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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05667779
• Other study ID #: QRL-101-01
• Secondary ID: 2022-002484-30
• Status: Completed
• Phase: Phase 1
• Start date: December 22, 2022
• Est. completion date: December 27, 2023

Study information

• Verified date: April 2024
• Source: QurAlis Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 27, 2023
• Est. primary completion date: December 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

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.

*Other inclusion and exclusion criteria may apply*

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.

Locations

Country	Name	City	State
Netherlands	ICON plc. Van Swietenlaan 6	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
QurAlis Corporation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with one or more treatment emergent adverse events and serious adverse events.	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.	Baseline through Follow up (Day 10)
Secondary	Pharmacokinetics (plasma): Maximum observed concentration of QRL-101	Endpoint: Maximum observed concentration (Cmax) of QRL-101	Baseline through Follow up (Day 10)
Secondary	Pharmacokinetics (plasma): Area under the concentration time curve from 0 to 24 h (AUC 0-24h) of QRL-101	Endpoint: Area under the concentration time curve from zero to infinity (AUC 0-24h) of QRL-101	Baseline through Follow up (Day 10)
Secondary	Pharmacokinetics (plasma): Time of maximum concentration of QRL-101	Endpoint: Time of maximum concentration (Tmax) of QRL-101	Baseline through Follow up (Day 10)