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: Completed Phase 1 study of Tuberculosis and Tuberculosis, Pulmonary, sponsored by Global Alliance for TB Drug Development.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Blood pressure measured.
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 |
What the finished NCT04865536 record still lists
NCT04865536 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 933-participant average among 29 other Tuberculosis trials with a reported enrollment target (97% lower).
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 a single indexed study location in 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.
Where NCT04865536's enrollment target sits among peer trials
28 27th of 29 higher than 2 of 29 other Tuberculosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tuberculosis 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
-
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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03471117 · 28 participants · Phase 4
Pioglitazone to Reduce Sympathetic Overactivity in CKD Patients
- NCT03523975 · 28 participants · Phase 1
Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma
- NCT03608631 · 28 participants · Phase 1
iExosomes in Treating Participants With Metastatic Pancreas Cancer With KrasG12D Mutation
- NCT03810651 · 28 participants · Early Phase 1
Pencil Beam Scanning in Patients With Renal Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI