Status:
COMPLETED
Safety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers
Lead Sponsor:
Affymax
Conditions:
Anemia
Chronic Kidney Disease
Eligibility:
MALE
18-40 years
Phase:
PHASE1
Brief 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....
Eligibility Criteria
Inclusion
- Main eligibility criteria:
- Participant is a healthy male, age ≥ 18 years and ≤ 40 years, with body mass index (BMI) ≥ 18 and ≤ 30 kilograms per squared meter (kg/m\^2), and weight ≥ 50 and ≤ 95 kilograms (kg)
- Participant has hemoglobin of ≤ 16 grams per deciliter (g/dL) at the time of study entry
- Participant has normal iron stores
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2005
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00097747
Start Date
August 1 2004
End Date
January 1 2005
Last Update
December 21 2012
Active Locations (1)
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1
Research Facility
London, United Kingdom, HA1 3UJ