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
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Republic of Moldova
Jade Clinical Site
RECRUITING
Chisinau
Ukraine
Jade Clinical Site
RECRUITING
Ivano-frankivsk
Jade Clinical Site
RECRUITING
Kyiv
Contact Information
Primary
Jade201 Study Contact
JADE201clinicaltrials@jadebiosciences.com
781-201-4781
Time Frame
Start Date: 2026-05-19
Estimated Completion Date: 2028-10
Participants
Target number of participants: 36
Treatments
Experimental: JADE201
Subcutaneous (SC) injection of JADE201
Experimental: Placebo
Subcutaneous (SC) injection of Placebo
Related Therapeutic Areas
Sponsors
Leads: Jade Biosciences, Inc.