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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
36
Jade Clinical Site
Chisinau, Moldova, Moldova
Jade Clinical Site
Ivano-Frankivsk, Ukraine, Ukraine
Jade Clinical Site
Kyiv, Ukraine, Ukraine
Safety and Tolerability of Single Ascending Doses of JADE201 in participants with Rheumatoid Arthritis
Incidence of treatment-emergent adverse events
Time frame: Day 1 through 36 weeks
Cmax
Maximum observed serum concentration
Time frame: Day 1 through Weeek 36
Tmax
Time to reach Cmax
Time frame: Day 1 through Week 36
AUClast
The area under the concentration-time curve from time zero to the time of the last observed quantifiable (non-zero) concentration
Time frame: Day 1 through Week 36
T1/2
Apparent first-order terminal elimination half-life
Time frame: Day 1 through Week 36
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.