This study is a randomized, parallel-group, open-label Phase I clinical trial designed to compare the bioavailability and safety of subcutaneous SHR-1819 injection administered via different injection devices in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
SHR-1819 injection.
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
Area under the serum concentration versus time curve from time zero to the real time of last measurable concentration (AUClast).
Time frame: Day 1 - Day 71.
Peak concentration (Cmax)
Pharmacokinetic parameters of multiple-site subcutaneous injection of SHR-1819.
Time frame: Day 1 - Day 71.
SHR-1819 Anti-Drug Antibodies (ADA)
Time frame: Day1; Day22 ; Day43; Day71.
Incidence and severity of adverse events (AEs)
Time frame: Day 1 - Day 71.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.