Trial | NCT00097747  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    peginesatide ...

  • Study Participants

    28
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and minimum pharmacologically active dose 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.
Study Started
Aug 31
2004
Primary Completion
Jan 31
2005
Study Completion
Jan 31
2005
Last Update
Dec 21
2012
Estimate

Drug Placebo

Drug peginesatide

  • Other names: Omontys, Hematide, AF37702 Injection

Placebo Placebo Comparator

Single injection administered intravenously

Peginesatide 0.025 mg/kg Experimental

Single peginesatide dose of 0.025 milligram per kilogram (mg/kg) administered intravenously.

Peginesatide 0.05 mg/kg Experimental

Single peginesatide dose of 0.05 mg/kg administered intravenously.

Peginesatide 0.10 mg/kg Experimental

Single peginesatide dose of 0.10 mg/kg administered intravenously.

Criteria 

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
No Results Posted