Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04865536 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate Safety, Tolerability, and the PK Profile of TBI-223 in Healthy Subjects
A Phase 1 study of Tuberculosis and Tuberculosis, Pulmonary, sponsored by Global Alliance for TB Drug Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT04865536 is a Phase 1 study of Tuberculosis and Tuberculosis, Pulmonary that has completed, run by Global Alliance for TB Drug Development. The registered enrollment target is 28 participants, below the 933-participant average among 29 other Tuberculosis trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04865536, a Phase 1 study of Tuberculosis and Tuberculosis, Pulmonary, has completed, sponsored by Global Alliance for TB Drug Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
A Phase 1, Partially-Blinded, Placebo-Controlled, Randomized, Multiple Ascending Dose Study to Include A Single Dose Food-Effect Study to Evaluate the Safety, Tolerability, and the PK Profile of TBI-223 in Healthy Subjects
Conditions Studied
Interventions
- DRUG TBI-223 1800 mg
- DRUG TBI-223 2400mg
- DRUG TBI-223 Placebo
Study Locations (1)
New Jersey
- TKL Research, Inc. - Fair Lawn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2021-02-03 |
| Est. Completion | 2022-05-17 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04865536
The ClinicalTrials.gov registry entry for NCT04865536 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 933-participant average among 29 other Tuberculosis trials with a reported enrollment target (97% lower). The listed sponsor is Global Alliance for TB Drug Development, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Tuberculosis appearing as the primary indexed condition, and to 3 interventions - of which TBI-223 1800 mg is the first listed.
NCT04865536 reports 1 study location spanning 1 distinct geographic area - top geographies include New Jersey.
Frequently Asked Questions
What is clinical trial NCT04865536 about?
NCT04865536 is a clinical study titled "Study to Evaluate Safety, Tolerability, and the PK Profile of TBI-223 in Healthy Subjects". A Phase 1, Partially-Blinded, Placebo-Controlled, Randomized, Multiple Ascending Dose Study to Include A Single Dose Food-Effect Study to Evaluate the Safety, Tolerability, and the PK Profile of TBI-223 in Healthy Subjects
What is the current status of trial NCT04865536?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2021-02-03. Estimated completion is 2022-05-17.
What conditions does trial NCT04865536 study?
This clinical trial studies the following conditions: Tuberculosis, Tuberculosis, Pulmonary.
What interventions are being tested in trial NCT04865536?
The interventions under investigation include: TBI-223 1800 mg (DRUG), TBI-223 2400mg (DRUG), TBI-223 Placebo (DRUG).
Who is sponsoring clinical trial NCT04865536?
This trial is sponsored by Global Alliance for TB Drug Development, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04865536 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Tuberculosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Pilot Study of Methodology to Rapidly Evaluate Drugs for Bactericidal Activity, Tolerance, and Pharmacokinetics in the Treatment of Pulmonary Tuberculosis Using Isoniazid and Levofloxacin
COMPLETED · Phase 1
-
Safety, Tolerability, and Effect of TMC207 and Efavirenz in Healthy Volunteers
COMPLETED · Phase 1
-
Phase I Trial of DAR-901
COMPLETED · Phase 1
-
Early Bactericidal Activity of Linezolid, Gatifloxacin, Levofloxacin, Isoniazid (INH) and Moxifloxacin in HIV Negative Adults With Initial Episodes of Sputum Smear-Positive Pulmonary Tuberculosis
COMPLETED · Phase 1
-
A Phase 1, Drug-Drug Interaction Study of TBAJ-876 in Healthy Adults
COMPLETED · Phase 1
-
Escalating Single-dose Safety, Tolerability, and Pharmacokinetics of SQ109 in Healthy Volunteers
COMPLETED · Phase 1
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.