Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BG-A3004 · 1 trial · 1 indication
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...
BG-A3004 is an investigational monoclonal antibody being developed for the treatment of immune-mediated skin diseases. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in healthy participants and patients with these conditions.
BG-A3004 targets KLRG1, a receptor expressed on certain immune cells. By binding to KLRG1, the monoclonal antibody is designed to modulate immune responses involved in skin disease pathology. This mechanism is being evaluated in early-stage clinical trials for its safety and potential therapeutic effects.
BG-A3004 is being developed by BeOne Medicines Ltd., a biopharmaceutical company listed on the stock exchange under the ticker ONC. The company is conducting clinical trials to evaluate the drug's safety and efficacy in immune-mediated skin diseases.
BG-A3004 is currently in Phase 1 clinical development. The drug is investigational and has not received regulatory approval. A Phase 1 study is actively recruiting participants to evaluate its safety in healthy volunteers and patients with immune-mediated skin diseases.
BG-A3004 is being studied in a Phase 1 clinical trial registered as NCT07412691. This randomized, double-blind, placebo-controlled study is evaluating the safety of BG-A3004 in healthy participants and patients with immune-mediated skin diseases. The trial is recruiting in China and aims to enroll 98 participants aged 18 years and older.
BG-A3004 is a monoclonal antibody that specifically targets KLRG1. While it is not known by alternative names, its mechanism of action involves binding to the KLRG1 receptor. This distinguishes it from other antibodies that may target different molecules in the immune system.