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

NCT ID: NCT00097747

Last Updated: 2012-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2005-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Anemia Chronic Kidney Disease Chronic Renal Failure Cancer

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Single injection administered intravenously

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Peginesatide 0.025 mg/kg

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

Group Type EXPERIMENTAL

peginesatide

Intervention Type DRUG

Peginesatide 0.05 mg/kg

Single peginesatide dose of 0.05 mg/kg administered intravenously.

Group Type EXPERIMENTAL

peginesatide

Intervention Type DRUG

Peginesatide 0.10 mg/kg

Single peginesatide dose of 0.10 mg/kg administered intravenously.

Group Type EXPERIMENTAL

peginesatide

Intervention Type DRUG

Interventions

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Placebo

Intervention Type DRUG

peginesatide

Intervention Type DRUG

Other Intervention Names

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Omontys Hematide AF37702 Injection

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Affymax

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Affymax

Role: STUDY_DIRECTOR

Affymax, Inc.

Locations

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Research Facility

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2004-001655-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AFX01-0401

Identifier Type: -

Identifier Source: org_study_id