RecruitingPhase 1NCT05638854

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)


Sponsor

Zenas BioPharma (USA), LLC

Enrollment

72 participants

Start Date

Dec 8, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests the safety and how the body processes a new drug called ZB002 — first in healthy volunteers, then in people with rheumatoid arthritis (an autoimmune condition that causes painful joint inflammation). It is an early-phase safety and dosing study. **You may be eligible if...** - For healthy volunteers: you are between 18 and 55 years old, weigh at least 50 kg (men) or 45 kg (women), and have a normal body mass index - For the rheumatoid arthritis group: you have a confirmed diagnosis of RA and meet additional criteria to be confirmed by your doctor - You are in generally good health aside from RA (for the RA group) **You may NOT be eligible if...** - You have significant chronic illnesses (for the healthy volunteer group) - You are outside the specified weight or age range - You have active infections or conditions that make this drug unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZB002

ZB002 will be administered subcutaneously as per schedule specified in the respective arm.

DRUGPlacebo

Placebo will be administered subcutaneously as per schedule specified in the respective arm.

DRUGZB002

ZB002 will be administered subcutaneously as per schedule specified in the respective arm.

DRUGPlacebo

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

View Full Details on ClinicalTrials.gov

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NCT05638854


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