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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05638854 | A Study to Evaluate Safety and Pharmacokinetics of ZB002 in Healthy Participants and Participants With Rheumatoid Arthritis | PHASE1 | RECRUITING | 72 | — | — | Dec 8, 2022 | Jul 1, 2025 | Apr 8, 2025 | 2 | Australia, New Zealand |
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...