NCT02284607

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2014

Shorter than P25 for phase_1

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

October 31, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

November 3, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 6, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2015

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

Enrollment Period

4 months

First QC Date

October 31, 2014

Last Update Submit

March 7, 2017

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (4)

  • Incidence and nature of adverse events (AEs)

    Until study discontinuation/termination, up to 120 days

  • Changes in vital signs during and following MHAA4549A administration

    From baseline to end of study, up to 120 days

  • Changes in ECG findings during and following MHAA4549A administration

    From baseline to end of study, up to 120 days

  • Severity of AEs

    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)

    Up to 120 days

Study Arms (3)

MHAA4549A higher dose

EXPERIMENTAL
Drug: MHAA4549A

MHAA4549A lower dose

EXPERIMENTAL
Drug: MHAA4549A

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

MHAA4549ADRUG

MHAA4549A single, intravenous dose administration, lower dose level

MHAA4549A lower dose
PlaceboDRUG

Matching placebo to MHAA4549A administration

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

inVentiv Health Clinique

Québec, Quebec, G1P 0A2, Canada

Location

Related Publications (1)

  • 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.

    PMID: 27381392DERIVED

MeSH Terms

Interventions

gedivumab

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2014

First Posted

November 6, 2014

Study Start

November 3, 2014

Primary Completion

March 13, 2015

Study Completion

March 13, 2015

Last Updated

March 9, 2017

Record last verified: 2017-03

Locations

CA(1)