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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Single intravenous infusion at day 0 of a liquid dose of 1, 5, 10 or 25 mg/kg body weight.
Taipei Veterans General Hospital (TVGH)
Taipei, Beitou District, Taiwan
Kaohsiung Veterans General Hospital (KVGH)
Kaohsiung City, Zuoying District, Taiwan
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
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
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