Day -1) to confirm eligibility.
- •Treatment with a live (attenuated) vaccine within 8 weeks before the screening visit.
- •Positive hepatitis B surface antigen, human immunodeficiency virus antibody, or hepatitis C antibody at the screening visit.
- •Use of any prescription within 14 days prior to study treatment administration or use of any over-the-counter medications including food supplements and herbal medications (e.g., St. John's wort), except for contraceptive medications and as needed (pro re nata) paracetamol (not exceeding 2 g/day) within 7 days prior to study treatment administration.
- •Participant has participated in another clinical study within the last 4 weeks or within 5 half-lives of the prior study drug, whichever is longer.
- •Participants that currently use (including "recreational use") any illicit drugs or have a history of drug abuse in the last 2 years.
研究组 & 干预措施
Part 2: Multiple Ascending Dose (MAD)
Participants will receive multiple oral doses of QX-4533 or placebo, once daily for 14 days under fasting conditions.
干预措施: Placebo (Drug)
Part 3: Food Effect - Sequence 1: AB
Participants will receive single oral dose of QX-4533 on Day 1 of Period 1 under fasted condition (A) followed by single oral dose of QX-4533 on Day 1 of Period 2 under fed (high fat meal) condition (B).
干预措施: QX-4533 (Drug)
Part 3: Food Effect - Sequence 2: BA
Participants will receive a single oral dose of QX-4533 on Day 1 of Period 1 under fed (high fat meal) condition (B) followed by single oral dose of QX-4533 on Day 1 of Period 2 under fasted condition (A).
干预措施: QX-4533 (Drug)
Part 1: Single Ascending Dose (SAD)
Participants will receive a single oral dose of QX-4533 or placebo on Day 1, under fasting conditions.
干预措施: QX-4533 (Drug)
Part 1: Single Ascending Dose (SAD)
Participants will receive a single oral dose of QX-4533 or placebo on Day 1, under fasting conditions.
干预措施: Placebo (Drug)
Part 2: Multiple Ascending Dose (MAD)
Participants will receive multiple oral doses of QX-4533 or placebo, once daily for 14 days under fasting conditions.
干预措施: QX-4533 (Drug)
结局指标
主要结局
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
时间窗: From enrollment through the safety follow-up visit (up to Day 9 [Part 1] and Day 23 [Part 2])
Number of Participants with Clinically Significant Change from Baseline in Clinical Laboratory Parameters
时间窗: From enrollment through the safety follow-up visit (up to Day 9 [Part 1] and Day 23 [Part 2])
次要结局
- Area Under the Concentration-Time Curve from Time Zero to the Last Quantifiable concentration-time point (AUClast)(Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2))
- Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUCinf)(Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2))
- Apparent Volume of Distribution at Steady State (Vz/F)(Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2))
- Maximum Observed Plasma Concentration (Cmax)(Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2))
- Time of the Maximum Measured Concentration (Tmax)(Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2))
- Apparent Clearance (CL/F)(Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2))
- Terminal Elimination Half-Life (t½el)(Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2))
- Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Findings(From enrollment through the safety follow-up visit (up to Day 9 [Part 1] and Day 23 [Part 2]))