A Study of VIS410 to Assess Safety and Pharmacokinetics

May 13, 2015 updated by: Visterra, Inc.

Double-Blind, Placebo-Controlled, Dose-Escalation Phase 1 Study in Healthy Volunteers to Evaluate the Safety and Pharmacokinetics of a Human Monoclonal Antibody (VIS410) to Influenza Type A Hemagglutinin

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • DaVita Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VIS410
VIS410 administered as a single infusion with ascending dose-escalation ranging from 2 to 50 mg/kg
Drug: VIS410
Placebo Comparator: Placebo
Placebo administered as a single infusion
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety assessment
Time Frame: 120 days post-infusion
Incidence of adverse events
120 days post-infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic analysis
Time Frame: 56 days post-infusion
Serum concentration-time profile
56 days post-infusion
Immunogenicity
Time Frame: 120 days post-infusion
Detect and measure anti-drug antibodies to VIS410
120 days post-infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Visterra, Inc.

Investigators

  • Principal Investigator: J K Berg, MD, DaVita Clinical Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

January 21, 2014

First Submitted That Met QC Criteria

January 22, 2014

First Posted (Estimate)

January 24, 2014

Study Record Updates

Last Update Posted (Estimate)

May 14, 2015

Last Update Submitted That Met QC Criteria

May 13, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIS-C001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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