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NCT Number: NCT00097747

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

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

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Key information

Conditions

Anemia Cancer Chronic Disease Chronic Kidney Disease Chronic Renal Failure Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Facility

London, HA1 3UJ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

peginesatide

Drug

Other names: Omontys, Hematide, AF37702 Injection

Primary outcomes

  1. Adverse events

    Time frame: 28 Days

Secondary outcomes

  1. PK parameters

    Time frame: 28 Days

  2. Pharmacodynamic (PD) parameters

    Time frame: 28 Days

Sponsors and collaborators

Lead sponsor

Affymax

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Dec 1, 2004
Registry last updated
Dec 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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