Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Healthy Male Volunteers

KAI Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Hyperparathyroidism, Secondary

Treatments: Drug: Etelcalcetide; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01134549

20130107 (Other Identifier)

KAI-4169-001

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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32 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received a single dose of placebo intravenous injection.

Treatment:

Drug: Placebo

Etelcalcetide

Experimental group

Description:

Participants received a single dose of etelcalcetide intravenous injection; the starting dose was 0.5 mg.

Treatment:

Drug: Etelcalcetide