Back to resultsA Study Evaluating Safety, Tolerability, and Pharmacokinetics of QRL-101 in Healthy Participants
Primary Purpose
Healthy Volunteers
Status
Recruiting
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
QRL-101
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Healthy Volunteers focused on measuring Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA 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 CRITERIA 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. *Other inclusion and exclusion criteria may apply*
Sites / Locations
- ICON plc. Van Swietenlaan 6Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
QRL-101
Placebo
Arm Description
Single-ascending doses of QRL-101 will be administered orally to healthy participants
Single-ascending doses of comparator placebo will be administered orally to healthy participants
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Pharmacokinetics (plasma): Maximum observed concentration of QRL-101
Endpoint: Maximum observed concentration (Cmax) of QRL-101
Pharmacokinetics (plasma): Area under the concentration time curve from 0 to 24 h (AUC 0-24h) of QRL-101
Endpoint: Area under the concentration time curve from zero to infinity (AUC 0-24h) of QRL-101
Pharmacokinetics (plasma): Time of maximum concentration of QRL-101
Endpoint: Time of maximum concentration (Tmax) of QRL-101
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05667779
Brief Title
A Study Evaluating Safety, Tolerability, and Pharmacokinetics of QRL-101 in Healthy Participants
Official Title
A Randomized, Placebo-Controlled, Double-blind, Single Ascending Dose, First in Human Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of QRL-101 in Healthy Participants
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 22, 2022 (Actual)
Primary Completion Date
January 23, 2024 (Anticipated)
Study Completion Date
January 23, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
QurAlis Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Phase 1, single-site study to evaluate the safety, tolerability, and pharmacokinetics (PK) of ascending single doses of QRL-101 administered orally in healthy male and female participants. Up to 16 cohorts of 8 participants each, randomized 6:2 (QRL-101: placebo) will be tested. The approximate total duration of study participation for each participant may be up to 40 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers
Keywords
Healthy Volunteers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantInvestigator
Masking Description
A participant and investigator-blinded, randomized, placebo-controlled design will be used to minimize bias in this study.
Allocation
Randomized
Enrollment
128 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
QRL-101
Arm Type
Experimental
Arm Description
Single-ascending doses of QRL-101 will be administered orally to healthy participants
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single-ascending doses of comparator placebo will be administered orally to healthy participants
Intervention Type
Drug
Intervention Name(s)
QRL-101
Intervention Description
Single-ascending doses of QRL-101 will be orally administered. The dose levels may change subject to available nonclinical, clinical, safety, and PK data.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
A placebo comparator will be administered at all dose levels.
Primary Outcome Measure Information:
Title
Number of participants with one or more treatment emergent adverse events and serious adverse events.
Description
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.
Time Frame
Baseline through Follow up (Day 10)
Secondary Outcome Measure Information:
Title
Pharmacokinetics (plasma): Maximum observed concentration of QRL-101
Description
Endpoint: Maximum observed concentration (Cmax) of QRL-101
Time Frame
Baseline through Follow up (Day 10)
Title
Pharmacokinetics (plasma): Area under the concentration time curve from 0 to 24 h (AUC 0-24h) of QRL-101
Description
Endpoint: Area under the concentration time curve from zero to infinity (AUC 0-24h) of QRL-101
Time Frame
Baseline through Follow up (Day 10)
Title
Pharmacokinetics (plasma): Time of maximum concentration of QRL-101
Description
Endpoint: Time of maximum concentration (Tmax) of QRL-101
Time Frame
Baseline through Follow up (Day 10)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA
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 CRITERIA
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.
*Other inclusion and exclusion criteria may apply*
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
QurAlis Corporation
Phone
617-720-9566
Email
clinicaltrials@quralis.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salah Hadi, MD
Organizational Affiliation
ICON plc
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICON plc. Van Swietenlaan 6
City
Groningen
ZIP/Postal Code
9728 NZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdullah Almotawa, MD
12. IPD Sharing Statement
Learn more about this trial
A Study Evaluating Safety, Tolerability, and Pharmacokinetics of QRL-101 in Healthy Participants
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