A 3-way Cross-over Study on the Effects of QRL-101 on Transcranial Magnetic Stimulation and Nerve Excitability in Healthy Participants

Phase 1

Recruiting

• Conditions: Healthy
• Interventions: Drug: QRL-101 Dose A; Drug: QRL-101 Dose B; Drug: Placebo

• Registration Number: NCT06681441
• Lead Sponsor: QurAlis Corporation

Brief 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 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Study Timeline

• Study Start: 2024-10-07
• Status Verified: 2024-11
• Study First Submitted: 2024-11-05
• Study First Submitted QC: 2024-11-06
• Last Update Submitted: 2024-11-06
• Study First Posted: 2024-11-08
• Last Update Posted: 2024-11-08
• Primary Completion: 2024-12-13
• Study Completion: 2024-12-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Males and postmenopausal women between the ages ≥ 18 and ≤ 55.
2. BMI ≥ 18.0 and ≤ 32.0 kg/m2, and body weight ≥ 50 kg, at screening.
3. Willing and able to practice effective contraception from the screening through at least 2 days after their last dose of study treatment.
4. Participants must be able to communicate effectively (in Dutch) with the study personnel and be willing to comply with the requirements of the study.

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Exclusion Criteria

1. 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.
2. History or presence of conditions which, in the judgment of the investigator, are known to interfere with drug absorption, distribution, metabolism, or excretion.
3. 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)
4. 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*

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment Group 5	QRL-101 Dose B	Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over
Treatment Group 1	QRL-101 Dose A	Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over
Treatment Group 1	QRL-101 Dose B	Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over
Treatment Group 1	Placebo	Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over
Treatment Group 2	QRL-101 Dose A	Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over
Treatment Group 2	QRL-101 Dose B	Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over
Treatment Group 2	Placebo	Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over
Treatment Group 3	QRL-101 Dose A	Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over
Treatment Group 3	QRL-101 Dose B	Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over
Treatment Group 3	Placebo	Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over
Treatment Group 4	QRL-101 Dose A	Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over
Treatment Group 4	QRL-101 Dose B	Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over
Treatment Group 4	Placebo	Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over
Treatment Group 5	QRL-101 Dose A	Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over
Treatment Group 5	Placebo	Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over
Treatment Group 6	QRL-101 Dose A	Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over
Treatment Group 6	QRL-101 Dose B	Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over
Treatment Group 6	Placebo	Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over

Primary Outcome Measures

Name	Time	Method
Single pulse TMS-EMG motor evoked potential (MEP) amplitude (μV) compared to placebo	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	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

Secondary Outcome Measures

Name	Time	Method
Other Single pulse TMS-EMG MEP parameters	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
pEEG: power in the alpha frequency bands in resting state with eyes open and closed	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 spontaneous brain activity measured by resting state pharmaco-encephalography (pEEG)
Incidence of AEs and SAEs	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.	Absolute values and changes from baseline values in vital signs, clinical laboratory tests, and ECG parameters
Plasma QRL-101 concentrations	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.	AUC0-24

Trial Locations

Locations (1)

Centre for Human Drug Research; 🇳🇱 Leiden, Netherlands