Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Healthy Male Volunteers

A Double-Blind, Randomized, Placebo-Controlled, Rising Single Intravenous Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of KAI-4169 in Healthy Male Volunteers

The purpose of this study is to characterize the safety and tolerability of etelcalcetide in healthy young males.

Inclusion Criteria:

• Male between 18 and 45 years of age who have provided written informed consent
• Subject is judged to be in good health based on medical history, physical examination, and routine laboratory tests

Exclusion Criteria:

• History or presence of any significant acute or chronic illness (e.g., cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease) according to the investigator
• History of any ongoing medical condition requiring treatment with prescription medication
• History of asthma, severe allergies including skin reactions or prior anaphylactic type reactions
• Clinically significant abnormalities on screening clinical examination or laboratory safety tests
• History of drug or alcohol abuse