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

Healthy Volunteer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02486809
• Other study ID #: GP29651
• Status: Completed
• Phase: Phase 1
• First received: June 29, 2015
• Last updated: November 1, 2016
• Start date: July 2015
• Est. completion date: October 2015

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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study will assess the bioequivalence in healthy participants between a high-concentration formulation of lebrikizumab withdrawn from a vial and administered SC as a single injection by a needle and syringe, and a low-concentration formulation of lebrikizumab administered SC as a single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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• Lebrikizumab
Participants will receive a single SC dose of lebrikizumab, delivered via needle and syringe or PFS-NSD.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Secondary	Incidence of adverse events		From Day -1 until study completion or premature withdrawal (up to approximately 3 months)	No
Secondary	Incidence of anti-therapeutic antibodies (ATAs) to lebrikizumab		From Day 1 until study completion or premature withdrawal (up to approximately 3 months)	No