A Phase 1, Double-blind, Placebo-controlled, Dose Escalation Study of the Safety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Adverse events
28 Days
Yes
Affymax
Study Director
Affymax, Inc.
United Kingdom: Medicines and Healthcare Products Regulatory Agency
AFX01-0401
NCT00097747
August 2004
January 2005
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