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

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study will assess the bioequivalence in healthy participants between a high-concentration formulation of lebrikizumab withdrawn from a vial and administered SC as a single injection by a needle and syringe, and a low-concentration formulation of lebrikizumab administered SC as a single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

Official Title
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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)

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: Lebrikizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment 1: Needle and Syringe<br>Healthy volunteers will receive a single SC injection of lebrikizumab, withdrawn from a vial and administered by a needle and syringe. | Drug: Lebrikizumab<br>* Participants will receive a single SC dose of lebrikizumab, delivered via needle and syringe or PFS-NSD.<br>|
| Experimental: Treatment 2: PFS-NSD<br>Healthy volunteers will receive a single SC injection of lebrikizumab, administered by PFS-NSD. | Drug: Lebrikizumab<br>* Participants will receive a single SC dose of lebrikizumab, delivered via needle and syringe or PFS-NSD.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed concentration (Cmax) of lebrikizumab |  | Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months) | 
| Time to maximum concentration (Tmax) of lebrikizumab |  | Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months) | 
| Area under the concentration-time curve to the last measurable concentration (AUC0-last) of lebrikizumab |  | Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months) | 
| Area under the concentration-time curve extrapolated to infinity (AUC0-inf) of lebrikizumab |  | Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months) | 
| Apparent terminal elimination rate constant of lebrikizumab |  | Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months) | 
| Apparent terminal elimination half-life (t1/2) of lebrikizumab |  | Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months) | 
| Apparent clearance (CL/F) of lebrikizumab |  | Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months) | 
| Apparent volume of distribution (Vz/F) of lebrikizumab |  | Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | From Day -1 until study completion or premature withdrawal (up to approximately 3 months) | 
| Incidence of anti-therapeutic antibodies (ATAs) to lebrikizumab |  | From Day 1 until study completion or premature withdrawal (up to approximately 3 months) |