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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 is a Phase 1 study that has completed, run by Global Alliance for TB Drug Development. The registered enrollment target is 86 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03758612
The ClinicalTrials.gov registry entry for NCT03758612 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Global Alliance for TB Drug Development, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which TBI-223 oral suspension is the first listed.
NCT03758612 reports 0 study locations.
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.
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