At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 32 enrolled
Drug / intervention
Etelcalcetide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Etelcalcetide and Placebo for Hyperparathyroidism, Secondary. Completed, enrolled 32 participants across 1 site.
Detailed Summary
The purpose of this study is to characterize the safety and tolerability of etelcalcetide in healthy young males.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperparathyroidism, Secondary
CountriesAustralia
CollaboratorsNucleus Network Ltd
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2010
Enrollment StartJun 2010
Primary CompletionJul 2010
TodayJul 2026
First PostedJun 2, 2010
Enrollment StartJun 9, 2010
Primary CompletionJul 31, 2010
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 16.1 years ago
Interventions
Etelcalcetidedrug
Administered as a single intravenous (IV) injection
Placebodrug
Administered as a single intravenous (IV) injection