A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBA-354 in Healthy Adult Subjects

ClinicalTrials.gov ID: NCT02288481

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Official title

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study With a Food Effect Cohort to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBA-354 in Healthy Adult Subjects

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The objective of this study is to evaluate the safety and tolerability of single oral doses of TBA-354 when administered to healthy adult subjects.

Study identification

NCT ID: NCT02288481
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Global Alliance for TB Drug Development; Other
Enrollment: 48 participants

Conditions and interventions

Conditions

Tuberculosis

Interventions

TBA-354 Drug
Placebo Other

Drug · Other

Eligibility (public fields only)

Age range: 19 Years to 50 Years
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jan 2015 (Type not available)
Primary completion: Jun 2015 (Actual)
Completion: Jun 2015 (Actual)
Last update posted: Sep 6, 2019

2015

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Celerion	Lincoln	Nebraska	68502	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02288481, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 6, 2019 · Synced Nov 11, 2026