HealthyPhase 1NCT06681441
A 3-way Cross-over Study on the Effects of QRL-101 on Transcranial Magnetic Stimulation and Nerve Excitability in Healthy Participants
A Phase 1 study testing QRL-101 Dose A and QRL-101 Dose B in people with Healthy, run by QurAlis Corporation at 1 site in Netherlands.
Trial summary
This is a phase I, prospective, single-center, randomized, double-blind, placebo-controlled, three-way cross-over study to evaluate the safety and tolerability of QRL-101 and investigate the pharmacodynamic effects of two dose levels of QRL-101 on transcranial magnetic stimulation (TMS) and nerve excitability… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- QRL-101 Dose A and QRL-101 Dose B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Oct 2024to 24 Dec 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and postmenopausal women between the ages ≥ 18 and ≤ 55.
- BMI ≥ 18.0 and ≤ 32.0 kg/m2, and body weight ≥ 50 kg, at screening.
- Willing and able to practice effective contraception from the screening through at least 2 days after their last dose of study treatment.
- Participants must be able to communicate effectively (in Dutch) with the study personnel and be willing to comply with the requirements of the study.
Who cannot join
- Evidence of any acute or chronic disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study.
- History or presence of conditions which, in the judgment of the investigator, are known to interfere with drug absorption, distribution, metabolism, or excretion.
- History or presence of conditions which might increase the risk of performing TMS (e.g., epilepsy, febrile seizures, intracranial mass lesion, hydrocephalus, clinically significant head injury or trauma, metal objects in the brain or skull, cochlear implant or a deep brain stimulation device)
- Any condition that could interfere with the quality of, or ability to perform, TMS (e.g., an abnormal sleeping pattern, unremovable dreadlocks or hairpieces, or a resting motor threshold (rMT) of more than 75%.
- Other inclusion and exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double-blind, Placebo-controlled, 3-way Cross-over Study to Assess the Pharmacodynamic Effects of Two-dose Levels of QRL-101 on Transcranial Magnetic Stimulation and Nerve Excitability Threshold Tracking in Healthy Participants
This is a phase I, prospective, single-center, randomized, double-blind, placebo-controlled, three-way cross-over study to evaluate the safety and tolerability of QRL-101 and investigate the pharmacodynamic effects of two dose levels of QRL-101 on transcranial magnetic stimulation (TMS) and nerve excitability threshold tracking (NETT) in healthy participants.
After screening and training, participants will be randomized to one of six treatment sequences of William's square balanced for first-order carry-over design consisting of two doses of QRL-101 or placebo, with at least seven days between each treatment.
- Conditions
- Healthy
- Being tested
- QRL-101 Dose A, QRL-101 Dose B, Placebo
- Keywords
- QRL-101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QRL-101 Dose ADrug
All participants will receive three single-dose oral administrations in randomized order, scheduled across three separate study visits, with a 7-day washout period between each visit.
QRL-101 Dose BDrug
All participants will receive three single-dose oral administrations in randomized order, scheduled across three separate study visits, with a 7-day washout period between each visit.
PlaceboDrug
All participants will receive three single-dose oral administrations in randomized order, scheduled across three separate study visits, with a 7-day washout period between each visit.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1 | Experimental | Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over Receives: Drug: QRL-101 Dose A; Drug: QRL-101 Dose B; Drug: Placebo |
| Treatment Group 2 | Experimental | Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over Receives: Drug: QRL-101 Dose A; Drug: QRL-101 Dose B; Drug: Placebo |
| Treatment Group 3 | Experimental | Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over Receives: Drug: QRL-101 Dose A; Drug: QRL-101 Dose B; Drug: Placebo |
| Treatment Group 4 | Experimental | Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over Receives: Drug: QRL-101 Dose A; Drug: QRL-101 Dose B; Drug: Placebo |
| Treatment Group 5 | Experimental | Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over Receives: Drug: QRL-101 Dose A; Drug: QRL-101 Dose B; Drug: Placebo |
| Treatment Group 6 | Experimental | Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over Receives: Drug: QRL-101 Dose A; Drug: QRL-101 Dose B; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single pulse TMS-EMG motor evoked potential (MEP) amplitude (μV) compared to placebo
To compare two dose levels of QRL-101 versus placebo on cortical excitability
Measured: 3 study periods, with a washout period of at least 7 days between each visit. Each study period consists of 2 nights and 1 study day.
mNETT strength-duration time constant (SDTC) compared to placebo SDTC
To compare two dose levels of QRL-101 versus placebo on peripheral motor nerve excitability
Measured: 3 study periods, with a washout period of at least 7 days between each visit. Each study period consists of 2 nights and 1 study day.
Secondary outcomes (4)
Other Single pulse TMS-EMG MEP parameters
To compare two dose levels of QRL-101 versus placebo on cortical excitability
Measured: 3 study periods, with a washout period of at least 7 days between each visit. Each study period consists of 2 nights and 1 study day.
pEEG: power in the alpha frequency bands in resting state with eyes open and closed
To compare two dose levels of QRL-101 versus placebo on spontaneous brain activity measured by resting state pharmaco-encephalography (pEEG)
Measured: 3 study periods, with a washout period of at least 7 days between each visit. Each study period consists of 2 nights and 1 study day.
Incidence of AEs and SAEs
Absolute values and changes from baseline values in vital signs, clinical laboratory tests, and ECG parameters
Measured: 3 study periods, with a washout period of at least 7 days between each visit. Each study period consists of 2 nights and 1 study day.
Plasma QRL-101 concentrations
AUC0-24
Measured: 3 study periods, with a washout period of at least 7 days between each visit. Each study period consists of 2 nights and 1 study day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start7 Oct 2024
- Primary completion24 Dec 2024
- Study completion24 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Crossover
- Model description
- This is a randomized, double-blind, placebo-controlled, 3-way cross-over, single-dose study to investigate the effects of QRL-101 on TMS-EMG-EEG, mNETT, and pEEG in healthy participants.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- QurAlis Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre for Human Drug Research, Netherlands
- Responsible party
- Sponsor
- Investigators
- Philip Kremer, PharmD, MD, PhD, Principal investigator, Centre for Human Drug ResearchK. (Kaye) de Cuba,, MD, Principal investigator, Centre for Human Drug Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681441
- Sponsor's protocol ID
- QRL-101-05
- Status last verified
- Mar 2025
- First submitted
- 5 Nov 2024
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-blind, Placebo-controlled, 3-way Cross-over Study to Assess the Pharmacodynamic Effects of Two-dose Levels of QRL-101 on Transcranial Magnetic Stimulation and Nerve Excitability Threshold Tracking in Healthy Participants
- ClinicalTrials.gov ID
- NCT06681441
- Acronym / sponsor ID
- QRL-101-05
- Conditions
- Healthy
- Keywords
- QRL-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- QurAlis CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Centre for Human Drug Research, Netherlands
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 24 Dec 2024 (actual)
- Study completion
- 24 Dec 2024 (actual)
- First posted
- 8 Nov 2024 (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 is a phase I, prospective, single-center, randomized, double-blind, placebo-controlled, three-way cross-over study to evaluate the safety and tolerability of QRL-101 and investigate the pharmacodynamic effects of two dose levels of QRL-101 on transcranial magnetic stimulation (TMS) and nerve excitability threshold tracking (NETT) in healthy participants.
After screening and training, participants will be randomized to one of six treatment sequences of William's square balanced for first-order carry-over design consisting of two doses of QRL-101 or placebo, with at least seven days between each treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- This is a randomized, double-blind, placebo-controlled, 3-way cross-over, single-dose study to investigate the effects of QRL-101 on TMS-EMG-EEG, mNETT, and pEEG in healthy participants.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1 | Experimental | Drug: QRL-101 Dose A, Drug: QRL-101 Dose B, Drug: PlaceboParticipants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over |
| Treatment Group 2 | Experimental | Drug: QRL-101 Dose A, Drug: QRL-101 Dose B, Drug: PlaceboParticipants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over |
| Treatment Group 3 | Experimental | Drug: QRL-101 Dose A, Drug: QRL-101 Dose B, Drug: PlaceboParticipants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over |
| Treatment Group 4 | Experimental | Drug: QRL-101 Dose A, Drug: QRL-101 Dose B, Drug: PlaceboParticipants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over |
| Treatment Group 5 | Experimental | Drug: QRL-101 Dose A, Drug: QRL-101 Dose B, Drug: PlaceboParticipants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over |
| Treatment Group 6 | Experimental | Drug: QRL-101 Dose A, Drug: QRL-101 Dose B, Drug: PlaceboParticipants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males and postmenopausal women between the ages ≥ 18 and ≤ 55.
- BMI ≥ 18.0 and ≤ 32.0 kg/m2, and body weight ≥ 50 kg, at screening.
- Willing and able to practice effective contraception from the screening through at least 2 days after their last dose of study treatment.
- Participants must be able to communicate effectively (in Dutch) with the study personnel and be willing to comply with the requirements of the study.
Key exclusion criteria (5 listed)
- Evidence of any acute or chronic disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study.
- History or presence of conditions which, in the judgment of the investigator, are known to interfere with drug absorption, distribution, metabolism, or excretion.
- History or presence of conditions which might increase the risk of performing TMS (e.g., epilepsy, febrile seizures, intracranial mass lesion, hydrocephalus, clinically significant head injury or trauma, metal objects in the brain or skull, cochlear implant or a deep brain stimulation device)
- Any condition that could interfere with the quality of, or ability to perform, TMS (e.g., an abnormal sleeping pattern, unremovable dreadlocks or hairpieces, or a resting motor threshold (rMT) of more than 75%.
- Other inclusion and exclusion criteria may apply
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-101 Dose AAll participants will receive three single-dose oral administrations in randomized order, scheduled across three separate study visits, with a 7-day washout period between each visit. | Drug | Treatment Group 1, Treatment Group 2, Treatment Group 3, Treatment Group 4, Treatment Group 5, Treatment Group 6 |
| QRL-101 Dose BAll participants will receive three single-dose oral administrations in randomized order, scheduled across three separate study visits, with a 7-day washout period between each visit. | Drug | Treatment Group 1, Treatment Group 2, Treatment Group 3, Treatment Group 4, Treatment Group 5, Treatment Group 6 |
| PlaceboAll participants will receive three single-dose oral administrations in randomized order, scheduled across three separate study visits, with a 7-day washout period between each visit. | Drug | Treatment Group 1, Treatment Group 2, Treatment Group 3, Treatment Group 4, Treatment Group 5, Treatment Group 6 |
Primary outcome
Single pulse TMS-EMG motor evoked potential (MEP) amplitude (μV) compared to placebo
Time frame: 3 study periods, with a washout period of at least 7 days between each visit. Each study period consists of 2 nights and 1 study day.
To compare two dose levels of QRL-101 versus placebo on cortical excitability
mNETT strength-duration time constant (SDTC) compared to placebo SDTC
Time frame: 3 study periods, with a washout period of at least 7 days between each visit. Each study period consists of 2 nights and 1 study day.
To compare two dose levels of QRL-101 versus placebo on peripheral motor nerve excitability
4 secondary outcomes
Other Single pulse TMS-EMG MEP parameters
Time frame: 3 study periods, with a washout period of at least 7 days between each visit. Each study period consists of 2 nights and 1 study day.
pEEG: power in the alpha frequency bands in resting state with eyes open and closed
Time frame: 3 study periods, with a washout period of at least 7 days between each visit. Each study period consists of 2 nights and 1 study day.
Incidence of AEs and SAEs
Time frame: 3 study periods, with a washout period of at least 7 days between each visit. Each study period consists of 2 nights and 1 study day.
Plasma QRL-101 concentrations
Time frame: 3 study periods, with a washout period of at least 7 days between each visit. Each study period consists of 2 nights and 1 study day.
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 25 Mar 2025.
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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.
Philip Kremer, PharmD, MD, PhD principal investigator
Centre for Human Drug Research
K. (Kaye) de Cuba,, MD principal investigator
Centre for Human Drug Research
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 Dose A and QRL-101 Dose B in people with Healthy, 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 5 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 25 Mar 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?
Single pulse TMS-EMG motor evoked potential (MEP) amplitude (μV) compared to placebo (time frame: 3 study periods, with a washout period of at least 7 days between each visit. Each study period consists of 2 nights and 1 study day.). The study lists 2 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 25 Mar 2025.