NCT06285201

Study of Felzartamab in Healthy Adult Subjects

A Phase 1 Clinical Study to Evaluate the Pharmacokinetic Comparability, Safety, Tolerability, and Immunogenicity of Felzartamab for Injection in Healthy Male Adult Subjects in China (Randomized, Double-blind, Crossover Design)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: TJ Biopharma Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

A Phase 1 Clinical Study to Evaluate the Pharmacokinetic Comparability, Safety, Tolerability, and Immunogenicity of Felzartamab for Injection Pre- and Post-changes of Process in Healthy Male Adult Subjects in China (Randomized, Double-blind, Single-dose, Two-formulation, Two-sequence, Two-period Crossover Design)

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	T	8 mg/kg IV of Test drug manufactured by I-Mab Biopharma(Hangzhou)
DRUG	R	8 mg/kg IV of Test drug manufactured by Patheon Italia

Timeline

• Start date: 2024-03-27
• Primary completion: 2024-08-15
• Completion: 2024-08-15
• First posted: 2024-02-29
• Last updated: 2025-08-28

Locations

1 site across 1 country: China