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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
55
Shanghai Mental Health Center
Shanghai, China
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
Time frame: Baseline up to Day 11
PK parameters - Cmax
Maximum Observed Plasma Concentration of NH102
Time frame: up to 72 hours
PK parameters - Tmax
Time to Reach the Maximum Plasma Concentration (Cmax) of NH102
Time frame: up to 72 hours
PK parameters - AUC0-∞
area under the concentration versus time curve (AUC) from time zero to infinity
Time frame: up to 72 hours
PK parameters - t½
apparent terminal elimination half-life
Time frame: up to 72 hours
PK parameters - Vz/F
apparent volume of distribution
Time frame: up to 72 hours
PK parameters - CL/F
the Apparent Clearance
Time frame: up to 72 hours
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