At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 12 enrolled
Drug / intervention
Icatibant (30 mg)drug
Likely dose
Icatibant (30 mg)from 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.
An Open-label, Single-arm Study to Assess the Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of Icatibant in Healthy Japanese Volunteers
In Brief
A Phase 1 clinical trial evaluating Icatibant (30 mg) for Hereditary Angioedema (HAE). Completed, enrolled 12 participants across 1 site.
Detailed Summary
This is a single-dose study to evaluate the pharmacokinetics, safety, and tolerability of icatibant administered to adult Japanese subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Angioedema (HAE)
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 2014
Enrollment StartFeb 2014
Primary CompletionFeb 2014
TodayJul 2026
First PostedJan 24, 2014
Enrollment StartFeb 21, 2014
Primary CompletionFeb 27, 2014
TodayJul 2, 2026
Enrollment to primary: 6 daysPosted 12.4 years ago
Interventions
Icatibant (30 mg)drug
On Day 1, subjects will receive a single 30mg subcutaneous injection of icatibant in their abdominal area. Subjects will be discharged from the study on Day 3 after collection of study related assessments