Clinical Study of JDB0131 Benzenesulfonate Tablets in Patients With Drug-sensitive Pulmonary Tube… (NCT06224036) | Clinical Trial Compass
UnknownPhase 2
Clinical Study of JDB0131 Benzenesulfonate Tablets in Patients With Drug-sensitive Pulmonary Tuberculosis
China52 participantsStarted 2023-10-31
Plain-language 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)
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Age of study participants: 18 years old≤ age ≤ 65 years old, male or female;
✓. Study participant weight: 40kg≤ body weight≤90kg
✓. Patients with clinically confirmed pulmonary tuberculosis, and have not received anti-tuberculosis therapy within 2 years, at least one positive sputum acid-fast bacilli smear (AFB at least 1+);
✓. Be willing to provide a blood sample for HIV testing;
✓. Non-lactating and non-pregnant women who agree to use highly effective contraception throughout the study period, and male study participants must agree to use appropriate contraceptive methods throughout the study period;
✓. The study participants fully understand the purpose, nature, methods and possible adverse reactions of the trial, voluntarily act as research participants, and sign informed consent;
✓. Those who are willing to complete the test according to the requirements of the program.
Exclusion criteria
✕. Rifampicin resistance;
What they're measuring
1
EBA
Timeframe: he change of TB bacterium burden in sputum from Day 0 to Day 2 and/or Day 14
✕. Positive for human immunodeficiency virus (HIV) antibodies; positive for hepatitis B surface antigen (HBsAg); positive for hepatitis C virus (HCV) antibodies; positive for treponemal antibodies;
✕. Clear hepatobiliary disease, including but not limited to chronic active hepatitis and/or severe hepatic insufficiency; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 times the upper limit of normal; Total serum bilirub (TBIL) \> 2 times the upper limit of normal;
✕. Have a history of kidney disease or manifestations related to renal disease: 1) history of unstable or rapidly progressive kidney disease; 2) Moderate/severe renal impairment or end-stage renal disease (eGFR\<60mL/min/1.73m2); 3) Serum creatinine (Cr) ≥ 133 μmol/L (1.5 mg/mL) in men, Cr ≥ 124 μmol/L (1.4 mg/mL) in women;
✕. Have a family history of QT prolongation syndrome or are taking drugs that cause QT interval prolongation, such as: quinidine, procainamide, amiodarone, sotalol, etc.;
✕. ECG showed the following abnormalities: 1) QTcF\>450 ms (corrected by Fridericia formula); 2) pathological Q wave (defined as \>40ms or depth \>0.4-0.5mV); 3) ECG suggests pre-excitation syndrome; 4) ECG suggests left bundle branch block or right bundle branch block; 5) ECG shows second- or third-degree heart block; 6) QRS duration \> 120ms indoor conduction delay; 7) Sinus heart rate \< bradycardia of 50bpm;
✕. Those who have any of the following cardiovascular diseases or other conditions within 6 months before enrollment: 1) myocardial infarction; 2) Cardiac surgery or coronary revascularization (coronary artery bypass grafting/percutaneous transluminal coronary angioplasty); 3) unstable angina; 4) congestive heart failure (New York Cardiology Society Cardiac Function Class III or IV); 5) transient ischemic attack or severe cerebrovascular disease;
✕. Anyone who is unable to comply with the uniform diet due to allergies or special dietary requirements;