A Clinical Trial of PGDM1400 and PGT121 Monoclonal Antibodies in HIV-infected and HIV-uninfected Adults

This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and anti-viral
efficacy of the PGDM1400 and PGT121 mAbs for HIV prevention and therapy. PGDM1400 mAb and
PGT121 mAb are recombinant human IgG1 monoclonal antibodies that target a V1V2 (PGDM1400) and
a V3 glycan-dependent (PGT121) epitope region of the HIV envelope protein (Jardine, Julien et
al. 2013, Sok, Doores et al. 2014). PGT121 and PGDM1400 mAb were chosen for this study
because they are potent, neutralize a wide array of HIV viruses, and can prevent and treat
simian-human immunodeficiency virus (SHIV) in rhesus monkeys.

Group 1 and 2 Inclusion Criteria:

• Willing to maintain low risk behavior for HIV infection

Group 1 and 2 Exclusion Criteria:

• confirmed HIV-infection, pregnancy or lactation, significant acute or chronic disease and
clinically significant laboratory abnormalities

Group 3 Inclusion Criteria:

• HIV-infected males or females not on antiretroviral therapy with HIV-1 RNA plasma level
between 1,000 and 100,000 copies/ml, CD4 cell count ≥ 300 cells/uL

Group 3 Exclusion Criteria:

• Significant acute or chronic medical condition other than HIV infection, and clinically
significant laboratory abnormalities