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CompletedNCT02528903Updated Oct 1, 2019

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MHAB5553A in Healthy Volunteers

A Phase 1 interventional study of MHAB5553A and Matching 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 2019-10-01.

Sponsored by Genentech, Inc. · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose study in healthy volunteers to investigate the safety, tolerability, and pharmacokinetics (PK) of MHAB5553A.

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

  • Signed informed consent form (ICF)
  • 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, and vital signs
  • Clinical laboratory evaluations should be within reference range for the test, unless deemed not clinically significant by the investigator and sponsor at screening
  • Willing to abstain from using drugs of abuse while enrolled in the study
  • Willing and able to comply with protocol-specified criteria in regard to contraceptive protection
  • Able to comply with the study protocol, in the investigator's judgment

Exclusion criteria

Exclusion Criteria:

  • History or clinically significant manifestations of metabolic, hepatic, renal, hematologic, immunodeficiency, pulmonary, cardiovascular, gastrointestinal, urologic, neurologic, or psychiatric disorders
  • History of anaphylaxis, hypersensitivity or drug allergies, unless approved by the investigator and sponsor
  • History or presence of an abnormal ECG, which, in the investigator's or sponsor's opinion, is clinically significant (including evidence of previous acute myocardial infarction, complete left bundle branch block, second-degree heart block, or complete heart block)
  • 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 or use of soft drugs (such as marijuana) within 3 months prior to screening visit or hard drugs (such as cocaine, phencyclidine [PCP], and crack) within 1 year prior to screening
  • Current tobacco smokers (positive history within 3 months before initiation of dosing on Day 1), or those with positive cotinine test at check-in
  • Positive drug screen at screening or at check-in
  • Positive pregnancy test result at screening or Day -1 or breast feeding during the study
  • Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe enrollment in and completion of the study
  • Unwillingness to comply or other conditions that, in the opinion of the investigator, would interfere with the ability to comply with the study protocol
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Cohort A

    Drug: MHAB5553A · Drug: Matching placebo

  • Experimental
    Cohort B

    Drug: MHAB5553A · Drug: Matching placebo

  • Experimental
    Cohort C

    Drug: MHAB5553A · Drug: Matching placebo

  • Experimental
    Cohort D

    Drug: MHAB5553A · Drug: Matching placebo

  • Experimental
    Cohort E

    Drug: MHAB5553A · Drug: Matching placebo

Interventions

  • DrugMHAB5553A

    Single intravenous administration, at various doses, depending on the cohort

  • DrugMatching placebo

    Single intravenous dose

06

What researchers measure

Primary outcomes

  1. Incidence of adverse events, graded by severity

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

  2. Changes in vital signs during and following MHAB5553A administration

    Time frame: Throughout the study, up to 120 days

  3. Changes in physical examination finding during and following MHAB5553A administration

    Time frame: Throughout the study, up to 120 days

  4. Changes in clinical laboratory results during and following MHAB5553A administration

    Time frame: Throughout the study, up to 120 days

  5. Changes in electrocardiogram (ECG) findings during and following MHAB5553A

    Time frame: Throughout the study, up to 120 days

  6. Incidence of serum anti-MHAB5553A antibodies

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

Secondary outcomes

  1. Maximum serum concentration (Cmax) of MHAB5553A

    Time frame: Up to 120 days

  2. Time to Cmax (tmax) of MHAB5553A

    Time frame: Up to 120 days

  3. Area under the concentration-time curve up to last measurable time point (AUC0-last) of MHAB5553A

    Time frame: Up to 120 days

  4. Area under the concentration-time curve extrapolated to infinity (AUC0-inf) of MHAB5553A

    Time frame: Up to 120 days

  5. Clearance (CL) of MHAB5553A

    Time frame: Up to 120 days

  6. Volume of distribution at steady-state (Vss) of MHAB5553A

    Time frame: Up to 120 days

  7. Terminal elimination half-life (t1/2) of MHAB5553A

    Time frame: Up to 120 days

  8. Mean Residence Time (MRT) of MHAB5553A

    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, Derby MA, Zhang Y, Deng R, Larouche R, Anderson M, Maia M, Carrier S, Pelletier I, Girard J, Kulkarni P, Newton E, Tavel JA. A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study To Investigate the Safety, Tolerability, and Pharmacokinetics of an Anti-Influenza B Virus Monoclonal Antibody, MHAB5553A, in Healthy Volunteers. Antimicrob Agents Chemother. 2017 Jul 25;61(8):e00279-17. doi: 10.1128/AAC.00279-17. Print 2017 Aug. PubMed 28559255 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02528903
Lead sponsor
Genentech, Inc.
Responsible party
Sponsor
First posted
Aug 19, 2015
Start date
Aug 18, 2015
Primary completion
Jan 26, 2016
Completion
Jan 26, 2016
Last update
Oct 1, 2019

Study contacts

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

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