Actively Recruiting

Phase 1
Age: 18Years - 70Years
All Genders
Healthy Volunteers
NCT05638854

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

Led by Zenas BioPharma (USA), LLC · Updated on 2025-04-08

72

Participants Needed

2

Research Sites

133 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy male or female participants aged 18 to 55 years for Part A
  • Body weight ≥ 50 kg for males and ≥ 45 kg for females in Part A
  • Body mass index between 18 and 35 kg/m² for Part A participants
  • Good health status as determined by the investigator for Part A
  • Female participants of child-bearing potential must agree to abstinence or effective contraception for Part A
  • Male participants must be surgically sterile or use effective contraception for Part A
  • Willingness and ability to understand the study and provide informed consent for Part A
  • Male or female participants aged 18 to 70 years for Part B
  • Body mass index between 18.0 and 40.0 kg/m² for Part B
  • Diagnosis of rheumatoid arthritis meeting 2010 ACR/EULAR criteria for at least 3 months before screening for Part B
  • Use of methotrexate (7.5 to 25 mg/week) for at least 3 months with stable dosing for at least 4 weeks before randomization for Part B
  • Use of hydroxychloroquine/chloroquine and/or sulfasalazine allowed if started at least 3 months before randomization with stable dosing after screening for Part B
Not Eligible

You will not qualify if you...

  • Surgery within 4 weeks before screening or planned surgery during the study for both parts
  • Use of prescription medications, biologics, or other medicines within 2 weeks before first dose or 5 half-lives prior for Part A
  • Use of over-the-counter medications or supplements within 7 days of dosing unless deemed safe for Part A
  • Treatment with investigational drugs within 30 days or 5 half-lives before first dose or current enrollment in other studies for Part A
  • Clinically significant ECG abnormalities for Part A
  • Positive tests for HIV, active hepatitis B or C, or COVID-19 infection for both parts
  • Positive tests for tuberculosis for both parts
  • Recent infections within 30 days before dosing for Part A and unresolved infections for Part B
  • History of drug abuse within 12 months or positive drug screen at screening for both parts
  • Blood donation or loss > 400 mL within 3 months before screening or transfusion within 3 months for Part A; blood donation or loss > 400 mL within 1 month for Part B
  • Relevant allergies making participation inappropriate for Part A
  • Smoking more than 10 cigarettes per day within 6 months for Part A
  • Alcohol consumption exceeding 14 standard units per week or positive alcohol breath test for Part A
  • Inflammatory joint diseases other than RA except secondary Sjogren's syndrome for Part B
  • History of malignancy within 5 years except certain treated cancers for Part B
  • Corticosteroid use exceeding 10 mg/day or dose increase after screening for Part B
  • Employees or related personnel of the study site, sponsor, or contract research organization for Part B

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Veritus Research

Melbourne, Australia

Not Yet Recruiting

2

NZCR New Zealand Clinical Research

Christchurch, New Zealand

Actively Recruiting

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Research Team

C

Cory D Sellwood, MBChB

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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