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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07264192 | A Study of HS-10518 in Healthy Adult Premenopausal Females in China | PHASE1 | COMPLETED | 60 | — | — | Mar 11, 2025 | Sep 9, 2025 | Mar 25, 2026 | 1 | China |
Assessment of safety and tolerability of multiple-dose HS- 10518 in healthy female participants in terms of the frequency, severity and causality of AEs, serious adverse events (SAEs) and AEs leading to study discontinuation.
Laboratory parameters include hematology, clinical chemistry, and urinalysis. The number and percentage of participants with clinically significant changes
Incidence of any clinically significant abnormal findings in 12-lead ECG is collected throughout study
| Arm | Type | Description |
|---|---|---|
| HS-10518 Dose 1 | EXPERIMENTAL | Dose level 1 of HS-10518, 10 mg Q12h, orally, 14 days |
| HS-10518 Dose 2 | EXPERIMENTAL | Dose leve2 of HS-10518, 20 mg QD, orally, 14 days |
| HS-10518 Dose 3 | EXPERIMENTAL | Dose leve3 of HS-10518, 20 mg Q12h, orally, 14 days |
| HS-10518 Dose 4 | EXPERIMENTAL | Dose leve4 of HS-10518, 40 mg QD, orally, 14 days |
| HS-10518 Dose 5 | EXPERIMENTAL | Dose leve5 of HS-10518, 80 mg QD, orally, 14 days |
| Placebo | PLACEBO_COMPARATOR | placebo, BID, orally, 14 days |
| Name | Type | Description |
|---|---|---|
| HS-10518 | DRUG | During the Dosing Period, four capsules of HS-10518 are administered twice daily at the same time points each day (morning and evening). The capsules should be swallowed whole with approximately 240 mL of water, and fluid intake is restricted within 1 hour before and after drug administration. Consecutive dosing should be maintained for 14 days. |
| Placebo | DRUG | During the Dosing Period, four capsules of HS-10518 Placebo are administered twice daily at the same time points each day (morning and evening). The capsules should be swallowed whole with approximately 240 mL of water, and fluid intake is restricted within 1 hour before and after drug administration. Consecutive dosing should be maintained for 14 days. |
Inclusion Criteria: * Subjects may be enrolled only if they meet all the following criteria: 1. At the time of signing the informed consent form, the subject must be 18 to 40 years old (inclusive). 2. Confirmed to be a healthy subject through medical assessment, including indicators such as me...