Status:
COMPLETED
Study of HBV-001 D1 in Healthy Adults
Lead Sponsor:
Hawaii Biotech, Inc.
Conditions:
Dengue Fever
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This is a single-center, double-blind, randomized, Phase 1 study to assess the safety and tolerability of HBV-001 D1 in healthy adult subjects.
Detailed Description
This is a single-center, double-blind, randomized, Phase 1 study to assess the safety and tolerability of HBV-001 D1 in healthy adult subjects. This will be an upward titration of two dose levels of H...
Eligibility Criteria
Inclusion
- Males or females age 18 to 45.
- Body weight ≥ 110 pounds (50 kg).
- Satisfactory medical condition established by medical history and physical examination.
- Females must be of non-child bearing potential (i.e., surgically sterile) or, if of child-bearing potential must be abstinent or willing to employ adequate means of contraception.
Exclusion
- Positive serum test for HIV, Hepatitis B surface antigens (HBsAg) and/or Hepatitis C antibodies.
- Abuse of drugs or alcohol within 12 months prior to screening.
- Use of corticosteroids or immunosuppressive drugs within 30 days of screening (use of topical or nasal corticosteroids is allowed).
- Any confirmed or suspected immunosuppressive or immunodeficient condition.
- Receipt of any vaccination within 30 days prior to screening.
- Receipt of blood products within 6 months of screening.
- Previous flavivirus vaccination (e.g., Japanese encephalitis or yellow fever) or flavivirus vaccination planned during the study period.
- History of flavivirus infection.
- No easy access to a fixed or mobile telephone.
- History of residing in a country endemic for dengue, Japanese encephalitis virus, or Yellow Fever virus for a period of \> 1 year.
- Donation of ≥ 450 mL of blood within the previous 12 weeks.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00936429
Start Date
July 1 2009
End Date
January 1 2011
Last Update
February 7 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Saint Louis University
St Louis, Missouri, United States, 63104