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NCT05275998 · ClinicalTrials.gov registry record · Phase 1
TMB-365 and TMB-380 in Suppressed HIV-1 Infected Individuals
A Phase 1 study, sponsored by TaiMed Biologics.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT05275998: Completed Phase 1 study, sponsored by TaiMed Biologics.
NCT05275998 is a Phase 1 study that has completed, run by TaiMed Biologics. The registered enrollment target is 51 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05275998, a Phase 1 study, has completed, sponsored by TaiMed Biologics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study 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.
Primary Outcome
Grade 3, Grade 4, Serious Adverse reactions related to TMB-365 and TMB-380 infusions
Interventions
- DRUG TMB-365/TMB-380
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2022-07-05 |
| Est. Completion | 2024-11-20 |
| Phase | Phase 1 |
What the finished NCT05275998 record still lists
NCT05275998 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 1 intervention - of which TMB-365/TMB-380 is the first listed.
NCT05275998 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05275998 about?
NCT05275998 is a clinical study titled "TMB-365 and TMB-380 in Suppressed HIV-1 Infected Individuals". 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 subjec...
What is the current status of trial NCT05275998?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2022-07-05. Estimated completion is 2024-11-20.
What interventions are being tested in trial NCT05275998?
The interventions under investigation include: TMB-365/TMB-380 (DRUG).
Who is sponsoring clinical trial NCT05275998?
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 NCT05275998's enrollment target sits among peer trials
51 969th of 2000 higher than 1,028 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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