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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07516639 | First-in-Human Study of ISH0613: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics | PHASE1 | NOT YET_RECRUITING | 26 | — | — | Apr 1, 2026 | Dec 31, 2026 | Apr 13, 2026 | 1 | China |
| Arm | Type | Description |
|---|---|---|
| Single-ascending dose：ISH0613 | EXPERIMENTAL | - |
| Single-ascending dose：Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ISH0613 for injection | DRUG | 80, 240, 480, 640 mg; i.v. |
| Placebo | DRUG | 80, 240, 480, 640 mg; i.v. |
Inclusion Criteria: 1. Healthy Chinese adult subjects, male or female, aged 18 to 45 years (inclusive); 2. Body mass index (BMI) between 19.0 and 28.0 kg/m² (inclusive); body weight generally ≥50 kg for males and ≥45 kg for females; 3. Male subjects and their partners, or female subjects, must agre...