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.
- Conditions
- ALSamyotrophic lateral sclerosis10041543
- Registration Number
- NL-OMON53647
- Lead Sponsor
- QurAlis Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 128
1. Age 18 to 70 years of age inclusive at the time of signing the informed
consent.
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To determine the safety and tolerability of QRL-101 after a single oral dose in<br /><br>Healthy Participants</p><br>
- Secondary Outcome Measures
Name Time Method <p>To determine the pharmacokinetic (PK) profile of QRL-101 after a single oral<br /><br>dose in Healthy Participants </p><br>