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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: QRL-101; Other: Placebo

• Registration Number: NCT05667779
• Lead Sponsor: QurAlis Corporation

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2022-12-19
• Study First Submitted QC: 2022-12-19
• Study Start: 2022-12-22
• Study First Posted: 2022-12-29
• Primary Completion: 2023-12-27
• Study Completion: 2023-12-27
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-12
• Last Update Posted: 2024-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QRL-101	QRL-101	Single-ascending doses of QRL-101 will be administered orally to healthy participants
Placebo	Placebo	Single-ascending doses of comparator placebo will be administered orally to healthy participants

Primary Outcome Measures

Name	Time	Method
Number of participants with one or more treatment emergent adverse events and serious adverse events.	Baseline through Follow up (Day 10)	Endpoints: A summary of treatment emergent adverse events (AEs), serious adverse events (SAEs), and other non-serious adverse events, regardless of causality, will be reported in the Reported Adverse Events module.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (plasma): Maximum observed concentration of QRL-101	Baseline through Follow up (Day 10)	Endpoint: Maximum observed concentration (Cmax) of QRL-101
Pharmacokinetics (plasma): Area under the concentration time curve from 0 to 24 h (AUC 0-24h) of QRL-101	Baseline through Follow up (Day 10)	Endpoint: Area under the concentration time curve from zero to infinity (AUC 0-24h) of QRL-101
Pharmacokinetics (plasma): Time of maximum concentration of QRL-101	Baseline through Follow up (Day 10)	Endpoint: Time of maximum concentration (Tmax) of QRL-101

Trial Locations

Locations (1)

ICON plc. Van Swietenlaan 6; 🇳🇱 Groningen, Netherlands