Status:
COMPLETED
A Study Evaluating Multiple Ascending Doses of QRL-101 in Healthy Participants
Lead Sponsor:
QurAlis Corporation
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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, a...
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, randomize...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06532396
Start Date
July 1 2024
End Date
December 20 2024
Last Update
February 14 2025
Active Locations (1)
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1
ICON plc. Van Swietenlaan 6
Groningen, Netherlands, 9728 NZ