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
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 |
The purpose of this study is to assess the safety, tolerability, immunogenicity and pharmacokinetics of single escalating doses of VIS410 in healthy volunteers.
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | DaVita Clinical Research | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Visterra, Inc. |
United States,
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 |
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