A Study of Lebrikizumab in Healthy Japanese and Caucasian Volunteers

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01423318
• Other study ID #: GB25741
• Status: Completed
• Phase: Phase 1
• First received: August 22, 2011
• Last updated: November 1, 2016
• Start date: August 2011
• Est. completion date: February 2012

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• lebrikizumab
Dose-level cohorts receiving single subcutaneous dose
• placebo
single dose subcutaneously

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	Safety: Incidence of adverse events in healthy Japanese subjects		120 days	No
Primary	Pharmacokinetics in healthy Japanese subjects: Area under the concentration-time curve (AUC)		120 days	No
Secondary	Comparison of safety (incidence of adverse events) in healthy Japanese and Caucasian subjects		approximately 5 months	No
Secondary	Comparison of pharmacokinetics (AUC) in healthy Japanese and Caucasian subjects		approximately 5 months	No