Healthy VolunteersPhase 1NCT06877624
A Study Evaluating the Pharmacokinetics of Three QRL-101 Formulations in Healthy Participants
A Phase 1 study testing QRL-101 in people with Healthy Volunteers, run by QurAlis Corporation at 1 site in Netherlands.
Trial summary
This study aims to evaluate the pharmacokinetics of three QRL-101 formulations in a fasted condition or in the presence of a high-fat meal in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- QRL-101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Jan 2025to 15 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 the 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Single Dose, Cross-Over Study to Evaluate the Pharmacokinetics of Three QRL-101 Formulations in a Fasted Condition or in the Presence of a High Fat Meal in Healthy Participants
This study aims to evaluate the pharmacokinetics of three QRL-101 formulations in a fasted condition or in the presence of a high-fat meal in healthy participants.
Read the detailed description
This is a randomized, open-label, single-dose, crossover study to evaluate the PK of three formulations of QRL-101 beginning in a fasted condition before moving to a fed cross-over design. Approximately 24 healthy participants will be enrolled in a 3-formulation, 4-period, 6-sequence crossover study design to evaluate the PK characteristics of three formulations of QRL-101.
- Conditions
- Healthy Volunteers
- Being tested
- QRL-101
- Keywords
- Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QRL-101Drug
This cross-over design study will evaluate three formulations (Formulations 1, 2, and 3) of QRL-101, beginning in a fasted condition before moving to a fed cross-over design.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence 1 (Formulation 1, 2, and 3) | Experimental | Participants randomized to Treatment Sequence 1 will receive Formulation 1 in the fasted condition in Treatment Period 1, followed by Formulation 1, 2, and 3 in the presence of a high-fat meal in Treatment Periods 2 through 4, respectively. Receives: Drug: QRL-101 |
| Treatment Sequence 2 (Formulation 2, 3, and 1) | Experimental | Participants randomized to Treatment Sequence 2 will receive Formulation 2 in the fasted condition in Treatment Period 1, followed by Formulation 2, 3, and 1 in the presence of a high-fat meal in Treatment Periods 2 through 4, respectively. Receives: Drug: QRL-101 |
| Treatment Sequence 3 (Formulation 3, 1, and 2) | Experimental | Participants randomized to Treatment Sequence 3 will receive Formulation 3 in the fasted condition in Treatment Period 1, followed by Formulation 3, 1, and 2 in the presence of a high-fat meal in Treatment Periods 2 through 4, respectively. Receives: Drug: QRL-101 |
| Treatment Sequence 4 (Formulation 2, 1, and 3) | Experimental | Participants randomized to Treatment Sequence 4 will receive Formulation 1 in the fasted condition in Treatment Period 1, followed by Formulation 1, 3, and 2 in the presence of a high-fat meal in Treatment Periods 2 through 4, respectively. Receives: Drug: QRL-101 |
| Treatment Sequence 5 (Formulation 2, 1, and 3) | Experimental | Participants randomized to Treatment Sequence 5 will receive Formulation 2 in the fasted condition in Treatment Period 1, followed by Formulation 2, 1, and 3 in the presence of a high-fat meal in Treatment Periods 2 through 4, respectively. Receives: Drug: QRL-101 |
| Treatment Sequence 6 (Formulation 3, 2, and 1) | Experimental | Participants randomized to Treatment Sequence 6 will receive Formulation 3 in the fasted condition in Treatment Period 1, followed by Formulation 3, 2, and 1 in the presence of a high-fat meal in Treatment Periods 2 through 4, respectively. Receives: Drug: QRL-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma PK profile (AUCinf)
The area under the curve to infinity
Measured: Baseline through Follow up (Day 9)
Plasma PK profile (AUClast)
The area under the curve to the last measurable time point
Measured: Baseline through Follow up (Day 9)
Plasma PK profile (Cmax)
Maximum concentration observed
Measured: Baseline through Follow up (Day 9)
Plasma PK profile (Ctrough)
Trough level concentration for defined dose regimen
Measured: Baseline through Follow up (Day 9)
Plasma PK profile (Tmax)
The time to peak drug concentration
Measured: Baseline through Follow up (Day 9)
Secondary outcomes (1)
Safety and tolerability
Adverse events (AEs) and serious adverse events (SAEs)
Measured: Baseline through Follow up (Day 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start10 Jan 2025
- Primary completion15 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be a randomized, open-label, single-dose, cross-over study to evaluate the pharmacokinetics of 3 QRL-101 formulations in a fasted condition or in the presence of a high-fat meal in healthy participants.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- QurAlis Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Salah Hadi, MD, Principal investigator, ICON plc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877624
- Sponsor's protocol ID
- QRL-101-06
- Status last verified
- Aug 2025
- First submitted
- 5 Mar 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Single Dose, Cross-Over Study to Evaluate the Pharmacokinetics of Three QRL-101 Formulations in a Fasted Condition or in the Presence of a High Fat Meal in Healthy Participants
- ClinicalTrials.gov ID
- NCT06877624
- Acronym / sponsor ID
- QRL-101-06
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- QurAlis CorporationIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the pharmacokinetics of three QRL-101 formulations in a fasted condition or in the presence of a high-fat meal in healthy participants.
Detailed description
This is a randomized, open-label, single-dose, crossover study to evaluate the PK of three formulations of QRL-101 beginning in a fasted condition before moving to a fed cross-over design. Approximately 24 healthy participants will be enrolled in a 3-formulation, 4-period, 6-sequence crossover study design to evaluate the PK characteristics of three formulations of QRL-101.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- This study will be a randomized, open-label, single-dose, cross-over study to evaluate the pharmacokinetics of 3 QRL-101 formulations in a fasted condition or in the presence of a high-fat meal in healthy participants.
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence 1 (Formulation 1, 2, and 3) | Experimental | Drug: QRL-101Participants randomized to Treatment Sequence 1 will receive Formulation 1 in the fasted condition in Treatment Period 1, followed by Formulation 1, 2, and 3 in the presence of a high-fat meal in Treatment Periods 2 through 4, respectively. |
| Treatment Sequence 2 (Formulation 2, 3, and 1) | Experimental | Drug: QRL-101Participants randomized to Treatment Sequence 2 will receive Formulation 2 in the fasted condition in Treatment Period 1, followed by Formulation 2, 3, and 1 in the presence of a high-fat meal in Treatment Periods 2 through 4, respectively. |
| Treatment Sequence 3 (Formulation 3, 1, and 2) | Experimental | Drug: QRL-101Participants randomized to Treatment Sequence 3 will receive Formulation 3 in the fasted condition in Treatment Period 1, followed by Formulation 3, 1, and 2 in the presence of a high-fat meal in Treatment Periods 2 through 4, respectively. |
| Treatment Sequence 4 (Formulation 2, 1, and 3) | Experimental | Drug: QRL-101Participants randomized to Treatment Sequence 4 will receive Formulation 1 in the fasted condition in Treatment Period 1, followed by Formulation 1, 3, and 2 in the presence of a high-fat meal in Treatment Periods 2 through 4, respectively. |
| Treatment Sequence 5 (Formulation 2, 1, and 3) | Experimental | Drug: QRL-101Participants randomized to Treatment Sequence 5 will receive Formulation 2 in the fasted condition in Treatment Period 1, followed by Formulation 2, 1, and 3 in the presence of a high-fat meal in Treatment Periods 2 through 4, respectively. |
| Treatment Sequence 6 (Formulation 3, 2, and 1) | Experimental | Drug: QRL-101Participants randomized to Treatment Sequence 6 will receive Formulation 3 in the fasted condition in Treatment Period 1, followed by Formulation 3, 2, and 1 in the presence of a high-fat meal in Treatment Periods 2 through 4, respectively. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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 the 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QRL-101This cross-over design study will evaluate three formulations (Formulations 1, 2, and 3) of QRL-101, beginning in a fasted condition before moving to a fed cross-over design. | Drug | Treatment Sequence 1 (Formulation 1, 2, and 3), Treatment Sequence 2 (Formulation 2, 3, and 1), Treatment Sequence 3 (Formulation 3, 1, and 2), Treatment Sequence 4 (Formulation 2, 1, and 3), Treatment Sequence 5 (Formulation 2, 1, and 3), Treatment Sequence 6 (Formulation 3, 2, and 1) |
Primary outcome
Plasma PK profile (AUCinf)
Time frame: Baseline through Follow up (Day 9)
The area under the curve to infinity
Plasma PK profile (AUClast)
Time frame: Baseline through Follow up (Day 9)
The area under the curve to the last measurable time point
Plasma PK profile (Cmax)
Time frame: Baseline through Follow up (Day 9)
Maximum concentration observed
Plasma PK profile (Ctrough)
Time frame: Baseline through Follow up (Day 9)
Trough level concentration for defined dose regimen
Plasma PK profile (Tmax)
Time frame: Baseline through Follow up (Day 9)
The time to peak drug concentration
1 secondary outcome
Safety and tolerability
Time frame: Baseline through Follow up (Day 9)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salah Hadi, MD principal investigator
ICON plc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QRL-101 in people with Healthy Volunteers, run by QurAlis Corporation at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma PK profile (AUCinf) (time frame: Baseline through Follow up (Day 9)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.