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

Genentech, Inc.176 enrolled

Overview

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study will assess the bioequivalence in healthy participants between a high-concentration formulation of lebrikizumab withdrawn from a vial and administered SC as a single injection by a needle and syringe, and a low-concentration formulation of lebrikizumab administered SC as a single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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

176

Conditions

Healthy Volunteer

Interventions

LebrikizumabDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

Unnamed facility

Daytona Beach, Florida, United States

Unnamed facility

Evansville, Indiana, United States

Unnamed facility

Dallas, Texas, United States

Unnamed facility

Madison, Wisconsin, United States