Healthy Participant StudyPhase 1NCT07421778
A Multiple Ascending Dose Study Evaluating the Safety and Tolerability of a Novel Formulation of QRL-101 in Healthy Participants
A Phase 1 study testing QRL-101 in people with Healthy Participant Study, run by QurAlis Corporation at 1 site in Netherlands.
Trial summary
QRL-101-08 is a multiple ascending dose (MAD) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of a novel formulation of QRL-101 in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participant Study
- What is being tested?
- QRL-101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Feb 2026to 31 Aug 2026
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 65 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, Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Novel Formulation of QRL-101 in Healthy Participants
QRL-101-08 is a multiple ascending dose (MAD) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of a novel formulation of QRL-101 in healthy participants.
Read the detailed description
Phase 1, single-site, multiple dose study to evaluate the safety, tolerability, and PK of a novel formulation of QRL-101 in healthy participants. Up to 4 cohorts of 12 participants each, randomized 9:3 (QRL-101:placebo) will be tested. The approximate total duration of study participation for each participant may be up to 59 days.
- Conditions
- Healthy Participant Study
- Being tested
- QRL-101, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QRL-101Drug
Multiple-ascending doses of QRL-101 will be orally administered to healthy participants.
PlaceboDrug
Multiple-ascending doses of comparator placebo will be administered orally to healthy participants.
| Study group | Role | What they receive |
|---|---|---|
| QRL-101 | Experimental | Not described Receives: Drug: QRL-101 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Number of participants with one or more treatment emergent adverse events and serious adverse events.
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.
Measured: Baseline through Follow up (Day 29)
Secondary outcomes (10)
Pharmacokinetics (plasma): Area under the concentration time curve during the dosing interval (AUCτ) of QRL-101
Area under the concentration time curve during the dosing interval (AUCτ) of QRL-101
Measured: Time Frame: Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Maximum observed concentration of QRL-101
Maximum observed concentration (Cmax) of QRL-101
Measured: Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Time of maximum concentration of QRL-101
Time of maximum concentration (Tmax) of QRL-101
Measured: Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Concentration of QRL-101 before the next dose
Concentration of QRL-101 reached by a drug immediately before the next dose
Measured: Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Terminal elimination half-life of QRL-101
Terminal elimination half-life of QRL-101
Measured: Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Area under the concentration time curve during the dosing interval (AUCτ) of QRL-101 major metabolites
Area under the concentration time curve during the dosing interval (AUCτ) of QRL-101 major metabolites
Measured: Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Maximum observed concentration of QRL-101 major metabolites
Maximum observed concentration (Cmax) of QRL-101 major metabolites
Measured: Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Time of maximum concentration of QRL-101 major metabolites
Time of maximum concentration (Tmax) of QRL-101 major metabolites
Measured: Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Concentration of QRL-101 major metabolites before the next dose
Concentration of QRL-101 major metabolites reached by a drug immediately before the next dose
Measured: Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Terminal elimination half-life of QRL-101 major metabolites
Terminal elimination half-life of QRL-101 major metabolites
Measured: Baseline through Follow up (Day 29)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start2 Feb 2026
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Participant StudyStudies 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, double-blind, placebo-controlled multiple ascending dose (MAD) study in healthy participants with the primary goal of evaluating the safety, tolerability, and PK of a novel formulation of QRL-101.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- QurAlis Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421778
- Sponsor's protocol ID
- QRL-101-08
- Other IDs
- 2025-524310-28-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 12 Feb 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Novel Formulation of QRL-101 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07421778
- Acronym / sponsor ID
- QRL-101-08
- Conditions
- Healthy Participant Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- QurAlis CorporationIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 19 Feb 2026 (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.
QRL-101-08 is a multiple ascending dose (MAD) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of a novel formulation of QRL-101 in healthy participants.
Detailed description
Phase 1, single-site, multiple dose study to evaluate the safety, tolerability, and PK of a novel formulation of QRL-101 in healthy participants. Up to 4 cohorts of 12 participants each, randomized 9:3 (QRL-101:placebo) will be tested. The approximate total duration of study participation for each participant may be up to 59 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This study will be a randomized, double-blind, placebo-controlled multiple ascending dose (MAD) study in healthy participants with the primary goal of evaluating the safety, tolerability, and PK of a novel formulation of QRL-101.
| Arm | Type | Receives |
|---|---|---|
| QRL-101 | Experimental | Drug: QRL-101 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 65 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-101Multiple-ascending doses of QRL-101 will be orally administered to healthy participants. | Drug | QRL-101 |
| PlaceboMultiple-ascending doses of comparator placebo will be administered orally to healthy participants. | Drug | Placebo |
Primary outcome
Safety and tolerability
Time frame: Baseline through Follow up (Day 29)
Number of participants with one or more treatment emergent adverse events and serious adverse events. 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.
10 secondary outcomes
Pharmacokinetics (plasma): Area under the concentration time curve during the dosing interval (AUCτ) of QRL-101
Time frame: Time Frame: Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Maximum observed concentration of QRL-101
Time frame: Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Time of maximum concentration of QRL-101
Time frame: Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Concentration of QRL-101 before the next dose
Time frame: Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Terminal elimination half-life of QRL-101
Time frame: Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Area under the concentration time curve during the dosing interval (AUCτ) of QRL-101 major metabolites
Time frame: Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Maximum observed concentration of QRL-101 major metabolites
Time frame: Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Time of maximum concentration of QRL-101 major metabolites
Time frame: Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Concentration of QRL-101 major metabolites before the next dose
Time frame: Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Terminal elimination half-life of QRL-101 major metabolites
Time frame: Baseline through Follow up (Day 29)
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 6 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Participant Study, 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 6 Oct 2026. 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. Some participants in this study may receive a placebo. 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?
Safety and tolerability (time frame: Baseline through Follow up (Day 29)). 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 6 Oct 2026.