The purpose of this study is to assess safety, PK and immunogenicity profile of a single dose of SHR-1139 in healthy volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Single dose of SHR-1139 given subcutaneously (dose level 1 )
Single dose of SHR-1139 given subcutaneously (dose level 2 )
Single dose of SHR-1139 given intravenously (dose level 3)
Linear
Perth, Western Australia, Australia
PK profile of SHR-1139 after a single administration
Pharmacokinetics- Area under the concentration-time curve from time 0 to last time point after SHR-1139 administration (AUC0-last)
Time frame: Start of Treatment to end of study (Day 253)
PK profile of SHR-1139 after a single administration
Pharmacokinetics- Area under the concentration-time curve (AUC0-inf)
Time frame: From time 0 to infinity after SHR-1139 administration (Day 253)
PK profile of SHR-1139 after a single administration:
Pharmacokinetics- Time to Cmax of SHR-1139 (Tmax )
Time frame: Start of Treatment to end of study (Day 253)
PK profile of SHR-1139 after a single administration
Pharmacokinetics-Terminal elimination half-life of SHR-1139 (t1/2)
Time frame: Start of Treatment to end of study (Day 253)
Immunogenicity profile of SHR-1139 after a single dose administration
The number of participants with anti-drug antibody (ADA)
Time frame: Day 253
Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events
Number of participants with Adverse events and Serious adverse events
Time frame: Day 295
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