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

Genentech

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: Lebrikizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02486809

GP29651

Details and patient eligibility

About

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study will assess the bioequivalence in healthy participants between a high-concentration formulation of lebrikizumab withdrawn from a vial and administered SC as a single injection by a needle and syringe, and a low-concentration formulation of lebrikizumab administered SC as a single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

Enrollment

176 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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