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

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

This study is a two-part, partially blinded, placebo controlled, combined single ascending dose (SAD) with food-effect and multiple ascending dose (MAD) study conducted in 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). ;

Study Design

Related Conditions & MeSH terms

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

Clinical Trial Details

NCT number	NCT04493671
Study type	Interventional
Source	Global Alliance for TB Drug Development
Contact
Status	Completed
Phase	Phase 1
Start date	June 8, 2020
Completion date	November 15, 2022

View Details

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