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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00097747
• Date of registration: 30/11/2004
• Prospective Registration: No
• Primary sponsor: Affymax
• Public title: Safety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers
• Scientific 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
• Date of first enrolment: August 2004
• Target sample size: 28
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00097747
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United Kingdom

Contacts

• Name: Affymax
• Affiliation: Affymax, Inc.

Key inclusion & 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



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Chronic Kidney Disease

Anemia

Chronic Renal Failure

Cancer

Intervention(s)

Drug: Placebo

Drug: peginesatide

Primary Outcome(s)

Adverse events [Time Frame: 28 Days]

Secondary Outcome(s)

Pharmacodynamic (PD) parameters [Time Frame: 28 Days]

PK parameters [Time Frame: 28 Days]

Secondary ID(s)

2004-001655-11

AFX01-0401

Source(s) of Monetary Support

Please refer to primary and secondary sponsors