NCT01140126
Completed
Phase 1
A Phase I, Open-label, Single-dose, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of the UB-421 Antibody in Asymptomatic HIV-1 Infected Adults
United Biomedical2 sites in 1 country20 target enrollmentMay 2010
Overview
- Phase
- Phase 1
- Intervention
- Antibody UB-421
- Conditions
- HIV-1 Infection in Adults (Asymptomatic)
- Sponsor
- United Biomedical
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- To evaluate safety and tolerability of a single intravenous infusion at escalating doses of UB-421.
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
The purpose of this Phase I study is to determine whether the antibody (UB-421), targeting the HIV-1 receptor on the CD4 molecule (domain 1) of T-lymphocytes and monocytes, is safe and well tolerated when administered to asymptomatic HIV-1 infected adults by intravenous infusion and to assess pharmacokinetic parameters of the antibody in blood and on cells. The neutralizing activity of UB-421 blocks HIV-1 from binding to its receptor on CD4-positive cells; thus, UB-421 functions as an immunotherapeutic intervention to prevent HIV-1 infection.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Asymptomatic, treatment-naive, HIV-1 seropositive
- •CD4+ T cell count \>350 cells/cubic millimeter
- •HIV-1 viral load \>5,000 copies/mL
- •Other inclusion criteria apply
Exclusion Criteria
- •Active infection requiring immediate therapy (except HIV-1)
- •Prior participation in any HIV vaccine trial
- •Previous exposure to a monoclonal antibody
- •Use of immunomodulating drugs or systemic chemotherapy
- •Other exclusion criteria apply
Arms & Interventions
Antibody (UB-421)
Intervention: Antibody UB-421
Outcomes
Primary Outcomes
To evaluate safety and tolerability of a single intravenous infusion at escalating doses of UB-421.
Time Frame: Screen, treatment & follow-up: 62 to 90 days
Secondary Outcomes
- To determine pharmacokinetic parameters of a single intravenous infusion at escalating doses of UB-421.(Screen, treatment & follow-up: 62 to 90 days)
Study Sites (2)
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