Actively Recruiting
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
Led by QurAlis Corporation · Updated on 2026-02-19
48
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new formulation of QRL-101 in a Phase 1 study focused on healthy adults aged 18 to 65 years. This study aims to assess the safety, tolerability, and how the body processes this drug when given in multiple ascending doses. The trial includes up to four groups, each with 12 participants, comparing QRL-101 to a placebo. Participants will receive multiple oral doses of either QRL-101 or a placebo, with a ratio of 9 receiving the drug to 3 receiving placebo in each group. The study is randomized and double-blind, meaning neither participants nor researchers know who is receiving the drug or placebo. The total participation period for each volunteer can be up to 59 days. During the study, participants will undergo various safety and laboratory evaluations, including measuring drug levels in the blood over time to understand pharmacokinetics. The main focus is on monitoring safety and tolerability from the start through a follow-up visit on day 29. Researchers will also assess how the drug and its metabolites behave in the body. The study is sponsored by QurAlis Corporation.
CONDITIONS
Brief Title
A Multiple Ascending Dose Study Evaluating the Safety and Tolerability of a Novel Formulation of QRL-101 in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years inclusive at the time of signing the informed consent
- Clinical chemistry laboratory values within acceptable range as judged by the investigator
- Body mass index of 18 to 32 kg/m2 inclusive
- Willing and able to practice effective contraception
You will not qualify if you...
- Currently enrolled in any other clinical trial involving a study drug, off-label drug use, device, or other incompatible medical research
- Participation in more than 4 studies per year or participation in a clinical trial within 1 month of the expected dosing date
- History or presence of medical illness including cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric, neurological diseases, convulsions, or clinically significant laboratory abnormalities that preclude participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 29 days
Participants receive multiple ascending oral doses of QRL-101 or placebo to evaluate safety, tolerability, and pharmacokinetics.
Multiple visits during dosing period
Duration - Up to Day 29 post-treatment
Participants are monitored for safety and tolerability after the last dose of study medication.
Follow-up visits for safety assessments
Trial Site Locations
Total: 1 location
1
ICON plc.
Groningen, Netherlands, 9728 NZ
Actively Recruiting
Research Team
Q
QurAlis Corporation
S
Salah Hadi, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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