Clinical trial NCT02486809: A Bioequivalence Study of Subcutaneous (SC) Lebrikizumab Administered by Needle and Syringe or by Prefilled Syringe With Needle Safety Device (PFS-NSD)
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2015-07-01
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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study will assess the bioequivalence in healthy participants between a high-concentration formulation of lebrikizumab withdrawn from a vial and administered SC as a single injection by a needle and syringe, and a low-concentration formulation of lebrikizumab administered SC as a single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


Eligibility criteria: 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

Primary outcomes:
measure: Maximum observed concentration (Cmax) of lebrikizumab
timeFrame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
measure: Time to maximum concentration (Tmax) of lebrikizumab
timeFrame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
measure: Area under the concentration-time curve to the last measurable concentration (AUC0-last) of lebrikizumab
timeFrame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
measure: Area under the concentration-time curve extrapolated to infinity (AUC0-inf) of lebrikizumab
timeFrame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
measure: Apparent terminal elimination rate constant of lebrikizumab
timeFrame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
measure: Apparent terminal elimination half-life (t1/2) of lebrikizumab
timeFrame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
measure: Apparent clearance (CL/F) of lebrikizumab
timeFrame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
measure: Apparent volume of distribution (Vz/F) of lebrikizumab
timeFrame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: From Day -1 until study completion or premature withdrawal (up to approximately 3 months)
measure: Incidence of anti-therapeutic antibodies (ATAs) to lebrikizumab
timeFrame: From Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Other outcomes:
Locations:
city: Daytona Beach
country: United States
state: Florida
city: Evansville
country: United States
state: Indiana
city: Dallas
country: United States
state: Texas
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: