A Bioequivalence Study of Subcutaneous (SC) Lebrikizumab Administered by Needle and Syringe or by Prefilled Syringe With Needle Safety Device (PFS-NSD)
Completed · Phase 1
Conditions studied: Healthy Volunteer
In brief
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study will assess the bioequivalence in healthy participants between a high-concentration formulation of lebrikizumab withdrawn from a vial and administered SC as a single injection by a needle and syringe, and a low-concentration formulation of lebrikizumab administered SC as a single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.
Key facts
- Study ID
- NCT02486809
- Run by
- Genentech, Inc.
- People needed
- 176
- Starts
- 2015-07-01
- Expected to finish
- 2015-10-01
- Last updated by the study team
- 2016-11-02
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Study site — Daytona Beach, Florida, United States
- Study site — Evansville, Indiana, United States
- Study site — Dallas, Texas, United States
- Study site — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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