NCT02045472

Brief Summary

The purpose of this study is to assess the safety, tolerability, immunogenicity and pharmacokinetics of single escalating doses of VIS410 in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 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

January 21, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 24, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 14, 2015

Status Verified

May 1, 2015

Enrollment Period

8 months

First QC Date

January 21, 2014

Last Update Submit

May 13, 2015

Conditions

Influenza

Keywords

InfluenzaMonoclonal antibody

Outcome Measures

Primary Outcomes (1)

  • Safety assessment

    Incidence of adverse events

    120 days post-infusion

Secondary Outcomes (2)

  • Pharmacokinetic analysis

    56 days post-infusion

  • Immunogenicity

    120 days post-infusion

Study Arms (2)

VIS410

EXPERIMENTAL

VIS410 administered as a single infusion with ascending dose-escalation ranging from 2 to 50 mg/kg

Drug: VIS410

Placebo

PLACEBO COMPARATOR

Placebo administered as a single infusion

Drug: Placebo

Interventions

VIS410DRUG
VIS410
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers
  • Body mass index between 18 and 33 kg/m2, inclusive
  • Normal labs
  • Volunteers agree to use acceptable contraceptive measures

You may not qualify if:

  • Prior receipt of antibody or biologic therapy
  • History of cancer, heart disease, diabetes, respiratory condition (eg asthma), autoimmune disorder, blood dyscrasias
  • Any chronic condition requiring daily prescription or over the counter medication
  • History of a previous severe allergic reaction
  • Drug or alcohol abuse within previous 12 months
  • Positive serology for human immunodeficiency virus (HIV) antibody, hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HBsAg)
  • Positive pregnancy test
  • Breast feeding
  • Positive drug or alcohol test at screening or check-in
  • Receipt of licensed vaccine (within 30 days) or other investigational product within 30 days or 5 half-lives, whichever is longer, before study product administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

Related Publications (1)

  • Wollacott AM, Boni MF, Szretter KJ, Sloan SE, Yousofshahi M, Viswanathan K, Bedard S, Hay CA, Smith PF, Shriver Z, Trevejo JM. Safety and Upper Respiratory Pharmacokinetics of the Hemagglutinin Stalk-Binding Antibody VIS410 Support Treatment and Prophylaxis Based on Population Modeling of Seasonal Influenza A Outbreaks. EBioMedicine. 2016 Feb 26;5:147-55. doi: 10.1016/j.ebiom.2016.02.021. eCollection 2016 Mar.

    PMID: 27077121DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

VIS410 monoclonal antibody

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • J K Berg, MD

    Davita Clinical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2014

First Posted

January 24, 2014

Study Start

September 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 14, 2015

Record last verified: 2015-05

Locations

US(1)