A Study of MHAA4549A in Healthy Volunteers in an Influenza Challenge Model

Healthy Volunteer Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study in Healthy Volunteers to Evaluate the Efficacy and Safety of MHAA4549A in an Influenza Challenge Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01980966
• Other study ID #: GV28985
• Secondary ID: 2013-001983-52
• Status: Completed
• Phase: Phase 2
• First received: November 5, 2013
• Last updated: March 7, 2017
• Start date: November 25, 2013
• Est. completion date: June 19, 2014

Study information

• Verified date: March 2017
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of MHAA4549A in healthy volunteers in an influenza challenge model. Subjects will be intranasally oculated with the challenge virus and will be randomly assigned to receive a intravenous dose of either MHAA4549A or placebo. In the stage 5 cohort, subjects will be randomly assigned to receive doses of MHAA4549A or placebo or Tamiflu (oseltamivir) orally twice daily for 5 days. All subjects in all cohorts may take Tamiflu twice daily from Day 7 to Day 11.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: June 19, 2014
• Est. primary completion date: June 19, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• In good health with no history of major medical conditions from medical history, physical examination and routine laboratory tests

• Male subjects and women of child-bearing potential must use effective contraception as defined by protocol, starting at entry to quarantine and continuing until Day 120 follow-up visit

• Sero-suitable for challenge virus

Exclusion Criteria:

• Women who have been pregnant within 6 months prior to the study, or who have been breastfeeding within 3 months prior to the study, or who have a positive pregnancy test at any point in the study

• Any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic, urological, neurological, psychiatric, renal, and/or other major disease or malignancy, as judged by the CI

• Abnormal pulmonary function evidenced by clinically significant abnormalities in spirometry

• History of asthma, COPD, pulmonary hypertension, reactive airway disease, or chronic lung disease of any etiology. A history of childhood asthma before the age of 12 is acceptable provided the subject is asymptomatic without treatment.

• History suggestive of respiratory infection within 14 days prior to admission to the unit

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• MHAA549A
IV dose
• Placebo
IV dose
• oseltamivir [Tamiflu]
Orally b.i.d, 5 days

Locations

Country	Name	City	State
United Kingdom	Retroscreen Ltd	London

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral area under the concentration-time curve (AUC) of nasopharyngeal viral load by quantitative Polymerase Chain Reaction (qPCR)		8 days
Secondary	Safety: Incidence of adverse events		120 days
Secondary	Safety: Change in lung function		from pre-challenge to Day 29
Secondary	Safety: Incidence of anti-therapeutic antibodies (ATAs)		120 days
Secondary	Pharmacokinetics: Area under the concentration-time curve		8 days
Secondary	AUC of nasopharyngeal viral load, as measured by cell culture		8 days
Secondary	Peak viral load (qPCR and cell culture)		8 days
Secondary	Duration of viral shedding		8 days
Secondary	Duration of Grade 2 or worse symptoms (from first occurrence of any Grade >2 symptom to last occurrence of any Grade >2 symptom)		8 days
Secondary	Peak/AUC of composite symptoms		8 days