Can a new injection calm rheumatoid arthritis? an early trial puts ZB002 to the test

NCT ID NCT05638854

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This early-stage trial evaluates an experimental drug called ZB002, given as an injection under the skin. In the first part, healthy volunteers receive a single dose to check safety and how the drug moves through the body. In the second part, people with rheumatoid arthritis receive multiple doses to see if the drug is safe and tolerable when taken repeatedly. The study is randomized and placebo-controlled, meaning some participants receive a dummy injection for comparison.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ZB002, an experimental drug given as an injection under the skin
What this could lead to
If ZB002 proves safe and well tolerated, it could advance to larger studies as a potential treatment for rheumatoid arthritis and other inflammatory conditions.
What could go wrong
This is an early phase 1 trial with a small number of participants, so the drug may not work as hoped or may cause unexpected side effects. The results will only show safety and how the body handles the drug, not whether it effectively treats arthritis.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

72 people

The number who actually took part.

Started

Dec 2022

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Main Inclusion Criteria Part A SAD (HV): * Healthy male or female participants 18 to 55 years of age. * Body weight ≥ 50 kg for male participants and ≥ 45 kg for female participants; body mass index of 18 to 35 kg/m\^2 for both male and female participants. * Considered in good health as determined by the Investigator. * Female participants of child-bearing potential must agree to abstinence or use an effective form of contraception. * Male participants must be surgically sterile or agree to use effective contraception. * Willing and able to understand the characteristics and purposes of the study, including possible risks involved, and willing to comply with all the study requirements and provide written informed consent for the study. Part B MAD (RA Participants): * Male or female participants 18 to 70 years (inclusive) of age at Screening. * Body mass index of ≥ 18.0 and ≤ 40.0 kg/m2. * Diagnosis of RA and meeting the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism classification criteria for RA ≥ 3 months before Screening. * Use of methotrexate at 7.5 to 25 mg/week for ≥ 3 months, with stable dosing for ≥ 4 weeks, before randomization. Hydroxychloroquine/chloroquine and/or sulfasalazine are allowed if started ≥ 3 months before randomization and a stable dose is maintained after the Screening Visit. Main Exclusion Criteria Part A SAD (HV): * Surgery within 4 weeks before Screening or planned surgery during the clinical study. * Use of prescription medications, biological products, or other medicines within 2 weeks before Study Day 1 or 5 half-lives of the product, whichever is greater. Use of over-the-counter medications or vitamins/dietary supplements within 7 days of dosing unless considered by the Investigator to not pose a risk or impact the study results. * Treatment with any investigational drug within 30 days or 5 half-lives, whichever is greater, before the first dose of the study drug, or currently enrolled in another clinical study. * Clinically significant ECG abnormality. * Positive for HIV infection, active hepatitis C, or hepatitis B. * Positive for COVID-19 virus. * Positive QuantiFERON®-TB Gold or T-SPOT® test for Mycobacterium tuberculosis. * Bacteria, viruses, systemic fungi, parasites, or other opportunistic infections within 30 days before Study Day 1. * Documented history of drug abuse in the previous 12 months before Screening, or positive for urine drug screen on Screening and/or Day -1. * Donated blood (including component blood) or lost \> 400 mL within 3 months before Screening or received a transfusion within 3 months of Screening. * History of relevant allergies (including allergy to any murine or human-derived protein or immunoglobulin products, rubber or latex, or other allergies that in the opinion of the Investigator make inclusion in the study inappropriate). * Average daily smoking \> 10 cigarettes or cigarette equivalents per day within 6 months of Screening. * Consume \> 14 standard units of alcohol per week (1 standard unit is equivalent to approximately 360 mL of beer, 45 mL of spirits with 40% alcohol, or 150 mL of wine) or a positive alcohol breath test on Day -1. Part B MAD (RA Participants): * Inflammatory joint disease other than RA. Note: Current diagnosis of secondary Sjogren's Syndrome is permitted. * Surgery within 4 weeks before Screening or planned surgery during the clinical study. * History of any malignancy within 5 years, except for successfully treated nonmelanoma skin cancer or localized carcinoma in situ of the cervix. * Documented history of drug abuse in the previous 12 months before Screening (Days -28 to -1), or positive for urine drug screen for nonprescribed drugs other than cannabinoid at Screening. * Any condition considered by the investigator to make participation in the study inappropriate. * Donated blood (including component blood) or lost \> 400 mL within 1 month before Screening or received a transfusion within 3 months of Screening. * After the Screening Visit, corticosteroid use \> 10 mg/day (prednisone equivalent) or increase in dose * Positive for HIV infection, active hepatitis C, or hepatitis B. * Test positive for Mycobacterium tuberculosis. * Bacterial, viral, systemic fungal, parasitic, or opportunistic infection not resolved at least 14 days before Study Day 1 or expected to be treated with antibiotics during the Treatment Period, or history of recurrent infections. * Employees or related personnel of the study site, the sponsor, or contract research organization.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • NZCR New Zealand Clinical Research

    Christchurch, New Zealand

  • Veritus Research

    Melbourne, Australia

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Other studies related to the condition(s) this trial covers.