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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 1
18 Years
40 Years
Not Enrolling
Male
Anemia, Chronic Kidney Disease, Chronic Renal Failure, Cancer

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Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Adverse events

Outcome Time Frame:

28 Days

Safety Issue:

Yes

Principal Investigator

Affymax

Investigator Role:

Study Director

Investigator Affiliation:

Affymax, Inc.

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

AFX01-0401

NCT ID:

NCT00097747

Start Date:

August 2004

Completion Date:

January 2005

Related Keywords:

  • Anemia
  • Chronic Kidney Disease
  • Chronic Renal Failure
  • Cancer
  • anemia
  • chronic kidney disease
  • CKD
  • chronic renal failure
  • CRF
  • erythropoietin
  • EPO
  • erythropoiesis stimulating agent
  • ESA
  • Hematide™
  • hemoglobin
  • Hb
  • Hgb
  • Omontys
  • peginesatide
  • red blood cell
  • red blood cell production
  • Anemia
  • Kidney Diseases
  • Kidney Failure, Chronic
  • Renal Insufficiency
  • Renal Insufficiency, Chronic

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