Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Healthy Male Volunteers

• Status: Completed
• Trial end date: 2010-07-31
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: KAI Pharmaceuticals
• Collaborator: Nucleus Network Ltd

Criteria

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