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

NCT05667779 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2024-04-15

No results posted yet for this study

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

Interventions

DRUG

QRL-101

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

OTHER

Placebo

A placebo comparator will be administered at all dose levels.

Sponsors & Collaborators

  • QurAlis Corporation

    lead INDUSTRY

Principal Investigators

  • Salah Hadi, MD · ICON plc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-22
Primary Completion
2023-12-27
Completion
2023-12-27

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05667779 on ClinicalTrials.gov