Safety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers
Phase 1
Completed
- Conditions
- AnemiaChronic Kidney DiseaseChronic Renal FailureCancer
- Interventions
- Drug: Placebo
- Registration Number
- NCT00097747
- Lead Sponsor
- Affymax
- 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. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 28
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Single injection administered intravenously Peginesatide 0.025 mg/kg peginesatide Single peginesatide dose of 0.025 milligram per kilogram (mg/kg) administered intravenously. Peginesatide 0.10 mg/kg peginesatide Single peginesatide dose of 0.10 mg/kg administered intravenously. Peginesatide 0.05 mg/kg peginesatide Single peginesatide dose of 0.05 mg/kg administered intravenously.
- Primary Outcome Measures
Name Time Method Adverse events 28 Days
- Secondary Outcome Measures
Name Time Method PK parameters 28 Days Pharmacodynamic (PD) parameters 28 Days
Trial Locations
- Locations (1)
Research Facility
🇬🇧London, United Kingdom