Actively Recruiting
A Phase 2b Clinical Study of JDB0131 Benzenesulfonate Tablets
Led by WestVac Biopharma Co., Ltd. · Updated on 2026-01-30
60
Participants Needed
7
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, randomized, open-label, active-controlled clinical study designed to evaluate the efficacy, safety, and pharmacokinetic characteristics of different doses of JDB0131 benzenesulfonate tablets compared with delamanid in combination with bedaquiline, linezolid, levofloxacin (moxifloxacin)/clofazimine, etc. in the treatment of patients with drug-resistant (including rifampicin-resistant) tuberculosis for 8 weeks.
CONDITIONS
Official Title
A Phase 2b Clinical Study of JDB0131 Benzenesulfonate Tablets
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 14 and 65 years, male or female
- Body weight between 40 kg and 90 kg
- Clinically confirmed pulmonary tuberculosis with rifampicin resistance confirmed by molecular or phenotypic testing within 3 months before enrollment
- Positive sputum acid-fast bacilli smear (at least 2+ once or 1+ twice)
- Agree to stop all anti-tuberculosis treatment and complete a 7-day washout period if currently taking such drugs
- Women of reproductive age must agree to use effective contraception during the study and for at least 6 months after stopping the drug; male participants with partners of reproductive age must also agree to use contraception
- Understand the trial purpose and requirements, voluntarily sign informed consent, and agree to follow the study rules
You will not qualify if you...
- Unable to take delamanid, bedaquiline, or linezolid for any reason
- Taken delamanid, bedaquiline, or linezolid for more than 1 month unless no resistance proven
- Hematogenously disseminated or severe extrapulmonary tuberculosis, or likely to require surgery within 8 weeks
- History or risk factors for torsades de pointes or long QT syndrome
- Cardiovascular diseases within 6 months: myocardial infarction, heart surgery, unstable angina, severe heart failure, transient ischemic attack, or severe cerebrovascular disease
- Peripheral neuropathy grade 3 or 4, or grade 1 or 2 expected to worsen; optic neuritis
- History of gastrointestinal surgery affecting drug absorption or excretion
- Unstable or severe cardiovascular, renal, hepatic, blood, tumor, endocrine, psychiatric, or rheumatic diseases
- Alcohol dependence or drug abuse within 6 months affecting safety or compliance
- Use of other investigational drugs within 3 months before enrollment
- Use of drugs causing bone marrow suppression or prolonging QT interval
- Use of certain antidepressants or serotonin-related drugs
- Chronic systemic corticosteroid therapy over 4 weeks within 3 months
- Allergy to investigational drugs
- Positive pregnancy test or breastfeeding
- Positive for hepatitis B, hepatitis C with high liver enzymes, HIV, or active syphilis
- Laboratory abnormalities including low hemoglobin or platelets, elevated liver enzymes, bilirubin, creatinine, or amylase beyond specified limits
- ECG abnormalities including prolonged QTcF, pathological Q waves, preexcitation syndrome, bundle branch blocks, heart block, conduction delays, or bradycardia
- Any condition affecting ability to comply, safety, or data interpretation as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 7 locations
1
Wuhan Pulmonary Hospital
Wuhan, Hubei, China
Actively Recruiting
2
Changsha Central Hospital
Changsha, Hunan, China
Actively Recruiting
3
The Second Hospital of Nanjing
Nanjing, Jiangsu, China
Actively Recruiting
4
Shandong Public Health Clinical Center
Jinan, Shandong, China
Actively Recruiting
5
Public Health Clinical Center of Chengdu
Chengdu, Sichuan, China
Actively Recruiting
6
Beijing Chest Hospital, Capital Medical University
Beijing, China
Actively Recruiting
7
Huashan Hospital Fudan University
Shanghai, China
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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