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

Affymax

Status and phase: Completed; Phase 1

Conditions: Chronic Kidney Disease; Anemia; Chronic Renal Failure; Cancer

Treatments: Drug: Placebo; Drug: peginesatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00097747

2004-001655-11 (EudraCT Number)

AFX01-0401

Details and patient eligibility

About

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

Full 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.

Enrollment: 28 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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28 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Single injection administered intravenously

Treatment:

Drug: Placebo

Peginesatide 0.025 mg/kg

Experimental group

Description:

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

Treatment:

Drug: peginesatide

Peginesatide 0.05 mg/kg

Experimental group

Description:

Single peginesatide dose of 0.05 mg/kg administered intravenously.

Treatment:

Drug: peginesatide

Peginesatide 0.10 mg/kg

Experimental group

Description:

Single peginesatide dose of 0.10 mg/kg administered intravenously.

Treatment:

Drug: peginesatide