CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 86 enrolled
Drug / intervention
TBI-223 oral suspension +6 moredrug
Likely dose
TBI-223 enteric capsule 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03758612
NCT03758612Phase 1Completed
CompareCT.gov

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.

Global Alliance for TB Drug Development·interventional·Posted Nov 29, 2018·Updated Dec 9, 2024

In Brief

A Phase 1 clinical trial evaluating TBI-223 oral suspension, TBI-223 enteric capsule, and 5 other interventions for Tuberculosis and Tuberculosis, Pulmonary. Completed, enrolled 86 participants across 1 site.

Detailed Summary

Partially-Blinded, Placebo-Controlled, Randomized, Single Ascending Dose (SAD) with a Food Effect Cohort to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adults.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis, Tuberculosis, Pulmonary
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedNov 29, 2018
Enrollment StartJan 16, 2019
Primary CompletionMar 15, 2020
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7.6 years ago

Interventions

TBI-223 oral suspensiondrug

TBI-223 oral suspension, orally administered.

TBI-223 enteric capsuledrug

TBI-223 enteric capsules filled with 150 mg of TBI-223 powder, orally administered.

TBI-223 SR Tablet Prototype 1drug

TBI-223 600 mg sustained-release (SR) tablet Prototype 1, orally administered.

TBI-223 SR Tablet Prototype 2drug

TBI-223 600 mg SR tablet Prototype 2, orally administered.

TBI-223 SR Tablet Prototype 3drug

TBI-223 900 mg SR tablet Prototype 3, orally administered.

TBI-223 IR Tabletdrug

TBI-223 1000 mg immediate release (IR) tablet, orally administered

Placebo suspensiondrug

Placebo for TBI-223 oral Suspension; orally administered.