NCT02486809

A Bioequivalence Study of Subcutaneous (SC) Lebrikizumab Administered by Needle and Syringe or by Prefilled Syringe With Needle Safety Device (PFS-NSD)

A Phase I, Randomized, Open-Label, Parallel-Group, Single-Dose, Multi-Center Study in Healthy Subjects to Investigate the Bioequivalence Between a High-Concentration Formulation of Lebrikizumab Administered Subcutaneously by a Needle and Syringe and a Low-Concentration Formulation of Lebrikizumab Administered Subcutaneously by a Prefilled Syringe With Needle Safety Device (PFS-NSD)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study will assess the bioequivalence in healthy participants between a high-concentration formulation of lebrikizumab withdrawn from a vial and administered SC as a single injection by a needle and syringe, and a low-concentration formulation of lebrikizumab administered SC as a single injection via PFS-NSD.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	Lebrikizumab	Participants will receive a single SC dose of lebrikizumab, delivered via needle and syringe or PFS-NSD.

Timeline

• Start date: 2015-07-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2015-07-01
• Last updated: 2016-11-02

Locations

4 sites across 1 country: United States