Safety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers
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ClinicalTrials.gov Identifier: NCT00097747 |
Recruitment Status :
Completed
First Posted : December 1, 2004
Last Update Posted : December 21, 2012
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Condition or disease | Intervention/treatment | Phase |
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Anemia Chronic Kidney Disease Chronic Renal Failure Cancer | Drug: Placebo Drug: peginesatide | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
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 : | August 2004 |
Actual Primary Completion Date : | January 2005 |
Actual Study Completion Date : | January 2005 |
Arm | Intervention/treatment |
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Placebo Comparator: Placebo
Single injection administered intravenously
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Drug: Placebo |
Experimental: Peginesatide 0.025 mg/kg
Single peginesatide dose of 0.025 milligram per kilogram (mg/kg) administered intravenously.
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Drug: peginesatide
Other Names:
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Experimental: Peginesatide 0.05 mg/kg
Single peginesatide dose of 0.05 mg/kg administered intravenously.
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Drug: peginesatide
Other Names:
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Experimental: Peginesatide 0.10 mg/kg
Single peginesatide dose of 0.10 mg/kg administered intravenously.
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Drug: peginesatide
Other Names:
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- Adverse events [ Time Frame: 28 Days ]
- PK parameters [ Time Frame: 28 Days ]
- Pharmacodynamic (PD) parameters [ Time Frame: 28 Days ]

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Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00097747
United Kingdom | |
Research Facility | |
London, United Kingdom, HA1 3UJ |
Study Director: | Affymax | Affymax, Inc. |
Responsible Party: | Affymax |
ClinicalTrials.gov Identifier: | NCT00097747 |
Other Study ID Numbers: |
AFX01-0401 2004-001655-11 ( EudraCT Number ) |
First Posted: | December 1, 2004 Key Record Dates |
Last Update Posted: | December 21, 2012 |
Last Verified: | December 2012 |
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 |
Kidney Diseases Renal Insufficiency, Chronic Renal Insufficiency Kidney Failure, Chronic Urologic Diseases |