Lebrikizumab
DrugParticipants will receive a single SC dose of lebrikizumab, delivered via needle and syringe or PFS-NSD.
NCT Number: NCT02486809
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study will assess the bioequivalence in healthy participants between a high-concentration formulation of lebrikizumab withdrawn from a vial and administered SC as a single injection by a needle and syringe, and a low-concentration formulation of lebrikizumab administered SC as a single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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Daytona Beach, Florida, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive a single SC dose of lebrikizumab, delivered via needle and syringe or PFS-NSD.
Time frame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Time frame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Time frame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Time frame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Time frame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Time frame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Time frame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Time frame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Time frame: From Day -1 until study completion or premature withdrawal (up to approximately 3 months)
Time frame: From Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Genentech, Inc.
Industry
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)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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