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ZB002 · 1 trial · 2 indications
To evaluate the safety and tolerability of ZB002 in HVs by assessing the number, severity and type of adverse events, including changes in laboratory safety test and electrocardiogram (ECG)
To evaluate the safety and tolerability of ZB002 in participants with RA by assessing the number of participants with Treatment-emergent adverse events (TEAEs), serious TEAEs, and TEAE leading to discontinuation
| Arm | Type | Description |
|---|---|---|
| Part A: SAD in Healthy Volunteers | EXPERIMENTAL | Healthy volunteers will receive a single dose of ZB002 or placebo |
| Part B: MAD in RA Participants | EXPERIMENTAL | RA participants will receive ZB002 or placebo every 4 weeks (Q4W) × 3 administrations |
| Name | Type | Description |
|---|---|---|
| ZB002 | DRUG | ZB002 will be administered subcutaneously as per schedule specified in the respective arm. |
| Placebo | DRUG | Placebo will be administered subcutaneously as per schedule specified in the respective arm. |
Main Inclusion Criteria Part A SAD (HV): * Healthy male or female participants 18 to 55 years of age. * Body weight ≥ 50 kg for male participants and ≥ 45 kg for female participants; body mass index of 18 to 35 kg/m\^2 for both male and female participants. * Considered in good health as determine...
ZB002 is an investigational small molecule being developed by Zenas BioPharma for immunology applications. It is currently in Phase 1 clinical development, with studies evaluating its safety and pharmacokinetics in healthy volunteers and participants with rheumatoid arthritis.
The molecular target of ZB002 has not been disclosed. It is a small molecule immunology therapeutic being developed by Zenas BioPharma, currently in Phase 1 clinical trials.
ZB002 is being developed by Zenas BioPharma, Inc., a biopharmaceutical company. The company is publicly traded under the ticker symbol ZBIO.
ZB002 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study has been completed, evaluating the drug in healthy volunteers and participants with rheumatoid arthritis.
ZB002 has one completed Phase 1 clinical trial, NCT05638854, which evaluated the safety and pharmacokinetics of ZB002 in healthy participants and participants with rheumatoid arthritis. The study enrolled 72 participants and was conducted in Australia and New Zealand.
No alternative names for ZB002 have been disclosed. It is an investigational small molecule developed by Zenas BioPharma, currently in Phase 1 clinical development.