NL-OMON53647招募中不适用
A Randomized, Placebo-Controlled, Double-blind, Single Ascending Dose, First in Human Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of QRL-101 in Healthy Participants. - Single Ascending Dose Study of QRL-101 in Healthy Participants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 128
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age 18 to 70 years of age inclusive at the time of signing the informed
- •2. Clinical chemistry laboratory values within acceptable range for the
- •population, as per
- •investigator judgment.
- •3. Body mass index of 18 to 32 kg/m2 (inclusive).
- •4. Are male or female participants, including those of childbearing potential
- •a. Females of childbearing potential must use at least 1 highly effective
- •method of contraception (see Table APP.3) during the trial and must have been
- •using contraception for at least 28-days prior to the first dose of IMP and
- •agree to use contraception during the study and after the study for at least 91
- •days; based on a rounding up of 5 predicted 5-hour half-lives in humans plus 90
- •days after the last dose of the study drug.
- •b. Men who are sexually active must agree to use a condom, if their partner is
- •a woman of childbearing potential. They do not need to use any contraception if:
- •- they have had a vasectomy, and surgical success has been confirmed by medical
- •assessment;
- •- their partner has had a bilateral tubal ligation; or
- •- their partner is not of childbearing potential.
- •Men must also refrain
- •i. from donating sperm, or
- •ii. from unprotected sex with a female partner who is a woman of childbearing
- •potential (WOCBP) for 91 days; based on a rounding up of 5 predicted 5-hour
- •half-lives in humans plus 90 days after the last dose of the study drug.
- •Contraceptive use by participants should be consistent with local regulations
- •regarding the
- •methods of contraception for those participating in clinical studies.
- •Contraception requirements
- •and definition of nonchildbearing potential are detailed in HMA CTFG
- •Contraception guidance.
- •5. 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.
排除标准
- •1. QurAlis Corporation employees, Contract Research Organization employees,
- •investigator or site personnel directly affiliated with this study and the
- •immediate families of either of these. Immediate family is defined as a spouse,
- •parent, child, or sibling, whether biological or legally adopted. 2. 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. 3. Any participant in
- •>4 studies a year and/or who has participated in a clinical trial within 1
- •month of expected dosing date. 4. Positive COVID-19 test, collected when
- •required per site policy, at the Day -1 visit. 5. Answered *yes* to either
- •Question 3, 4 or 5 on the *Suicidal Ideation* portion of the Columbia-Suicide
- •Severity Rating Scale (C-SSRS) and the ideation occurred within the past month;
- •or 6. Answered *yes* to any of the suicide-related behaviors on the *Suicidal
- •Behavior* portion of C-SSRS and the behavior occurred within the past month
- •Further criteria apply
研究者
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