drugset / Trial / NCT05275998

TMB-365 and TMB-380 in Suppressed HIV-1 Infected Individuals

NCT05275998

Phase 1/2 Completed 51 enrolled TaiMed Biologics Inc.
Non-randomizedSequentialOpen-labelTreatment

Summary

TMB-365 is a monoclonal antibody that binds to the CD4 receptor. TMB-380, aka VRC-07-523LS is a monoclonal antibody that binds to HIV. Both interfere with HIV entry. This study is designed to test various doses of the combination of the antibodies for safety and pharmacokinetics in suppressed subjects on cART. Once dosing is established based on safety and PK, the optimally dosed combinations will be assessed as maintenance therapy in HIV infected suppressed individuals discontinuing oral cART for 24 weeks.

Timeline

Start
2022-07-05
Primary completion
2024-11-20
Completion
2024-11-20

Drugs

EvaluationDrugModalityDoseRoute
Subject TMB-365 Monoclonal antibody 2400 mg Intravenous
Subject TMB-365 Monoclonal antibody 3200 mg Intravenous
Subject TMB-365 Monoclonal antibody 4800 mg Intravenous
Subject VRC07-523LS Monoclonal antibody 2400 mg Intravenous
Subject VRC07-523LS Monoclonal antibody 3200 mg Intravenous
Subject VRC07-523LS Monoclonal antibody 4800 mg Intravenous