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NCT03110549 · ClinicalTrials.gov registry record · Phase 1
Study of the Safety, Tolerability and Pharmacokinetics of TMB-607 in HIV-Negative Volunteers
A Phase 1 study, sponsored by TaiMed Biologics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT03110549: Clinical Trial Phase 1 study, sponsored by TaiMed Biologics.
NCT03110549 is a Phase 1 study that was terminated before completion, run by TaiMed Biologics. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03110549, a Phase 1 study, was terminated before completion, sponsored by TaiMed Biologics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
The study is a Phase 1, randomized, double-blinded, placebo-controlled, sequential single dose escalation safety, tolerability and pharmacokinetic study of subcutaneous and intramuscular TMB-607 administered to HIV-negative volunteers.
Primary Outcome
Measurements of concentrations of TMB-607 in plasma will be used to determine the concentration-time profile of subcutaneous and intramuscular TMB-607 in all participants. TMB-607 plasma concentrations will be measured by a central lab using high-performance liquid chromatography - mass (HPLC-MS) method validated for the measurement of TMB-607 in human plasma.
Interventions
- DRUG Placebo
- DRUG TMB-607
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2016-11-21 |
| Est. Completion | 2019-07-22 |
| Phase | Phase 1 |
Why NCT03110549 stopped before completion
NCT03110549 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03110549 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03110549 about?
NCT03110549 is a clinical study titled "Study of the Safety, Tolerability and Pharmacokinetics of TMB-607 in HIV-Negative Volunteers". The study is a Phase 1, randomized, double-blinded, placebo-controlled, sequential single dose escalation safety, tolerability and pharmacokinetic study of subcutaneous and intramuscular TMB-607 administered to HIV-negative volunteers.
What is the current status of trial NCT03110549?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2016-11-21. Estimated completion is 2019-07-22.
What interventions are being tested in trial NCT03110549?
The interventions under investigation include: Placebo (DRUG), TMB-607 (DRUG).
Who is sponsoring clinical trial NCT03110549?
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 NCT03110549's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 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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