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New RA drug JADE201 enters first human safety trial

NCT ID NCT07533955

Disease control Sponsor: Jade Biosciences, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests a single injection of JADE201 in 36 adults with rheumatoid arthritis. The main goal is to check safety and how the body processes the drug. Participants receive either JADE201 or a placebo, and researchers monitor side effects and drug levels in the blood.

What this could mean

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

Active substance
JADE201
What this could lead to
If safe and effective, JADE201 could become a new treatment option to control rheumatoid arthritis symptoms and inflammation.
What could go wrong
This is a very early Phase 1 trial with only 36 people. The main goal is safety, not effectiveness. Many drugs fail at this stage.

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

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Oct 2028

An estimate. End dates often move.

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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.

Inclusion Criteria: 1. Male and female participants 18-70 years of age, inclusive. 2. A body weight between 50-100 kg and a body mass index (BMI) between 18-32 kg/m2 (all inclusive) at screening. 3. Confirmed diagnosis of RA according to 2010 ACR/EULAR criteria 4. Willing and able to comply with the inpatient stay at the site, scheduled visits, treatment plans, laboratory tests, and other study procedures specified in the protocol. 5. Willing and able to comply with contraceptive and lifestyle requirements specified in the protocol. Exclusion Criteria: 1. With the exception of RA, known history of clinically significant disease 2. Diagnosis or symptoms suggestive of any systemic autoimmune or inflammatory condition other than RA 3. positive serology for Hep A, Hep B, or Hep C virus 4. Positive, indeterminate, or invalid test of TB 5. Current tobacco users who smoke \>5 cigarettes per day or equivalent 6. Nursing, lactating or pregnant, or who have plans to become pregnant during the study 7. Treatment with an investigational drug within 30 days or 5 half lives prior to study drug administration

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Conditions

The condition(s) this trial relates to.

rheumatoid arthritis

As listed by the trial registrant

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

Rhematoid arthritis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Jade Clinical Site

    RECRUITING

    Chisinau, Moldova, 2025, Moldova

  • Jade Clinical Site

    RECRUITING

    Ivano-Frankivsk, Ukraine, 76018, Ukraine

  • Jade Clinical Site

    RECRUITING

    Kyiv, Ukraine, 02000, Ukraine

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