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NCT04027387 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Safety Study of TMB-365 in HIV-1 Infected Participants
A Phase 1 study, sponsored by TaiMed Biologics.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT04027387 is a Phase 1 study that has completed, run by TaiMed Biologics. The registered enrollment target is 24 participants.
The verdict
NCT04027387, a Phase 1 study, has completed, sponsored by TaiMed Biologics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study 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).
Interventions
- BIOLOGICAL TMB-365
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2019-12-14 |
| Est. Completion | 2021-08-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04027387
The ClinicalTrials.gov registry entry for NCT04027387 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is TaiMed Biologics, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which TMB-365 is the first listed.
NCT04027387 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04027387 about?
NCT04027387 is a clinical study titled "Dose Escalation Safety Study of TMB-365 in HIV-1 Infected Participants". 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 dru...
What is the current status of trial NCT04027387?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2019-12-14. Estimated completion is 2021-08-18.
What interventions are being tested in trial NCT04027387?
The interventions under investigation include: TMB-365 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04027387?
This trial is sponsored by TaiMed Biologics, which has 9 total clinical trials registered on ClinicalTrials.gov.
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