NCT07254325

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 114 (estimated)
• Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a randomized, double-blind, parallel-controlled, single-dose phase I clinical study in healthy Chinese male subjects. A total of 114 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 new process 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.

Conditions

• Psoriasis

Interventions

Type	Name	Description
BIOLOGICAL	Secukinumab 150mg s.c.	for subcutaneous injection only

Timeline

• Start date: 2025-12-15
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2025-11-28
• Last updated: 2025-11-28