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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02045472
Other study ID # VIS-C001
Secondary ID
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


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
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