Clinical Study of JDB0131 Benzenesulfonate Tablets in Patients With Drug-sensitive Pulmonary Tuberculosis

Summary

A randomized, open, drug controlled design of experiments was used to evaluate the early bactericidal activity, safety, tolerance and pharmacokinetic characteristics of JDB0131 benzenesulfonate tablet taken orally by drug sensitive pulmonary tuberculosis patients. Five groups are proposed to be set up in this test (JDB0131 benzenesulfonate 100mg BID, JDB0131 benzenesulfonate 200mg QD, JDB0131 benzenesulfonate 200mg BID, anti tuberculosis drug fixed dose composite dosage QD is determined according to the weight of the study participants, and delamanid 100mg BID)

Timeline

Start

2023-10-31

Primary completion

2024-03-31

Completion

2024-03-31

Publications

• Chu N, Nie W, Du J, Wang M, Ma L, Wang Q, Wang J, Hu X, Wu J, Lu Y, Huang M, Wei Y, Wang Z, He JQ, Ding Z, Wei X. A novel antituberculosis agent exhibits potent clinical efficacy and good safety profile: an open-label, randomized-controlled, multicenter, phase 2a trial. Signal Transduct Target Ther. 2025 Dec 30;10(1):427. doi: 10.1038/s41392-025-02517-z.

Drugs

Indications