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

NCT06532396 | Completed Phase 1

• 1 other identifier: QRL-101-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers; QRL-101

Outcome Measures

Primary Outcomes (1)

• Number of participants with one or more treatment emergent adverse events and serious adverse events.

  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 Outcomes (5)

• Pharmacokinetics (plasma): Area under the concentration time curve during the dosing interval (AUCτ) of QRL-101

  Baseline through Follow up Day 5

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

  Baseline through Follow up Day 5

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

  Baseline through Follow up Day 5

• Pharmacokinetics (plasma): Concentration of QRL-101 before the next dose

  Baseline through Follow up Day 5

• Pharmacokinetics (plasma): Terminal elimination half-life of QRL-101

  Baseline through Follow up Day 5

Study Arms (2)

QRL-101

EXPERIMENTAL

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

Drug: QRL-101

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

QRL-101 DRUG

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

QRL-101

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 70 years of age inclusive at the time of signing the informed consent.
• Clinical chemistry laboratory values within acceptable range for the population, as per investigator judgment.
• Body mass index of 18 to 32 kg/m2 (inclusive).
• Willing and able to practice effective contraception.

You may not qualify if:

• 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.
• Any participant in \>4 studies a year and/or has participated in a clinical trial within 1 month of expected dosing date.
• 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.

Sponsors & Collaborators

• QurAlis Corporation: lead

Study Sites (1)

ICON plc. Van Swietenlaan 6

Groningen, 9728 NZ, Netherlands

Location

Study Officials

• Salah Hadi, MD

  ICON plc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: A participant and investigator-blinded, randomized, placebo-controlled design will be used to minimize bias in this study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: July 1, 2024
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

NL (1)