A Study of VIS410 to Assess Safety and Pharmacokinetics

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02045472

Enrollment

Registered

2014-01-24

Start date

2014-09-30

Completion date

2015-05-31

Last updated

2015-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

Influenza, Monoclonal antibody

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.

Interventions

DRUGVIS410

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Safety assessment	120 days post-infusion	Incidence of adverse events

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026