Tests JADE201 for safety in adults with rheumatoid arthritis
Tests a new drug, JADE201, against placebo in adults with rheumatoid arthritis.
Plain-language title generated from the registry record
Registry title: A Phase 1 Study of JADE201 in Participants With Rheumatoid Arthritis
Key facts
- Where
- Bucharest and Cluj-Napoca, RomaniaSee the 2 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07533955, who can take part
Where in Romania
- BucharestBucharest, RomaniaTaking people
- Cluj-NapocaCluj-Napoca, RomaniaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jade Biosciences, Inc.
- Trial code
- NCT07533955
- Record updated
- 23 October 2026
- Original description
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 ArthritisRead full original descriptionShow less
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
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
Inclusion: 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.
Exclusion: Treatment with an investigational drug within 30 days or 5 half lives prior to study drug administration; 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; 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.