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A Phase 1, 2-Part, Single Ascending Dose (SAD) Study to Evaluate the Safety and Pharmacokinetics (PK) of ZB002 in Healthy Volunteers (HVs) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety and PK of ZB002 in Participants With Rheumatoid Arthritis (RA)

Trial Profile

A Phase 1, 2-Part, Single Ascending Dose (SAD) Study to Evaluate the Safety and Pharmacokinetics (PK) of ZB002 in Healthy Volunteers (HVs) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety and PK of ZB002 in Participants With Rheumatoid Arthritis (RA)

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 17 Apr 2025

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At a glance

  • Drugs Adalimumab-biobetter (Primary)
  • Indications Autoimmune disorders
  • Focus Adverse reactions
  • Sponsors Zenas BioPharma

Most Recent Events

  • 26 Sep 2024 Status changed from active, no longer recruiting to recruiting.
  • 15 Jun 2024 Results (from Single Ascending Dose Study) assessing ZB002 safety and tolerability, pharmacokinetics , immunogenicity, and pharmacodynamics in healthy volunteers presented at the 25th Annual Congress of the European League Against Rheumatism
  • 05 Mar 2024 Planned number of patients changed from 48 to 72.

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