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

NCT05667779 | Completed Phase 1

• 2 other identifiers: QRL-101-012022-002484-30
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  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

  Baseline through Follow up (Day 10)

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

  Baseline through Follow up (Day 10)

Study Arms (2)

QRL-101

EXPERIMENTAL

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

Drug: QRL-101

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

QRL-101 DRUG

Single-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 OTHER

A placebo comparator will be administered at all dose levels.

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 single ascending dose (SAD) study in healthy participants with the primary goal of evaluating the safety and tolerability of QRL-101.

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: December 29, 2022
• Study Start: December 22, 2022
• Primary Completion: December 27, 2023
• Study Completion: December 27, 2023
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

NL (1)