A Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Novel Formulation of QRL-101 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Safety and tolerability
研究概览
简要总结
QRL-101-08 is a multiple ascending dose (MAD) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of a novel formulation of QRL-101 in healthy participants.
详细描述
Phase 1, single-site, multiple dose study to evaluate the safety, tolerability, and PK of a novel formulation of QRL-101 in healthy participants. Up to 4 cohorts of 12 participants each, randomized 9:3 (QRL-101:placebo) will be tested. The approximate total duration of study participation for each participant may be up to 59 days.
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
- 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
- •Age 18 to 65 years of age inclusive at the time of signing the informed consent.
- •Clinical chemistry laboratory values within acceptable range for the population, as per investigator judgment.
- •Body mass index of 18 to 32 kg/m2 (inclusive).
- •Willing and able to practice effective contraception.
排除标准
- •Currently enrolled in any other clinical trial involving a study drug or off-label use of a drug or device, or any other type of medical research judged not to be scientifically or medically compatible with this study.
- •Any participant in >4 studies a year and/or has participated in a clinical trial within 1 month of the expected dosing date.
- •History or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric, or neurological disease, convulsions, or any clinically significant laboratory abnormality that, in the judgment of the investigator, indicate a medical problem that would preclude study participation.
研究组 & 干预措施
QRL-101
干预措施: QRL-101 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: Baseline through Follow up (Day 29)
Number of participants with one or more treatment emergent adverse events and serious adverse events. A summary of treatment emergent adverse events (AEs), serious adverse events (SAEs), and other non-serious adverse events, regardless of causality, will be reported in the Reported Adverse Events module.
次要结局
- Pharmacokinetics (plasma): Terminal elimination half-life of QRL-101(Baseline through Follow up (Day 29))
- Pharmacokinetics (plasma): Area under the concentration time curve during the dosing interval (AUCτ) of QRL-101(Time Frame: Baseline through Follow up (Day 29))
- Pharmacokinetics (plasma): Maximum observed concentration of QRL-101(Baseline through Follow up (Day 29))
- Pharmacokinetics (plasma): Time of maximum concentration of QRL-101(Baseline through Follow up (Day 29))
- Pharmacokinetics (plasma): Concentration of QRL-101 before the next dose(Baseline through Follow up (Day 29))
- Pharmacokinetics (plasma): Area under the concentration time curve during the dosing interval (AUCτ) of QRL-101 major metabolites(Baseline through Follow up (Day 29))
- Pharmacokinetics (plasma): Maximum observed concentration of QRL-101 major metabolites(Baseline through Follow up (Day 29))
- Pharmacokinetics (plasma): Time of maximum concentration of QRL-101 major metabolites(Baseline through Follow up (Day 29))
- Pharmacokinetics (plasma): Concentration of QRL-101 major metabolites before the next dose(Baseline through Follow up (Day 29))
- Pharmacokinetics (plasma): Terminal elimination half-life of QRL-101 major metabolites(Baseline through Follow up (Day 29))