Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05195203 | A Study of HS-10353 in Chinese Participants. | PHASE1 | COMPLETED | 96 | — | — | Jan 27, 2021 | Mar 31, 2023 | Aug 3, 2023 | 1 | China |
The incidence, severity, and association of AE, SAE and AE leading to withdrawal from the trial
| Arm | Type | Description |
|---|---|---|
| HS-10353 | EXPERIMENTAL | Capsules；Single dose: only one administration; Multiple doses: continuous administration for 7 days |
| Placebo | PLACEBO_COMPARATOR | Capsules；Single dose: only one administration; Multiple doses: continuous administration for 7 days |
| Name | Type | Description |
|---|---|---|
| HS-10353 | DRUG | Single or multiple dose(s) of HS-10353 |
| Placebo | DRUG | Single or multiple dose(s) of placebo |
SAD Inclusion Criteria 1. Healthy male or female subjects between 18 and 45 years old; 2. Body weight more than 50.0kg (male) or 45.0kg (female), body mass index (BMI) within the range of 19.0\~26.0kg/m2; 3. Volunteers agree to refrain from smoking, drinking alcohol. Avoid xanthine or caffeine (inc...