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CompletedNCT01877785Updated Nov 2, 2016

A Study of MHAA4549A to Assess Safety And Pharmacokinetics in Healthy Volunteers

A Phase 1 interventional study of MHAA4549A and Placebo 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 2016-11-02.

Sponsored by Genentech, Inc. (part of Hoffmann-La Roche) · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

This randomized, double-blind, placebo-controlled, single-ascending dose study will assess the safety, tolerability and pharmacokinetics of ascending doses of MHAA4549A in healthy volunteers. Volunteers will be randomized to receive a single dose of MHAA4549A or matching placebo.

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Conditions studied

  • Healthy Volunteer
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In context

Lead sponsor

Genentech, Inc. is the lead sponsor of 517 studies on the registry; 21 are open to participants now.

Of its 95 completed or terminated interventional studies of FDA-regulated products, 52 (55%) have results posted.

First submitted after Genentech, Inc. became part of Hoffmann-La Roche.

Browse Genentech, Inc. studies →All Hoffmann-La Roche studies →

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

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Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy volunteers
  • Body mass index (BMI) between 18 and 32 kg/m2, inclusive
  • Weight 40 to 100 kg
  • In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
  • Clinical laboratory evaluations should be within the reference range for the test laboratory unless deemed not clinically significant by the investigator and Sponsor
  • Volunteers agree to use acceptable contraceptive measures

Exclusion criteria

Exclusion Criteria:

  • History or clinically significant manifestations of disorders
  • History of anaphylaxis, hypersensitivity 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
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Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    MHAA4549A Arm

    Drug: MHAA4549A

  • Placebo comparator
    Placebo Arm

    Drug: Placebo

Interventions

  • DrugMHAA4549A

    Single-ascending dose of MHAA4549A

  • DrugPlacebo

    Placebo to MHAA4549A

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What researchers measure

Primary outcomes

  1. Safety: Incidence of adverse events

    Time frame: 120 days

Secondary outcomes

  1. Incidence of anti-therapeutic antibodies

    Time frame: 120 days

  2. Pharmacokinetics: Serum concentration-time profile of MHAA4549A

    Time frame: Pre-dose on day 1 to day 120 post-dose

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Study locations

1 site
  • Québec, Quebec G1P 0A2, Canada
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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 Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01877785
Lead sponsor
Genentech, Inc.
Responsible party
Sponsor
First posted
Jun 14, 2013
Start date
Jul 2013
Primary completion
Nov 2013
Completion
Nov 2013
Last update
Nov 2, 2016

Study contacts

Clinical Trials
study director · Genentech, Inc.
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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