A Phase 1 interventional study of BR201 and Cosentyx(Secukinumab ) in Psoriasis, sponsored by BioRay Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-24.
Sponsored by BioRay Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment
This is a randomized, open-label, controlled Phase I study of BR201 administered by subcutaneous injection. This study will characterize the pharmacokinetic, safety and immunogenicity of BR201 versus Cosentyx(Secukinumab ) in healthy male subjects after a single dose.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 88 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →BioRay Pharmaceutical Co., Ltd. is the lead sponsor of 17 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: BR201
Drug: Cosentyx(Secukinumab )
One-dosage on D1 and review pharmacokinetic and safety until D112 after drug given
One-dosage on D1 and review pharmacokinetic and safety until D112 after drug given
AUC0-inf
Area under the cure from 0 to infinite
Time frame: Till Day112
Cmax
The max concentration after drug given
Time frame: Till Day112
AUC0-t
Area under the cure from 0 to some time
Time frame: Till Day112
Tmax
The time for drug enlarge to max concentration
Time frame: Till Day112
T1/2
Half life
Time frame: Till Day112
Vz/F
Apparent volume of distribution
Time frame: Till Day112
CL/F
Clearance
Time frame: Till Day112
Immunogenicity
ADA
Time frame: Till Day112
AE
Advance event
Time frame: Till Day112
Evaluation about injection site reactions
Evaluation about injection site reactions
Time frame: 0 mins, 0.5 hours, 24 hours and 72 hours after drug given
ECG
ECG
Time frame: Till Day112
Incidence of laboratory abnormalities
To be summarized using descriptive statistics
Time frame: Till Day112
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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BioRay Pharmaceutical Co., Ltd.