TuberculosisPhase 2NCT07170800
A Phase 2b Clinical Study of JDB0131 Benzenesulfonate Tablets
A Phase 2 study testing JDB0131 100mg, JDB0131 200mg and Delamanid (D) in people with Tuberculosis and Multidrug Resistant Pulmonary Tuberculosis, run by WestVac Biopharma Co., Ltd. at 7 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Tuberculosis, Multidrug Resistant Pulmonary Tuberculosis, Rifampicin-resistant Tuberculosis
- What is being tested?
- JDB0131 100mg, JDB0131 200mg and Delamanid (D)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesChina
- Study dates
- 19 Sep 2025to 4 Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age: 14 years through 65 years of age, male or female
- Weight: 40kg ≤ weight ≤ 90kg
- Patients with clinically confirmed pulmonary tuberculosis, Drug Susceptibility Testing (DST) results confirmed to be at least rifampicin-resistant, molecular or phenotypic DST results within 3 months before enrollment can be received
- Sputum acid-fast bacilli smear is positive (≥2+ once or 1+ twice at least)
- Patients who are currently taking anti-tuberculosis treatment or using drugs with anti-tuberculosis effects agree to stop all anti-tuberculosis drug treatment and complete a 7-day washout period
- Women of reproductive age must agree to use highly effective contraceptive measures throughout the study and for at least 6 months after discontinuation of the drug. Male participants whose partners are women of reproductive age must agree to use appropriate contraceptive methods throughout the study and for at least 6 months after discontinuation of the drug (see protocol Appendix 1)
- Fully understand the purpose and requirements of this trial, voluntarily sign the written informed consent and agree to abide by the relevant provisions of the informed consent
Who cannot join
- Those who cannot take delamanid, bedaquiline, or linezolid for various reasons
- Take delamanid, bedaquiline, or linezolid for more than 1 month (can be enrolled if evidence of no resistance to the above drugs is provided)
- Hematogenously disseminated pulmonary tuberculosis or severe extrapulmonary tuberculosis as determined by the investigator; or patients with pulmonary tuberculosis who are assessed by the investigator to be likely to require surgical treatment within 8 weeks
- History of torsades de pointes or risk factors, including a personal or family history of long QT syndrome (LQTS), persistent hypothyroidism, or bradycardia
- Anyone with any of the following cardiovascular diseases or other conditions within 6 months before enrollment:
- Myocardial infarction;
Show all 38Show fewer
- Heart surgery or coronary revascularization (coronary artery bypass grafting/percutaneous transluminal coronary angioplasty);
- Unstable angina;
- Congestive heart failure (New York Heart Association functional class III or IV);
- Transient ischemic attack or severe cerebrovascular disease.
- Peripheral neuropathy CTCAE grade 3 or 4; Grade 1 or 2 peripheral neuropathy that the investigator judges may progress/worsen during the study; Patients with optic neuritis
- History of gastrointestinal surgery or resection that may affect the absorption and/or excretion of oral medications
- Patients who are considered by the investigator to be unsuitable for this trial due to unstable or severe cardiovascular, renal, hepatic, blood, tumor, endocrine metabolic, psychiatric or rheumatic diseases
- History of alcohol dependence or drug abuse within 6 months before screening, the investigator believes that it may affect the safety of the participants and affect the trial compliance
- Patients who have used other clinical trial investigational drugs within 3 months before administration
- Concomitant take drugs that cause bone marrow suppression
- Concomitant take serotonin reuptake inhibitors, tricyclic antidepressants, serotonin, serotonin receptor agonists, and other drugs
- Concomitant take drugs that prolong the QT interval, such as quinidine, procainamide, amiodarone, sotalol, etc.
- Chronic systemic corticosteroid therapy, cumulative take for more than 4 weeks within 3 months before enrollment
- Allergic to any investigational drug or related substance as confirmed by the researcher's clinical judgment
- Women who have a positive pregnancy test during screening or are breastfeeding
- Patients with hepatitis B virus (HBV) positive results (HBsAg, HBeAg, and HBcAb); positive hepatitis C virus (HCV) antibodies and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels >3 times the upper limit of normal; positive Human Immunodeficiency Virus (HIV) antibody test; positive syphilis antibody test and active syphilis
- Laboratory tests show any of the following:
- Hemoglobin < 80 g/L;
- platelets < 75 ✕ 109 /L;
- Aspartate aminotransferase (AST) > 3 times the upper limit of normal;
- Alanine aminotransferase (ALT) > 3 times the upper limit of normal;
- Serum total bilirubin (TBIL) > 2 times the upper limit of normal;
- Serum creatinine (Cr) > 1.5 times the upper limit of normal;
- Serum amylase > 2 times the upper limit of normal.
- The following abnormalities were found in the electrocardiogram (ECG):
- At least twice QTcF intervals > 450 ms (male) or > 470 ms (female);
- Pathological Q waves (defined as >40 ms or deep >0.4-0.5mV);
- ECG suggests preexcitation syndrome;
- ECG suggests left bundle branch block or right bundle branch block; or second or third degree heart block;
- Intraventricular conduction delay with QRS duration >120ms;
- Bradycardia with a sinus rate < 50 bpm.
- In the investigator's judgment, any condition that affects the subject's compliance with the study protocol, or any serious medical or psychological condition that may affect the interpretation of efficacy and safety data, or any condition that may affect the subject's safety when participating in the trial
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Beijing Chest Hospital, Capital Medical University
Beijing
Naihui Chu, 010-89509321, dongchu1994@sina.com
- Recruiting
Changsha Central Hospital
Changsha, Hunan
Yi Pei, 0731-85667612, 1113284116@qq.com
- Recruiting
Public Health Clinical Center of Chengdu
Chengdu, Sichuan
Guihui Wu, 028-84521550, wghwgh2584@sina.com
- Recruiting
Shandong Public Health Clinical Center
Jinan, Shandong
Yu Xiong, 0531-83347665, yiyiruguol@163.com
- Recruiting
The Second Hospital of Nanjing
Nanjing, Jiangsu
Yun Chi, 025-58006129, shuiyeyun@126.com
- Not yet recruiting
Huashan Hospital Fudan University
Shanghai
- Recruiting
Wuhan Pulmonary Hospital
Wuhan, Hubei
Juan Du, +86 027-83602347, dudu1109@126.com
About this study
Official title: A Multicenter, Open-label, Randomized, Active-controlled Clinical Study to Compare the Efficacy and Safety of Different Combination Regimens of JDB0131 Benzenesulfonate Tablets With Delamanid in Patients With Rifampin-resistant Tuberculosis (JD-RISE)
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
- Tuberculosis, Multidrug Resistant Pulmonary Tuberculosis, Rifampicin-resistant Tuberculosis
- Being tested
- JDB0131 100mg, JDB0131 200mg, Delamanid (D)
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JDB0131 100mgDrug
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.
JDB0131 200mgDrug
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.
Delamanid (D)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A: BJLLfx(M)/C | Experimental | Bedaquiline (B) and JDB0131 (J) and Linezolid (L) and Levofloxacin (Lfx) or (Moxifloxacin (M)) / Clofazimine (C)
Patients will take medications for 8 consecutive weeks.
Patients will be randomized based on fluoroquinolone resistance. If fluoroquinolone-susceptible, patients in group A will receive Levofloxacin (Lfx) or Moxifloxacin (M). If fluoroquinolone-resistant, patients in group A will receive Clofazimine （C）. Receives: Drug: JDB0131 100mg |
| Group B: BJLLfx(M)/C | Experimental | Bedaquiline (B) and JDB0131 (J) and Linezolid (L) and Levofloxacin (Lfx) or (Moxifloxacin (M)) / Clofazimine (C).
Patients will take medications for 8 consecutive weeks.
Patients will be randomized based on fluoroquinolone resistance. If fluoroquinolone-susceptible, patients in group A will receive Levofloxacin (Lfx) or Moxifloxacin (M). If fluoroquinolone-resistant, patients in group A will receive Clofazimine （C）. Receives: Drug: JDB0131 200mg |
| Group C: BDLLfx/C | Active comparator | Bedaquiline (B) and Delamanid (D) and Linezolid (L) and Levofloxacin (Lfx) / Clofazimine (C).
Patients will take medications for 8 consecutive weeks.
Patients will be randomized based on fluoroquinolone resistance. If fluoroquinolone-susceptible, patients in group C will receive Levofloxacin (Lfx). If fluoroquinolone-resistant, patients in group C will receive Clofazimine (C). Receives: Drug: Delamanid (D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients with Sputum Culture Conversion (SCC)
SCC was defined as a patient without SCC at baseline who subsequently met the definition of SCC. A patient was classified as having achieved SCC if he/she achieved 2 consecutive sputum cultures negative for growth of mycobacterium tuberculosis (MTB) at least 7 days apart and had no further sputum cultures that were positive for growth within the specified time frame. Patients who have sputum cultures that were positive during treatment but only converted to negative at the end of treatment were also counted as negative.
Measured: During the 8-week treatment period and after treatment
Secondary outcomes (24)
Time to Sputum Culture Conversion (SCC)
SCC was defined as a patient without SCC at baseline who subsequently met the definition of SCC. A patient was classified as having achieved SCC if he/she achieved 2 consecutive sputum cultures negative for growth of mycobacterium tuberculosis (MTB) at least 7 days apart and had no further sputum cultures that were positive for growth within the specified time frame. Patients who have sputum cultures that were positive during treatment but only converted to negative at the end of treatment were also counted as negative.
Time to SCC was defined as the earliest time of two consecutive sputum cultures negative for growth, that is, the time (specimen collection time) of the first sputum culture negative for growth among two consecutive sputum cultures negative for growth of mycobacterium tuberculosis (MTB) at least 7 days apart was taken as the negative conversion time, expressed in days.
Measured: During the 8-week treatment period and after treatment
Time to positivity (TTP)
Time-to-positivity (TTP) is defined as the length of time from the beginning of culture incubation to the positive detection of mycobacterium tuberculosis growth.
Measured: During the 8-week treatment period and after treatment
Number of Participants With Clinically Significant Abnormality in Vital Signs
Vital signs included body temperature (degree Celsius), heart rate [beats/minute (bpm)], breathe [times/minute (tpm)], systolic and diastolic blood pressure [millimetre of mercury (mm Hg)].
Measured: During the 8-week treatment period
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Values
The clinically significant abnormal ECG values including ventricular rate outlier, PR outlier, QRS outlier, QT outlier and QTcF outlier.
Measured: During the 8-week treatment period
Number of Participants With Clinical Significant Abnormality in Laboratory Test
Laboratory assessments included parameters for serum chemistry (Aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, lactate dehydrogenase, glutamyl transpeptidase, total bilirubin, direct bilirubin, sodium, potassium, chlorine, urea, creatinine), hematology (Red blood cell count, hemoglobin concentration, mean corpuscular volume, white blood cell count, platelet count, neutrophil count, lymphocyte count, monocyte count, eosinophil count, basophil count), urinalysis (Urine leukocytes, urine red blood cells, urine pH, urine specific gravity, urine protein, urine glucose, urine occult blood), stool routine (stool characteristics, stool color, fecal white blood cells, fecal red blood cells, fecal occult blood test) and other serum chemistry (specified in protocol).
Measured: During the 8-week treatment period
Number of Patients With Adverse Events (AEs) and at least one Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a participant/clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with treatment. A TEAE is any new AE or worsening of an existing condition after initiation of study drug.
Measured: During the 8-week treatment period
Number of Patients With Serious Adverse Events (SAEs)
An SAE is an AE that resulted in death, inpatient hospitalization/prolongation of existing hospitalization, persistent or significant disability or incapacity, life-threatening, a congenital anomaly/birth defect, or an important medical event.
Measured: During the 8-week treatment period
Number of Participants With Any Concomitant Medication Usage
Concomitant medications are defined as medications that started on or after the first day of study treatment or were started prior to study treatment but were ongoing on the first day of study treatment.
Measured: During the 8-week treatment period
Time to peak (Tmax)
Measured: During the 8-week treatment period (specified in protocol)
Peak concentration (Cmax)
Measured: During the 8-week treatment period (specified in protocol)
Area under the plasma concentration-time curve from the first medication to 12 hours (AUC0-12)
Measured: During the 8-week treatment period (specified in protocol)
Time to peak at steady state (Tss,max)
Measured: During the 8-week treatment period (specified in protocol)
Peak concentration at steady state (Css,max)
Measured: During the 8-week treatment period (specified in protocol)
Trough concentration at steady state (Css,min)
Measured: During the 8-week treatment period (specified in protocol)
Average steady-state plasma concentration (Css,avg)
Measured: During the 8-week treatment period (specified in protocol)
Elimination half-life (t1/2,ss)
Measured: During the 8-week treatment period (specified in protocol)
Area under the plasma concentration-time curve from the last dose to 12 hours (AUC0-12,ss)
Measured: During the 8-week treatment period (specified in protocol)
Area under the plasma concentration-time curve from the last dose to the last measurable concentration time t (AUC0-t,ss)
Measured: During the 8-week treatment period (specified in protocol)
Area under the plasma concentration-time curve from the last dose extrapolated to infinity (AUC0-∞,ss)
Measured: During the 8-week treatment period (specified in protocol)
Apparent volume of distribution (Vd,ss/F)
Measured: During the 8-week treatment period (specified in protocol)
Oral clearance (CLss/F)
Measured: During the 8-week treatment period (specified in protocol)
Accumulation ratio: Rac(Cmax) = Cmax,ss on day 56 / Cmax on day 1
Measured: During the 8-week treatment period (specified in protocol)
Rac (AUC) = AUC0-12,ss on day 56 / AUC0-12 on day 1
Measured: During the 8-week treatment period (specified in protocol)
Fluctuation coefficient: fluctuation percentage at steady state = 100 * (Css,max - Css,min) / Css,avg
Measured: During the 8-week treatment period (specified in protocol)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start19 Sep 2025
- Primary completion28 Feb 2026 (estimated)
- Study completion4 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WestVac Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170800
- Sponsor's protocol ID
- JDB-131-202
- Status last verified
- Dec 2025
- First submitted
- 3 Sep 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Randomized, Active-controlled Clinical Study to Compare the Efficacy and Safety of Different Combination Regimens of JDB0131 Benzenesulfonate Tablets With Delamanid in Patients With Rifampin-resistant Tuberculosis (JD-RISE)
- ClinicalTrials.gov ID
- NCT07170800
- Acronym / sponsor ID
- JDB-131-202
- Conditions
- Tuberculosis, Multidrug Resistant Pulmonary Tuberculosis, Rifampicin-resistant Tuberculosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- WestVac Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Sep 2025 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 4 Sep 2026 (estimated)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: BJLLfx(M)/C | Experimental | Drug: JDB0131 100mgBedaquiline (B) and JDB0131 (J) and Linezolid (L) and Levofloxacin (Lfx) or (Moxifloxacin (M)) / Clofazimine (C) Patients will take medications for 8 consecutive weeks. Patients will be randomized based on fluoroquinolone resistance. If fluoroquinolone-susceptible, patients in group A will receive Levofloxacin (Lfx) or Moxifloxacin (M). If fluoroquinolone-resistant, patients in group A will receive Clofazimine （C）. |
| Group B: BJLLfx(M)/C | Experimental | Drug: JDB0131 200mgBedaquiline (B) and JDB0131 (J) and Linezolid (L) and Levofloxacin (Lfx) or (Moxifloxacin (M)) / Clofazimine (C). Patients will take medications for 8 consecutive weeks. Patients will be randomized based on fluoroquinolone resistance. If fluoroquinolone-susceptible, patients in group A will receive Levofloxacin (Lfx) or Moxifloxacin (M). If fluoroquinolone-resistant, patients in group A will receive Clofazimine （C）. |
| Group C: BDLLfx/C | Active comparator | Drug: Delamanid (D)Bedaquiline (B) and Delamanid (D) and Linezolid (L) and Levofloxacin (Lfx) / Clofazimine (C). Patients will take medications for 8 consecutive weeks. Patients will be randomized based on fluoroquinolone resistance. If fluoroquinolone-susceptible, patients in group C will receive Levofloxacin (Lfx). If fluoroquinolone-resistant, patients in group C will receive Clofazimine (C). |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age: 14 years through 65 years of age, male or female
- Weight: 40kg ≤ weight ≤ 90kg
- Patients with clinically confirmed pulmonary tuberculosis, Drug Susceptibility Testing (DST) results confirmed to be at least rifampicin-resistant, molecular or phenotypic DST results within 3 months before enrollment can be received
- Sputum acid-fast bacilli smear is positive (≥2+ once or 1+ twice at least)
- Patients who are currently taking anti-tuberculosis treatment or using drugs with anti-tuberculosis effects agree to stop all anti-tuberculosis drug treatment and complete a 7-day washout period
Key exclusion criteria (38 listed)
- Those who cannot take delamanid, bedaquiline, or linezolid for various reasons
- Take delamanid, bedaquiline, or linezolid for more than 1 month (can be enrolled if evidence of no resistance to the above drugs is provided)
- Hematogenously disseminated pulmonary tuberculosis or severe extrapulmonary tuberculosis as determined by the investigator; or patients with pulmonary tuberculosis who are assessed by the investigator to be likely to require surgical treatment within 8 weeks
- History of torsades de pointes or risk factors, including a personal or family history of long QT syndrome (LQTS), persistent hypothyroidism, or bradycardia
- Anyone with any of the following cardiovascular diseases or other conditions within 6 months before enrollment:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JDB0131 100mgBedaquiline (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 | Group A: BJLLfx(M)/C |
| JDB0131 200mgBedaquiline (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 | Group B: BJLLfx(M)/C |
| 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. | Drug | Group C: BDLLfx/C |
Primary outcome
Percentage of Patients with Sputum Culture Conversion (SCC)
Time frame: During the 8-week treatment period and after treatment
SCC was defined as a patient without SCC at baseline who subsequently met the definition of SCC. A patient was classified as having achieved SCC if he/she achieved 2 consecutive sputum cultures negative for growth of mycobacterium tuberculosis (MTB) at least 7 days apart and had no further sputum cultures that were positive for growth within the specified time frame. Patients who have sputum cultures that were positive during treatment but only converted to negative at the end of treatment were also counted as negative.
24 secondary outcomes
Time to Sputum Culture Conversion (SCC)
Time frame: During the 8-week treatment period and after treatment
Time to positivity (TTP)
Time frame: During the 8-week treatment period and after treatment
Number of Participants With Clinically Significant Abnormality in Vital Signs
Time frame: During the 8-week treatment period
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Values
Time frame: During the 8-week treatment period
Number of Participants With Clinical Significant Abnormality in Laboratory Test
Time frame: During the 8-week treatment period
Number of Patients With Adverse Events (AEs) and at least one Treatment-emergent Adverse Events (TEAEs)
Time frame: During the 8-week treatment period
Number of Patients With Serious Adverse Events (SAEs)
Time frame: During the 8-week treatment period
Number of Participants With Any Concomitant Medication Usage
Time frame: During the 8-week treatment period
Time to peak (Tmax)
Time frame: During the 8-week treatment period (specified in protocol)
Peak concentration (Cmax)
Time frame: During the 8-week treatment period (specified in protocol)
Area under the plasma concentration-time curve from the first medication to 12 hours (AUC0-12)
Time frame: During the 8-week treatment period (specified in protocol)
Time to peak at steady state (Tss,max)
Time frame: During the 8-week treatment period (specified in protocol)
Peak concentration at steady state (Css,max)
Time frame: During the 8-week treatment period (specified in protocol)
Trough concentration at steady state (Css,min)
Time frame: During the 8-week treatment period (specified in protocol)
Average steady-state plasma concentration (Css,avg)
Time frame: During the 8-week treatment period (specified in protocol)
Elimination half-life (t1/2,ss)
Time frame: During the 8-week treatment period (specified in protocol)
Area under the plasma concentration-time curve from the last dose to 12 hours (AUC0-12,ss)
Time frame: During the 8-week treatment period (specified in protocol)
Area under the plasma concentration-time curve from the last dose to the last measurable concentration time t (AUC0-t,ss)
Time frame: During the 8-week treatment period (specified in protocol)
Area under the plasma concentration-time curve from the last dose extrapolated to infinity (AUC0-∞,ss)
Time frame: During the 8-week treatment period (specified in protocol)
Apparent volume of distribution (Vd,ss/F)
Time frame: During the 8-week treatment period (specified in protocol)
Oral clearance (CLss/F)
Time frame: During the 8-week treatment period (specified in protocol)
Accumulation ratio: Rac(Cmax) = Cmax,ss on day 56 / Cmax on day 1
Time frame: During the 8-week treatment period (specified in protocol)
Rac (AUC) = AUC0-12,ss on day 56 / AUC0-12 on day 1
Time frame: During the 8-week treatment period (specified in protocol)
Fluctuation coefficient: fluctuation percentage at steady state = 100 * (Css,max - Css,min) / Css,avg
Time frame: During the 8-week treatment period (specified in protocol)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JDB0131 100mg, JDB0131 200mg and Delamanid (D) in people with Tuberculosis and Multidrug Resistant Pulmonary Tuberculosis, run by WestVac Biopharma Co., Ltd. at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients with Sputum Culture Conversion (SCC) (time frame: During the 8-week treatment period and after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.