The main purpose of this study is to evaluate the safety, Tolerability and Pharmacokinetics (PK) of SHR1314 with axial spondyloarthritis.
This was a phase I, multicenter, double-blind, randomized, placebo-controlled study. The study originally planned to enroll 5 cohorts of 8 subjects each (N=40).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
45
Pharmaceutical form: Injection solution. Route of administration: subcutaneous injection.
Jianwen Chen
Shanghai, China
The safety and tolerability of multiple subcutaneous injections of SHR1314 in adult patients with axial spondyloarthritis 1.Incidence of Treatment-Emergent Adverse Events 2.Incidence of Injection site reaction
Safety and tolerability of multiple subcutaneous injections of SHR1314 assessed by adverse events and serious adverse events. 1. Incidence of Treatment-Emergent Adverse Events 2. Incidence of Injection site reaction
Time frame: Baseline to 169 days after dose administration
Maximum observed serum concentration (Cmax) of SHR-1314
maximum concentration (Cmax)
Time frame: Baseline to 169 days after dose administration
Time to maximum observed serum concentration (tmax) of SHR-1314
Time to maximum concentration (Tmax)
Time frame: Baseline to 169 days after dose administration
Time to elimination half-life (t1/2) of SHR-1314
t1/2
Time frame: Baseline to 169 days after dose administration
Assessment of development of Anti-drug Antibodies (ADAs)
Incidence of development of Anti-drug Antibodies (ADAs)
Time frame: Baseline to 169 days after dose administration
Proportion of Participants Achieving an ASAS20 Response
ASAS20 Response
Time frame: Week2, 4, 6, 8, 12,16
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.