NCT05864261

Pharmacokinetics Comparison Study of JT1801 and NESP® After Single Dose Administration in Chinese Health Male Volunteers

A Randomized, Blinding, Single-dose, Positive-drug Parallel Control Study to Compare the Pharmacokinetics Following Administration of JT1801 and Darbepoetin Alfa Injection (NESP®) in Chinese Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Yi Fang · Academic / Other
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the similarity of major pharmacokinetic parameters after a single intravenous administration of JT1801 and NESP® in chinese healthy male volunteers. And to evaluate the safety, immunogenicity and pharmacodynamic characteristics of JT1801 and NESP® in chinese healthy male volunteers

Conditions

• Renal Anemia

Interventions

Type	Name	Description
DRUG	JT1801 60ug	JT1801, 60ug, IV injection
DRUG	NESP 60ug	NESP, 60ug, IV injection

Timeline

• Start date: 2023-05-15
• Primary completion: 2023-08-28
• Completion: 2023-08-28
• First posted: 2023-05-18
• Last updated: 2023-11-22

Locations

1 site across 1 country: China