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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: Completed Phase 1 study, sponsored by TaiMed Biologics.
NCT04027387 is a Phase 1 study that has completed, run by TaiMed Biologics. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
% of subjects with treatment-emergent adverse events
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 |
What the finished NCT04027387 record still lists
NCT04027387 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which TMB-365 is the first listed.
NCT04027387 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04027387's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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