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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...
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ZB002 is an investigational small molecule being developed by Zenas BioPharma, Inc. for rheumatoid arthritis. It is in Phase 1 clinical development and has been studied in a completed trial that enrolled 72 participants, including healthy volunteers and people with rheumatoid arthritis.
ZB002 is being developed as a potential treatment for rheumatoid arthritis. It is an investigational therapy and has not been approved for any indication. Its clinical program to date includes a completed Phase 1 study in healthy participants and participants with rheumatoid arthritis.
ZB002 targets IGF1R, a protein receptor. By binding to IGF1R, the small molecule is designed to modulate signaling through this pathway. This targeted mechanism distinguishes it from other approaches being studied in immunology and rheumatoid arthritis.
ZB002 is being developed by Zenas BioPharma, Inc., which trades under the ticker ZBIO. The company is advancing the small molecule through clinical development for rheumatoid arthritis and other potential immunology applications.
ZB002 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any regulatory agency. The Phase 1 program has completed one trial, and no active trials are currently listed.
ZB002 has been evaluated in a completed Phase 1 trial, NCT05638854, titled a study to evaluate safety and pharmacokinetics of ZB002 in healthy participants and participants with rheumatoid arthritis. The trial enrolled 72 participants across Australia and New Zealand and was randomized, double-blind, and controlled.