NCT07421778

A Multiple Ascending Dose Study Evaluating the Safety and Tolerability of a Novel Formulation of QRL-101 in Healthy Participants

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: QurAlis Corporation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy Participant Study

Interventions

Type	Name	Description
DRUG	QRL-101	Multiple-ascending doses of QRL-101 will be orally administered to healthy participants.
DRUG	Placebo	Multiple-ascending doses of comparator placebo will be administered orally to healthy participants.

Timeline

• Start date: 2026-02-02
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2026-02-19
• Last updated: 2026-02-19

Locations

1 site across 1 country: Netherlands