A Bioequivalence Study of Subcutaneous (SC) Lebrikizumab Administered by Needle and Syringe or by Prefilled Syringe With Needle Safety Device (PFS-NSD)
- Registration Number
- NCT02486809
- Lead Sponsor
- Genentech, Inc.
- 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study will assess the bioequivalence in healthy participants between a high-concentration formulation of lebrikizumab withdrawn from a vial and administered SC as a single injection by a needle and syringe, and a low-concentration formulation of lebrikizumab administered SC as a single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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 176
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment 1: Needle and Syringe Lebrikizumab Healthy volunteers will receive a single SC injection of lebrikizumab, withdrawn from a vial and administered by a needle and syringe. Treatment 2: PFS-NSD Lebrikizumab Healthy volunteers will receive a single SC injection of lebrikizumab, administered by PFS-NSD.
- Primary Outcome Measures
Name Time Method 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) 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) 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) 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) 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) 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) 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)
- Secondary Outcome Measures
Name Time Method 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)