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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07412691 | A Study to Evaluate the Safety of BG-A3004 in Healthy Participants and Patients With Immune-Mediated Skin Diseases | PHASE1 | RECRUITING | 98 | — | — | Mar 19, 2026 | Aug 8, 2028 | Mar 23, 2026 | 1 | China |
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including clinically significant abnormalities from laboratory tests, vital signs and electrocardiogram results
| Arm | Type | Description |
|---|---|---|
| Part A: Single Ascending Doses (SAD) of BG-A3004 | EXPERIMENTAL | Sequential cohorts of increasing dose levels of BG-A3004 will be evaluated after a single dose in healthy participants. |
| Part B: Multiple Ascending Doses (MAD) of BG-A3004 | EXPERIMENTAL | Sequential cohorts of increasing dose levels of BG-A3004 will be evaluated after multiple doses in participants with immune-mediated skin diseases. |
| SAD Placebo | PLACEBO_COMPARATOR | Sequential cohorts of healthy participants will receive a single dose of matching placebo. |
| MAD Placebo | PLACEBO_COMPARATOR | Sequential cohorts of participants with immune-mediated skin diseases will receive multiple doses of matching placebo. |
| Name | Type | Description |
|---|---|---|
| BG-A3004 | BIOLOGICAL | Administered subcutaneously |
| Placebo | BIOLOGICAL | Administered subcutaneously |
Inclusion Criteria * Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study. * Female participants of childbearing potential must be willing to use a highly effective method of birth control and ref...