A Study of Lebrikizumab in Healthy Japanese and Caucasian Volunteers

NCT01423318 | Completed Phase 1

• 1 other identifier: GB25741
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (2)

A

EXPERIMENTAL

Drug: lebrikizumab

B

PLACEBO COMPARATOR

Drug: placebo

Interventions

lebrikizumab DRUG

Dose-level cohorts receiving single subcutaneous dose

A

placebo DRUG

single dose subcutaneously

B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (1)

Unknown Facility

Honolulu, Hawaii, 96813, United States

Location

MeSH Terms

Interventions

lebrikizumab

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2011
• First Posted: August 25, 2011
• Study Start: August 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (1)