This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of JADE101 in healthy Japanese and Chinese participants.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
40
JADE101 is supplied as sterile solution to be administered by SC injection
Parexel Early Phase Clinical Unit (EPCU)
Glendale, California, United States
RECRUITINGSafety and tolerability of single dose of JADE101 in healthy Japanese and Chinese participants
Incidence of treatment-emergent adverse events
Time frame: Day 1 through 48 weeks
Cmax
Maximum observed serum concentration
Time frame: Day 1 through 48 weeks
Tmax
Time to reach Cmax
Time frame: Day 1 through 48 weeks
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 48 weeks
T1/2
Apparent first-order terminal elimination half-life
Time frame: Day 1 through 48 weeks
Immunogenicity of JADE101 in healthy Japanese and Chinese participants
Incidence and titers of serum anti-drug antibodies (ADAs)
Time frame: Day 1 through 48 weeks
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