A Study of HS-10353 in Chinese Participants.
- Registration Number
- NCT05195203
- Lead Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Brief Summary
The primary objective of this study is to assess the safety and tolerability of single and multiple oral administered doses of HS-10353 separately in Chinese healthy and major depressive disorder subjects.
- Detailed Description
This is a phase I, randomized, double-blinded, placebo-controlled, both single ascending doses (SAD) study and multiple ascending dose (MAD) clinical trial to assess the safety, tolerability, and pharmacokinetics of HS-10353 tablet(s) separately in Chinese healthy and major depressive disorder (MDD) subjects.
Approximately six sequential dose cohorts will be evaluated in SAD study. Sentinel dosing will be employed for the first SAD cohort to protect the subjects' safety. Escalation to the next dose cohort will be undertaken only after safety and PK data are reviewed by the Safety Review Committee (SRC) and agreement reach that it is safe to increase the dose. Each SAD cohort is dosed at approximately weekly intervals to allow adequate time for collection and review of safety and PK data.
Approximately three sequential dose cohorts will be evaluated in MAD study. The total daily dose for each MAD cohort will be based on information obtained from the SAD study. Each subject will receive only one dose regimen in this study.
Safety data up to Day14 (±1) in SAD and up to Day20 (±1) in MAD will be reviewed prior to the next dose level. The number of Cohorts in SAD and MAD would be adjusted based on the assessment of SRC.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description HS-10353 HS-10353 Capsules；Single dose: only one administration; Multiple doses: continuous administration for 7 days Placebo Placebo Capsules；Single dose: only one administration; Multiple doses: continuous administration for 7 days
- Primary Outcome Measures
Name Time Method Endpoints of the trial：AE，SAE Baseline to end of follow-up (a maximum of 20 days) The incidence, severity, and association of AE, SAE and AE leading to withdrawal from the trial
- Secondary Outcome Measures
Name Time Method MAD pharmacokinetic endpoints：AUCss, 0-t Day1-Day12 The area under the plasma concentration-time curve from time zero to the time of the last measurable concentration over the dosing interval at steady state (AUCss, 0-t)
SAD pharmacokinetic endpoints：Tmax Day1-Day6 Time to Cmax (Tmax)
SAD pharmacokinetic endpoints：t½ Day1-Day6 Half-life (t½)
SAD pharmacokinetic endpoints：Vz/F Day1-Day6 Apparent volume of distribution following oral administration (Vz/F)
SAD pharmacokinetic endpoints：MRT Day1-Day6 Mean residence time (MRT)
MAD pharmacokinetic endpoints：Css,av Day1-Day12 Average steady state drug concentration in plasma during dosing interval (Css,av)
MAD pharmacokinetic endpoints：Rac Day1-Day12 Accumulation ratio (Rac)
SAD pharmacokinetic endpoints：AUC0-t Day1-Day6 The area under the plasma concentration-time curve from time zero to the time of the last measurable concentration (AUC0-t)
SAD pharmacokinetic endpoints：Cmax Day1-Day6 The maximum plasma concentration (Cmax)
SAD pharmacokinetic endpoints：AUC0-∞ Day1-Day6 The area under the plasma concentration-time curve from time zero to infinite time (AUC0-∞)
SAD pharmacokinetic endpoints：λz Day1-Day6 Terminal rate constant (λz)
SAD pharmacokinetic endpoints：CL/F Day1-Day6 Apparent clearance following oral administration (CL/F)
MAD pharmacokinetic endpoints：Css,max Day1-Day12 The maximum steady state drug concentration in plasma during dosing interval (Css,max)
MAD pharmacokinetic endpoints：Tss,max Day1-Day12 Time to Css, max (Tss,max)
MAD pharmacokinetic endpoints：DF Day1-Day12 Coefficient of fluctuation（DF）
MAD pharmacokinetic endpoints：Css,min Day1-Day12 The minimum steady state drug concentration in plasma during dosing interval (Css,min)
Trial Locations
- Locations (1)
West China Hospital
🇨🇳Chengdu, Sichuan, China