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Completed

NCT Number: NCT02486809

A Bioequivalence Study of Subcutaneous (SC) Lebrikizumab Administered by Needle and Syringe or by 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study will assess the bioequivalence in healthy participants between a high-concentration formulation of lebrikizumab withdrawn from a vial and administered SC as a single injection by a needle and syringe, and a low-concentration formulation of lebrikizumab administered SC as a single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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Daytona Beach, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lebrikizumab

Drug

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

Primary outcomes

  1. Maximum observed concentration (Cmax) of lebrikizumab

    Time frame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)

  2. Time to maximum concentration (Tmax) of lebrikizumab

    Time frame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)

  3. Area under the concentration-time curve to the last measurable concentration (AUC0-last) of lebrikizumab

    Time frame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)

  4. Area under the concentration-time curve extrapolated to infinity (AUC0-inf) of lebrikizumab

    Time frame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)

  5. Apparent terminal elimination rate constant of lebrikizumab

    Time frame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)

  6. Apparent terminal elimination half-life (t1/2) of lebrikizumab

    Time frame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)

  7. Apparent clearance (CL/F) of lebrikizumab

    Time frame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)

  8. Apparent volume of distribution (Vz/F) of lebrikizumab

    Time frame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)

Secondary outcomes

  1. Incidence of adverse events

    Time frame: From Day -1 until study completion or premature withdrawal (up to approximately 3 months)

  2. Incidence of anti-therapeutic antibodies (ATAs) to lebrikizumab

    Time frame: From Day 1 until study completion or premature withdrawal (up to approximately 3 months)

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

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)

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 1, 2015
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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