NCT01980966

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 11, 2013

Completed
14 days until next milestone

Study Start

First participant enrolled

November 25, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2014

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

Enrollment Period

7 months

First QC Date

November 5, 2013

Last Update Submit

March 7, 2017

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

  • Viral area under the concentration-time curve (AUC) of nasopharyngeal viral load by quantitative Polymerase Chain Reaction (qPCR)

    8 days

Secondary Outcomes (9)

  • Safety: Incidence of adverse events

    120 days

  • Safety: Change in lung function

    from pre-challenge to Day 29

  • Safety: Incidence of anti-therapeutic antibodies (ATAs)

    120 days

  • Pharmacokinetics: Area under the concentration-time curve

    8 days

  • AUC of nasopharyngeal viral load, as measured by cell culture

    8 days

  • +4 more secondary outcomes

Study Arms (3)

MHAA4549A

EXPERIMENTAL
Drug: MHAA549A

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Tamiflu

ACTIVE COMPARATOR
Drug: oseltamivir [Tamiflu]

Interventions

MHAA549ADRUG

IV dose

MHAA4549A
PlaceboDRUG

IV dose

Placebo
oseltamivir [Tamiflu]DRUG

Orally b.i.d, 5 days

Tamiflu

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Retroscreen Ltd

London, NW1 0NH, United Kingdom

Location

Related Publications (2)

  • McBride JM, Lim JJ, Burgess T, Deng R, Derby MA, Maia M, Horn P, Siddiqui O, Sheinson D, Chen-Harris H, Newton EM, Fillos D, Nazzal D, Rosenberger CM, Ohlson MB, Lambkin-Williams R, Fathi H, Harris JM, Tavel JA. Phase 2 Randomized Trial of the Safety and Efficacy of MHAA4549A, a Broadly Neutralizing Monoclonal Antibody, in a Human Influenza A Virus Challenge Model. Antimicrob Agents Chemother. 2017 Oct 24;61(11):e01154-17. doi: 10.1128/AAC.01154-17. Print 2017 Nov.

    PMID: 28807912DERIVED

  • Deng R, Lee AP, Maia M, Lim JJ, Burgess T, Horn P, Derby MA, Newton E, Tavel JA, Hanley WD. Pharmacokinetics of MHAA4549A, an Anti-Influenza A Monoclonal Antibody, in Healthy Subjects Challenged with Influenza A Virus in a Phase IIa Randomized Trial. Clin Pharmacokinet. 2018 Mar;57(3):367-377. doi: 10.1007/s40262-017-0564-y.

    PMID: 28639229DERIVED

MeSH Terms

Interventions

Oseltamivir

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbons

Study Officials

  • Clinical Trials

    Genentech, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2013

First Posted

November 11, 2013

Study Start

November 25, 2013

Primary Completion

June 19, 2014

Study Completion

June 19, 2014

Last Updated

March 9, 2017

Record last verified: 2017-03

Locations

GB(1)