NCT02085473

A Study of Tralokinumab When Delivered Subcutaneously at Different Flow Rates to Healthy Volunteers

A Phase 1 Study to Evaluate the Pharmacokinetics and Tolerability of a Single Subcutaneous Dose of Tralokinumab When Delivered as a 2 mL Injection at Different Flow Rates to Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to evaluate the pharmacokinetics (PK) and tolerability of tralokinumab when delivered subcutaneously at different flow rates to healthy volunteers.

Detailed description

This is a Phase 1, open-label, assessor-blind, parallel-group study to evaluate the PK and tolerability of a single subcutaneous dose of 300 milligram (mg) tralokinumab when delivered as a 2 milliliters (mL) injection at different flow rates to healthy adult volunteers.

Conditions

• Asthma
• Healthy Subjects or Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	Tralokinumab 300 mg	Participants will receive 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at different flow rates.

Timeline

• Start date: 2014-03-19
• Primary completion: 2014-07-10
• Completion: 2014-07-10
• First posted: 2014-03-12
• Last updated: 2018-12-31
• Results posted: 2018-11-23

Locations

2 sites across 1 country: United States