NCT06532396

A Study Evaluating Multiple Ascending Doses of QRL-101 in Healthy Participants

A Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of QRL-101 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: QurAlis Corporation · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

QRL-101-03 is a multiple ascending dose (MAD) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of QRL-101 in healthy participants. QRL-101-03 is a follow-on study to QRL-101-01, an ongoing Phase 1, single ascending dose study to determine the safety, tolerability, and PK profile of QRL-101 after a single dose (ClinicalTrials.gov ID: NCT05667779).

Detailed description

Phase 1, single-site, multiple-dose study to evaluate the safety, tolerability, and PK of multiple ascending doses of QRL-101 in healthy participants. Up to 5 cohorts of 8 participants each, randomized 6:2 (QRL-101: placebo) will be tested. The approximate total duration of study participation for each participant may be up to 39 days.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	QRL-101	Multiple-ascending doses of QRL-101 will be orally administered. The dose levels may change subject to available nonclinical, clinical, safety, and PK data.
DRUG	Placebo	Multiple-ascending doses of comparator placebo will be administered orally to healthy participants.

Timeline

• Start date: 2024-07-01
• Primary completion: 2024-12-20
• Completion: 2024-12-20
• First posted: 2024-08-01
• Last updated: 2025-02-14

Locations

1 site across 1 country: Netherlands