NCT04503603

A Study to Determine the Safety, Tolerability, and Pharmacokinetics of Lanadelumab Administered Intravenously in Healthy Adult Volunteer Participants

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

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

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Lanadelumab	Participants will receive lanadelumab 300 mg IV infusion on Day 1 followed by Day 4.
OTHER	Placebo	Participants will receive placebo matching to lanadelumab IV infusion on Day 1 followed by Day 4.

Timeline

• Start date: 2020-08-10
• Primary completion: 2020-12-23
• Completion: 2020-12-23
• First posted: 2020-08-07
• Last updated: 2022-03-07
• Results posted: 2022-03-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study