A Phase 2b Clinical Study of JDB0131 Benzenesulfonate Tablets

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

September 10, 2025

Primary Completion Date

February 28, 2026

Study Completion Date

September 4, 2026

Conditions
TuberculosisMultidrug Resistant Pulmonary TuberculosisRifampicin-resistant Tuberculosis
Interventions
DRUG

JDB0131 100mg

"Bedaquiline (B): For the first 2 weeks, 400 mg qd; then adjust to 200 mg tiw.~JDB0131 (J): 100 mg bid.~Linezolid (L): 600 mg qd.~Levofloxacin (Lfx): According to body weight, patients ≤50 kg, 750 mg qd; patients \>50 kg, 1000 mg qd.~Moxifloxacin (M): 400 mg qd.~Clofazimine (C): 100 mg qd."

DRUG

JDB0131 200mg

"Bedaquiline (B): For the first 2 weeks, 400 mg qd; then adjust to 200 mg tiw.~JDB0131 (J): 200 mg bid.~Linezolid (L): 600 mg qd.~Levofloxacin (Lfx): According to body weight, patients ≤50 kg, 750 mg qd; patients \>50 kg, 1000 mg qd.~Moxifloxacin (M): 400 mg qd.~Clofazimine (C): 100 mg qd."

DRUG

Delamanid (D)

"Bedaquiline (B): For the first 2 weeks, 400 mg qd; then adjust to 200 mg tiw.~Delamanid (D): 100 mg bid.~Linezolid (L): 600 mg qd.~Levofloxacin (Lfx): According to body weight, patients ≤50 kg, 750 mg qd; patients \>50 kg, 1000 mg qd.~Moxifloxacin (M): 400 mg qd.~Clofazimine (C): 100 mg qd."

Trial Locations (7)

Unknown

Wuhan Pulmonary Hospital, Wuhan

Changsha Central Hospital, Changsha

The Second Hospital of Nanjing, Nanjing

Shandong Public Health Clinical Center, Jinan

Public Health Clinical Center of Chengdu, Chengdu

Beijing Chest Hospital, Capital Medical University, Beijing

Huashan Hospital Fudan University, Shanghai

All Listed Sponsors
lead

WestVac Biopharma Co., Ltd.

INDUSTRY

NCT07170800 - A Phase 2b Clinical Study of JDB0131 Benzenesulfonate Tablets | Biotech Hunter | Biotech Hunter