NCT07525427

Bactericidal Activity of TBD09 in Combination With Other Drugs in Pulmonary Tuberculosis

A Phase 2, Open-Label, Multi-Group, Controlled, Randomized Trial of the Safety, Bactericidal Activity, and Pharmacokinetics of TBD09 in Combination With Other Active Agents in Adults With Drug-Sensitive Pulmonary Tuberculosis

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Gates Medical Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate if TBD09 in combination with other active agents in adults with drug sensitive pulmonary tuberculosis has potential to be safe and effective.

Conditions

• Drug Susceptible Pulmonary Tuberculosis

Interventions

Type	Name	Description
DRUG	Bedaquiline, pretomanid and TBD09	Group 1 (30 participants): The combination of TBD09 (100 mg three times weekly, TIW), bedaquiline (200 mg daily, QD), and pretomanid (200 mg QD), 28 days
DRUG	Bedaquiline, pretomanid and TBD09	Group 2 (30 participants): The combination of TBD09 (100 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days
DRUG	Bedaquiline, pretomanid and TBD09	Group 3 (30 participants): The combination of TBD09 (300 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days
DRUG	Bedaquiline, pretomanid and TBD09	Group 4 (30 participants): The combination of TBD09 (500 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days
DRUG	Bedaquiline, pretomanid and linezolid	Group 5 (30 participants): The combination of linezolid (600 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days

Timeline

• Start date: 2026-04-10
• Primary completion: 2026-11-05
• Completion: 2026-11-05
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

13 sites across 1 country: South Africa