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)

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study will assess the bioequivalence in healthy participants between a high-concentration formulation of lebrikizumab withdrawn from a vial and administered SC as a single injection by a needle and syringe, and a low-concentration formulation of lebrikizumab administered SC as a single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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: Lebrikizumab

• Study Type: Interventional
• Enrollment (Actual): 176
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
  • Indiana
    • Evansville, Indiana, United States, 47710
  • Texas
    • Dallas, Texas, United States, 75247
  • Wisconsin
    • Madison, Wisconsin, United States, 53704

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy adults 18 to 65 years of age, inclusive
• Body mass index (BMI) 18 to 32 kg/m^2 and body weight 50 to 100 kg, inclusive
• Nonpregnant and nonlactating females
• Agreement to utilize effective contraception among men and women of childbearing potential

Exclusion Criteria:

• Known allergy or hypersensitivity to study drug or components
• History of alcohol or drug abuse within 12 months prior to study drug, or positive test for alcohol or drugs of abuse
• Receipt of an investigational agent within 30 days of 5 half-lives prior to Day -1
• Biological therapy within 90 days prior to Day -1
• Parasitic or Listeria monocytogenes infection within 6 months prior to Screening
• Receipt of blood products within 2 months prior to study entry
• Donation or loss of blood/plasma within up to 6 months prior to study drug, depending upon volume
• Receipt of live attenuated vaccine within 1 month prior to study drug
• Use of tobacco- or nicotine-containing products within 14 days prior to Screening
• Use of any prescription or nonprescription medication within 14 days prior to study drug

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment 1: Needle and Syringe; Healthy volunteers will receive a single SC injection of lebrikizumab, withdrawn from a vial and administered by a needle and syringe.	Drug: Lebrikizumab; Participants will receive a single SC dose of lebrikizumab, delivered via needle and syringe or PFS-NSD.
Experimental: Treatment 2: PFS-NSD; Healthy volunteers will receive a single SC injection of lebrikizumab, administered by PFS-NSD.	Drug: Lebrikizumab; Participants will receive a single SC dose of lebrikizumab, delivered via needle and syringe or PFS-NSD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed concentration (Cmax) of lebrikizumab	Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Time to maximum concentration (Tmax) of lebrikizumab	Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Area under the concentration-time curve to the last measurable concentration (AUC0-last) of lebrikizumab	Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Area under the concentration-time curve extrapolated to infinity (AUC0-inf) of lebrikizumab	Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Apparent terminal elimination rate constant of lebrikizumab	Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Apparent terminal elimination half-life (t1/2) of lebrikizumab	Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Apparent clearance (CL/F) of lebrikizumab	Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Apparent volume of distribution (Vz/F) of lebrikizumab	Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events	From Day -1 until study completion or premature withdrawal (up to approximately 3 months)
Incidence of anti-therapeutic antibodies (ATAs) to lebrikizumab	From Day 1 until study completion or premature withdrawal (up to approximately 3 months)

Collaborators and Investigators

• Sponsor: Genentech, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: June 29, 2015
• First Submitted That Met QC Criteria: June 29, 2015
• First Posted (Estimate): July 1, 2015

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: GP29651