Clinical trial NCT06532396: A Study Evaluating Multiple Ascending Doses of QRL-101 in Healthy Participants
Official title: A Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of QRL-101 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers
QRL-101
Lead sponsor: QurAlis Corporation
Sponsor class: INDUSTRY
First posted: 2024-08-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be a randomized, double-blind, placebo-controlled multiple ascending dose (MAD) study in healthy participants with the primary goal of evaluating the safety and tolerability of QRL-101.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Number of participants with one or more treatment emergent adverse events and serious adverse events.
timeFrame: Baseline through Follow up (Day 10)
Secondary outcomes:
measure: Pharmacokinetics (plasma): Area under the concentration time curve during the dosing interval (AUCτ) of QRL-101
timeFrame: Baseline through Follow up Day 5
measure: Pharmacokinetics (plasma): Maximum observed concentration of QRL-101
timeFrame: Baseline through Follow up Day 5
measure: Pharmacokinetics (plasma): Time of maximum concentration of QRL-101
timeFrame: Baseline through Follow up Day 5
measure: Pharmacokinetics (plasma): Concentration of QRL-101 before the next dose
timeFrame: Baseline through Follow up Day 5
measure: Pharmacokinetics (plasma): Terminal elimination half-life of QRL-101
timeFrame: Baseline through Follow up Day 5
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: ICON plc. Van Swietenlaan 6
Study officials:
affiliation: ICON plc
name: Salah Hadi, MD
role: PRINCIPAL_INVESTIGATOR
References: