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

Sponsor

Affymax (Industry)

Overall Status

Completed

CT.gov ID

NCT00097747

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anemia Chronic Kidney Disease Chronic Renal Failure Cancer	Drug: Placebo Drug: peginesatide	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2004

Actual Primary Completion Date :

Jan 1, 2005

Actual Study Completion Date :

Jan 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Single injection administered intravenously	Drug: Placebo
Experimental: Peginesatide 0.025 mg/kg Single peginesatide dose of 0.025 milligram per kilogram (mg/kg) administered intravenously.	Drug: peginesatide Other Names: Omontys Hematide AF37702 Injection
Experimental: Peginesatide 0.05 mg/kg Single peginesatide dose of 0.05 mg/kg administered intravenously.	Drug: peginesatide Other Names: Omontys Hematide AF37702 Injection
Experimental: Peginesatide 0.10 mg/kg Single peginesatide dose of 0.10 mg/kg administered intravenously.	Drug: peginesatide Other Names: Omontys Hematide AF37702 Injection

Outcome Measures

Primary Outcome Measures

Adverse events [28 Days]

Secondary Outcome Measures

PK parameters [28 Days]
Pharmacodynamic (PD) parameters [28 Days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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