Back to resultsA Study of VIS410 to Assess Safety and Pharmacokinetics
Primary Purpose
Influenza
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
VIS410
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Influenza focused on measuring Influenza, Monoclonal antibody
Eligibility Criteria
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
Sites / Locations
- DaVita Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
VIS410
Placebo
Arm Description
VIS410 administered as a single infusion with ascending dose-escalation ranging from 2 to 50 mg/kg
Placebo administered as a single infusion
Outcomes
Primary Outcome Measures
Safety assessment
Incidence of adverse events
Secondary Outcome Measures
Pharmacokinetic analysis
Serum concentration-time profile
Immunogenicity
Detect and measure anti-drug antibodies to VIS410
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02045472
Brief Title
A Study of VIS410 to Assess Safety and Pharmacokinetics
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Visterra, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Monoclonal antibody
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VIS410
Arm Type
Experimental
Arm Description
VIS410 administered as a single infusion with ascending dose-escalation ranging from 2 to 50 mg/kg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered as a single infusion
Intervention Type
Drug
Intervention Name(s)
VIS410
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Safety assessment
Description
Incidence of adverse events
Time Frame
120 days post-infusion
Secondary Outcome Measure Information:
Title
Pharmacokinetic analysis
Description
Serum concentration-time profile
Time Frame
56 days post-infusion
Title
Immunogenicity
Description
Detect and measure anti-drug antibodies to VIS410
Time Frame
120 days post-infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J K Berg, MD
Organizational Affiliation
Davita Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
DaVita Clinical Research
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27077121
Citation
Wollacott AM, Boni MF, Szretter KJ, Sloan SE, Yousofshahi M, Viswanathan K, Bedard S, Hay CA, Smith PF, Shriver Z, Trevejo JM. Safety and Upper Respiratory Pharmacokinetics of the Hemagglutinin Stalk-Binding Antibody VIS410 Support Treatment and Prophylaxis Based on Population Modeling of Seasonal Influenza A Outbreaks. EBioMedicine. 2016 Feb 26;5:147-55. doi: 10.1016/j.ebiom.2016.02.021. eCollection 2016 Mar.
Results Reference
derived
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A Study of VIS410 to Assess Safety and Pharmacokinetics
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