NCT04493671

Evaluate Safety, Tolerability, PK of TBAJ-876 in Healthy Adults

A Phase 1, Partially Blind, Placebo Controlled, Randomized, Combined Single Ascending Dose With a Food Effect Cohort, Multiple Ascending Dose, and Relative Bioavailability Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBAJ-876 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Global Alliance for TB Drug Development · Academic / Other
• Sex: All
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

A Phase 1, Partially Blind, Placebo Controlled, Randomized, Combined Single Ascending Dose (SAD) with a Food Effect Cohort (Part 1), Multiple Ascending Dose (MAD) (Part 2), and Relative Bioavailability (rBA) (Part 3) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBAJ-876 in Healthy Adult Subjects

Detailed description

This study is a three-part, partially blinded, placebo controlled, combined single ascending dose with food-effect, multiple ascending dose study, and a single dose relative bioavailability study conducted at one study center in the United States. Safety will be assessed throughout the study for all subjects. Safety assessments will include physical examinations, vital signs, serial ECGs, cardiac monitoring, adverse events (AEs), and clinical laboratory tests (including hematology, serum chemistry, coagulation, and urinalysis).

Conditions

• Pulmonary Disease
• Tuberculosis, Pulmonary
• Tuberculosis
• Multi Drug Resistant Tuberculosis
• Drug Sensitive Tuberculosis
• Drug-resistant Tuberculosis
• Mycobacterium Tuberculosis Infection

Interventions

Type	Name	Description
DRUG	TBAJ-876 suspension	TBAJ-876 oral suspension, orally administered
DRUG	Placebo suspension	Placebo for TBAJ-876 oral Suspension; orally administered
DRUG	TBAJ-876 100 mg tablet	TBAJ-876 100 mg tablets, orally administered
DRUG	TBAJ-876 25 mg tablet	TBAJ-876 25 mg tablets, orally administered

Timeline

• Start date: 2020-06-08
• Primary completion: 2022-06-16
• Completion: 2022-11-15
• First posted: 2020-07-30
• Last updated: 2025-06-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study