NCT05638854

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

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: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Zenas BioPharma (USA), LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

Part A (SAD): Up to approximately 48 healthy volunteers across 6 cohorts randomized to receive ZB002 or placebo as a single dose. Part B (MAD): Up to approximately 24 participants with RA across 3 cohorts randomized to receive ZB002 or placebo as multiple doses.

Conditions

• Healthy Volunteers
• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	ZB002	ZB002 will be administered subcutaneously as per schedule specified in the respective arm.
DRUG	Placebo	Placebo will be administered subcutaneously as per schedule specified in the respective arm.
DRUG	ZB002	ZB002 will be administered subcutaneously as per schedule specified in the respective arm.
DRUG	Placebo	Placebo will be administered subcutaneously as per schedule specified in the respective arm.

Timeline

• Start date: 2022-12-08
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2022-12-06
• Last updated: 2025-04-08

Locations

2 sites across 2 countries: Australia, New Zealand