A Phase 2 interventional study of TBAJ-587 50 mg and Pretomanid 200mg in Tuberculosis, Pulmonary, sponsored by TASK Applied Science. Not yet recruiting at 1 site in South Africa. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by TASK Applied Science · Phase 2, Interventional, and Treatment
A phase 2, two-part, multicentre, open label, controlled, randomised clinical trial in adult participants with newly diagnosed, sputum-positive pulmonary drug-sensitive tuberculosis (DSTB). Assessing the Safety and Efficacy of TBAJ-587 as Part of a Combination Regimen in Newly Diagnosed, Drug-Sensitive, Sputum-Positive Pulmonary Tuberculosis
This is a phase 2, two-part, multicentre, open label, controlled, randomised clinical trial in adult participants with newly diagnosed, sputum-positive pulmonary DS-TB. The trial will be performed in two sequential parts, each part containing parallel treatment arms.
Part A: Participants will be randomly assigned to one of two TBAJ-587 experimental regimens (TBA-587PaL, 100 mg or 200mg dose) or the active SOC control arm (HRZE:). Data from Part A will inform dose selection for Part B.
Part B: Participants will be randomly assigned to one of three experimental regimens. The sequential design allows for an interim analysis (section 10.5) between Parts A and B to evaluate the safety and efficacy of lower and higher TBAJ-587 doses before progressing to Part B, where the selected dose will be used. TBAJ-587 may be replaced by a similar diarylquinolone compound if, based on the interim analysis - for scientific and/or safety reasons - determines that TBAJ-587 should not proceed into Part B. Should this occur, the protocol will be updated via submission of a formal protocol amendment.
The active control arm included in Part A provides an internal benchmark to confirm that study procedures, microbiological methods, and clinical conduct perform as expected. Data generated from the Part A control arm will therefore serve as the primary internal reference for interpretation of Part B results. Therefore, there is no control arm in Part B.
In addition, the bacteriological endpoints used in this study, including time to positivity (TTP) and related measures of early bactericidal activity, are well characterised for HRZE in the published literature. These established external data provide a robust contextual framework against which Part B outcomes can be interpreted, without the need for an additional concurrent control arm.
This approach limits unnecessary exposure of participants to standard therapy beyond what is required to establish study validity, while allowing efficient evaluation of the selected investigational regimen in Part B.
319 studies on the registry are indexed under Tuberculosis, Pulmonary; 71 are open to participants now.
This study's planned enrollment of 135 is close to the median of 146 across 227 interventional studies indexed under Tuberculosis, Pulmonary.
Browse Tuberculosis, Pulmonary studies →TASK Applied Science is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
To be eligible to participate in this trial, an individual must meet all the following criteria:
Clinical evidence of active TB disease, meeting either or both of the following criteria:
At least one sputum specimen produced at screening tested on either of the following:
Xpert MTB/XDR and Ultra with:
does not show rifampicin and/or isoniazid resistance. OR
a. Sputum smear
Individuals with a history of TB may be enrolled in this trial if they meet the following criteria:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this trial:
Taking a concomitant medication that has a known or predicted interaction with any of the study drugs to which the participant might be randomised
The participant need not be excluded if:
Any of the following laboratory parameters at screening:
(HIV) antibody positive (known, or on test performed at screening) unless ALL of the following conditions are met:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TBAJ-587 100 mg OD plus Pa 200 mg OD plus L 600 mg OD for 8 weeks
Drug: TBAJ-587 50 mg · Drug: Pretomanid 200mg · Drug: Linezolid 600Mg Tab
TBAJ-587 200 mg OD plus Pa 200 mg OD plus L 600 mg OD for 8 weeks
Drug: TBAJ-587 50 mg · Drug: Pretomanid 200mg · Drug: Linezolid 600Mg Tab
H 75 mg, R 150 mg, Z 400 mg, E 275 mg fixed dose combination, weight-based dosing for 8 weeks
Drug: HRZE (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol combination)
TBAJ-587 selected dose OD plus Pa 200 mg OD plus T 1 000 mg OD for 8 weeks
Drug: TBAJ-587 50 mg · Drug: Pretomanid 200mg · Drug: BTZ-043 250 mg or 500 mg
TBAJ-587 selected dose OD plus Pa 200 mg OD plus Q 30 mg OD for 8 weeks
Drug: TBAJ-587 50 mg · Drug: Pretomanid 200mg · Drug: Quabodepistat (Q) 30 mg
TBAJ-587 selected dose OD plus Pa 200 mg OD plus G 20 mg OD plus L 600 mg OD for 8 weeks
Drug: TBAJ-587 50 mg · Drug: Pretomanid 200mg · Drug: Linezolid 600Mg Tab · Drug: Ganfeborole 20 mg
TBAJ-587LD Tablet 50 mg 100 mg OD TBAJ-587HD Tablet 50 mg 200 mg OD TBAJ-587SD Tablet 50 mg Dose selected from Part A daily
Also known as: Pretomanid 200mg and Linezolid 600mg
Pretomanid Tablet 200 mg 200 mg OD
600 mg OD
1 000 mg OD
H 75 mg, R 150 mg, Z 400 mg, E 275 mg fixed dose combination
30 mg OD
20 mg OD
Rate of Change in Log10-Transformed Sputum Culture Time to Positivity From Baseline Through Week 8
Time to positivity is the time, measured in hours, required for a sputum culture to produce a positive result indicating detectable growth of Mycobacterium tuberculosis. The rate of change in log10-transformed time to positivity will be estimated for each treatment arm. Increasing time to positivity indicates a reduction in the viable mycobacterial load in sputum. Measured as change in log10(days).
Time frame: From baseline to the end of treatment at 8 weeks
Time to Sustained Sputum Culture Conversion From Baseline Through Week 8
Sustained sputum culture conversion is defined as the first of two consecutive negative sputum cultures, with no subsequent positive culture. Time to conversion will be calculated from baseline to the date of the first negative culture that meets this definition. Measured in days.
Time frame: From baseline to the end of treatment at 8 weeks
Percentage of Participants With Sustained Sputum Culture Conversion at Week 8
Sustained sputum culture conversion is defined as the first of two consecutive negative sputum cultures, with no subsequent positive culture. Participants who meet this definition by Week 8 will be included in the percentage. Measured as percentage of participants.
Time frame: At the end of treatment at 8 weeks
Percentage of Participants With Treatment-Emergent Adverse Events
A treatment-emergent adverse event (TEAE) is an adverse event that begins or worsens after the participant receives the first dose of study treatment. Participants experiencing one or more TEAEs will be counted once. Measured as percentage of participants.
Time frame: From enrollment through the final follow-up visit at Week 12
Percentage of Participants With Treatment-Emergent Adverse Events by Maximum Severity Grade as Assessed by CTCAE Version 5.0
The severity of each TEAE will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grades range from 1 to 5: Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening and Grade 5 is death. Participants will be summarized according to their maximum recorded severity grade. Measured as percentage of participants.
Time frame: From enrollment through the final follow-up visit at Week 12
Percentage of Participants With Drug-Related Treatment-Emergent Adverse Events
A drug-related TEAE is a treatment-emergent adverse event assessed by the investigator as having a causal relationship to one or more study drugs. Participants experiencing one or more drug-related TEAEs will be counted once. Measured as percentage of participants.
Time frame: From enrollment through the final follow-up visit at Week 12
Percentage of Participants With Serious Treatment-Emerent Adverse Events
A serious TEAE is a treatment-emergent adverse event that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability or incapacity, causes a congenital anomaly or birth defect, or is considered another medically important event. Participants experiencing one or more serious TEAEs will be counted once. Measured as percentage of participants.
Time frame: From enrollment through the final follow-up visit at Week 12
Percentage of Participants With Treatment-Emergent Adverse Events Leading to Treatment Discontinuation
Participants who permanently discontinue one or more study drugs because of a TEAE will be included in this measure. Participants experiencing more than one qualifying event will be counted once. Measured as a percentage of participants.
Time frame: From enrollment through the final follow-up visit at Week 12
Percentage of Participants With Treatment-Emergent Adverse Events Leading to Death
Participants who die as a result of a TEAE will be included in this measure. Each participant will be counted once, regardless of the number of TEAEs contributing to the death. Measured as a percentage of participants.
Time frame: From enrollment through the final follow-up visit at Week 12
Percentage of Participants With Adverse Events of Special Interest
Adverse events of special interest are protocol-defined events that require specific monitoring because of their potential clinical importance in relation to the study drugs. Participants experiencing one or more adverse events of special interest will be counted once. Measured as a percentage of participants.
Time frame: From enrollment through the final follow-up visit at Week 12
Maximum Observed Plasma Concentration of Study Drugs and Their Metabolites
The maximum observed plasma concentration (Cmax) will be estimated using non-compartmental analysis for the applicable study drugs and metabolites in each treatment arm. These include TBAJ-587 and its metabolites M2, M3 and M12; pretomanid; linezolid; BTZ-043 and its metabolite M1; quabodepistat; and ganfeborole. No pharmacokinetic measurements will be performed in the HRZE control arm. Measured in ng/mL
Time frame: At Day 15 and Week 8 for participants in Part A and at Day 15 for participants in Part B
Minimum Observed Plasma Concentration of Study Drugs and Their Metabolites
The minimum observed plasma concentration (Cmin) will be estimated using non-compartmental analysis for the applicable study drugs and metabolites in each treatment arm. These include TBAJ-587 and its metabolites M2, M3 and M12; pretomanid; linezolid; BTZ-043 and its metabolite M1; quabodepistat; and ganfeborole. No pharmacokinetic measurements will be performed in the HRZE control arm. Measured as ng/mL.
Time frame: At Day 15 and Week 8 for participants in Part A and at Day 15 for participants in Part B
Time to Maximum Observed Plasma Concentration of Study Drugs and Their Metabolites
The time to maximum observed plasma concentration (Tmax) will be estimated using non-compartmental analysis for the applicable study drugs and metabolites in each treatment arm. These include TBAJ-587 and its metabolites M2, M3 and M12; pretomanid; linezolid; BTZ-043 and its metabolite M1; quabodepistat; and ganfeborole. No pharmacokinetic measurements will be performed in the HRZE control arm. Measured in hours.
Time frame: At Day 15 and Week 8 for participants in Part A and at Day 15 for participants in Part B
Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours for Study Drugs and Their Metabolites
The area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24) will be estimated using non-compartmental analysis for the applicable study drugs and metabolites in each treatment arm. These include TBAJ-587 and its metabolites M2, M3 and M12; pretomanid; linezolid; BTZ-043 and its metabolite M1; quabodepistat; and ganfeborole. No pharmacokinetic measurements will be performed in the HRZE control arm. Measured as ng-h/mL
Time frame: At Day 15 and Week 8 for participants in Part A and at Day 15 for participants in Part B
Change in Sputum Mycobacterial Load Measured Using the Molecular Bacterial Load Assay From Baseline Through Week 8
The Molecular Bacterial Load Assay (MBLA) measures viable Mycobacterium tuberculosis in sputum by quantifying mycobacterial ribosomal RNA. Mycobacterial load will be expressed as estimated colony-forming units per millilitre (eCFU/mL). The model-estimated change in log10-transformed mycobacterial load from baseline through Week 8 will be reported for each treatment arm. A decrease indicates a reduction in viable mycobacterial load. Measured as change in log10(eCFU/mL).
Time frame: From baseline to the end of treatment at 8 weeks
Change in Sputum Lipoarabinomannan Concentration Measured Using the PATHFAST TB LAM Ag Assay From Baseline Through Week 8
The PATHFAST TB LAM Ag assay will be used to quantify lipoarabinomannan (LAM), a component of the Mycobacterium tuberculosis cell wall, in sputum. LAM concentration will be measured in picograms per millilitre. The model-estimated change in log10-transformed sputum LAM concentration from baseline through Week 8 will be reported for each treatment arm. A decrease indicates a reduction in sputum LAM concentration. Measured as change in log10(pg/mL).
Time frame: From baseline to the end of treatment at 8 weeks
Change From Baseline in the TB27 Host Blood Transcriptomic Signature Score at Day 15
The TB27 host transcriptomic signature will be measured in whole-blood samples collected at baseline and Day 15. The change in the TB27 signature score from baseline to Day 15 will be calculated for each participant. The TB27 signature is an RNA-based host-response marker intended to predict time to sputum culture conversion. Associations between changes in the TB27 signature score and microbiological markers will be analysed separately.
Time frame: From baseline before the first dose of study treatment to Day 15
Minimum Inhibitory Concentration of Investigational Medicinal Products Against Mycobacterium tuberculosis Through Week 8
The minimum inhibitory concentration (MIC), defined as the lowest concentration of a study drug that inhibits growth of Mycobacterium tuberculosis, will be determined for applicable investigational medicinal products using isolates collected at baseline and during treatment. MIC values will be compared across assessment time points. A fourfold or greater increase from the baseline MIC will be considered a significant MIC shift and will trigger further testing as specified in the protocol. Measured as µg/mL.
Time frame: From baseline before the first dose of study treatment to the end of treatment at Week 8, including the make-up or early-withdrawal visit where applicable
Mycobacterium tuberculosis Isolates With Resistance-Associated Mutations Following a Fourfold or Greater MIC Increase
Whole-genome sequencing will be performed on post-baseline Mycobacterium tuberculosis isolates showing a fourfold or greater increase from baseline in the minimum inhibitory concentration of a study drug. Sequencing will assess mutations associated with resistance to study drugs. Results will be reported as the number of sequenced isolates in which one or more resistance-associated mutations are identified.
Time frame: From baseline before the first dose of study treatment to the end of treatment at Week 8, including the make-up or early-withdrawal visit where applicable
Association Between Individual Drug Exposure and Change in Log10-Transformed Sputum Culture Time to Positivity Through Week 8
Individual drug exposure will be estimated using pharmacokinetic samples collected at Day 15 and Week 8 in Part A and at Day 15 in Part B. Exposure-response modelling will assess the relationship between estimated drug exposure and the change in log10-transformed sputum culture time to positivity from baseline through Week 8. Increasing time to positivity indicates a reduction in viable mycobacterial load.
Time frame: From baseline to the end of treatment at Week 8; pharmacokinetic exposure is assessed at Day 15 and Week 8 in Part A and at Day 15 in Part B
Plan to share: Yes — Plan not yet available
Supporting information: Study protocol
Time frame: Immediately after publication.
Access criteria: Not available yet
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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TASK Applied Science