NCT05667779

A Study Evaluating Safety, Tolerability, and Pharmacokinetics of QRL-101 in Healthy Participants

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: QurAlis Corporation · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of ascending single doses of QRL-101 in male and female healthy participants. The findings from this study will be used to inform the development of QRL-101 for people living with ALS.

Detailed description

Phase 1, single-site study to evaluate the safety, tolerability, and pharmacokinetics (PK) of ascending single doses of QRL-101 administered orally in healthy male and female participants. Up to 16 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 40 days.

Conditions

• Healthy Volunteers

Interventions

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

Timeline

• Start date: 2022-12-22
• Primary completion: 2023-12-27
• Completion: 2023-12-27
• First posted: 2022-12-29
• Last updated: 2024-04-15

Locations

1 site across 1 country: Netherlands