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Completed

NCT Number: NCT02045472

A Study of VIS410 to Assess Safety and Pharmacokinetics

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

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VIS410

Drug

Placebo

Drug

Primary outcomes

  1. Safety assessment

    Time frame: 120 days post-infusion

    Incidence of adverse events

Secondary outcomes

  1. Pharmacokinetic analysis

    Time frame: 56 days post-infusion

    Serum concentration-time profile

  2. Immunogenicity

    Time frame: 120 days post-infusion

    Detect and measure anti-drug antibodies to VIS410

Sponsors and collaborators

Lead sponsor

Visterra, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 24, 2014
Registry last updated
May 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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