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

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

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study will assess the bioequivalence in healthy participants between a high-concentration formulation of lebrikizumab withdrawn from a vial and administered SC as a single injection by a needle and syringe, and a low-concentration formulation of lebrikizumab administered SC as a single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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Antibodies, Monoclonal

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