Status and phase
Conditions
Treatments
About
This is a randomized, double-blinded, controlled Phase I study of CMAB015 administered by subcutaneous injection. This study will characterize the pharmacokinetic, safety and immunogenicity of CMAB015 versus Cosentyx(Secukinumab ) in healthy male subjects after a single dose.
Full description
This is a randomized, double-blind, parallel-controlled, single-dose phase I clinical study in healthy Chinese male subjects. A total of 130 subjects were planned to be enrolled and randomly assigned to the test group or the control group in a 1:1 ratio. Subjects in both groups received a single upper arm subcutaneous injection of CMAB015 or Cosentyx(Secukinumab) 150 mg, respectively. Subjects in both groups were observed for 112 days after administration to evaluate similarities in pharmacokinetics, safety, and immunogenicity.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
130 participants in 2 patient groups
Loading...
Central trial contact
Hu Wei, Doctor; Zhang Jing
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal