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

NCT06532396 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-02-14

No results posted yet for this study

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

Interventions

DRUG

QRL-101

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

DRUG

Placebo

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

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
2024-07-01
Primary Completion
2024-12-20
Completion
2024-12-20

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

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 NCT06532396 on ClinicalTrials.gov