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RECRUITING
NCT05638854
PHASE1

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

Sponsor: Zenas BioPharma (USA), LLC

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2022-12-08

Completion Date

2025-07

Last Updated

2025-04-08

Healthy Volunteers

Yes

Interventions

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.

Locations (2)

Veritus Research

Melbourne, Australia

NZCR New Zealand Clinical Research

Christchurch, New Zealand