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Study to Evaluate Safety, Tolerability, and the PK Profile of TBI-223 in Healthy Subjects

NCT04865536 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-06-05

No results posted yet for this study

Summary

A Phase 1, Partially-Blinded, Placebo-Controlled, Randomized, Multiple Ascending Dose Study to Include A Single Dose Food-Effect Study to Evaluate the Safety, Tolerability, and the PK Profile of TBI-223 in Healthy Subjects

Conditions

Interventions

DRUG

TBI-223 1800 mg

3 x 600 mg SR1 tablets

DRUG

TBI-223 2400mg

3 x 600 mg SR1 tablets and 1 x 600 mg IR tablets

DRUG

TBI-223 Placebo

Placebo SR and IR tablets for TBI-223

Sponsors & Collaborators

  • Global Alliance for TB Drug Development

    lead OTHER

Principal Investigators

  • Jerry Nedelman · 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
2021-02-03
Primary Completion
2021-05-17
Completion
2022-05-17
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 NCT04865536 on ClinicalTrials.gov