A Study of VIS410 to Assess Safety and Pharmacokinetics

Influenza Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02045472
• Other study ID #: VIS-C001
• Status: Completed
• Phase: Phase 1
• First received: January 21, 2014
• Last updated: May 13, 2015
• Start date: September 2014
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Visterra, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Drug:
• VIS410

• Placebo

Locations

Country	Name	City	State
United States	DaVita Clinical Research	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Visterra, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessment	Incidence of adverse events	120 days post-infusion	No
Secondary	Pharmacokinetic analysis	Serum concentration-time profile	56 days post-infusion	No
Secondary	Immunogenicity	Detect and measure anti-drug antibodies to VIS410	120 days post-infusion	No