NCT07246291

Comparative Study of EnliTuo® Before and After Technology Change in Healthy Male Volunteers

Randomized, Double-Blind, Parallel-Controlled, Single-Dose Pharmacokinetic, Safety, and Immunogenicity Comparative Study of EnliTuo® Before and After Technology Change in Healthy Male Volunteers

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is a randomized, double-Blind, parallel-controlled, single-dose pharmacokinetic, safety, and immunogenicity comparative study of EnliTuo® before and after technology change in healthy male volunteers.

Conditions

• Healthy Adult Male

Interventions

Type	Name	Description
BIOLOGICAL	New technology Enlituo	250 mg/m\^2, single intravenous drip
BIOLOGICAL	Approved technology Enlituo	250 mg/m\^2, single intravenous drip

Timeline

• Start date: 2025-11-11
• Primary completion: 2026-02-03
• Completion: 2026-02-03
• First posted: 2025-11-24
• Last updated: 2025-11-24

Locations

1 site across 1 country: China