A Study of VIS410 to Assess Safety and Pharmacokinetics

Visterra

Status and phase: Completed; Phase 1

Conditions: Influenza

Treatments: Drug: Placebo; Drug: VIS410

Study type: Interventional

Funder types: Industry

Identifiers

NCT02045472

VIS-C001

Details and patient eligibility

About

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

Enrollment: 41 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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41 participants in 2 patient groups, including a placebo group

VIS410

Experimental group

Description:

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

Treatment:

Drug: VIS410

Placebo

Placebo Comparator group

Description:

Placebo administered as a single infusion

Treatment:

Drug: Placebo