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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07444294 | A Single- and Multiple-Ascending Dose Study of SRK-439 in Healthy Adults | PHASE1 | RECRUITING | 76 | — | — | Nov 21, 2025 | Jun 9, 2027 | Mar 2, 2026 | 1 | United States |
• Incidence of AEs
| Arm | Type | Description |
|---|---|---|
| Part A | EXPERIMENTAL | Participants will be treated with a single dose of SRK-439 or matching placebo. |
| Part B | EXPERIMENTAL | Participants will be treated with multiple doses of SRK-439 or matching placebo. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Matching placebo to SRK-439, subcutaneous administration |
| SRK-439 | DRUG | Single ascending dose, subcutaneous administration |
Key Inclusion Criteria: 1. Male or female participants, ≥18 to ≤55 years of age, at the time of informed consent 2. BMI of ≥18 kg/m2 to ≤35 kg/m2 (inclusive) at screening Exclusion Criteria: 1. Previous treatment with SRK-439 or apitegromab, or with other anti-myostatin therapies, including ACTR ...