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

QurAlis

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: QRL-101; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05667779

QRL-101-01

2022-002484-30 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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*

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 2 patient groups, including a placebo group

QRL-101

Experimental group

Description:

Single-ascending doses of QRL-101 will be administered orally to healthy participants

Treatment:

Drug: QRL-101

Placebo

Placebo Comparator group

Description:

Single-ascending doses of comparator placebo will be administered orally to healthy participants

Treatment:

Other: Placebo