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

• Sponsor: Genentech, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02486809
• Collaborator: (none)
• Enrollment: 176
• Locations: 4
• Arms: 2
• Duration (Months): 3
• Patients Per Site: 44
• Patients Per Site Per Month: 14.6

Study Details

Study Description

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study will assess the bioequivalence in healthy participants between a high-concentration formulation of lebrikizumab withdrawn from a vial and administered SC as a single injection by a needle and syringe, and a low-concentration formulation of lebrikizumab administered SC as a single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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer	Drug: Lebrikizumab	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 176 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

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Experimental: Treatment 1: Needle and Syringe Healthy volunteers will receive a single SC injection of lebrikizumab, withdrawn from a vial and administered by a needle and syringe.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

Outcome Measures

Primary Outcome Measures

1. 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)]

2. 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)]

3. 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)]

4. 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)]

5. 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)]

6. 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)]

7. 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)]

8. 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

1. Incidence of adverse events [From Day -1 until study completion or premature withdrawal (up to approximately 3 months)]

2. Incidence of anti-therapeutic antibodies (ATAs) to lebrikizumab [From Day 1 until study completion or premature withdrawal (up to approximately 3 months)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Daytona Beach	Florida	United States	32117
2		Evansville	Indiana	United States	47710
3		Dallas	Texas	United States	75247
4		Madison	Wisconsin	United States	53704

Sponsors and Collaborators

• Genentech, Inc.

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Genentech, Inc.
• ClinicalTrials.gov Identifier: NCT02486809
• Other Study ID Numbers: GP29651
• First Posted: Jul 1, 2015
• Last Update Posted: Nov 2, 2016
• Last Verified: Nov 1, 2016

Study Results

No Results Posted as of Nov 2, 2016