Study to Evaluate Safety and Pharmacokinetics of UB-421 Antibody in HIV-1 Infected Adults
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- 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 ] [ Designated as safety issue: Yes ]
- To determine pharmacokinetic parameters of a single intravenous infusion at escalating doses of UB-421. [ Time Frame: Screen, treatment & follow-up: 62 to 90 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2010|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
|Experimental: Antibody (UB-421)||
Drug: Antibody UB-421
Single intravenous infusion at day 0 of a liquid dose of 1, 5, 10 or 25 mg/kg body weight.
Other Name: N.A.
|Taipei Veterans General Hospital (TVGH)|
|Taipei City, Beitou District, Taiwan, 11217|
|Kaohsiung Veterans General Hospital (KVGH)|
|Kaohsiung City, Zuoying District, Taiwan, 81362|
|Principal Investigator:||Wing Wai Wong, M.D.||Taipei Veterans General Hospital (TVGH), Taiwan|
|Principal Investigator:||Hung Chin Tsai, M.D.||Kaohsiung Veterans General Hospital (KVGH), Taiwan|