Increasing doses of a new QRL-101 formulation in healthy adults

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

This will test repeated doses of a new QRL-101 formulation in healthy adults to see if it is safe and to measure how the body processes it.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: QurAlis Corporation (Industry-sponsored)
• Locations: 1 site (Groningen)
• Trial ID: NCT07421778 on ClinicalTrials.gov

What this trial studies

This is a Phase 1, single-site multiple ascending dose study giving repeated doses of a novel QRL-101 formulation to healthy adults to monitor safety, tolerability, and pharmacokinetics. Up to four cohorts of 12 participants each will be randomized 9:3 to receive QRL-101 or placebo. Participants may be involved for up to 59 days with scheduled dosing and follow-up visits. Clinical exams, laboratory tests, and PK sampling will be used to detect adverse events and characterize drug levels over time.

Who should consider this trial

Good fit: Healthy adults aged 18–65 with a BMI of 18–32 kg/m2 who can use effective contraception and have no significant medical problems are the intended participants.

Not a fit: People with active cardiovascular, hepatic, respiratory, psychiatric, neurological, or other significant medical conditions, those outside the age/BMI ranges, or those recently in other drug trials are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the study could identify a safe dosing range and a pharmacokinetic profile to support further clinical development of QRL-101.

How similar studies have performed: Multiple ascending dose Phase 1 designs are a common and established way to characterize safety and pharmacokinetics, though this specific QRL-101 formulation is novel and not previously reported in human MAD data.

Eligibility criteria

Inclusion Criteria:

1. Age 18 to 65 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. Willing and able to practice effective contraception.

Exclusion Criteria:

1. 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.
2. Any participant in \>4 studies a year and/or has participated in a clinical trial within 1 month of the expected dosing date.
3. 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.

Where this trial is running

Groningen

• ICON plc. — Groningen, Netherlands (Recruiting)

Study contacts

• Study coordinator: QurAlis Corporation

Conditions Healthy Participant Study