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NCT04493671 · ClinicalTrials.gov registry record · Phase 1
Evaluate Safety, Tolerability, PK of TBAJ-876 in Healthy Adults
A Phase 1 study, sponsored by Global Alliance for TB Drug Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 137
- Enrollment target
NCT04493671: Completed Phase 1 study, sponsored by Global Alliance for TB Drug Development.
NCT04493671 is a Phase 1 study that has completed, run by Global Alliance for TB Drug Development. The registered enrollment target is 137 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (128% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04493671, a Phase 1 study, has completed, sponsored by Global Alliance for TB Drug Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 137 participants
- Enrollment target
Study Summary
A Phase 1, Partially Blind, Placebo Controlled, Randomized, Combined Single Ascending Dose (SAD) with a Food Effect Cohort (Part 1), Multiple Ascending Dose (MAD) (Part 2), and Relative Bioavailability (rBA) (Part 3) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBAJ-876 in Healthy Adult Subjects
Primary Outcome
Subjects will be monitored for any adverse events from the signing of the consent form until the end-of-study visit. The Investigator or a Sub-Investigator will assess its relationship to the study drug.
Interventions
- DRUG Placebo suspension
- DRUG TBAJ-876 suspension
- DRUG TBAJ-876 100 mg tablet
- DRUG TBAJ-876 25 mg tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2020-06-08 |
| Est. Completion | 2022-11-15 |
| Phase | Phase 1 |
What the finished NCT04493671 record still lists
NCT04493671 is an interventional study that assigns participants to a tested intervention. The registered 137 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (128% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo suspension is the first listed.
NCT04493671 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04493671 about?
NCT04493671 is a clinical study titled "Evaluate Safety, Tolerability, PK of TBAJ-876 in Healthy Adults". A Phase 1, Partially Blind, Placebo Controlled, Randomized, Combined Single Ascending Dose (SAD) with a Food Effect Cohort (Part 1), Multiple Ascending Dose (MAD) (Part 2), and Relative Bioavailability (rBA) (Part 3) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBAJ-876 in Hea...
What is the current status of trial NCT04493671?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 137 participants. The study started on 2020-06-08. Estimated completion is 2022-11-15.
What interventions are being tested in trial NCT04493671?
The interventions under investigation include: Placebo suspension (DRUG), TBAJ-876 suspension (DRUG), TBAJ-876 100 mg tablet (DRUG), TBAJ-876 25 mg tablet (DRUG).
Who is sponsoring clinical trial NCT04493671?
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 NCT04493671's enrollment target sits among peer trials
137 420th of 2000 higher than 1,579 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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