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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 65
Updated:8/3/2016
Start Date:July 2015
End Date:October 2015

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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)

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high-concentration formulation of lebrikizumab withdrawn from a vial and administered SC as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.


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
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