Study to Evaluate Safety and Pharmacokinetics of UB-421 Antibody in HIV-1 Infected Adults

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.

Timeline

Start

2010-05

Primary completion

2011-07

Completion

2011-07

Publications

• Background Wang CY, Sawyer LS, Murthy KK, Fang X, Walfield AM, Ye J, Wang JJ, Chen PD, Li ML, Salas MT, Shen M, Gauduin MC, Boyle RW, Koup RA, Montefiori DC, Mascola JR, Koff WC, Hanson CV. Postexposure immunoprophylaxis of primary isolates by an antibody to HIV receptor complex. Proc Natl Acad Sci U S A. 1999 Aug 31;96(18):10367-72. doi: 10.1073/pnas.96.18.10367.

Drugs

Indications

No indication recorded.