A Phase 1 Study of JADE201 in Participants With Rheumatoid Arthritis

This is a multisite, Phase 1, double-blind, placebo-controlled, randomized, first-in-human (FIH), single ascending dose study evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of JADE201 in participants with Rheumatoid Arthritis. Approximately 36 evaluable participants (6 in each cohort) will be enrolled. JADE201 will be administered by a subcutaneous injection. The results of this study will form the foundation for subsequent clinical development of JADE201 in autoimmune indications.

Inclusion criteria

• 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 criteria

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