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

QurAlis Corporation88 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteers

Interventions

QRL-101DRUG

Single-ascending doses of QRL-101 will be orally administered. The dose levels may change subject to available nonclinical, clinical, safety, and PK data.

PlaceboOTHER

A placebo comparator will be administered at all dose levels.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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\*

Locations (1)

ICON plc. Van Swietenlaan 6

Groningen, Netherlands

Outcomes

Primary Outcomes

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.

Time frame: Baseline through Follow up (Day 10)

Secondary Outcomes

Pharmacokinetics (plasma): Maximum observed concentration of QRL-101

Endpoint: Maximum observed concentration (Cmax) of QRL-101

Time frame: Baseline through Follow up (Day 10)

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

Time frame: Baseline through Follow up (Day 10)

Pharmacokinetics (plasma): Time of maximum concentration of QRL-101

Endpoint: Time of maximum concentration (Tmax) of QRL-101

Time frame: Baseline through Follow up (Day 10)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.