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

QurAlis

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: QRL-101 Dose A; Drug: QRL-101 Dose B

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06681441

QRL-101-05

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

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*

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 6 patient groups

Treatment Group 1

Experimental group

Description:

Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over

Treatment:

Drug: QRL-101 Dose B

Drug: QRL-101 Dose A

Drug: Placebo

Treatment Group 2

Experimental group

Description:

Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over

Treatment:

Drug: QRL-101 Dose B

Drug: QRL-101 Dose A

Drug: Placebo

Treatment Group 3

Experimental group

Description:

Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over

Treatment:

Drug: QRL-101 Dose B

Drug: QRL-101 Dose A

Drug: Placebo

Treatment Group 4

Experimental group

Description:

Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over

Treatment:

Drug: QRL-101 Dose B

Drug: QRL-101 Dose A

Drug: Placebo

Treatment Group 5

Experimental group

Description:

Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over

Treatment:

Drug: QRL-101 Dose B

Drug: QRL-101 Dose A

Drug: Placebo

Treatment Group 6

Experimental group

Description:

Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over

Treatment:

Drug: QRL-101 Dose B

Drug: QRL-101 Dose A

Drug: Placebo