A Phase 1 Study of JADE201 in Participants With Rheumatoid Arthritis
ConditionRhematoid Arthritis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorJade Biosciences, Inc.
About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- JADE201
- Placebo
Treatment groups
36 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov