drugset / Trial / NCT07254325

Pharmacokinetic, Safety and Immunogenicity Study of New Process CMAB015 and Cosentyx in Healthy Volunteers

NCT07254325

Phase 1 Active not recruiting 114 enrolled Taizhou Mabtech Pharmaceutical Co.,Ltd
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a randomized, double-blinded, controlled Phase I study of new process CMAB015 administered by subcutaneous injection. This study will characterize the pharmacokinetic, safety and immunogenicity of new process CMAB015 versus Cosentyx(Secukinumab ) in healthy male subjects after a single dose.

Timeline

Start
2025-12-15
Primary completion
2026-06-01
Completion
2026-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Secukinumab Monoclonal antibody 150 mg Subcutaneous

Indications