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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06801119 | Efficacy and Safety of HN2301 in Autoimmune Diseases（AIDs） | PHASE1 | RECRUITING | 30 | — | — | Mar 16, 2025 | Jun 30, 2028 | Apr 28, 2026 | 1 | China |
Incidence, nature, and severity of treatment-emergent adverse events, assessed according to the study protocol and applicable toxicity grading criteria.
| Arm | Type | Description |
|---|---|---|
| HN2301 treatment group | EXPERIMENTAL | Participants will receive HN2301 Injection at the specified dose level and on the specified study days. |
| Name | Type | Description |
|---|---|---|
| HN2301 injection | DRUG | Dosing will begin at a lower dose level and may be escalated to dose levels considered safe and potentially effective according to the study protocol. |
Inclusion Criteria: * Patients aged between 18 and 69 (inclusive), of any gender; * Appropriate bone marrow, coagulation, cardiopulmonary, liver, and kidney functions. Bone marrow function: ANC ≥1.5×10\^9/L, ALC ≥0.8×10\^9/L, Hb ≥80g/L. No use of transfusions and growth factors allowed within 7 day...