A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adults
Public ClinicalTrials.gov record NCT03758612. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1, Partially-Blinded, Placebo-Controlled, Randomized, Single Ascending Dose (SAD) With a Food Effect Cohort Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adult Participants.
Study identification
- NCT ID
- NCT03758612
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Lead sponsor
- Global Alliance for TB Drug Development
- Other
- Enrollment
- 86 participants
Conditions and interventions
Conditions
Interventions
- Placebo suspension Drug
- TBI-223 IR Tablet Drug
- TBI-223 SR Tablet Prototype 1 Drug
- TBI-223 SR Tablet Prototype 2 Drug
- TBI-223 SR Tablet Prototype 3 Drug
- TBI-223 enteric capsule Drug
- TBI-223 oral suspension Drug
Drug
Eligibility (public fields only)
- Age range
- 19 Years to 50 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 15, 2019
- Primary completion
- Mar 14, 2020
- Completion
- Mar 14, 2020
- Last update posted
- Dec 8, 2024
2019 – 2020
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Worldwide Clinical Trials (WCT) | San Antonio | Texas | 78217 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03758612, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 8, 2024 · Synced May 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03758612 live on ClinicalTrials.gov.