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

NCT04493671 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2025-06-04

No results posted yet for this study

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

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Global Alliance for TB Drug Development

    lead OTHER

Principal Investigators

  • Antonio Lombardi, MD · Global Alliance for TB Drug Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-08
Primary Completion
2022-06-16
Completion
2022-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04493671 on ClinicalTrials.gov