Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07254325
PHASE1

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

Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd

View on ClinicalTrials.gov

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.

Official title: Phase I Comparison of Pharmacokinetics, Safety, and Immunogenicity of New Process CMAB015 Injection and Cosentyx in a Randomized, Double-blind, Parallel Controlled, Single-dose Study in Healthy Chinese Male Subjects

Key Details

Gender

MALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

114

Start Date

2025-12-15

Completion Date

2026-05-01

Last Updated

2025-11-28

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

Secukinumab 150mg s.c.

for subcutaneous injection only