NCT06224036

Brief 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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

October 31, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

January 25, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

July 9, 2023

Last Update Submit

January 16, 2024

Conditions

Drug-resistant Tuberculosis

Outcome Measures

Primary Outcomes (1)

  • EBA

    Early bactericidal activity (EBA), counted by daily log (CFU) change

    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)

    average of 6 month

  • Percentage of Participants With Immediately Reportable Events (IREs)

    average of 6 month

  • ECG

    an average of 6 month

  • Safe tolerance

    through study completion, an average of 6 month

  • Safe tolerance

    through study completion, an average of 6 month

  • +16 more secondary outcomes

Study Arms (5)

First group

EXPERIMENTAL

JDB0131 Benzenesulfonate tablets,100mg BID group,12 cases

Drug: JDB0131

Second group

EXPERIMENTAL

JDB0131 Benzenesulfonate tablets 200mg QD group,12 cases

Drug: JDB0131

Third group

EXPERIMENTAL

JDB0131 Benzenesulfonate tablets 200mg BID group,12 cases

Drug: JDB0131

Forth group

ACTIVE COMPARATOR

Ethylpyrazine rifampicide (II) QD group,8 cases

Drug: Ethylpyrazine rifampicide (II)

Fifth group

ACTIVE COMPARATOR

Delamanid Tablets 100mg BID group,8 cases

Drug: Delamanid

Interventions

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.

First groupSecond groupThird group
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.

Fifth group
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.

Forth group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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.

You may not qualify if:

  • (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.;
  • 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;
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Wuhan Chest Hospital (Wuhan Institute For Tuberculosis Control)

Wuhan, Hubei, 430014, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Tuberculosis, Multidrug-Resistant

Interventions

OPC-67683

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Central Study Contacts

Naihui Chu, Dr.

CONTACT

+86 13611326573dongchu1994@sina.com

Mailing Huang, Dr.

CONTACT

+86 13720046915Huangmailing@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
TB Director

Study Record Dates

First Submitted

July 9, 2023

First Posted

January 25, 2024

Study Start

October 31, 2023

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

January 25, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)