At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 12 enrolled
Drug / intervention
Lanadelumab +1 moredrug
Likely dose
Lanadelumab 300 mgfrom 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 Randomized, Double-blind, Placebo-Controlled, Repeat-dose, Single-center Phase 1a Study to Determine the Safety, Tolerability, and Pharmacokinetics of Lanadelumab Administered Intravenously in Healthy Adult Volunteer Subjects
In Brief
A Phase 1 clinical trial evaluating Lanadelumab and Placebo for Healthy Volunteers. Completed, enrolled 12 participants across 1 site.
Detailed Summary
The purpose of this study to evaluate the safety, tolerability and pharmacokinetics (PK) of lanadelumab administered by Intravenous (IV) infusion in healthy adult volunteers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
CollaboratorsTakeda Development Center Americas, Inc.
Timeline
Phase 1CompletedFinished
202120222023202420252026
First PostedAug 2020
Enrollment StartAug 2020
Primary CompletionDec 2020
TodayJul 2026
First PostedAug 7, 2020
Enrollment StartAug 10, 2020
Primary CompletionDec 23, 2020
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 5.9 years ago
Interventions
Lanadelumabdrug
Participants will receive lanadelumab 300 mg IV infusion on Day 1 followed by Day 4.
Placeboother
Participants will receive placebo matching to lanadelumab IV infusion on Day 1 followed by Day 4.