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| Name | Class |
|---|---|
| Centre for Human Drug Research, Netherlands | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group 1 | Experimental | Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over |
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| Treatment Group 2 | Experimental | Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over |
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| Treatment Group 3 | Experimental | Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over |
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| Treatment Group 4 | Experimental | Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over |
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| Treatment Group 5 | Experimental | Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QRL-101 Dose A | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Other Single pulse TMS-EMG MEP parameters | To compare two dose levels of QRL-101 versus placebo on cortical excitability | 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 |
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Inclusion Criteria:
Exclusion Criteria:
*Other inclusion and exclusion criteria may apply*
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| Name | Affiliation | Role |
|---|---|---|
| Philip Kremer, PharmD, MD, PhD | Centre for Human Drug Research | Principal Investigator |
| K. (Kaye) de Cuba,, MD | Centre for Human Drug Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Human Drug Research | Leiden | 2333 | Netherlands |
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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.
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A participant and investigator-blinded, randomized, placebo-controlled design will be used to minimize bias in this study.
| Treatment Group 6 | Experimental | Participants will be randomized into 1 of 6 treatment sequences in a 3-way cross-over |
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| QRL-101 Dose B | Drug | 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. |
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| Placebo | Drug | 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. |
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To compare two dose levels of QRL-101 versus placebo on spontaneous brain activity measured by resting state pharmaco-encephalography (pEEG) |
| 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 | 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 | 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. |