JADE201: a first-in-human test for rheumatoid arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, first-in-human, double-blind, placebo-controlled trial evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of JADE201 in adults with rheumatoid arthritis. About 36 evaluable participants (6 per cohort) will be enrolled across multiple sites and receive subcutaneous JADE201 or placebo. The study will determine safety signals and how the drug is processed in the body to guide future development in autoimmune diseases. Results will support subsequent clinical testing in autoimmune indications. The trial uses a randomized, inpatient design with careful monitoring for adverse events and laboratory changes.

Why it matters

Who can join: the full rules

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

Where it's running

• Jade Clinical Site
  Sofia, Bulgaria Recruiting
• Jade Clinical Site
  Tbilisi, Georgia Recruiting
• Jade Clinical Site
  Berlin, Germany Recruiting
• Jade Clinical Site
  Chisinau, Moldova, Moldova Recruiting
• Jade Clinical Site
  Bucharest, Romania Recruiting
• Jade Clinical Site
  Cluj-Napoca, Romania Recruiting

Study contacts

• Study coordinator: Jade201 Study Contact
• Email: JADE201clinicaltrials@jadebiosciences.com
• Phone: 781-201-4781

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• JADE101 in IgA Nephropathy (phase 3, blinded)

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  Recruiting at 4 sites Phase 3 Jade Biosciences, Inc. · Arvada, Colorado and 3 other locations · NCT07902817

• JADE101 in IgA Nephropathy: a Phase 2 test in adults

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• Single-dose JADE101 in healthy Japanese and Chinese adults

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  Recruiting Phase 1 Jade Biosciences, Inc. · Glendale, California · NCT07525947

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.