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This study is a randomized, double-blind, placebo-controlled clinical trial featuring both single ascending dose (SAD), food effect and multiple ascending dose (MAD) phases intended to evaluate the safety, tolerability, PK, PD, and active metabolites of LWP779 after oral administration in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Dose - 150 mg | Experimental |
| |
| Single Ascending Dose - 300 mg | Experimental |
| |
| Single Ascending Dose - 600 mg | Experimental |
| |
| Single Ascending Dose - 900 mg | Experimental |
| |
| Single Ascending Dose - 1200 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LWP779 | Drug | Active |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and proportion of participants with a treatment-emergent adverse event (TEAE) | From baseline to Day 7 (±1) for SAD, baseline to Day16 (±2) for FE, baseline to Day 14 (± 2) for MAD | |
| 12-lead electrocardiogram (ECG) (QT Interval) | From baseline to Day 7 (±1) for SAD, baseline to Day16 (±2) for FE, baseline to Day 14 (± 2) for MAD | |
| Number of participants with abnormal vital signs | From baseline to Day 7 (±1) for SAD, baseline to Day16 (±2) for FE, baseline to Day 14 (± 2) for MAD | |
| Number of participants with abnormal physical examination findings | From baseline to Day 7 (±1) for SAD, baseline to Day16 (±2) for FE, baseline to Day 14 (± 2) for MAD | |
| Columbia Suicide Severity Rating Scale (C-SSRS) | The Columbia Suicide Severity Rating Scale (C-SSRS) is used to assess suicidal ideation and suicidal behavior. Within the module "Answer for Actual Suicidal Attempts Only", the scoring range is 0 to 5. A score of 0 indicates no physical damage or very minor physical damage (e.g. surface scratches), and a score of 5 indicates death. | From baseline to Day 7 (±1) for SAD, baseline to Day16 (±2) for FE, baseline to Day 14 (± 2) for MAD |
| Number of participants with abnormal laboratory tests results | From baseline to Day 7 (±1) for SAD, baseline to Day16 (±2) for FE, baseline to Day 14 (± 2) for MAD | |
| Number of participants with abnormal ophthalmoscopic-examination findings | From baseline to Day 7 (±1) for SAD, baseline to Day16 (±2) for FE, baseline to Day 14 (± 2) for MAD |
| Measure | Description | Time Frame |
|---|---|---|
| C-QTc in the dose escalation part of SAD(in the dose groups of ≥300 mg) | Wthin 30 minutes before administration and to 24 hours after administration. | |
| Maximum concentration (Cmax) of LWP779 and its active metabolites in plasma | Within 30 minutes before administration to 48 hours after single administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tingting Yan | Contact | +86 15989276332 | tingting.yan1@longwoodtech.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX Clinical Research Pty Ltd | Recruiting | Adelaide | Australia |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Placebo of LWP779 | Drug | Placebo |
|
| Time to reach Cmax (Tmax) of LWP779 and its active metabolites in plasma | Within 30 minutes before administration to 48 hours after single administration |
| Total area under the concentration time curve (AUC) of LWP779 and its active metabolites in plasma | Within 30 minutes before administration to 48 hours after single administration |
| Apparent terminal half-life (t1/2) of LWP779 and its active metabolites in plasma | Within 30 minutes before administration to 48 hours after single administration |
| Terminal elimination rate constant (λz) of LWP779 and its active metabolites in plasma | Within 30 minutes before administration to 48 hours after single administration |
| Apparent clearance (CL/F) of LWP779 and its active metabolites in plasma | Within 30 minutes before administration to 48 hours after single administration |
| Apparent volume of distribution divided by bioavailability (Vd/F) of LWP779 and its active metabolites in plasma | Within 30 minutes before administration to 48 hours after single administration |
| Lag time (tlag) of LWP779 and its active metabolites in plasma | Within 30 minutes before administration to 48 hours after single administration |
| Steady-state minimum concentration (Cmin,ss) of LWP779 and its active metabolites in plasma | Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6. |
| Steady-state maximum concentration (Cmax,ss) of LWP779 and its active metabolites in plasma | Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6. |
| Steady-state average concentration (Cavg,ss) of LWP779 and its active metabolites in plasma | Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6. |
| Area under the concentration-time curve from time zero to tau (AUC0-τ) of LWP779 and its active metabolites in plasma | Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6. |
| Time to reach Cmax (Tmax) of LWP779 and its active metabolites in plasma | Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6. |
| Terminal elimination rate constant (λz) of LWP779 and its active metabolites in plasma | Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6. |
| Apparent terminal half-life (t1/2) of LWP779 and its active metabolites in plasma | Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6. |
| Accumulation index (AUC0-τ (D7) / AUC0-τ (D1)) of LWP779 and its active metabolites in plasma | Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6. |
| Cmax (D7) / Cmax (D1)) of LWP779 and its active metabolites in plasma | Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6. |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |