Clinical Trial

A Study to Evaluate Safety and Pharmacokinetics of ZB002 in Healthy Participants and Participants With Rheumatoid Arthritis

Recruiting Phase 1
View on ClinicalTrials.gov →
Record status
This record was last updated April 8, 2025 (before its estimated July 2025 completion). Its status may not reflect the trial's current state.
Summary
This double-blind, randomized, placebo-controlled study will assess the safety and pharmacokinetics of ZB002 in healthy participants and in participants with rheumatoid arthritis (RA). The study consists of 2 parts. Part A: Single Ascending Dose (SAD), which will include only healthy volunteers. Part B: Multiple Ascending Dose (MAD), will commence after completion of the SAD study and will include RA participants.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2022-12-04; most recent amendment 2025-04-04.
Status change: Active, Not Recruiting → Recruiting 2024-09-24
Status change: Recruiting → Active, Not Recruiting 2024-01-22
Status change: Active, Not Recruiting → Recruiting 2023-10-09
Status change: Recruiting → Active, Not Recruiting 2023-05-15
Status change: Not Yet Recruiting → Recruiting 2022-12-15
Trial Details
NCT Number NCT05638854
Lead Sponsor Zenas BioPharma (USA), LLC
Conditions Healthy Volunteers, Rheumatoid Arthritis
Enrollment 72 participants
Start Date 2022-12-08
Primary Completion 2025-07 (estimated)
Study Completion 2025-07 (estimated)
Updated on ClinicalTrials.gov 2025-04-08