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PK of JT1801 vs NESP in Healthy Chinese Volunteers
NCT05864261Phase 4
Key facts
- Status
- Completed
- Start
- May 2023
- Primary completion
- Aug 2023
- Countries
- 1
- Sponsor
- InventisBio
- Modality
- Biosimilar, rProtein (Recombinant Protein), Biologic
- Drugs
- JT-1801
- Conditions
- anemia of chronic kidney disease
01
Overview
Phase 4, randomised trial of JT-1801 in anemia of chronic kidney disease (2 arms), sponsored by InventisBio. Primary endpoints: Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration at Day 20 and Area Under the Concentration-Time Curve From Time Zero to Infinity at Day 20. Started May 2023; status: completed.
02
Design
2 arms- Study design
- Randomized
JT1801 Arm
Single dose of JT1801 60ug IV
NESP Arm
Single dose of NESP 60ug IV
03
Endpoints
Primary
Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration
Area Under the Concentration-Time Curve From Time Zero to Infinity
Secondary
Time to Maximum Effect
Maximum Effect
Area Under the Effect-Time Curve
Change in Area Under the Effect-Time Curve
Change in Maximum Effect
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