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high-concentration formulation of lebrikizumab withdrawn from a vial and administered SC as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high-concentration formulation of lebrikizumab withdrawn from a vial and administered SC as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