drugset / Trial / NCT06681441
A 3-way Cross-over Study on the Effects of QRL-101 on Transcranial Magnetic Stimulation and Nerve Excitability in Healthy Participants
Phase 1
Completed
24 enrolled
QurAlis Corporation
Centre for Human Drug Research, Netherlands · collab
RandomizedCrossoverDouble-blindTreatment
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.
Timeline
- Start
- 2024-10-07
- Primary completion
- 2024-12-24
- Completion
- 2024-12-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | QRL-101 | Unknown | — | Oral |
Indications
No indication recorded.