drugset / Trial / NCT04027387

Dose Escalation Safety Study of TMB-365 in HIV-1 Infected Participants

NCT04027387

Phase 1 Completed 24 enrolled TaiMed Biologics Inc. Westat · collab
RandomizedSequentialQuadruple-blindTreatment

Summary

This study will evaluate the safety and behavior in the body of the experimental drug TMB-365 in people with HIV-1 infection. This will be the first test of TMB-365 in humans. One dose of the study drug is given to each participant, followed by 10 weeks of monitoring for safety and levels of the drug in the blood. The first group of participants will receive the lowest dose (400 mg). If no safety concerns are seen, the next group will begin at a higher dose (800 mg). If no safety concerns are seen in the second group, the third group will begin at the highest dose in this study (1600 mg).

Timeline

Start
2019-12-14
Primary completion
2021-08-18
Completion
2021-08-18

Drugs

EvaluationDrugModalityDoseRoute
Subject TMB-365 Monoclonal antibody 400 mg Intravenous
Subject TMB-365 Monoclonal antibody 800 mg Intravenous
Subject TMB-365 Monoclonal antibody 1600 mg Intravenous