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

Phase 1

Recruiting

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

• Registration Number: NCT06532396
• Lead Sponsor: QurAlis Corporation

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07-01
• Study First Submitted: 2024-07-29
• Study First Submitted QC: 2024-07-29
• Last Update Submitted: 2024-07-29
• Study First Posted: 2024-08-01
• Last Update Posted: 2024-08-01
• Primary Completion: 2024-12-20
• Study Completion: 2024-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Age 18 to 70 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.

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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 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Multiple-ascending doses of comparator placebo will be administered orally to healthy participants.
QRL-101	QRL-101	Multiple-ascending doses of QRL-101 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)	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): Area under the concentration time curve during the dosing interval (AUCτ) of QRL-101	Baseline through Follow up Day 5	Area under the concentration time curve during the dosing interval (AUCτ) of QRL-101
Pharmacokinetics (plasma): Concentration of QRL-101 before the next dose	Baseline through Follow up Day 5	Concentration of QRL-101 reached by a drug immediately before the next dose
Pharmacokinetics (plasma): Terminal elimination half-life of QRL-101	Baseline through Follow up Day 5	Terminal elimination half-life of QRL-101
Pharmacokinetics (plasma): Maximum observed concentration of QRL-101	Baseline through Follow up Day 5	Maximum observed concentration (Cmax) of QRL-101
Pharmacokinetics (plasma): Time of maximum concentration of QRL-101	Baseline through Follow up Day 5	Time of maximum concentration (Tmax) of QRL-101

Trial Locations

Locations (1)

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