At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 32 enrolled
Drug / intervention
Lanadelumabdrug
Likely dose
Lanadelumab 300mgfrom 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 Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics of a Single Dose of Lanadelumab Administered Subcutaneously in Healthy Adult Japanese Subjects and Matched Healthy Adult Caucasian Subjects
In Brief
A Phase 1 clinical trial evaluating Lanadelumab for Healthy Volunteers. Completed, enrolled 32 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the pharmacokinetics (PK), safety and tolerability and pharmacodynamics (PD) of lanadelumab in healthy adult Japanese subjects and matched non-Hispanic healthy adult Caucasian subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
Enrollment StartJan 2018
First PostedJan 2018
Primary CompletionMay 2018
TodayJul 2026
First PostedJan 17, 2018
Enrollment StartJan 15, 2018
Primary CompletionMay 30, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.5 years ago
Interventions
Lanadelumabdrug
SC injection of 300mg in 2mL (150 mg/mL) solution of lanadelumab will be administered as a single dose injection in the abdomen.