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CompletedNCT02284607Updated Mar 9, 2017

A Study of High Dose MHAA4549A in Healthy Volunteers

A Phase 1 interventional study of MHAA4549A and MHAA4549A in Healthy Volunteer, sponsored by Genentech, Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-09.

Sponsored by Genentech, Inc. · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This Phase 1, randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability and pharmacokinetics of two, single intravenous (IV) high doses of MHAA4549A as compared to placebo when administered to healthy volunteers.

02

Conditions studied

  • Healthy Volunteer
03

In context

Lead sponsor

Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age 18 years and older
  • Body mass index (BMI) between 18 and 32 kg/m2, inclusive
  • Weight 40 - 100 kg
  • In good health, determined by no clinically significant findings from medical history, 12-lead ECG, vital signs, and clinical laboratory evaluations
  • Willing to use acceptable contraceptive measures as defined by the protocol
  • Agreeable to, and deemed able to by the investigator, to comply with the requirements of the study, including the follow-up period
  • Willing to abstain from the use of drugs of abuse while enrolled in the study

Exclusion criteria

Exclusion Criteria:

  • History or clinically significant manifestations of disorders
  • History of acute allergic reaction or drug allergies
  • History or presence of an abnormal ECG
  • History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit
  • History of significant drug abuse within 1 year prior to screening
  • Current tobacco smokers
  • Positive drug screen at screening or at check-in
  • Positive pregnancy test result at screening or Day -1 or breast feeding during the study
  • Males who have a pregnant female partner
  • Donation of plasma within 7 days prior to study drug administration
  • Donation or loss of whole blood
  • Receipt of blood products within 2 months before initiation of dosing on Day 1
  • History of malignancy within 10 years of screening except completely excised basal cell carcinoma or squamous cell carcinoma of the skin
  • History of severe systemic bacterial, fungal, or parasitic infections associated with more than two hospitalizations per year or more than two courses of intravenous (IV) antibiotics within 1 year
  • Received oral antibiotics within 4 weeks before initiation of dosing on Day 1, or IV antibiotics within 8 weeks before initiation of dosing
  • Hospitalization within 4 weeks before initiation of dosing on Day 1
  • Use of any over the counter or prescription medications/products within 7 days prior to Day 1 and unwilling to abstain from the use of such drugs up until at least the Day 29 study visit, unless deemed acceptable by the investigator and Sponsor
  • Participation in a clinical trial within 4 weeks
  • Received any vaccine within 14 days prior to screening
  • Positive blood test for chronic viral infections
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    MHAA4549A higher dose

    Drug: MHAA4549A

  • Experimental
    MHAA4549A lower dose

    Drug: MHAA4549A

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugMHAA4549A

    MHAA4549A single, intravenous dose administration, lower dose level

  • DrugMHAA4549A

    MHAA4549A single, intravenous dose administration, higher dose level

  • DrugPlacebo

    Matching placebo to MHAA4549A administration

06

What researchers measure

Primary outcomes

  1. Incidence and nature of adverse events (AEs)

    Time frame: Until study discontinuation/termination, up to 120 days

  2. Changes in vital signs during and following MHAA4549A administration

    Time frame: From baseline to end of study, up to 120 days

  3. Changes in ECG findings during and following MHAA4549A administration

    Time frame: From baseline to end of study, up to 120 days

  4. Severity of AEs

    Time frame: Until study discontinuation/termination, up to 120 days

Secondary outcomes

  1. Pharmacokinetics (composite outcome measure): parameters derived from the nasal and serum concentration-time profile of MHAA4549A (area under the concentration-time curve [AUC], Cmax, tmax, clearance, Vss, half-life (t1/2), mean residence time)

    Time frame: Up to 120 days

07

Study locations

1 site
  • inVentiv Health Clinique
    Quebec, G1P 0A2, Canada
08

References and documents

Publications

  • Lim JJ, Deng R, Derby MA, Larouche R, Horn P, Anderson M, Maia M, Carrier S, Pelletier I, Burgess T, Kulkarni P, Newton E, Tavel JA. Two Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Studies To Investigate the Safety, Tolerability, and Pharmacokinetics of an Anti-Influenza A Virus Monoclonal Antibody, MHAA4549A, in Healthy Volunteers. Antimicrob Agents Chemother. 2016 Aug 22;60(9):5437-44. doi: 10.1128/AAC.00607-16. Print 2016 Sep. PubMed 27381392 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02284607
Lead sponsor
Genentech, Inc.
Responsible party
Sponsor
First posted
Nov 6, 2014
Start date
Nov 3, 2014
Primary completion
Mar 13, 2015
Completion
Mar 13, 2015
Last update
Mar 9, 2017

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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