NCT01800305

PK & PD Study of Pegylated rhEPO, and Evaluated Its Safety and Tolerability in Male Healthy Individual

A Randomized, Positive-controlled, Single-dose, Dose-escalation Phase I Trial to Evaluate Safety & Tolerability, and Explore the Pharmacokinetics and Pharmacodynamics Profile of Pegylated rhEPO in Male Healthy Individual

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Xiamen Amoytop Biotech Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The object of this randomized, parallel, positive controlled study is to explore the pharmacokinetics and pharmacodynamics profile of the test drug after single-dose subcutaneous administration, compared to the comparator drug (EPIAO®) after multiple-dose subcutaneous administration, by assessing plasma concentration of the drug and the reticulocyte count, hemoglobin concentration and hematocrit following subcutaneous administration, evaluate the security and tolerability of the test drug in healthy subjects, and provide sufficient information for dose selection in the future phase II and III study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Pegylated rhEPO
DRUG	EPIAO®

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2013-02-27
• Last updated: 2015-08-31

Locations

1 site across 1 country: China