Evaluation of Early Bactericidal Activity and Safety in Pulmonary Tuberculosis With WX-081

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-center, randomized, parallel, open-label, positive-controlled Phase 2 clinical trial, which aims to evaluate the early bactericidal activity, safety and tolerability of WX-081 in patients with drug-naive&susceptible and drug-resistant tuberculosis. Also the efficacy of WX-081 will be explored in participants with drug-resistant tuberculosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiatan Pharmatech Co., Ltd
• Treatments: Bedaquiline

Criteria

Inclusion Criteria:

1. Male or female, aged between 18 and 65 years.

2. Body weight between 40 and 90 kg.

3. Newly-treated drug sensitivity tuberculosis: clinically diagnosed as pulmonary tuberculosis, without treatment, sputum smear-positive for acid-fast bacilli (AFB at least 1+), and no resistant to rifampicin or isoniazid in the drug sensitivity test.

4. Drug-resistant tuberculosis: re-treatment pulmonary tuberculosis patients, diagnosed as rifampicin resistance (RR-TB) or isoniazid and rifampicin resistance (MDR-TB) by molecular biology methods, and sputum smear-positive for acid-fast bacilli. Patients must be willing to discontinue all TB drugs to allow 7 days washout.

5. Patients must consent to HIV-testing, or provide HIV-negative report within 6 months.

6. Women are not breastfeeding or pregnant, and agree to practice effective contraception throughout the trial.

7. Provide voluntary and written informed consent prior to all trial-related procedures, agree to comply with the requirements and restrictions listed in the informed consent form and agreement.

Exclusion Criteria:

1. Patients with HIV infection.

2. Patients with miliary tuberculosis or extrapulmonary tuberculosis judged by the investigator.

3. Patients with certain QT/QTc interval characteristics as described in the protocol.

4. the patients have a history of, or current evidence of clinically relevant unstable or severe cardiovascular, kidney, liver, blood, tumor, endocrine and metabolic, mental or rheumatic diseases, or any other condition that will not be suitable to participate in this study, according to the judgement of the investigator.

5. Patients who have participated in other clinical studies within 8 weeks prior to trial start.

6. Patients having a known or suspected hypersensitivity or serious adverse reaction to drugs used in this trial.

7. Women who are pregnant, breastfeeding, or planning to become pregnant.

8. Current or past history of alcohol and/or drug use that, in the investigator's opinion, would compromise the participant's safety or compliance to the study protocol procedures.