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

NCT05638854 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-04-08

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Zenas BioPharma (USA), LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-08
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05638854 on ClinicalTrials.gov