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NCT07533955RecruitingPhase 1

A Phase 1 Study of JADE201 in Participants With Rheumatoid Arthritis

A Phase 1, Randomized, Double-blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JADE201 Administered Subcutaneously in Participants With Rheumatoid Arthritis

Source: ClinicalTrials.gov · Last updated 23 Oct 2026

Brief summary (registry, in English)

This is a Phase 1, first in human study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of JADE201 compared to placebo in participants with Rheumatoid Arthritis

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
36 (estimated)
First submitted
10 Apr 2026
Start date
19 May 2026
Primary completion date
31 Oct 2027
Lead sponsor
Jade Biosciences, Inc.
NCT number
NCT07533955

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 36
  • From 19 May 2026 to the primary completion date, 31 Oct 2027
  • 8 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Treatment with an investigational drug within 30 days or 5 half lives prior to study drug administration

Other illness

  • With the exception of RA, known history of clinically significant disease
  • Diagnosis or symptoms suggestive of any systemic autoimmune or inflammatory condition other than RA

Other

  • positive serology for Hep A, Hep B, or Hep C virus
  • Positive, indeterminate, or invalid test of TB
  • Current tobacco users who smoke \>5 cigarettes per day or equivalent
  • Nursing, lactating or pregnant, or who have plans to become pregnant during the study

Who the study is looking for

  • Male and female participants 18-70 years of age, inclusive.
  • A body weight between 50-100 kg and a body mass index (BMI) between 18-32 kg/m2 (all inclusive) at screening.
  • Confirmed diagnosis of RA according to 2010 ACR/EULAR criteria
  • 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.
  • Willing and able to comply with contraceptive and lifestyle requirements specified in the protocol.

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Jade Clinical Site
Coordinator of this site? Confirm its status
SofiaBulgariaRecruiting
Jade Clinical Site
Coordinator of this site? Confirm its status
BerlinGermanyRecruiting
Jade Clinical Site
Coordinator of this site? Confirm its status
TbilisiGeorgiaRecruiting
Jade Clinical Site
Coordinator of this site? Confirm its status
ChisinauMoldovaRecruiting
Jade Clinical Site
Coordinator of this site? Confirm its status
BucharestRomaniaRecruiting
Jade Clinical Site
Coordinator of this site? Confirm its status
Cluj-NapocaRomaniaRecruiting
Jade Clinical Site
Coordinator of this site? Confirm its status
Ivano-FrankivskUkraineRecruiting
Jade Clinical Site
Coordinator of this site? Confirm its status
KyivUkraineRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.