A Study of Lebrikizumab in Healthy Japanese and Caucasian Volunteers

Sponsor

Genentech, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01423318

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

9.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the safety and pharmacokinetics of subcutaneous lebrikizumab in healthy Japanese volunteers. Healthy Japanese and Caucasian volunteers will be randomized to receive a single subcutaneous dose of either lebrikizumab or placebo.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Doses of Lebrikizumab in Healthy Japanese and Caucasian Volunteers

Study Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Feb 1, 2012

Actual Study Completion Date :

Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	Drug: lebrikizumab Dose-level cohorts receiving single subcutaneous dose
Placebo Comparator: B	Drug: placebo single dose subcutaneously

Arm

Intervention/Treatment

Experimental: A

Drug: lebrikizumab

Dose-level cohorts receiving single subcutaneous dose

Placebo Comparator: B

Drug: placebo

single dose subcutaneously

Outcome Measures

Primary Outcome Measures

Safety: Incidence of adverse events in healthy Japanese subjects [120 days]
Pharmacokinetics in healthy Japanese subjects: Area under the concentration-time curve (AUC) [120 days]

Secondary Outcome Measures

Comparison of safety (incidence of adverse events) in healthy Japanese and Caucasian subjects [approximately 5 months]
Comparison of pharmacokinetics (AUC) in healthy Japanese and Caucasian subjects [approximately 5 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Adult healthy males and females, 18 to 55 years of age inclusive
Caucasian, Japanese, or non-Japanese subjects. Caucasian or non-Japanese subjects will have no parents or grandparents of Japanese descent; Japanese subjects must be first, second or third generation
Body weight between 45 and 105 kg, inclusive
In good health, determined by no clinically significant findings from medical history, 12-lead ECG, vital signs, and laboratory evaluations
Fertile males and women of childbearing potential must use appropriate form of contraception from screening until 60 days after study completion
Negative for hepatitis B, hepatitis C, and HIV infection
Negative for selected drugs of abuse at screening (not including alcohol) and at check-in (including alcohol)

Exclusion Criteria:

Pregnant and lactating women
History of clinically significant drug allergy and/or a known hypersensitivity to the study drug or formulation components
History of helminthic infection or travel within the past 3 months to areas of high risk for parasitic exposure
Use of prescription drugs including inhaled, oral, or parenteral corticosteroids and/or beta agonists, within 7 days prior to dosing or during the study
Use of tobacco- or nicotine-containing products from 7 days prior to check-in, resulting in urinary cotinine >500 ng/mL. Minimal/intermittent smoking will be permitted during the study
Participation in any other investigational drug trial in which receipt of an investigational study drug occurred within 30 days or 5 half-lives, whichever is longer, prior to check-in (Day -1)
History of significant, chronic, or recurrent infections requiring treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Honolulu	Hawaii	United States	96813

Sponsors and Collaborators

Genentech, Inc.

Investigators

Study Director: Clinical Trials, Genentech, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Genentech, Inc.

ClinicalTrials.gov Identifier:

NCT01423318

Other Study ID Numbers:

GB25741

First Posted:

Aug 25, 2011

Last Update Posted:

Nov 2, 2016

Last Verified:

Nov 1, 2016

Study Results

No Results Posted as of Nov 2, 2016