Drug-resistant TuberculosisPhase 2NCT06224036
Clinical Study of JDB0131 Benzenesulfonate Tablets in Patients With Drug-sensitive Pulmonary Tuberculosis
A Phase 2 study testing JDB0131, Delamanid and Ethylpyrazine rifampicide (II) in people with Drug-resistant Tuberculosis, run by Beijing Chest Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Drug-resistant Tuberculosis
- What is being tested?
- JDB0131, Delamanid and Ethylpyrazine rifampicide (II)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesChina
- Study dates
- 31 Oct 2023to 31 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (Those who must meet all the selection criteria can enter the group)
- 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.
Who cannot join
- (Meet any of the following criteria will be excluded)
- Rifampicin resistance;
- 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.;
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- 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;
- Those with a history of gastrointestinal surgery or resection that may affect the absorption and/or excretion of oral medications;
- Those who have abnormal ophthalmic examination during the screening period and are judged by the investigator to be unsuitable for participating in this trial;
- Depression: those with a score higher than 7 on the Hamilton Depression Scale (17 items, see Appendix 2);
- Those who are judged to have any unstable or severe cardiovascular, renal, liver, hematology, tumor, endocrine metabolism, psychiatric or rheumatic diseases and therefore consider them unsuitable to participate in this trial;
- Those who cannot control the consumption of alcohol or alcohol-containing products from 48 h before administration to the completion of the last pharmacokinetic blood sample collection, and do not consume any food or beverage containing or metabolizing caffeine or xanthines (such as coffee, strong tea, cola, chocolate);
- Patients who have used other clinical trial study drugs within 3 months prior to administration;
- Patients with a history of alcohol dependence or substance abuse within 6 months prior to screening, which the investigator believes may affect the safety of study participants and affect trial adherence;
- Use of psychotropic drugs such as barbiturates, opioids, and phenothiazines within 30 days;
- Chronic systemic corticosteroid therapy, defined as any dose of systemic corticosteroid therapy, cumulative use for more than 4 weeks in the 3 months prior to enrollment;
- Those who are allergic to any investigational drug or related substances confirmed by the clinical judgment of the investigator;
- Strong inducers or inhibitors of cytochrome P450 enzyme (e.g., carbamazepine, phenytoin, rifampicin, clarithromycin, ritonavir, ketoconazole, itraconazole, etc.) within 30 days before treatment;
- Women with a positive pregnancy test or breastfeeding during screening;
- Those who received live attenuated vaccine within 4 weeks before the study drug (except inactivated influenza vaccine such as seasonal influenza vaccine for injection);
- Any condition that, in the judgment of the investigator, affects the study participant's adherence to the study protocol, or incorporates any serious medical or psychological condition that may affect the interpretation of efficacy and safety data, or that the study participant's participation in the trial may affect his or her own safety.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Jianqing He, +86 18980602293, jianqing_he@scu.edu.cn
- Recruiting
Wuhan Chest Hospital (Wuhan Institute For Tuberculosis Control)
Wuhan, Hubei, 430014
Juan Du, +86 15327334680, dudu1109@126.com
About this study
Official title: A Randomized, Open, Multicenter, Phase IIa Clinical Study on the Early Bactericidal Activity, Safety, Tolerance and Pharmacokinetics of JDB0131 Benzenesulfonate Tablets in Drug Sensitive Pulmonary Tuberculosis Patients
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)
- Conditions
- Drug-resistant Tuberculosis
- Being tested
- JDB0131, Delamanid, Ethylpyrazine rifampicide (II)
- Medical subject headings
- Tuberculosis, Multidrug-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JDB0131Drug
JDB0131 benzenesulfonate is a new anti tuberculosis compound based on delamanid. According to the existing results of pre clinical in vitro activity, in vivo efficacy, pharmacokinetics and safety in human body, JDB0131 benzenesulfonate has the same in vivo efficacy, better lung tissue distribution and better safety as delamanid.
In December 2016, JDB0131 obtained the drug clinical approval issued by the CFDA, and were approved the clinical stage research that development of drug-resistant tuberculosis adaptation.
DelamanidDrug
Delamanid is a new drug developed by Otsuka Pharmaceutical Co., Ltd. in Japan to treat multidrug resistant tuberculosis. In 2014, Delamanid was conditionally approved for marketing by the European Medicines Agency and recommended for use in adult MDR-TB patients who cannot form an effective regimen due to drug resistance or tolerance reasons. In the same year, WHO recommended that Delamanid be conditionally used for long-term treatment of adult MDR-TB. In 2016, the WHO recommended widening the age range for Delamanid to 6-17 years old. In March 2018, Delamanid was listed in China.
Ethylpyrazine rifampicide (II)Drug
Ethylpyrazine rifampicide (II) is suitable for the first two months of intensive treatment of pulmonary tuberculosis with short-term therapy. This product is a compound preparation, consisting of 0.15g of rifampicin (C43H58N4O12), 0.075g of isoniazid (C6H7N3O), 0.4g of pyrazinamide (C5H5N3O), and 0.275g of ethambutol hydrochloride (C10H24N2O2 · 2HCl) per tablet.
| Study group | Role | What they receive |
|---|---|---|
| First group | Experimental | JDB0131 Benzenesulfonate tablets,100mg BID group,12 cases Receives: Drug: JDB0131 |
| Second group | Experimental | JDB0131 Benzenesulfonate tablets 200mg QD group,12 cases Receives: Drug: JDB0131 |
| Third group | Experimental | JDB0131 Benzenesulfonate tablets 200mg BID group,12 cases Receives: Drug: JDB0131 |
| Forth group | Active comparator | Ethylpyrazine rifampicide (II) QD group,8 cases Receives: Drug: Ethylpyrazine rifampicide (II) |
| Fifth group | Active comparator | Delamanid Tablets 100mg BID group,8 cases Receives: Drug: Delamanid |
What is being measured
The primary outcome is the main question the study is designed to answer.
EBA
Early bactericidal activity (EBA), counted by daily log (CFU) change
Measured: he change of TB bacterium burden in sputum from Day 0 to Day 2 and/or Day 14
Secondary outcomes (21)
Percentage of Participants With Adverse Events (AEs)
An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug-related by the investigator.
Measured: average of 6 month
Percentage of Participants With Immediately Reportable Events (IREs)
An AE was considered serious if it was fatal; life-threatening; persistently or significantly disabling or incapacitating; required in-participant hospitalization or prolonged hospitalization; a congenital anomaly/birth defect; or other medically significant event that, based upon appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above. The following were considered as IREs- serious adverse events (SAEs), pregnancies in trial participants or their partners, and all events involving overdose, misuse and abuse.problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug-related by the investigator.
Measured: average of 6 month
ECG
ECG QT Interval
Measured: an average of 6 month
Safe tolerance
laboratory tests
Measured: through study completion, an average of 6 month
Safe tolerance
Eye examination and depression scale scores
Measured: through study completion, an average of 6 month
Tmax
Time to Reach Maximal Peak Plasma Concentration for JDB0131
Measured: Day 0 to Day 21
Cmax
Maximal Peak Plasma Concentration for JDB0131
Measured: Day 0 to Day 21
AUC0-24h
Area under plasma concentration time curve from initial administration to 12 hours for JDB0131
Measured: Day 0 to Day 21
T Tss,max
Steady state peak time for JDB0131
Measured: Day 0 to Day 21
Css,max
Steady state peak concentration for JDB0131
Measured: Day 0 to Day 21
Css,min
Steady-state valley concentration for JDB0131
Measured: Day 0 to Day 21
Css,avg
Mean steady-state blood drug concentration for JDB0131
Measured: Day 0 to Day 21
t1/2,ss
Elimination half life for JDB0131
Measured: Day 0 to Day 21
AUC0-12,ss
Area under the plasma concentration time curve from the last administration to 12 hours for JDB0131
Measured: Day 0 to Day 21
AUC0-t,ss
Area under the plasma concentration-time curve from the last dose to the last measurable concentration time "t" for JDB0131
Measured: Day 0 to Day 21
AUC0-∞,ss
Area under the plasma concentration-time curve from the last dose extrapolated to infinity for JDB0131
Measured: Day 0 to Day 21
Vd,ss
Apparent volume of distribution for JDB0131
Measured: Day 0 to Day 21
CL,ss
Oral clearance for JDB0131
Measured: Day 0 to Day 21
Rac（Cmax）
Ratio of Cmax,ss at day 14 to Cmax at day 1
Measured: Day 0 to Day 21
Rac（AUC）
AUC0-12,ss at day 14 compared to AUC0-12 at day 1
Measured: Day 0 to Day 21
Fluctuation coefficient
Percent fluctuation at steady state = 100 * (Css, max - Css, min) / Css, avg.
Measured: Day 0 to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start31 Oct 2023
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug-resistant 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
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital, Wuhan Pulmonary Hospital
- Responsible party
- Principal investigator, Chu naihui, Beijing Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224036
- Sponsor's protocol ID
- JDB-131-201
- Status last verified
- Jan 2024
- First submitted
- 9 Jul 2023
- Last updated
- 25 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 41461639
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open, Multicenter, Phase IIa Clinical Study on the Early Bactericidal Activity, Safety, Tolerance and Pharmacokinetics of JDB0131 Benzenesulfonate Tablets in Drug Sensitive Pulmonary Tuberculosis Patients
- ClinicalTrials.gov ID
- NCT06224036
- Acronym / sponsor ID
- JDB-131-201
- Conditions
- Drug-resistant Tuberculosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Beijing Chest HospitalUniversity, hospital or other
- Collaborators
- West China Hospital, Wuhan Pulmonary Hospital
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 25 Jan 2024 (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.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| First group | Experimental | Drug: JDB0131JDB0131 Benzenesulfonate tablets,100mg BID group,12 cases |
| Second group | Experimental | Drug: JDB0131JDB0131 Benzenesulfonate tablets 200mg QD group,12 cases |
| Third group | Experimental | Drug: JDB0131JDB0131 Benzenesulfonate tablets 200mg BID group,12 cases |
| Forth group | Active comparator | Drug: Ethylpyrazine rifampicide (II)Ethylpyrazine rifampicide (II) QD group,8 cases |
| Fifth group | Active comparator | Drug: DelamanidDelamanid Tablets 100mg BID group,8 cases |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- (Those who must meet all the selection criteria can enter the group)
Key exclusion criteria (23 listed)
- (Meet any of the following criteria will be excluded)
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 |
|---|---|---|
| JDB0131JDB0131 benzenesulfonate is a new anti tuberculosis compound based on delamanid. According to the existing results of pre clinical in vitro activity, in vivo efficacy, pharmacokinetics and safety in human body, JDB0131 benzenesulfonate has the same in vivo efficacy, better lung tissue distribution and better safety as delamanid. In December 2016, JDB0131 obtained the drug clinical approval issued by the CFDA, and were approved the clinical stage research that development of drug-resistant tuberculosis adaptation. | Drug | First group, Second group, Third group |
| DelamanidDelamanid is a new drug developed by Otsuka Pharmaceutical Co., Ltd. in Japan to treat multidrug resistant tuberculosis. In 2014, Delamanid was conditionally approved for marketing by the European Medicines Agency and recommended for use in adult MDR-TB patients who cannot form an effective regimen due to drug resistance or tolerance reasons. In the same year, WHO recommended that Delamanid be conditionally used for long-term treatment of adult MDR-TB. In 2016, the WHO recommended widening the age range for Delamanid to 6-17 years old. In March 2018, Delamanid was listed in China. | Drug | Fifth group |
| Ethylpyrazine rifampicide (II)Ethylpyrazine rifampicide (II) is suitable for the first two months of intensive treatment of pulmonary tuberculosis with short-term therapy. This product is a compound preparation, consisting of 0.15g of rifampicin (C43H58N4O12), 0.075g of isoniazid (C6H7N3O), 0.4g of pyrazinamide (C5H5N3O), and 0.275g of ethambutol hydrochloride (C10H24N2O2 · 2HCl) per tablet. | Drug | Forth group |
Primary outcome
EBA
Time frame: he change of TB bacterium burden in sputum from Day 0 to Day 2 and/or Day 14
Early bactericidal activity (EBA), counted by daily log (CFU) change
21 secondary outcomes
Percentage of Participants With Adverse Events (AEs)
Time frame: average of 6 month
Percentage of Participants With Immediately Reportable Events (IREs)
Time frame: average of 6 month
ECG
Time frame: an average of 6 month
Safe tolerance
Time frame: through study completion, an average of 6 month
Safe tolerance
Time frame: through study completion, an average of 6 month
Tmax
Time frame: Day 0 to Day 21
Cmax
Time frame: Day 0 to Day 21
AUC0-24h
Time frame: Day 0 to Day 21
T Tss,max
Time frame: Day 0 to Day 21
Css,max
Time frame: Day 0 to Day 21
Css,min
Time frame: Day 0 to Day 21
Css,avg
Time frame: Day 0 to Day 21
t1/2,ss
Time frame: Day 0 to Day 21
AUC0-12,ss
Time frame: Day 0 to Day 21
AUC0-t,ss
Time frame: Day 0 to Day 21
AUC0-∞,ss
Time frame: Day 0 to Day 21
Vd,ss
Time frame: Day 0 to Day 21
CL,ss
Time frame: Day 0 to Day 21
Rac（Cmax）
Time frame: Day 0 to Day 21
Rac（AUC）
Time frame: Day 0 to Day 21
Fluctuation coefficient
Time frame: Day 0 to Day 21
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Derived from this study: PubMed 41461639Chu 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
2 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, Delamanid and Ethylpyrazine rifampicide (II) in people with Drug-resistant Tuberculosis, run by Beijing Chest Hospital at 2 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 8 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naihui Chu, Dr. (+86 13611326573, dongchu1994@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EBA (time frame: he change of TB bacterium burden in sputum from Day 0 to Day 2 and/or Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06224036, which also lists 1 linked publication.
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 25 Jan 2024.