A Study of VIS410 to Assess Safety and Pharmacokinetics

Phase 1

Completed

• Conditions: Influenza
• Interventions: Drug: Placebo; Drug: VIS410

• Registration Number: NCT02045472
• Lead Sponsor: Visterra, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-21
• Study First Submitted QC: 2014-01-22
• Study First Posted: 2014-01-24
• Study Start: 2014-09
• Status Verified: 2015-05
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Last Update Submitted: 2015-05-13
• Last Update Posted: 2015-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Safety assessment	120 days post-infusion	Incidence of adverse events

Secondary Outcome Measures

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

Trial Locations

Locations (1)

DaVita Clinical Research; 🇺🇸 Minneapolis, Minnesota, United States