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NCT03758612 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adults
A Phase 1 study, sponsored by Global Alliance for TB Drug Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 86
- Enrollment target
NCT03758612: Completed Phase 1 study, sponsored by Global Alliance for TB Drug Development.
NCT03758612 is a Phase 1 study that has completed, run by Global Alliance for TB Drug Development. The registered enrollment target is 86 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03758612, a Phase 1 study, has completed, sponsored by Global Alliance for TB Drug Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 86 participants
- Enrollment target
Study Summary
Partially-Blinded, Placebo-Controlled, Randomized, Single Ascending Dose (SAD) with a Food Effect Cohort to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adults.
Primary Outcome
A treatment-related adverse event (AE) is defined for this study as any AE classified as possibly, probably or certainly related to the study drug. Adverse events (AEs) for participants who received at least one dose of study treatment were collected from the signing of informed consent till the end of study visit. An Investigator reviewed each AE collected and assessed its relationship to drug treatment based on all available information at the time of the completion of the study.
Interventions
- DRUG TBI-223 oral suspension
- DRUG TBI-223 enteric capsule
- DRUG TBI-223 SR Tablet Prototype 1
- DRUG TBI-223 SR Tablet Prototype 2
- DRUG TBI-223 SR Tablet Prototype 3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2019-01-16 |
| Est. Completion | 2020-03-15 |
| Phase | Phase 1 |
What the finished NCT03758612 record still lists
NCT03758612 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% higher).
The record links to 0 conditions, and to 5 interventions - of which TBI-223 oral suspension is the first listed.
NCT03758612 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03758612 about?
NCT03758612 is a clinical study titled "A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adults". Partially-Blinded, Placebo-Controlled, Randomized, Single Ascending Dose (SAD) with a Food Effect Cohort to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adults.
What is the current status of trial NCT03758612?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 86 participants. The study started on 2019-01-16. Estimated completion is 2020-03-15.
What interventions are being tested in trial NCT03758612?
The interventions under investigation include: TBI-223 oral suspension (DRUG), TBI-223 enteric capsule (DRUG), TBI-223 SR Tablet Prototype 1 (DRUG), TBI-223 SR Tablet Prototype 2 (DRUG), TBI-223 SR Tablet Prototype 3 (DRUG).
Who is sponsoring clinical trial NCT03758612?
This trial is sponsored by Global Alliance for TB Drug Development, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03758612's enrollment target sits among peer trials
86 652nd of 2000 higher than 1,345 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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