A Phase 2 Study to Evaluate Early Bactericidal Activity, Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of Telacebec (Q203)

NCT03563599 | Completed Phase 2 FDA Drug

• 1 other identifier: Q203-TB-P2-ZA001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

This is a Phase IIa, open-label, randomized study in treatment-naïve, sputum smear-positive patients with drug-sensitive pulmonary TB to assess the early bactericidal activity of telacebec (Q203).

Conditions

Treatment-naïve, Sputum Smear-positive Patients With Drug-sensitive Pulmonary TB

Outcome Measures

Primary Outcomes (1)

• The EBA (early bactericidal activity) of telacebec (Q203)

  The EBA determined by the rate of change in the time to positivity (TTP) in sputum over the periods Days 0 to 14

  Days 0 to 14 post dose

Study Arms (2)

Telacebec (Q203) tablet

EXPERIMENTAL

Drug: Telacebec (Q203)

Rifafour e-275

ACTIVE COMPARATOR

Drug: Rifafour e-275

Interventions

Telacebec (Q203) DRUG

High, Mid, Low dose of telacebec

Telacebec (Q203) tablet

Rifafour e-275 DRUG

RHZE (R=rifampicin: H=isoniazid: Z=pyrazinamide: E=ethambutol)

Rifafour e-275

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A new episode of pulmonary TB determined by testing at the study appointed laboratory: Mycobacterium tuberculosis positive and rifampicin and isoniazid sensitive on a rapid molecular test
• A chest X-ray taken no more than 14 days before Screening which in the opinion of the Investigator is consistent with TB
• Sputum smear positive on direct microscopy for acid-fast bacilli on at least 1 pre-treatment sputum sample
• Ability to produce an adequate volume of sputum as determined by an approximately 16-hour overnight sample collection
• Be of non-childbearing potential or using effective methods of birth control, as defined in the protocol

You may not qualify if:

• The patient is mentally or legally incapacitated at Screening
• Any condition or circumstance, in the opinion of the Investigator, which may make the patient unlikely to complete the study or comply with study procedures and requirements, or may pose a risk to the patient's safety
• Clinically significant evidence of extra-thoracic TB (miliary TB, abdominal TB, urogenital TB, osteoarthritic TB, TB meningitis), as judged by the Investigator
• The patient has been infected with hepatitis B or C virus as confirmed by tests for hepatitis B core antibodies, hepatitis B surface antigens, and the hepatitis C virus antibodies
• The patient with history of allergic reaction to isoniazid, rifampicin, pyrazinamide, ethambutol or related substances (eg, tosylate), as confirmed by the clinical judgement of the Investigator

Sponsors & Collaborators

• Qurient Co., Ltd.: lead

Study Sites (2)

TASK Applied Science

Cape Town, South Africa

Location

UCT Lung Institute

Cape Town, South Africa

Location

Related Publications (1)

• Janssen S, Upton C, de Jager VR, van Niekerk C, Dawson R, Hutchings J, Kim J, Choi J, Nam K, Sun E, Diacon AH. Telacebec, a Potent Agent in the Fight against Tuberculosis: Findings from a Randomized, Phase 2 Clinical Trial and Beyond. Am J Respir Crit Care Med. 2025 Aug;211(8):1504-1512. doi: 10.1164/rccm.202408-1632OC.

  PMID: 40116781 DERIVED

MeSH Terms

Interventions

telacebec

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2018
• First Posted: June 20, 2018
• Study Start: July 23, 2018
• Primary Completion: September 9, 2019
• Study Completion: September 9, 2019
• Last Updated: September 10, 2019

Record last verified: 2019-09

Locations

ZA (2)