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The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of NH102 when administered as single oral dose at escalating dose levels in healthy participants.
The drug being tested in this study is called NH102. NH102 is being tested to treat people who have depression. This study will look at the safety, tolerability and PK of NH102 in healthy participants.
The study may enroll up to 72 participants. Participants will be randomly assigned within each cohort to receive NH102 or placebo which will remain undisclosed to the participants and study doctor during the study (unless there is an urgent medical need). Each cohort will enroll 12 participants,which including 2 sentries (all were male, one receive NH102 and the other receive placebo) and 10 subjects(4 males and 4 females receive NH102 and 1 male and 1 female receive placebo). Participants enrolled in Cohort 1 to 6 will receive NH102 3mg, 9mg, 20mg, 40mg, 60mg and 80 mg or NH102 placebo-matching tablet. 2 sentries in all cohorts can be administered at the same time, and the remaining subjects of the same cohort can be administered only after observation for at least 24 hours and initial safety confirmation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NH102 3mg | Experimental | NH102 3mg, tablet, orally, once on Day 1 or NH102 placebo-matching tablet, orally, once on Day 1. NH102 or placebo will be administered after an overnight fast of approximately at least 10 hours. |
|
| NH102 9mg | Experimental | NH102 9mg, tablet, orally, once on Day 1 or NH102 placebo-matching tablet, orally, once on Day 1. NH102 or placebo will be administered after an overnight fast of approximately at least 10 hours. |
|
| NH102 20mg | Experimental | NH102 20mg, tablet, orally, once on Day 1 or NH102 placebo-matching tablet, orally, once on Day 1. NH102 or placebo will be administered after an overnight fast of approximately at least 10 hours. |
|
| NH102 40mg | Experimental | NH102 40mg, tablet, orally, once on Day 1 or NH102 placebo-matching tablet, orally, once on Day 1. NH102 or placebo will be administered after an overnight fast of approximately at least 10 hours. |
|
| NH102 60mg | Experimental | NH102 60mg, tablet, orally, once on Day 1 or NH102 placebo-matching tablet, orally, once on Day 1. NH102 or placebo will be administered after an overnight fast of approximately at least 10 hours. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NH102 | Drug | tablets, orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of safety and tolerability | To investigate the safety and tolerability of NH102 by assessment of AEs following administration in SAD | Baseline up to Day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters - Cmax | Maximum Observed Plasma Concentration of NH102 | up to 72 hours |
| PK parameters - Tmax | Time to Reach the Maximum Plasma Concentration (Cmax) of NH102 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huafang Li, MD | Shanghai Mental Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Shanghai | China |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| NH102 80mg | Experimental | NH102 80mg, tablet, orally, once on Day 1 or NH102 placebo-matching tablet, orally, once on Day 1. NH102 or placebo will be administered after an overnight fast of approximately at least 10 hours. |
|
|
| Placebo | Drug | tablets, orally |
|
| up to 72 hours |
| PK parameters - AUC0-∞ | area under the concentration versus time curve (AUC) from time zero to infinity | up to 72 hours |
| PK parameters - t½ | apparent terminal elimination half-life | up to 72 hours |
| PK parameters - Vz/F | apparent volume of distribution | up to 72 hours |
| PK parameters - CL/F | the Apparent Clearance | up to 72 hours |