A Phase III Study of Oral Sudapyridine (WX-081) Tablets in Rifampicin-Resistant Pulmonary Tuberculosis Patients

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 testhas proved to be at least resistant to rifampicin, phenotypic or molecular drugsensitivity test results within 3 months before the subject signs informedconsent 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-daywashout period;

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

• Drug susceptibility test before screening showed resistance to more than 4 ofthe 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 forpointy torsion ventricular tachycardia;

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

• Documented cardiovascular diseases;

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

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