Spots Global Cancer Trial Database for Safety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers

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Trial Identification

Brief Title: Safety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers

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 ID: NCT00097747

Conditions

Anemia

Chronic Kidney Disease

Chronic Renal Failure

Cancer

Interventions

Placebo

peginesatide

Study Description

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

Detailed Description: 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.