Sudapyridine (WX-081) in RR-TB Patients

• Status: Enrolling by invitation
• Trial end date: 2024-12-22
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to demonstrate that the antibacterial activity of Sudapyridine (WX-081) is not inferior to Bedaquiline when added to a Background Regimen (BR) for treatment of rifampicin- resistant TB. Also, safety and clinical outcome will be evaluated.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• • Body mass index (BMI) and body weight of subjects: 15.0≤BMI≤28.0 kg/m2, and 40kg≤ body weight ≤90kg;

• For clinically diagnosed patients with tuberculosis whose drug sensitivity test has proved to be at least resistant to rifampicin, phenotypic or molecular drug sensitivity test results within 3 months before the subject signs informed consent can be accepted;

• Direct sputum smear positive for acid-fast bacilli (AFB at least 1+);

• Willing to discontinue all previous anti-tuberculosis drugs and accept a 7-day washout period;

• Non-lactating and pregnant women who agree to use contraception throughout the treatment; Or the male patient's spouse agrees to use contraception throughout the treatment.

Exclusion Criteria:

• • Allergic to any study drug or its ingredients;

• A history of alcohol dependence or drug abuse;

• With hematogenous disseminated pulmonary tuberculosis or extrapulmonary tuberculosis;

• Drug susceptibility test before screening showed resistance to more than 4 of the 8 antituberculosis drugs in this study;

• Have taken Bedaquiline before;

• HIV-positive patients;

• Laboratory obvious abnormalities;

• A history of pointy torsion ventricular tachycardia or cardiac risk factors for pointy torsion ventricular tachycardia;

• Repeated QTcF intervals > 450ms; Clinically significant ventricular arrhythmias that may require medical or surgical treatment;

• Documented cardiovascular diseases;

• Peripheral neuropathy CTCAE grade 3 or grade 4; Grade 1 or grade 2 neuropathy that the investigator believes is likely to progress/worsen over the course of the study; optic neuritis;

• Any serious cardiovascular, kidney, liver, blood, tumor, endocrine and metabolic, autoimmune or rheumatic diseases.