drugset / Trial / NCT04027387
Dose Escalation Safety Study of TMB-365 in HIV-1 Infected Participants
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TMB-365 | Monoclonal antibody | 400 mg | Intravenous |
| Subject | TMB-365 | Monoclonal antibody | 800 mg | Intravenous |
| Subject | TMB-365 | Monoclonal antibody | 1600 mg | Intravenous |