NCT00097747

Safety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers

A Phase 1, Double-blind, Placebo-controlled, Dose Escalation Study of the Safety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Affymax · Industry
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and minimum pharmacologically active dose of peginesatide in Healthy Volunteers.

Detailed description

This was a Phase 1, double-blind, placebo-controlled trial of peginesatide, an erythropoiesis stimulating agent, with approximately 7 treatment cohorts and 7 healthy volunteer participants per cohort. In each cohort of 7 participants, a ratio of 5:2 participants was randomly assigned to receive a single dose of peginesatide or placebo, respectively, administered as an intravenous infusion. Planned peginesatide dose levels were to escalate by cohort. The study was conducted at a single clinical center.

Conditions

• Anemia
• Chronic Kidney Disease
• Chronic Renal Failure
• Cancer

Interventions

Type	Name	Description
DRUG	Placebo
DRUG	peginesatide

Timeline

• Start date: 2004-08-01
• Primary completion: 2005-01-01
• Completion: 2005-01-01
• First posted: 2004-12-01
• Last updated: 2012-12-21

Locations

1 site across 1 country: United Kingdom