A Study of VIS410 to Assess Safety and Pharmacokinetics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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VIS410

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

Group Type EXPERIMENTAL

VIS410

Intervention Type DRUG

Placebo

Placebo administered as a single infusion

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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VIS410

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes