Healthy Volunteer
Conditions
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study will assess the bioequivalence in healthy participants between a high-concentration formulation of lebrikizumab withdrawn from a vial and administered SC as a single injection by a needle and syringe, and a low-concentration formulation of lebrikizumab administered SC as a single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.
Interventions
DRUGLebrikizumab
Participants will receive a single SC dose of lebrikizumab, delivered via needle and syringe or PFS-NSD.
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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) |
| 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) |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of anti-therapeutic antibodies (ATAs) to lebrikizumab | From Day 1 until study completion or premature withdrawal (up to approximately 3 months) |
| Incidence of adverse events | From Day -1 until study completion or premature withdrawal (up to approximately 3 months) |
Countries
United States
Outcome results
None listed