Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a phase 1,randomized, double-blind, placebo-controlled, MAD study to evaluate the safety, tolerability and pharmacokinetics of oral LPM526000133 Fumarate Capsules (LY03017) in healthy adult subjects
Primary:
To assess the safety and tolerability of multiple oral doses of LY03017 in healthy adult subjects.
Secondary:
To assess the pharmacokinetics (PK) of LY03017 after multiple oral doses of LY03017 in healthy adult subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY03017 | Experimental | LY03017 will be administrated with multiple doses from 10mg to 40mg on day 1~5 |
|
| LY03017-Placebo | Placebo Comparator | Placebo will be administrated with multiple doses on day 1~5. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY03017 | Drug | administered orally |
| |
| LY03017-Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) | up to day 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration at steady state (Cmax,ss) of LPM526000133 in plasma | up to day 9 | |
| Time to maximum observed concentration at steady state (Tmax,ss) of LPM526000133 in plasma | up to day 9 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
QT interval (QTc) ≥450 ms (Male) or 460 ms (Female) .
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Shanghai | China |
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
administered orally |
|
| Minimum observed concentration at steady state (Cmin,ss) of LPM526000133 in plasma | up to day 9 |
| Area Under the Concentration-Time Curve from Time Zero to Tau over a Dosing Interval at Steady State(AUC0-τ,ss)of LPM526000133 in plasma | up to day 9 |
| The area under the concentration-time curve from time zero extrapolated to infinity at steady state (AUC0-∞,ss) of LPM526000133 in plasma | up to day 9 |
| Apparent terminal elimination half-life (t1/2) of LPM526000133 in plasma | up to day 9 |
| Accumulation ratio (Ra) of LPM526000133 in plasma | up to day 9 |
| ID | Term |
|---|---|
| D006212 | Hallucinations |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided