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

Study Overview
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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.

Official Title
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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

Conditions
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Chronic Renal Failure, Anemia, Chronic Kidney Disease, Cancer

Intervention / Treatment
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* Drug: Placebo
* Drug: peginesatide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Single injection administered intravenously | Drug: Placebo<br> <br> |
| Experimental: Peginesatide 0.025 mg/kg<br>Single peginesatide dose of 0.025 milligram per kilogram (mg/kg) administered intravenously. | Drug: peginesatide<br> <br> * Other names: AF37702 Injection;|
| Experimental: Peginesatide 0.05 mg/kg<br>Single peginesatide dose of 0.05 mg/kg administered intravenously. | Drug: peginesatide<br> <br> * Other names: AF37702 Injection;|
| Experimental: Peginesatide 0.10 mg/kg<br>Single peginesatide dose of 0.10 mg/kg administered intravenously. | Drug: peginesatide<br> <br> * Other names: AF37702 Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 28 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameters |  | 28 Days | 
| Pharmacodynamic (PD) parameters |  | 28 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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