Evidence map›Paper›PMID 40067046›Full record

Trial reportAntimicrobial agents and chemotherapy2025

Pharmacokinetics, tolerability, and safety of TBI-223, a novel oxazolidinone, in healthy participants.

Antonio Lombardi, Fran Pappas, Paul Bruinenberg, Jerry Nedelman, Rajneesh Taneja, Dean Hickman, Maria Beumont, Eugene Sun

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04865536 (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), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04865536 phase1completednot on this map

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

TypeinterventionalSponsorGlobal Alliance for TB Drug DevelopmentRan2021 to 2022Enrolled28ConditionsTuberculosis, Tuberculosis, PulmonaryArmsTBI-223 1800 mg, TBI-223 2400mg, TBI-223 Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Antonio LombardiGlobal Alliance for TB Drug Development, New York, New York, USA.ORCID 0009-0001-7383-2495
Fran PappasGlobal Alliance for TB Drug Development, New York, New York, USA.
Paul BruinenbergVast Therapeutics, Morrisville, North Carolina, USA.
Jerry NedelmanGlobal Alliance for TB Drug Development, New York, New York, USA.ORCID 0000-0002-0205-522X
Rajneesh TanejaGlobal Alliance for TB Drug Development, New York, New York, USA.
Dean HickmanGlobal Alliance for TB Drug Development, New York, New York, USA.
Maria BeumontGlobal Alliance for TB Drug Development, New York, New York, USA.
Eugene SunGlobal Alliance for TB Drug Development, New York, New York, USA.

Funding

Bill and Melinda Gates Foundation (GF) OPP1129600Bundesministerium für Bildung und Forschung (BMBF)Department of Foreign Affairs and Trade, Australian Government (DFAT)Foreign, Commonwealth and Development Office (FCDO)Irish AidUnited States Agency for International Development (USAID)
6 · The paper itself

Abstract

TBI-223 is an oxazolidinone antibiotic under clinical development for the treatment of tuberculosis. Preclinical data indicate potent antituberculosis activity and a potentially improved safety profile over linezolid. In a single-ascending dose study and a multiple-ascending dose study in 114 healthy adults, TBI-223 was generally safe and well tolerated at single doses up to 2,600 mg and multiple doses up to 2,400 mg daily over 14 days. No deaths, serious or severe adverse events, or discontinuations resulting from adverse effects (other than COVID-19) occurred. Except for two instances of orthostatic tachycardia in the single-ascending dose (SAD) study that resolved, no clinically significant electrocardiogram changes were noted. Concentration-QTc modeling found significant relationships of QTc with concentrations of TBI-223 and its main metabolite. However, groups receiving TBI-223 experienced QTc > 450 ms at a similar rate to those receiving placebo. TBI-223 exposures were nearly dose proportional. In the SAD study, TBI-223 exhibited a terminal half-life of 1.9-3.8 hours. Sustained-release tablets achieved a mean AUC

Indexed as

Antitubercular AgentsOxazolidinonesAdolescentAdultDouble-Blind MethodElectrocardiographyFemaleHalf-LifeHealthy VolunteersHumansMaleMiddle AgedYoung AdultAntitubercular AgentsOxazolidinonesantimicrobial safetyoxazolidinonepharmacokineticsphase 1TBI-223tuberculosis

Identifiers

PMID40067046
PMCPMC11963608

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.