A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adults

PHASE1CompletedINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

January 16, 2019

Primary Completion Date

March 15, 2020

Study Completion Date

March 15, 2020

Conditions
TuberculosisTuberculosis, Pulmonary
Interventions
DRUG

TBI-223 oral suspension

TBI-223 oral suspension, orally administered.

DRUG

TBI-223 enteric capsule

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

DRUG

TBI-223 SR Tablet Prototype 1

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

DRUG

TBI-223 SR Tablet Prototype 2

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

DRUG

TBI-223 SR Tablet Prototype 3

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

DRUG

TBI-223 IR Tablet

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

DRUG

Placebo suspension

Placebo for TBI-223 oral Suspension; orally administered.

Trial Locations (1)

78217

Worldwide Clinical Trials (WCT), San Antonio

All Listed Sponsors
lead

Global Alliance for TB Drug Development

OTHER

NCT03758612 - A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adults | Biotech Hunter | Biotech Hunter