NCT01134549

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: KAI Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Hyperparathyroidism, Secondary

Interventions

Type	Name	Description
DRUG	Etelcalcetide	Administered as a single intravenous (IV) injection
DRUG	Placebo	Administered as a single intravenous (IV) injection

Timeline

• Start date: 2010-06-09
• Primary completion: 2010-07-31
• Completion: 2010-07-31
• First posted: 2010-06-02
• Last updated: 2017-04-14
• Results posted: 2017-04-14

Locations

1 site across 1 country: Australia