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

NCT02486809 | Completed Phase 1

• 1 other identifier: GP29651
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 4

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study will assess the bioequivalence in healthy participants between a high-concentration formulation of lebrikizumab withdrawn from a vial and administered SC as a single injection by a needle and syringe, and a low-concentration formulation of lebrikizumab administered SC as a single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

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (2)

• 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)

Study Arms (2)

Treatment 1: Needle and Syringe

EXPERIMENTAL

Healthy volunteers will receive a single SC injection of lebrikizumab, withdrawn from a vial and administered by a needle and syringe.

Drug: Lebrikizumab

Treatment 2: PFS-NSD

EXPERIMENTAL

Healthy volunteers will receive a single SC injection of lebrikizumab, administered by PFS-NSD.

Drug: Lebrikizumab

Interventions

Lebrikizumab DRUG

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

Treatment 1: Needle and Syringe; Treatment 2: PFS-NSD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (4)

Unknown Facility

Daytona Beach, Florida, 32117, United States

Location

Unknown Facility

Evansville, Indiana, 47710, United States

Location

Unknown Facility

Dallas, Texas, 75247, United States

Location

Unknown Facility

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

lebrikizumab

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: July 1, 2015
• Study Start: July 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (4)