Early Bactericidal Activity of TBA-7371 in Pulmonary Tuberculosis

A Phase 2a, Dose Escalation, Controlled, Randomized Study to Evaluate Safety, Early Bactericidal Activity (EBA) and Pharmacokinetics of TBA-7371 in Adult Patients With Rifampicin-sensitive Pulmonary Tuberculosis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04176250

Enrollment

Registered

2019-11-25

Start date

2020-01-16

Completion date

2022-10-05

Last updated

2024-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Tuberculosis

Keywords

Rifampicin-sensitive pulmonary tuberculosis, TBA-7371, Pulmonary tuberculosis

Brief summary

The purpose of this study is to assess the safety, early bactericidal activity (EBA) and pharmacokinetics of TBA-7371 in adult participants with rifampicin-sensitive tuberculosis and select dose regimen(s) for future studies.

Interventions

DRUGTBA-7371

Participants will receive TBA-7371 oral suspension 100 milligram (mg) once daily (QD) for 14 days.

DRUGHRZE

Participants will receive Isoniazid \[H\] / rifampicin \[R\] / pyrazinamide \[Z\] / ethambutol \[E\] (HRZE), a fixed dose combination tablet QD for 14 days, based on weight as 40-54 kilograms (kg): 3 tablets; 55-70 kg: 4 tablets and 71 kg and over: 5 tablets.

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Participants between 18 to 60 years of age inclusive at the time of signing the informed consent. * Body weight within 40 and 100 kilogram (inclusive). * Untreated, rifampicin-sensitive pulmonary tuberculosis, as defined by all of the following: 1. isoniazid urine screen negativity 2. sputum smear positivity on direct microscopy for acid-fast bacilli, defined as at least 1+ on the International Unit Against Tuberculosis and Lung Disease/ World Health Organization scale 3. chest X-rays which in the opinion of the investigator is consistent with tuberculosis (TB). 4. Mycobacterium tuberculosis (Mtb) positivity on molecular test (GeneXpert®) 5. rifampicin sensitivity on molecular test (GeneXpert®). * Participants must be able to produce at least 10 milliliter of sputum during the overnight sputum collection (day -7 to -3 or day -2 of the Screening Phase). * Female and male participants should be of non-childbearing potential or using an effective method of birth control. * Non-childbearing potential is defined as follows: 1. participant is not heterosexually active or practices sexual abstinence, OR 2. female participant or sexual partner has undergone bilateral oophorectomy, bilateral tubal ligation and/or hysterectomy, OR 3. female participant or sexual partner has been postmenopausal with a history of no menses for at least 12 consecutive months, OR 4. male participant or sexual partner has undergone vasectomy or bilateral orchidectomy at least three months prior to screening, OR 5. male participant with pregnant sexual partner (for duration of the study) who does not have any other sexual partners. * An effective method of birth control is defined as follows: 1. double barrier method, which can include any 2 of the following: a male condom, diaphragm, cervical cap, or female condom (male and female condoms should not be used together), OR 2. barrier method (one of the above) combined with hormone-based contraceptives or an intra-uterine device for the female participant or partner, AND 3. participant willing to continue practicing one of the above-mentioned birth control methods throughout 14-day Study Treatment Phase and for 4 weeks after the last dose of study medication or discontinuation from study medication in case of early withdrawal. * Participants must be capable of giving signed informed consent, which includes agreeing to compliance with the requirements and restrictions listed in the informed consent form and the protocol.

Exclusion criteria

* Need for immediate effective anti-TB treatment as judged by the investigator. * Evidence and/or history of extra-thoracic TB (e.g. miliary TB, abdominal TB, urogenital TB, osteoarthritic TB, TB meningitis, ocular TB), as judged by the investigator. * Evidence and/or history in the last 5 years of one or any combination of the following: 1. uveitis; 2. color vision deficiency; 3. amblyopia; 4. visual acuity worse than 20/25 after correction in either eye; 5. any known eye disease or prior eye surgery; 6. any systemic condition with ocular manifestations (i.e. Marfan, syphilis, diabetes, Beçhet, Vogt-Koyanagi-Harada, Lyme, or chronic inflammatory condition such as sarcoidosis, rheumatoid arthritis, psoriatic arthritis) * Evidence and/or history in the last 5 years of clinically significant medical condition(s) as judged by the investigator, including malignancies and unstable or uncontrolled hypertension. * Any current medical, psychiatric, occupational, or substance abuse problems that, in the opinion of the investigator, will make it unlikely that the participant will comply with the protocol. * For Human Immunodeficiency Virus infected participants: 1. CD4+ count \<350 cells/microliter, OR 2. Acquired Immune Deficiency Syndrome-defining opportunistic infection or malignancies (except pulmonary TB). * Seated systolic/diastolic blood pressure assessed as vital sign \[i.e. not from electrocardiogram (ECG)\] is less than 95/40 millimeters of Mercury (mmHg) or greater than 145/95 mmHg at screening. Out-of-range blood pressure may be repeated twice with at least 5 minutes intervening. * Seated heart rate assessed as vital sign (i.e. not from ECG) is lower than 40 beats per minute (bpm) or higher than 110 bpm at screening. Out-of-range heart rate may be repeated twice with at least 5 minutes intervening. * A clinically significant ECG abnormality at screening. NOTE: The following can be considered not clinically significant: 1. mild first-degree atrio-ventricular block (P-R interval \<0.23 seconds); 2. right or left axis deviation; 3. incomplete right bundle branch block; 4. isolated left anterior fascicular block (left anterior hemiblock) in young athletic participants. * A list of commonly used prohibited medications with the features described below are prohibited: * Use of medications active against Mtb within 3 months prior to the first dose of study drug. * Use of systemic immunosuppressive medications within 14 days prior to the first dose of study drug. * Use of strong inhibitors or strong inducers of cytochrome P450 (CYP) enzymes within 14 days prior to the first dose of study drug. * Use of inhibitors of phosphodiesterase (PDE) enzymes within 14 days prior to the first dose of study drug. * Use of medications known to affect the eye within 3 months prior to the first dose of study drug. * For Human Immunodeficiency Virus positive participants, use of medications listed in the protocol within 3 months prior to the first dose of study drug. * Participation in other clinical study(-ies) with investigational agent(s) within 6 months prior to trial start. * The following laboratory values from blood collected during the Screening Phase, which represent Grade 2 or higher abnormalities per Division of Acquired Immune Deficiency Syndrome (DAIDS) Toxicity Table Version 2.1, will be cause for exclusion: * Aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase ≥ 2.5x upper limit of normal (ULN) for local laboratory values * Total bilirubin ≥ 1.6x ULN * Creatinine ≥ 1.3x ULN * Hemoglobin \< 10 grams per deciliter (g/dL) \[male\] or 9.5 g/dL \[female\] * White Blood Cells \< 2,000 /cubic millimeter (mm3) * Platelets ≤ 100,000 /mm3 * International normalized ratio of prothrombin time (INR) ≥ 1.5x ULN * Partial thromboplastin time (PTT) ≥ 1.66 ULN * Prothrombin time (PT) ≥ 1.25x ULN * Grade 2 or higher abnormalities in other laboratory parameters from blood or urine Grade 1 abnormalities, or abnormalities from laboratory parameters not included in the DAIDS Toxicity Table Version 2.1, may lead to exclusion if the investigator considers them clinically significant. * History of allergy or hypersensitivity to any of the study drugs or related substances. * Positive urine drug screening for cocaine AND/OR amphetamines AND/OR opiates AND/OR methamphetamines. Note: screening will also be conducted for cannabinoids and results documented in the case report form; however, a positive test for cannabinoids is not an exclusion criterion. * Female participants currently pregnant or lactating/nursing; OR having positive serum pregnancy test during the Screening Phase OR planning a pregnancy within the 1 month after first dose of study drug.

Design outcomes

Primary

Measure	Time frame	Description
Average Change Per Day (Slope) of Log Colony Forming Units (CFU) Counts From Day 0 to Day 14 (BACFU [0-14]) to Assess Bactericidal Activity	Day 0 to Day 14	Overnight sputum samples were collected daily. Bacterial burden was assessed on each sputum sample by CFU on solid culture media. Baseline log10CFU measure was taken as the average of Day -2 and Day -1 log10CFU values. Log10CFU values from subsequent overnight sputum samples (Day 1 to Day 14) were used to assess changes in bacterial burden during the Study Treatment Phase (bactericidal activity). BACFU was the average change in log10CFU count per day over the 14 day Study Treatment Phase. Negative mean BACFU (0-14) values were indicative of a reduction in log10CFU from Baseline, i.e., bactericidal activity. The lower the mean BACFU (0-14) the greater the reduction given it is negative. Positive mean BACFU (0-14) values indicated an increase in log10CFU from Baseline.
Number of Participants Reporting ≥Grade 3 Adverse Events (AEs) and Serious Adverse Events (SAEs)	Up to Day 15	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Clinical signs and symptoms that constitute AEs/SAEs were classified by the investigator as mild (Grade 1), moderate (Grade 2), severe (Grade 3), potentially life threatening (Grade 4), death (Grade 5). Number of participants reporting one or more severe AEs (≥grade 3) and SAEs is presented.

Secondary

Measure	Time frame	Description
Average Change Per Day (Slope) of the log10 Sputum Lipoarabinomannan (LAM) Measurements From Day 0 to Day 14 (BALAM [0-14]), From Day 0 to Day 2 (BALAM [0-2]) and From Day 2 to Day 14 (BALAM [2-14]) to Assess Bactericidal Activity	Day 0 to Day 14, Day 0 to Day 2 and Day 2 to Day 14	Overnight sputum samples were collected daily. Bacterial burden was assessed on each sputum sample by LAM assay in picograms/mL. Baseline log10LAM measure was taken as the average of Day -2 and Day -1 log10LAM values. Log10LAM values from subsequent overnight sputum samples (Day 1 to 14) were used to assess changes in bacterial burden during the Study Treatment Phase (bactericidal activity). Negative mean BALAM values were indicative of a reduction in log10 LAM from Baseline. The lower the Mean BALAM, the greater the reduction given it is negative. Positive mean BALAM values indicated an increase in log10 LAM from Baseline.
Number of Participants Reporting Any Adverse Events (AEs)	Up to Day 15	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants reporting any AEs is presented.
Number of Participants Reporting Grade >=3 AEs by Preferred Term	Up to Day 15	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Clinical signs and symptoms that constitute AEs were classified by the investigator as mild (Grade 1), moderate (Grade 2), severe (Grade 3), potentially life threatening (Grade 4), death (Grade 5). Number of participants who experienced grade \>=3 AEs by preferred term is presented.
Number of Participants Reporting AEs (Presented by Severity)	Up to Day 15	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants reporting Reporting AEs is presented by Severity: Mild- Grade 1 (An event that is usually transient in nature and generally does not interfere with normal activities), Moderate-Grade 2 (An AE that is sufficiently discomforting to interfere with normal activities) and Severe- ≥Grade 3 (An AE that is incapacitating and prevents normal activities). The higher the grade, the more severe the symptoms.
Number of Participants Experiencing AEs Related to Study Intervention	Up to Day 15	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with use of a study intervention, whether or not considered related to study intervention. An AE is considered related to study intervention if there was a reasonable possibility that the study intervention contributed to the AE.
Number of Participants With Any New Eye Symptom in One or Both Eyes	Up to Day 15	Eye symptoms were assessed by non-leading questions delivered by trained staff based on a standardized script. A participant with multiple eye symptoms within a preferred term was counted once. Number of participants with any new eye symptom in one or both eyes is presented. All the eye symptoms have been included in the adverse events section of this study.
Average Duration of New Eye Symptom in One or Both Eyes	Up to Day 15	Average duration of eye symptoms in one or both eyes that were observed after screening for an individual participant was computed as the average duration of all symptoms using the number of symptoms as denominator. Average duration of new eye symptoms in one of both eyes was measured in Hours.
Total Number of Days With New Eye Symptoms in One or Both Eyes	Up to Day 15	Any day that a participant reported an eye symptom in one or both eyes after screening was counted toward the number of days of having eye symptoms in the study for that participant. Total Number of Days with New Eye Symptoms in One or Both Eyes is presented.
Change From Baseline in SBP and DBP	Baseline (Day 1) and at Day 4, Day 7, Day 10 and Day 14	SBP and DBP were measured twice as follows: after 10 minutes supine (manual, supine) and after 2 (±0.5) minutes standing (manual, 2-minute standing). Baseline was measured on Day 1 before the first dose of study medication was administered. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Tau (AUCtau) After Administration of TBA7371	Days 1, 7 and 14	Blood samples were collected at indicated time points for pharmacokinetic analysis of TBA7371. PK parameters were analyzed using standard non-compartmental analysis. Tau represents the dosing interval of 24 hours.
Change From Baseline in Visual Acuity Score	Baseline and up to Day 15	The visual acuity scores were converted to logarithm to the base 10 of the minimum angle of resolution (logMAR) scale for analyzing change from Baseline. LogMar scale was computed as logMAR = -log(visual acuity score in decimal scale). In logMAR scale, lower scores corresponded to better vision, and as acuity became worse, the value of the logMAR increased. Worst logMAR score was defined to be the highest value of logMAR scores measured on left and right eyes at a given time point. The International Classification of Diseases 11 for distance vision impairment used was: Normal: Equal to or better than 20/40; Mild: Worse than 20/40 and equal to or better than 20/70; Moderate: Worse than 20/70 and equal to or better than 20/200; Severe: Worse than 20/200 and equal to or better than 20/400; Blindness: Worse than 20/400. Baseline was defined as the last assessment at screening. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Number of Participants With Color Vision Abnormality in One or Both Eyes	Up to Day 15	Color vision abnormality was defined as the most severe of protan, deutan, or tritan color deficiency in one or both eyes at a given time point. The degree of severity of color vision deficiency was graded as mild, moderate, severe. The severity of color vision abnormality was assigned to the highest degree of severity of the 3 color vision deficits. Number of participants with color vision abnormality in one or both eyes is presented.
Change From Baseline in Heart Rate (HR)	Baseline and up to Day 15	HR was measured twice as follows: after 10 minutes supine (manual, supine) and after 2 (±0.5) minutes standing (manual, 2-minute standing). Baseline was measured on Day 1 before the first dose of study medication was administered. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Baseline and up to Day 15	SBP and DBP were measured twice as follows: after 10 minutes supine (manual, supine) and after 2 (±0.5) minutes standing (manual, 2-minute standing). Baseline was measured on Day 1 before the first dose of study medication was administered. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Change From Baseline in HR as Measured by Electrocardiogram (ECG)	Baseline and at Day 15	12-lead ECG was recorded after at least 10 minutes of supine rest to measure HR. Baseline was measured on Day 1 before the first dose of study medication was administered. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	Day 1 and up to Day 15	HR, SBP and DBP were measured twice as follows: after 10 minutes supine (manual, supine) and after 2 (±0.5) minutes standing (manual, 2-minute standing). Number of participants with ≥25% intraday increase in HR, ≥25% intraday decrease in SBP, ≥25% intraday decrease in DBP at any intraday time is presented.
Mean Number of Days With ≥25% Increase in HR From Baseline	Baseline (Day 1) and up to Day 15	HR was measured twice as follows: after 10 minutes supine (manual, supine) and after 2 (±0.5) minutes standing (manual, 2-minute standing). Mean number of days with ≥25% increase in HR from Baseline is presented.
Average Change Per Day (Slope) of Log CFU Counts From Day 0 to Day 2 (BACFU [0-2]) and From Day 2 to Day 14 (BACFU [2-14]) to Assess Bactericidal Activity	Day 0 to Day 2 and Day 2 to Day 14	Overnight sputum samples were collected daily. Bacterial burden was assessed on each sputum sample by CFU on solid culture media. Baseline log10CFU measure was taken as the average of Day -2 and Day -1 log10CFU values. Log10CFU values from subsequent overnight sputum samples (Day 1 to Day 14) were used to assess changes in bacterial burden during the Study Treatment Phase (bactericidal activity). BACFU was the average change in log10CFU count per day over the 14 day Study Treatment Phase. Negative mean BACFU (0-2) and BACFU (2-14) values were indicative of a reduction in log10CFU from Baseline, i.e., bactericidal activity. The lower the mean BACFU (0-2) and BACFU (2-14), the greater the reduction given it is negative. Positive mean BACFU (0-2) and BACFU (2-14) values indicated an increase in log10CFU from Baseline.
Change From Baseline in Electrocardiogram (ECG) Parameters	Baseline and up to Day 15	12-lead ECG was recorded once at each time point after at least 10 minutes of supine rest to assess PR interval, QRS duration, QT interval, QT Corrected for HR Using Fridericia's Method (QTcF) interval and RR interval. Baseline was measured on Day 1 before the first dose of study medication was administered. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Change From Baseline in HR	Baseline (Day 1) and at Day 4, Day 7, Day 10 and Day 14	HR was measured twice as follows: after 10 minutes supine (manual, supine) and after 2 (±0.5) minutes standing (manual, 2-minute standing). Baseline was measured on Day 1 before the first dose of study medication was administered. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Number of Participants With New Eye Symptoms in Any Eye	Day 1, Day 4, Day 7, Day 10, Day 14 and 15	Eye symptoms were assessed by non-leading questions delivered by trained staff based on a standardized script. A participant with multiple eye symptoms within a preferred term was counted once. Severe eye symptoms were events with grade 3 intensity or greater. Number of participants with new eye symptoms in any eye including: any, severe and serious is presented.
Number of Participants With Shift From Baseline in Hematology Parameters	Day 3, Day 7, Day 15 and Day 42	Blood samples were collected from participants for analysis of following hematology parameters: Erythrocytes, Hemoglobin, Hematocrit, Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelets. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, were recorded in the 'To Normal or No Change' category. Baseline was defined as the last assessment at screening. Only the abnormal values were reported where normal to high and normal to low changes were reported.
Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Day 3, Day 7, Day 15 and Day 42	Blood samples were collected from participants for analysis of following hematology parameters; Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Creatinine, Urea Nitrogen, Sodium and Potassium. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, were recorded in the 'To Normal or No Change' category. Baseline was defined as the last assessment at screening. Only the abnormal values were reported where normal to high and normal to low changes were reported.
Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Day 3, Day 7, Day 15 and Day 42	Blood samples were collected from participants for analysis of following serum coagulation: Prothrombin time, Activated Partial Thromboplastin Time and Prothrombin International Normalized Ratio. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, were recorded in the 'To Normal or No Change' category. Baseline was defined as the last assessment at screening. Only the abnormal values were reported where normal to high and normal to low changes were reported.
Change From Baseline in Urinalysis Parameter: Urine Specific Gravity	Baseline and at Day 3, Day 7 and Day 42	Urine samples were collected to measure urine specific gravity. Baseline was defined as the last assessment at screening. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Baseline and at Day 3, Day 7 and Day 42	Urine samples were collected to measure urine pH. Baseline was defined as the last assessment at screening. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Maximum Observed Serum Concentration (Cmax) After Administration of TBA7371	Days 1, 7 and 14	Blood samples were collected at indicated time points for pharmacokinetic analysis of TBA7371. PK parameters were analyzed using standard non-compartmental analysis.
Time at Maximum Plasma Concentration (Tmax) After Administration of TBA7371	Days 1, 7 and 14	Blood samples were collected at indicated time points for pharmacokinetic analysis of TBA7371. PK parameters were analyzed using standard non-compartmental analysis.
Last Quantifiable Concentration (Clast) After Administration of TBA7371	Days 1, 7 and 14	Blood samples were collected at indicated time points for pharmacokinetic analysis of TBA7371. PK parameters were analyzed using standard non-compartmental analysis.
Time at Last Quantifiable Concentration (Tlast) After Administration of TBA7371	Days 1, 7 and 14	Blood samples were collected at indicated time points for pharmacokinetic analysis of TBA7371. PK parameters were analyzed using standard non-compartmental analysis.
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 Extrapolated to Infinity (AUCinf) After Administration of TBA7371	Day 1	Blood samples were collected at indicated time points for pharmacokinetic analysis of TBA7371. PK parameters were analyzed using standard non-compartmental analysis.
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Last Quantifiable Concentration (AUClast) After Administration of TBA7371	Days 1, 7 and 14	Blood samples were collected at indicated time points for pharmacokinetic analysis of TBA7371. PK parameters were analyzed using standard non-compartmental analysis.
Minimum Observed Plasma Concentration (Cmin) After Administration of TBA7371	Days 7 and 14	Blood samples were collected at indicated time points for pharmacokinetic analysis of TBA7371. PK parameters were analyzed using standard non-compartmental analysis. Mean and standard deviation for Cmin could not be calculated due to high proportion of NQ values (\>30% of values were imputed)
Half-life (T1/2) After Administration of TBA7371	Days 1, 7 and 14	Blood samples were collected at indicated time points for pharmacokinetic analysis of TBA7371. PK parameters were analyzed using standard non-compartmental analysis.
Accumulation Ratio After Administration of TBA7371	Days 7 and 14	Blood samples were collected at indicated time points for pharmacokinetic analysis of TBA7371. PK parameters were analyzed using standard non-compartmental analysis.
Mean Number of Days With ≥25% Decrease in SBP and Decrease in DBP From Baseline	Baseline (Day 1) and up to Day 15	SBP and DBP were measured twice as follows: after 10 minutes supine (manual, supine) and after 2 (±0.5) minutes standing (manual, 2-minute standing). Mean number of days with ≥25% decrease in SBP and decrease in DBP from Baseline is presented.
Average Change Per Day(Slope)of Time to Sputum Culture Positivity(TTP) in Mycobacteria Growth Indicator Tube (MGIT) System From Day0 to Day14 (BATTP[0-14]),From Day0 to Day2(BATTP[0-2]), and From Day2 to Day14(BATTP [2-14]) to Assess Bactericidal Activity	Day 0 to Day 14, Day 0 to Day 2 and Day 2 to Day 14	Overnight sputum samples were collected daily. Bacterial burden was assessed on each sputum sample by time to positivity (TTP; hours) in MGIT system. Baseline TTP measure was taken as the average of Day -2 and Day -1 TTP values. TTP values from subsequent overnight sputum samples (Day 1 to 14) were used to assess changes in bacterial burden during the Study Treatment Phase (bactericidal activity). BATTP was the average change of time to (sputum culture) Positivity (hours) per day in MGIT system per day over 14 days. Positive mean BATTP values were indicative of an increase in TTP from Baseline. The higher the Mean BATTP, the greater the increase given it is positive. Negative mean BATTP values indicated a reduction in TTP from Baseline.

Countries

South Africa

Participant flow

Recruitment details

The study was conducted in South Africa.

Pre-assignment details

This was a dose escalation, controlled, randomized study to evaluate safety, early bactericidal activity (EBA) and pharmacokinetics (PK) of TBA-7371 in adult participants with rifampicin-sensitive pulmonary tuberculosis (TB). Participants were randomized 5:1 to TBA-7371 or HRZE. Data are presented by intervention.

Participants by arm

Arm	Count
TBA-7371 100 mg QD Participants were randomized to receive TBA-7371 oral suspension 100 mg QD for 14 days	15
TBA-7371 100 mg BID Participants were randomized to receive TBA-7371 oral suspension 100 mg BID for 14 days	15
TBA-7371 200 mg QD Participants were randomized to receive TBA-7371 oral suspension 200 mg QD for 14 days.	15
TBA-7371 100 mg TID Participants were randomized to receive TBA-7371 oral suspension 100 mg TID for 14 days.	17
TBA-7371 400 mg QD Participants were randomized to receive TBA-7371 oral suspension 400 mg QD for 14 days.	15
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE) Participants were randomized to receive HRZE, a fixed dose combination tablet QD for 14 days, based on weight as 40-54 kilograms (kg): 3 tablets; 55-70 kg: 4 tablets and 71 kg and over: 5 tablets.	15
Total	92

Withdrawals & dropouts

Period	Reason	FG001	FG002	FG003	FG004	FG005
Overall Study	Adverse Event	1	0	1	0	1
Overall Study	Positive CoronaVIrus Disease(COVID)/Severe Acute Respiratory Syndrome CoronaVirus 2(SARS-CoV-2) test	0	1	1	0	0
Overall Study	Randomized in error	0	0	0	1	0
Overall Study	Withdrawal by Subject	0	0	0	0	1

Baseline characteristics

Characteristic	TBA-7371 100 mg QD	TBA-7371 100 mg BID	TBA-7371 200 mg QD	TBA-7371 100 mg TID	TBA-7371 400 mg QD	Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Total
Age, Continuous	25.5 Years STANDARD_DEVIATION 5.1	36.3 Years STANDARD_DEVIATION 10.49	27.4 Years STANDARD_DEVIATION 6.99	33.4 Years STANDARD_DEVIATION 9.27	31.3 Years STANDARD_DEVIATION 12	27.3 Years STANDARD_DEVIATION 9.37	30.2 Years STANDARD_DEVIATION 8.87
Race/Ethnicity, Customized Black	9 Participants	12 Participants	9 Participants	10 Participants	7 Participants	9 Participants	56 Participants
Race/Ethnicity, Customized Mixed Race	3 Participants	1 Participants	5 Participants	7 Participants	6 Participants	5 Participants	27 Participants
Race/Ethnicity, Customized South African Colored	3 Participants	2 Participants	1 Participants	0 Participants	2 Participants	1 Participants	9 Participants
Sex: Female, Male Female	5 Participants	2 Participants	4 Participants	6 Participants	4 Participants	4 Participants	25 Participants
Sex: Female, Male Male	10 Participants	13 Participants	11 Participants	11 Participants	11 Participants	11 Participants	67 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk
deaths Total, all-cause mortality	0 / 15	0 / 15	0 / 15	0 / 17	0 / 15	0 / 15
other Total, other adverse events	11 / 15	14 / 15	13 / 15	12 / 17	15 / 15	11 / 15
serious Total, serious adverse events	0 / 15	1 / 15	1 / 15	0 / 17	0 / 15	0 / 15

Outcome results

Primary

Average Change Per Day (Slope) of Log Colony Forming Units (CFU) Counts From Day 0 to Day 14 (BACFU [0-14]) to Assess Bactericidal Activity

Overnight sputum samples were collected daily. Bacterial burden was assessed on each sputum sample by CFU on solid culture media. Baseline log10CFU measure was taken as the average of Day -2 and Day -1 log10CFU values. Log10CFU values from subsequent overnight sputum samples (Day 1 to Day 14) were used to assess changes in bacterial burden during the Study Treatment Phase (bactericidal activity). BACFU was the average change in log10CFU count per day over the 14 day Study Treatment Phase. Negative mean BACFU (0-14) values were indicative of a reduction in log10CFU from Baseline, i.e., bactericidal activity. The lower the mean BACFU (0-14) the greater the reduction given it is negative. Positive mean BACFU (0-14) values indicated an increase in log10CFU from Baseline.

Time frame: Day 0 to Day 14

Population: mITT Population. Only those participants with data available at the specified data points were analyzed.

Arm	Measure	Value (MEAN)
TBA-7371 100 mg QD	Average Change Per Day (Slope) of Log Colony Forming Units (CFU) Counts From Day 0 to Day 14 (BACFU [0-14]) to Assess Bactericidal Activity	-0.039 log10 CFU per milliliter (/mL) per day
TBA-7371 100 mg BID	Average Change Per Day (Slope) of Log Colony Forming Units (CFU) Counts From Day 0 to Day 14 (BACFU [0-14]) to Assess Bactericidal Activity	-0.086 log10 CFU per milliliter (/mL) per day
TBA-7371 200 mg QD	Average Change Per Day (Slope) of Log Colony Forming Units (CFU) Counts From Day 0 to Day 14 (BACFU [0-14]) to Assess Bactericidal Activity	-0.065 log10 CFU per milliliter (/mL) per day
TBA-7371 100 mg TID	Average Change Per Day (Slope) of Log Colony Forming Units (CFU) Counts From Day 0 to Day 14 (BACFU [0-14]) to Assess Bactericidal Activity	-0.130 log10 CFU per milliliter (/mL) per day
TBA-7371 400 mg QD	Average Change Per Day (Slope) of Log Colony Forming Units (CFU) Counts From Day 0 to Day 14 (BACFU [0-14]) to Assess Bactericidal Activity	-0.096 log10 CFU per milliliter (/mL) per day
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Average Change Per Day (Slope) of Log Colony Forming Units (CFU) Counts From Day 0 to Day 14 (BACFU [0-14]) to Assess Bactericidal Activity	-0.203 log10 CFU per milliliter (/mL) per day

Primary

Number of Participants Reporting ≥Grade 3 Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Clinical signs and symptoms that constitute AEs/SAEs were classified by the investigator as mild (Grade 1), moderate (Grade 2), severe (Grade 3), potentially life threatening (Grade 4), death (Grade 5). Number of participants reporting one or more severe AEs (≥grade 3) and SAEs is presented.

Time frame: Up to Day 15

Population: Safety Population: included all participants randomly assigned to study intervention and who received at least one dose of the study intervention.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
TBA-7371 100 mg QD	Number of Participants Reporting ≥Grade 3 Adverse Events (AEs) and Serious Adverse Events (SAEs)	≥Grade 3 AEs	0 Participants
TBA-7371 100 mg QD	Number of Participants Reporting ≥Grade 3 Adverse Events (AEs) and Serious Adverse Events (SAEs)	SAEs	0 Participants
TBA-7371 100 mg BID	Number of Participants Reporting ≥Grade 3 Adverse Events (AEs) and Serious Adverse Events (SAEs)	≥Grade 3 AEs	1 Participants
TBA-7371 100 mg BID	Number of Participants Reporting ≥Grade 3 Adverse Events (AEs) and Serious Adverse Events (SAEs)	SAEs	1 Participants
TBA-7371 200 mg QD	Number of Participants Reporting ≥Grade 3 Adverse Events (AEs) and Serious Adverse Events (SAEs)	≥Grade 3 AEs	1 Participants
TBA-7371 200 mg QD	Number of Participants Reporting ≥Grade 3 Adverse Events (AEs) and Serious Adverse Events (SAEs)	SAEs	1 Participants
TBA-7371 100 mg TID	Number of Participants Reporting ≥Grade 3 Adverse Events (AEs) and Serious Adverse Events (SAEs)	≥Grade 3 AEs	2 Participants
TBA-7371 100 mg TID	Number of Participants Reporting ≥Grade 3 Adverse Events (AEs) and Serious Adverse Events (SAEs)	SAEs	0 Participants
TBA-7371 400 mg QD	Number of Participants Reporting ≥Grade 3 Adverse Events (AEs) and Serious Adverse Events (SAEs)	≥Grade 3 AEs	0 Participants
TBA-7371 400 mg QD	Number of Participants Reporting ≥Grade 3 Adverse Events (AEs) and Serious Adverse Events (SAEs)	SAEs	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants Reporting ≥Grade 3 Adverse Events (AEs) and Serious Adverse Events (SAEs)	≥Grade 3 AEs	3 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants Reporting ≥Grade 3 Adverse Events (AEs) and Serious Adverse Events (SAEs)	SAEs	0 Participants

Secondary

Accumulation Ratio After Administration of TBA7371

Blood samples were collected at indicated time points for pharmacokinetic analysis of TBA7371. PK parameters were analyzed using standard non-compartmental analysis.

Time frame: Days 7 and 14

Population: PK Population. Only those participants with data available at the specified data points were analyzed

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
TBA-7371 100 mg QD	Accumulation Ratio After Administration of TBA7371	Day 7	1.058 Ratio	Geometric Coefficient of Variation 11.9
TBA-7371 100 mg QD	Accumulation Ratio After Administration of TBA7371	Day 14	1.083 Ratio	Geometric Coefficient of Variation 12.3
TBA-7371 100 mg BID	Accumulation Ratio After Administration of TBA7371	Day 7	1.118 Ratio	Geometric Coefficient of Variation 18.8
TBA-7371 100 mg BID	Accumulation Ratio After Administration of TBA7371	Day 14	1.096 Ratio	Geometric Coefficient of Variation 15.9
TBA-7371 200 mg QD	Accumulation Ratio After Administration of TBA7371	Day 7	0.885 Ratio	Geometric Coefficient of Variation 22.2
TBA-7371 200 mg QD	Accumulation Ratio After Administration of TBA7371	Day 14	0.898 Ratio	Geometric Coefficient of Variation 13.5
TBA-7371 100 mg TID	Accumulation Ratio After Administration of TBA7371	Day 14	1.237 Ratio	Geometric Coefficient of Variation 17.5
TBA-7371 100 mg TID	Accumulation Ratio After Administration of TBA7371	Day 7	1.277 Ratio	Geometric Coefficient of Variation 20.2
TBA-7371 400 mg QD	Accumulation Ratio After Administration of TBA7371	Day 7	1.006 Ratio	Geometric Coefficient of Variation 19.3
TBA-7371 400 mg QD	Accumulation Ratio After Administration of TBA7371	Day 14	0.930 Ratio	Geometric Coefficient of Variation 16

Secondary

Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 Extrapolated to Infinity (AUCinf) After Administration of TBA7371

Blood samples were collected at indicated time points for pharmacokinetic analysis of TBA7371. PK parameters were analyzed using standard non-compartmental analysis.

Time frame: Day 1

Population: PK Population. Only those participants with data available at the specified data points were analyzed

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
TBA-7371 100 mg QD	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 Extrapolated to Infinity (AUCinf) After Administration of TBA7371	51913.151 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 25.5
TBA-7371 100 mg BID	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 Extrapolated to Infinity (AUCinf) After Administration of TBA7371	44922.259 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 23.4
TBA-7371 200 mg QD	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 Extrapolated to Infinity (AUCinf) After Administration of TBA7371	111041.711 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 24.9
TBA-7371 100 mg TID	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 Extrapolated to Infinity (AUCinf) After Administration of TBA7371	44095.496 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 24.2
TBA-7371 400 mg QD	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 Extrapolated to Infinity (AUCinf) After Administration of TBA7371	256358.739 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 23.3

Secondary

Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Last Quantifiable Concentration (AUClast) After Administration of TBA7371

Blood samples were collected at indicated time points for pharmacokinetic analysis of TBA7371. PK parameters were analyzed using standard non-compartmental analysis.

Time frame: Days 1, 7 and 14

Population: PK Population. Only those participants with data available at the specified data points were analyzed

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
TBA-7371 100 mg QD	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Last Quantifiable Concentration (AUClast) After Administration of TBA7371	Day 1	44912.674 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 19.9
TBA-7371 100 mg QD	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Last Quantifiable Concentration (AUClast) After Administration of TBA7371	Day 14	34087.526 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 19.1
TBA-7371 100 mg QD	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Last Quantifiable Concentration (AUClast) After Administration of TBA7371	Day 7	33754.808 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 20.1
TBA-7371 100 mg BID	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Last Quantifiable Concentration (AUClast) After Administration of TBA7371	Day 1	30784.091 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 10.9
TBA-7371 100 mg BID	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Last Quantifiable Concentration (AUClast) After Administration of TBA7371	Day 7	30283.336 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 20.8
TBA-7371 100 mg BID	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Last Quantifiable Concentration (AUClast) After Administration of TBA7371	Day 14	28951.529 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 21.5
TBA-7371 200 mg QD	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Last Quantifiable Concentration (AUClast) After Administration of TBA7371	Day 14	62866.262 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 12.1
TBA-7371 200 mg QD	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Last Quantifiable Concentration (AUClast) After Administration of TBA7371	Day 1	92918.441 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 15.7
TBA-7371 200 mg QD	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Last Quantifiable Concentration (AUClast) After Administration of TBA7371	Day 7	61079.440 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 26.7
TBA-7371 100 mg TID	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Last Quantifiable Concentration (AUClast) After Administration of TBA7371	Day 1	21893.926 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 17.5
TBA-7371 100 mg TID	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Last Quantifiable Concentration (AUClast) After Administration of TBA7371	Day 7	26404.542 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 21.5
TBA-7371 100 mg TID	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Last Quantifiable Concentration (AUClast) After Administration of TBA7371	Day 14	24619.446 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 15.6
TBA-7371 400 mg QD	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Last Quantifiable Concentration (AUClast) After Administration of TBA7371	Day 14	123208.287 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 13.5
TBA-7371 400 mg QD	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Last Quantifiable Concentration (AUClast) After Administration of TBA7371	Day 1	192193.142 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 12.8
TBA-7371 400 mg QD	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Last Quantifiable Concentration (AUClast) After Administration of TBA7371	Day 7	131687.234 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 13.1

Secondary

Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Tau (AUCtau) After Administration of TBA7371

Blood samples were collected at indicated time points for pharmacokinetic analysis of TBA7371. PK parameters were analyzed using standard non-compartmental analysis. Tau represents the dosing interval of 24 hours.

Time frame: Days 1, 7 and 14

Population: PK Population. Only those participants with data available at the specified data points were analyzed.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
TBA-7371 100 mg QD	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Tau (AUCtau) After Administration of TBA7371	Day 1	44938.373 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 19.9
TBA-7371 100 mg QD	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Tau (AUCtau) After Administration of TBA7371	Day 14	35470.923 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 20.2
TBA-7371 100 mg QD	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Tau (AUCtau) After Administration of TBA7371	Day 7	35906.584 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 21.6
TBA-7371 100 mg BID	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Tau (AUCtau) After Administration of TBA7371	Day 7	30368.520 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 20.9
TBA-7371 100 mg BID	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Tau (AUCtau) After Administration of TBA7371	Day 1	31068.093 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 11.1
TBA-7371 100 mg BID	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Tau (AUCtau) After Administration of TBA7371	Day 14	29016.288 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 21.5
TBA-7371 200 mg QD	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Tau (AUCtau) After Administration of TBA7371	Day 7	65868.027 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 29.5
TBA-7371 200 mg QD	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Tau (AUCtau) After Administration of TBA7371	Day 1	93060.286 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 15.7
TBA-7371 200 mg QD	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Tau (AUCtau) After Administration of TBA7371	Day 14	67309.556 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 14
TBA-7371 100 mg TID	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Tau (AUCtau) After Administration of TBA7371	Day 1	22051.648 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 17.5
TBA-7371 100 mg TID	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Tau (AUCtau) After Administration of TBA7371	Day 14	24778.661 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 15.7
TBA-7371 100 mg TID	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Tau (AUCtau) After Administration of TBA7371	Day 7	26551.127 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 21.6
TBA-7371 400 mg QD	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Tau (AUCtau) After Administration of TBA7371	Day 7	145179.826 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 15.9
TBA-7371 400 mg QD	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Tau (AUCtau) After Administration of TBA7371	Day 1	192442.015 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 12.8
TBA-7371 400 mg QD	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Tau (AUCtau) After Administration of TBA7371	Day 14	134863.281 Hoursnanograms per milliliter (hng/mL)	Geometric Coefficient of Variation 14.8

Secondary

Average Change Per Day (Slope) of Log CFU Counts From Day 0 to Day 2 (BACFU [0-2]) and From Day 2 to Day 14 (BACFU [2-14]) to Assess Bactericidal Activity

Overnight sputum samples were collected daily. Bacterial burden was assessed on each sputum sample by CFU on solid culture media. Baseline log10CFU measure was taken as the average of Day -2 and Day -1 log10CFU values. Log10CFU values from subsequent overnight sputum samples (Day 1 to Day 14) were used to assess changes in bacterial burden during the Study Treatment Phase (bactericidal activity). BACFU was the average change in log10CFU count per day over the 14 day Study Treatment Phase. Negative mean BACFU (0-2) and BACFU (2-14) values were indicative of a reduction in log10CFU from Baseline, i.e., bactericidal activity. The lower the mean BACFU (0-2) and BACFU (2-14), the greater the reduction given it is negative. Positive mean BACFU (0-2) and BACFU (2-14) values indicated an increase in log10CFU from Baseline.

Time frame: Day 0 to Day 2 and Day 2 to Day 14

Population: mITT Population. Only those participants with data available at the specified data points were analyzed.

Arm	Measure	Group	Value (MEAN)
TBA-7371 100 mg QD	Average Change Per Day (Slope) of Log CFU Counts From Day 0 to Day 2 (BACFU [0-2]) and From Day 2 to Day 14 (BACFU [2-14]) to Assess Bactericidal Activity	BACFU (0-2)	0.094 log10 CFU/mL/day
TBA-7371 100 mg QD	Average Change Per Day (Slope) of Log CFU Counts From Day 0 to Day 2 (BACFU [0-2]) and From Day 2 to Day 14 (BACFU [2-14]) to Assess Bactericidal Activity	BACFU (2-14)	-0.061 log10 CFU/mL/day
TBA-7371 100 mg BID	Average Change Per Day (Slope) of Log CFU Counts From Day 0 to Day 2 (BACFU [0-2]) and From Day 2 to Day 14 (BACFU [2-14]) to Assess Bactericidal Activity	BACFU (0-2)	-0.111 log10 CFU/mL/day
TBA-7371 100 mg BID	Average Change Per Day (Slope) of Log CFU Counts From Day 0 to Day 2 (BACFU [0-2]) and From Day 2 to Day 14 (BACFU [2-14]) to Assess Bactericidal Activity	BACFU (2-14)	-0.068 log10 CFU/mL/day
TBA-7371 200 mg QD	Average Change Per Day (Slope) of Log CFU Counts From Day 0 to Day 2 (BACFU [0-2]) and From Day 2 to Day 14 (BACFU [2-14]) to Assess Bactericidal Activity	BACFU (0-2)	-0.310 log10 CFU/mL/day
TBA-7371 200 mg QD	Average Change Per Day (Slope) of Log CFU Counts From Day 0 to Day 2 (BACFU [0-2]) and From Day 2 to Day 14 (BACFU [2-14]) to Assess Bactericidal Activity	BACFU (2-14)	-0.026 log10 CFU/mL/day
TBA-7371 100 mg TID	Average Change Per Day (Slope) of Log CFU Counts From Day 0 to Day 2 (BACFU [0-2]) and From Day 2 to Day 14 (BACFU [2-14]) to Assess Bactericidal Activity	BACFU (0-2)	-0.229 log10 CFU/mL/day
TBA-7371 100 mg TID	Average Change Per Day (Slope) of Log CFU Counts From Day 0 to Day 2 (BACFU [0-2]) and From Day 2 to Day 14 (BACFU [2-14]) to Assess Bactericidal Activity	BACFU (2-14)	-0.127 log10 CFU/mL/day
TBA-7371 400 mg QD	Average Change Per Day (Slope) of Log CFU Counts From Day 0 to Day 2 (BACFU [0-2]) and From Day 2 to Day 14 (BACFU [2-14]) to Assess Bactericidal Activity	BACFU (0-2)	-0.305 log10 CFU/mL/day
TBA-7371 400 mg QD	Average Change Per Day (Slope) of Log CFU Counts From Day 0 to Day 2 (BACFU [0-2]) and From Day 2 to Day 14 (BACFU [2-14]) to Assess Bactericidal Activity	BACFU (2-14)	-0.081 log10 CFU/mL/day
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Average Change Per Day (Slope) of Log CFU Counts From Day 0 to Day 2 (BACFU [0-2]) and From Day 2 to Day 14 (BACFU [2-14]) to Assess Bactericidal Activity	BACFU (0-2)	-0.396 log10 CFU/mL/day
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Average Change Per Day (Slope) of Log CFU Counts From Day 0 to Day 2 (BACFU [0-2]) and From Day 2 to Day 14 (BACFU [2-14]) to Assess Bactericidal Activity	BACFU (2-14)	-0.179 log10 CFU/mL/day

Secondary

Average Change Per Day (Slope) of the log10 Sputum Lipoarabinomannan (LAM) Measurements From Day 0 to Day 14 (BALAM [0-14]), From Day 0 to Day 2 (BALAM [0-2]) and From Day 2 to Day 14 (BALAM [2-14]) to Assess Bactericidal Activity

Overnight sputum samples were collected daily. Bacterial burden was assessed on each sputum sample by LAM assay in picograms/mL. Baseline log10LAM measure was taken as the average of Day -2 and Day -1 log10LAM values. Log10LAM values from subsequent overnight sputum samples (Day 1 to 14) were used to assess changes in bacterial burden during the Study Treatment Phase (bactericidal activity). Negative mean BALAM values were indicative of a reduction in log10 LAM from Baseline. The lower the Mean BALAM, the greater the reduction given it is negative. Positive mean BALAM values indicated an increase in log10 LAM from Baseline.

Time frame: Day 0 to Day 14, Day 0 to Day 2 and Day 2 to Day 14

Population: mITT Population. Only those participants with data available at the specified data points were analyzed

Arm	Measure	Group	Value (MEAN)
TBA-7371 100 mg QD	Average Change Per Day (Slope) of the log10 Sputum Lipoarabinomannan (LAM) Measurements From Day 0 to Day 14 (BALAM [0-14]), From Day 0 to Day 2 (BALAM [0-2]) and From Day 2 to Day 14 (BALAM [2-14]) to Assess Bactericidal Activity	BALAM (2-14)	-0.079 Picograms per milliliter (pg/mL) per day
TBA-7371 100 mg QD	Average Change Per Day (Slope) of the log10 Sputum Lipoarabinomannan (LAM) Measurements From Day 0 to Day 14 (BALAM [0-14]), From Day 0 to Day 2 (BALAM [0-2]) and From Day 2 to Day 14 (BALAM [2-14]) to Assess Bactericidal Activity	BALAM (0-2)	-0.145 Picograms per milliliter (pg/mL) per day
TBA-7371 100 mg QD	Average Change Per Day (Slope) of the log10 Sputum Lipoarabinomannan (LAM) Measurements From Day 0 to Day 14 (BALAM [0-14]), From Day 0 to Day 2 (BALAM [0-2]) and From Day 2 to Day 14 (BALAM [2-14]) to Assess Bactericidal Activity	BALAM (0-14)	-0.082 Picograms per milliliter (pg/mL) per day
TBA-7371 100 mg BID	Average Change Per Day (Slope) of the log10 Sputum Lipoarabinomannan (LAM) Measurements From Day 0 to Day 14 (BALAM [0-14]), From Day 0 to Day 2 (BALAM [0-2]) and From Day 2 to Day 14 (BALAM [2-14]) to Assess Bactericidal Activity	BALAM (0-2)	-0.148 Picograms per milliliter (pg/mL) per day
TBA-7371 100 mg BID	Average Change Per Day (Slope) of the log10 Sputum Lipoarabinomannan (LAM) Measurements From Day 0 to Day 14 (BALAM [0-14]), From Day 0 to Day 2 (BALAM [0-2]) and From Day 2 to Day 14 (BALAM [2-14]) to Assess Bactericidal Activity	BALAM (2-14)	-0.085 Picograms per milliliter (pg/mL) per day
TBA-7371 100 mg BID	Average Change Per Day (Slope) of the log10 Sputum Lipoarabinomannan (LAM) Measurements From Day 0 to Day 14 (BALAM [0-14]), From Day 0 to Day 2 (BALAM [0-2]) and From Day 2 to Day 14 (BALAM [2-14]) to Assess Bactericidal Activity	BALAM (0-14)	-0.096 Picograms per milliliter (pg/mL) per day
TBA-7371 200 mg QD	Average Change Per Day (Slope) of the log10 Sputum Lipoarabinomannan (LAM) Measurements From Day 0 to Day 14 (BALAM [0-14]), From Day 0 to Day 2 (BALAM [0-2]) and From Day 2 to Day 14 (BALAM [2-14]) to Assess Bactericidal Activity	BALAM (0-2)	-0.007 Picograms per milliliter (pg/mL) per day
TBA-7371 200 mg QD	Average Change Per Day (Slope) of the log10 Sputum Lipoarabinomannan (LAM) Measurements From Day 0 to Day 14 (BALAM [0-14]), From Day 0 to Day 2 (BALAM [0-2]) and From Day 2 to Day 14 (BALAM [2-14]) to Assess Bactericidal Activity	BALAM (0-14)	-0.090 Picograms per milliliter (pg/mL) per day
TBA-7371 200 mg QD	Average Change Per Day (Slope) of the log10 Sputum Lipoarabinomannan (LAM) Measurements From Day 0 to Day 14 (BALAM [0-14]), From Day 0 to Day 2 (BALAM [0-2]) and From Day 2 to Day 14 (BALAM [2-14]) to Assess Bactericidal Activity	BALAM (2-14)	-0.107 Picograms per milliliter (pg/mL) per day
TBA-7371 100 mg TID	Average Change Per Day (Slope) of the log10 Sputum Lipoarabinomannan (LAM) Measurements From Day 0 to Day 14 (BALAM [0-14]), From Day 0 to Day 2 (BALAM [0-2]) and From Day 2 to Day 14 (BALAM [2-14]) to Assess Bactericidal Activity	BALAM (2-14)	-0.115 Picograms per milliliter (pg/mL) per day
TBA-7371 100 mg TID	Average Change Per Day (Slope) of the log10 Sputum Lipoarabinomannan (LAM) Measurements From Day 0 to Day 14 (BALAM [0-14]), From Day 0 to Day 2 (BALAM [0-2]) and From Day 2 to Day 14 (BALAM [2-14]) to Assess Bactericidal Activity	BALAM (0-14)	-0.114 Picograms per milliliter (pg/mL) per day
TBA-7371 100 mg TID	Average Change Per Day (Slope) of the log10 Sputum Lipoarabinomannan (LAM) Measurements From Day 0 to Day 14 (BALAM [0-14]), From Day 0 to Day 2 (BALAM [0-2]) and From Day 2 to Day 14 (BALAM [2-14]) to Assess Bactericidal Activity	BALAM (0-2)	-0.123 Picograms per milliliter (pg/mL) per day
TBA-7371 400 mg QD	Average Change Per Day (Slope) of the log10 Sputum Lipoarabinomannan (LAM) Measurements From Day 0 to Day 14 (BALAM [0-14]), From Day 0 to Day 2 (BALAM [0-2]) and From Day 2 to Day 14 (BALAM [2-14]) to Assess Bactericidal Activity	BALAM (0-2)	-0.092 Picograms per milliliter (pg/mL) per day
TBA-7371 400 mg QD	Average Change Per Day (Slope) of the log10 Sputum Lipoarabinomannan (LAM) Measurements From Day 0 to Day 14 (BALAM [0-14]), From Day 0 to Day 2 (BALAM [0-2]) and From Day 2 to Day 14 (BALAM [2-14]) to Assess Bactericidal Activity	BALAM (2-14)	-0.097 Picograms per milliliter (pg/mL) per day
TBA-7371 400 mg QD	Average Change Per Day (Slope) of the log10 Sputum Lipoarabinomannan (LAM) Measurements From Day 0 to Day 14 (BALAM [0-14]), From Day 0 to Day 2 (BALAM [0-2]) and From Day 2 to Day 14 (BALAM [2-14]) to Assess Bactericidal Activity	BALAM (0-14)	-0.095 Picograms per milliliter (pg/mL) per day
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Average Change Per Day (Slope) of the log10 Sputum Lipoarabinomannan (LAM) Measurements From Day 0 to Day 14 (BALAM [0-14]), From Day 0 to Day 2 (BALAM [0-2]) and From Day 2 to Day 14 (BALAM [2-14]) to Assess Bactericidal Activity	BALAM (0-14)	-0.099 Picograms per milliliter (pg/mL) per day
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Average Change Per Day (Slope) of the log10 Sputum Lipoarabinomannan (LAM) Measurements From Day 0 to Day 14 (BALAM [0-14]), From Day 0 to Day 2 (BALAM [0-2]) and From Day 2 to Day 14 (BALAM [2-14]) to Assess Bactericidal Activity	BALAM (0-2)	-0.314 Picograms per milliliter (pg/mL) per day
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Average Change Per Day (Slope) of the log10 Sputum Lipoarabinomannan (LAM) Measurements From Day 0 to Day 14 (BALAM [0-14]), From Day 0 to Day 2 (BALAM [0-2]) and From Day 2 to Day 14 (BALAM [2-14]) to Assess Bactericidal Activity	BALAM (2-14)	-0.078 Picograms per milliliter (pg/mL) per day

Secondary

Average Change Per Day(Slope)of Time to Sputum Culture Positivity(TTP) in Mycobacteria Growth Indicator Tube (MGIT) System From Day0 to Day14 (BATTP[0-14]),From Day0 to Day2(BATTP[0-2]), and From Day2 to Day14(BATTP [2-14]) to Assess Bactericidal Activity

Overnight sputum samples were collected daily. Bacterial burden was assessed on each sputum sample by time to positivity (TTP; hours) in MGIT system. Baseline TTP measure was taken as the average of Day -2 and Day -1 TTP values. TTP values from subsequent overnight sputum samples (Day 1 to 14) were used to assess changes in bacterial burden during the Study Treatment Phase (bactericidal activity). BATTP was the average change of time to (sputum culture) Positivity (hours) per day in MGIT system per day over 14 days. Positive mean BATTP values were indicative of an increase in TTP from Baseline. The higher the Mean BATTP, the greater the increase given it is positive. Negative mean BATTP values indicated a reduction in TTP from Baseline.

Time frame: Day 0 to Day 14, Day 0 to Day 2 and Day 2 to Day 14

Population: mITT Population. Only those participants with data available at the specified data points were analyzed.

Arm	Measure	Group	Value (MEAN)
TBA-7371 100 mg QD	Average Change Per Day(Slope)of Time to Sputum Culture Positivity(TTP) in Mycobacteria Growth Indicator Tube (MGIT) System From Day0 to Day14 (BATTP[0-14]),From Day0 to Day2(BATTP[0-2]), and From Day2 to Day14(BATTP [2-14]) to Assess Bactericidal Activity	BATTP (0-2)	0.961 Hours per day
TBA-7371 100 mg QD	Average Change Per Day(Slope)of Time to Sputum Culture Positivity(TTP) in Mycobacteria Growth Indicator Tube (MGIT) System From Day0 to Day14 (BATTP[0-14]),From Day0 to Day2(BATTP[0-2]), and From Day2 to Day14(BATTP [2-14]) to Assess Bactericidal Activity	BATTP (0-14)	2.334 Hours per day
TBA-7371 100 mg QD	Average Change Per Day(Slope)of Time to Sputum Culture Positivity(TTP) in Mycobacteria Growth Indicator Tube (MGIT) System From Day0 to Day14 (BATTP[0-14]),From Day0 to Day2(BATTP[0-2]), and From Day2 to Day14(BATTP [2-14]) to Assess Bactericidal Activity	BATTP (2-14)	2.182 Hours per day
TBA-7371 100 mg BID	Average Change Per Day(Slope)of Time to Sputum Culture Positivity(TTP) in Mycobacteria Growth Indicator Tube (MGIT) System From Day0 to Day14 (BATTP[0-14]),From Day0 to Day2(BATTP[0-2]), and From Day2 to Day14(BATTP [2-14]) to Assess Bactericidal Activity	BATTP (0-2)	0.902 Hours per day
TBA-7371 100 mg BID	Average Change Per Day(Slope)of Time to Sputum Culture Positivity(TTP) in Mycobacteria Growth Indicator Tube (MGIT) System From Day0 to Day14 (BATTP[0-14]),From Day0 to Day2(BATTP[0-2]), and From Day2 to Day14(BATTP [2-14]) to Assess Bactericidal Activity	BATTP (0-14)	4.143 Hours per day
TBA-7371 100 mg BID	Average Change Per Day(Slope)of Time to Sputum Culture Positivity(TTP) in Mycobacteria Growth Indicator Tube (MGIT) System From Day0 to Day14 (BATTP[0-14]),From Day0 to Day2(BATTP[0-2]), and From Day2 to Day14(BATTP [2-14]) to Assess Bactericidal Activity	BATTP (2-14)	4.249 Hours per day
TBA-7371 200 mg QD	Average Change Per Day(Slope)of Time to Sputum Culture Positivity(TTP) in Mycobacteria Growth Indicator Tube (MGIT) System From Day0 to Day14 (BATTP[0-14]),From Day0 to Day2(BATTP[0-2]), and From Day2 to Day14(BATTP [2-14]) to Assess Bactericidal Activity	BATTP (0-2)	2.749 Hours per day
TBA-7371 200 mg QD	Average Change Per Day(Slope)of Time to Sputum Culture Positivity(TTP) in Mycobacteria Growth Indicator Tube (MGIT) System From Day0 to Day14 (BATTP[0-14]),From Day0 to Day2(BATTP[0-2]), and From Day2 to Day14(BATTP [2-14]) to Assess Bactericidal Activity	BATTP (0-14)	3.250 Hours per day
TBA-7371 200 mg QD	Average Change Per Day(Slope)of Time to Sputum Culture Positivity(TTP) in Mycobacteria Growth Indicator Tube (MGIT) System From Day0 to Day14 (BATTP[0-14]),From Day0 to Day2(BATTP[0-2]), and From Day2 to Day14(BATTP [2-14]) to Assess Bactericidal Activity	BATTP (2-14)	3.811 Hours per day
TBA-7371 100 mg TID	Average Change Per Day(Slope)of Time to Sputum Culture Positivity(TTP) in Mycobacteria Growth Indicator Tube (MGIT) System From Day0 to Day14 (BATTP[0-14]),From Day0 to Day2(BATTP[0-2]), and From Day2 to Day14(BATTP [2-14]) to Assess Bactericidal Activity	BATTP (0-2)	8.633 Hours per day
TBA-7371 100 mg TID	Average Change Per Day(Slope)of Time to Sputum Culture Positivity(TTP) in Mycobacteria Growth Indicator Tube (MGIT) System From Day0 to Day14 (BATTP[0-14]),From Day0 to Day2(BATTP[0-2]), and From Day2 to Day14(BATTP [2-14]) to Assess Bactericidal Activity	BATTP (0-14)	5.547 Hours per day
TBA-7371 100 mg TID	Average Change Per Day(Slope)of Time to Sputum Culture Positivity(TTP) in Mycobacteria Growth Indicator Tube (MGIT) System From Day0 to Day14 (BATTP[0-14]),From Day0 to Day2(BATTP[0-2]), and From Day2 to Day14(BATTP [2-14]) to Assess Bactericidal Activity	BATTP (2-14)	5.624 Hours per day
TBA-7371 400 mg QD	Average Change Per Day(Slope)of Time to Sputum Culture Positivity(TTP) in Mycobacteria Growth Indicator Tube (MGIT) System From Day0 to Day14 (BATTP[0-14]),From Day0 to Day2(BATTP[0-2]), and From Day2 to Day14(BATTP [2-14]) to Assess Bactericidal Activity	BATTP (0-2)	12.930 Hours per day
TBA-7371 400 mg QD	Average Change Per Day(Slope)of Time to Sputum Culture Positivity(TTP) in Mycobacteria Growth Indicator Tube (MGIT) System From Day0 to Day14 (BATTP[0-14]),From Day0 to Day2(BATTP[0-2]), and From Day2 to Day14(BATTP [2-14]) to Assess Bactericidal Activity	BATTP (0-14)	3.767 Hours per day
TBA-7371 400 mg QD	Average Change Per Day(Slope)of Time to Sputum Culture Positivity(TTP) in Mycobacteria Growth Indicator Tube (MGIT) System From Day0 to Day14 (BATTP[0-14]),From Day0 to Day2(BATTP[0-2]), and From Day2 to Day14(BATTP [2-14]) to Assess Bactericidal Activity	BATTP (2-14)	2.604 Hours per day
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Average Change Per Day(Slope)of Time to Sputum Culture Positivity(TTP) in Mycobacteria Growth Indicator Tube (MGIT) System From Day0 to Day14 (BATTP[0-14]),From Day0 to Day2(BATTP[0-2]), and From Day2 to Day14(BATTP [2-14]) to Assess Bactericidal Activity	BATTP (0-14)	13.877 Hours per day
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Average Change Per Day(Slope)of Time to Sputum Culture Positivity(TTP) in Mycobacteria Growth Indicator Tube (MGIT) System From Day0 to Day14 (BATTP[0-14]),From Day0 to Day2(BATTP[0-2]), and From Day2 to Day14(BATTP [2-14]) to Assess Bactericidal Activity	BATTP (2-14)	10.660 Hours per day
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Average Change Per Day(Slope)of Time to Sputum Culture Positivity(TTP) in Mycobacteria Growth Indicator Tube (MGIT) System From Day0 to Day14 (BATTP[0-14]),From Day0 to Day2(BATTP[0-2]), and From Day2 to Day14(BATTP [2-14]) to Assess Bactericidal Activity	BATTP (0-2)	30.872 Hours per day

Secondary

Average Duration of New Eye Symptom in One or Both Eyes

Average duration of eye symptoms in one or both eyes that were observed after screening for an individual participant was computed as the average duration of all symptoms using the number of symptoms as denominator. Average duration of new eye symptoms in one of both eyes was measured in Hours.

Time frame: Up to Day 15

Population: Safety Population. Only those participants with data available at the specified data points were analyzed

Arm	Measure	Value (MEDIAN)
TBA-7371 100 mg QD	Average Duration of New Eye Symptom in One or Both Eyes	12.13 Hours
TBA-7371 100 mg BID	Average Duration of New Eye Symptom in One or Both Eyes	12.00 Hours
TBA-7371 200 mg QD	Average Duration of New Eye Symptom in One or Both Eyes	1.79 Hours
TBA-7371 100 mg TID	Average Duration of New Eye Symptom in One or Both Eyes	72.00 Hours
TBA-7371 400 mg QD	Average Duration of New Eye Symptom in One or Both Eyes	2.00 Hours
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Average Duration of New Eye Symptom in One or Both Eyes	936.00 Hours

Secondary

Change From Baseline in Electrocardiogram (ECG) Parameters

12-lead ECG was recorded once at each time point after at least 10 minutes of supine rest to assess PR interval, QRS duration, QT interval, QT Corrected for HR Using Fridericia's Method (QTcF) interval and RR interval. Baseline was measured on Day 1 before the first dose of study medication was administered. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

Time frame: Baseline and up to Day 15

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
TBA-7371 100 mg QD	Change From Baseline in Electrocardiogram (ECG) Parameters	RR interval: Day 15	-27.5 Milliseconds (ms)	Standard Deviation 94.6
TBA-7371 100 mg QD	Change From Baseline in Electrocardiogram (ECG) Parameters	QTcF interval: Day 15	1.2 Milliseconds (ms)	Standard Deviation 14.68
TBA-7371 100 mg QD	Change From Baseline in Electrocardiogram (ECG) Parameters	QRS duration: Day 15	-0.9 Milliseconds (ms)	Standard Deviation 6.97
TBA-7371 100 mg QD	Change From Baseline in Electrocardiogram (ECG) Parameters	QT interval: Day 15	-3.0 Milliseconds (ms)	Standard Deviation 22.56
TBA-7371 100 mg QD	Change From Baseline in Electrocardiogram (ECG) Parameters	PR interval: Day 15	-0.8 Milliseconds (ms)	Standard Deviation 9.06
TBA-7371 100 mg BID	Change From Baseline in Electrocardiogram (ECG) Parameters	QT interval: Day 15	0.7 Milliseconds (ms)	Standard Deviation 17.89
TBA-7371 100 mg BID	Change From Baseline in Electrocardiogram (ECG) Parameters	QTcF interval: Day 15	-0.8 Milliseconds (ms)	Standard Deviation 10.61
TBA-7371 100 mg BID	Change From Baseline in Electrocardiogram (ECG) Parameters	RR interval: Day 15	8.4 Milliseconds (ms)	Standard Deviation 83.59
TBA-7371 100 mg BID	Change From Baseline in Electrocardiogram (ECG) Parameters	QRS duration: Day 15	-0.2 Milliseconds (ms)	Standard Deviation 4.63
TBA-7371 100 mg BID	Change From Baseline in Electrocardiogram (ECG) Parameters	PR interval: Day 15	-0.7 Milliseconds (ms)	Standard Deviation 6.88
TBA-7371 200 mg QD	Change From Baseline in Electrocardiogram (ECG) Parameters	QT interval: Day 15	13.4 Milliseconds (ms)	Standard Deviation 20.66
TBA-7371 200 mg QD	Change From Baseline in Electrocardiogram (ECG) Parameters	RR interval: Day 15	41.4 Milliseconds (ms)	Standard Deviation 60.99
TBA-7371 200 mg QD	Change From Baseline in Electrocardiogram (ECG) Parameters	QTcF interval: Day 15	7.4 Milliseconds (ms)	Standard Deviation 14.62
TBA-7371 200 mg QD	Change From Baseline in Electrocardiogram (ECG) Parameters	PR interval: Day 15	0.5 Milliseconds (ms)	Standard Deviation 10.06
TBA-7371 200 mg QD	Change From Baseline in Electrocardiogram (ECG) Parameters	QRS duration: Day 15	0.1 Milliseconds (ms)	Standard Deviation 8.91
TBA-7371 100 mg TID	Change From Baseline in Electrocardiogram (ECG) Parameters	QT interval: Day 15	9.3 Milliseconds (ms)	Standard Deviation 18.45
TBA-7371 100 mg TID	Change From Baseline in Electrocardiogram (ECG) Parameters	PR interval: Day 15	0.5 Milliseconds (ms)	Standard Deviation 8.1
TBA-7371 100 mg TID	Change From Baseline in Electrocardiogram (ECG) Parameters	QRS duration: Day 15	-0.1 Milliseconds (ms)	Standard Deviation 4.04
TBA-7371 100 mg TID	Change From Baseline in Electrocardiogram (ECG) Parameters	QTcF interval: Day 15	5.7 Milliseconds (ms)	Standard Deviation 7.15
TBA-7371 100 mg TID	Change From Baseline in Electrocardiogram (ECG) Parameters	RR interval: Day 15	27.1 Milliseconds (ms)	Standard Deviation 86.48
TBA-7371 400 mg QD	Change From Baseline in Electrocardiogram (ECG) Parameters	QTcF interval: Day 15	3.1 Milliseconds (ms)	Standard Deviation 9.59
TBA-7371 400 mg QD	Change From Baseline in Electrocardiogram (ECG) Parameters	PR interval: Day 15	4.1 Milliseconds (ms)	Standard Deviation 15.42
TBA-7371 400 mg QD	Change From Baseline in Electrocardiogram (ECG) Parameters	RR interval: Day 15	46.6 Milliseconds (ms)	Standard Deviation 100.19
TBA-7371 400 mg QD	Change From Baseline in Electrocardiogram (ECG) Parameters	QRS duration: Day 15	-2.9 Milliseconds (ms)	Standard Deviation 5.84
TBA-7371 400 mg QD	Change From Baseline in Electrocardiogram (ECG) Parameters	QT interval: Day 15	10.6 Milliseconds (ms)	Standard Deviation 18.9
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in Electrocardiogram (ECG) Parameters	PR interval: Day 15	2.9 Milliseconds (ms)	Standard Deviation 7.42
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in Electrocardiogram (ECG) Parameters	QTcF interval: Day 15	6.2 Milliseconds (ms)	Standard Deviation 13.24
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in Electrocardiogram (ECG) Parameters	QRS duration: Day 15	0.8 Milliseconds (ms)	Standard Deviation 6.56
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in Electrocardiogram (ECG) Parameters	RR interval: Day 15	52.4 Milliseconds (ms)	Standard Deviation 86.55
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in Electrocardiogram (ECG) Parameters	QT interval: Day 15	14.2 Milliseconds (ms)	Standard Deviation 20.01

Secondary

Change From Baseline in Heart Rate (HR)

HR was measured twice as follows: after 10 minutes supine (manual, supine) and after 2 (±0.5) minutes standing (manual, 2-minute standing). Baseline was measured on Day 1 before the first dose of study medication was administered. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

Time frame: Baseline and up to Day 15

Population: Safety Population. Only those participants with data available at the specified data points were analyzed

Arm	Measure	Group	Value (MEAN)	Dispersion
TBA-7371 100 mg QD	Change From Baseline in Heart Rate (HR)	Supine HR	0.6 Beats per minute	Standard Deviation 9.37
TBA-7371 100 mg QD	Change From Baseline in Heart Rate (HR)	Standing HR	12.9 Beats per minute	Standard Deviation 22.2
TBA-7371 100 mg BID	Change From Baseline in Heart Rate (HR)	Supine HR	0.0 Beats per minute	Standard Deviation 9.43
TBA-7371 100 mg BID	Change From Baseline in Heart Rate (HR)	Standing HR	2.3 Beats per minute	Standard Deviation 16.13
TBA-7371 200 mg QD	Change From Baseline in Heart Rate (HR)	Supine HR	-4.3 Beats per minute	Standard Deviation 11.3
TBA-7371 200 mg QD	Change From Baseline in Heart Rate (HR)	Standing HR	-5.5 Beats per minute	Standard Deviation 18.27
TBA-7371 100 mg TID	Change From Baseline in Heart Rate (HR)	Supine HR	-2.8 Beats per minute	Standard Deviation 11.26
TBA-7371 100 mg TID	Change From Baseline in Heart Rate (HR)	Standing HR	6.1 Beats per minute	Standard Deviation 15.53
TBA-7371 400 mg QD	Change From Baseline in Heart Rate (HR)	Supine HR	-2.3 Beats per minute	Standard Deviation 11.3
TBA-7371 400 mg QD	Change From Baseline in Heart Rate (HR)	Standing HR	-7.4 Beats per minute	Standard Deviation 12.34
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in Heart Rate (HR)	Supine HR	-1.8 Beats per minute	Standard Deviation 14.16
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in Heart Rate (HR)	Standing HR	-3.2 Beats per minute	Standard Deviation 10.73

Secondary

Change From Baseline in HR

Time frame: Baseline and at Day 28 and Day 42

Population: Safety Population. Only those participants with data available at the specified data points were analyzed

Arm	Measure	Group	Value (MEAN)	Dispersion
TBA-7371 100 mg QD	Change From Baseline in HR	Supine HR: Day 28	-2.5 Beats per minute	Standard Deviation 13.1
TBA-7371 100 mg QD	Change From Baseline in HR	Standing HR: Day 28	1.3 Beats per minute	Standard Deviation 23.25
TBA-7371 100 mg QD	Change From Baseline in HR	Supine HR: Day 42	-8.0 Beats per minute	Standard Deviation 12.12
TBA-7371 100 mg QD	Change From Baseline in HR	Standing HR: Day 42	-4.4 Beats per minute	Standard Deviation 22.6
TBA-7371 100 mg BID	Change From Baseline in HR	Supine HR: Day 42	3.9 Beats per minute	Standard Deviation 12.53
TBA-7371 100 mg BID	Change From Baseline in HR	Standing HR: Day 28	-9.3 Beats per minute	Standard Deviation 22.73
TBA-7371 100 mg BID	Change From Baseline in HR	Supine HR: Day 28	-3.6 Beats per minute	Standard Deviation 17.61
TBA-7371 100 mg BID	Change From Baseline in HR	Standing HR: Day 42	0.2 Beats per minute	Standard Deviation 16.94
TBA-7371 200 mg QD	Change From Baseline in HR	Standing HR: Day 42	-9.5 Beats per minute	Standard Deviation 21
TBA-7371 200 mg QD	Change From Baseline in HR	Supine HR: Day 42	-3.0 Beats per minute	Standard Deviation 12.67
TBA-7371 200 mg QD	Change From Baseline in HR	Standing HR: Day 28	-0.6 Beats per minute	Standard Deviation 15.22
TBA-7371 200 mg QD	Change From Baseline in HR	Supine HR: Day 28	0.3 Beats per minute	Standard Deviation 10.22
TBA-7371 100 mg TID	Change From Baseline in HR	Supine HR: Day 28	-0.6 Beats per minute	Standard Deviation 12.9
TBA-7371 100 mg TID	Change From Baseline in HR	Standing HR: Day 42	-7.1 Beats per minute	Standard Deviation 9.93
TBA-7371 100 mg TID	Change From Baseline in HR	Standing HR: Day 28	1.2 Beats per minute	Standard Deviation 15.4
TBA-7371 100 mg TID	Change From Baseline in HR	Supine HR: Day 42	-4.5 Beats per minute	Standard Deviation 13.57
TBA-7371 400 mg QD	Change From Baseline in HR	Supine HR: Day 42	-2.3 Beats per minute	Standard Deviation 17.06
TBA-7371 400 mg QD	Change From Baseline in HR	Standing HR: Day 42	-11.3 Beats per minute	Standard Deviation 20.36
TBA-7371 400 mg QD	Change From Baseline in HR	Standing HR: Day 28	-3.6 Beats per minute	Standard Deviation 17.81
TBA-7371 400 mg QD	Change From Baseline in HR	Supine HR: Day 28	0.8 Beats per minute	Standard Deviation 15.84
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in HR	Standing HR: Day 28	-12.0 Beats per minute	Standard Deviation 12.65
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in HR	Supine HR: Day 42	-9.3 Beats per minute	Standard Deviation 13.53
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in HR	Standing HR: Day 42	-17.1 Beats per minute	Standard Deviation 8.59
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in HR	Supine HR: Day 28	-4.7 Beats per minute	Standard Deviation 9.9

Secondary

Change From Baseline in HR

Time frame: Baseline (Day 1) and at Day 4, Day 7, Day 10 and Day 14

Population: Safety Population. Only those participants with data available at the specified data points were analyzed

Arm	Measure	Group	Value (MEAN)	Dispersion
TBA-7371 100 mg QD	Change From Baseline in HR	Supine HR: Day 7	1.1 Beats per minute	Standard Deviation 7.58
TBA-7371 100 mg QD	Change From Baseline in HR	Supine HR: Day 4	-0.8 Beats per minute	Standard Deviation 7.59
TBA-7371 100 mg QD	Change From Baseline in HR	Standing HR: Day 4	6.7 Beats per minute	Standard Deviation 16.59
TBA-7371 100 mg QD	Change From Baseline in HR	Standing HR: Day 7	8.7 Beats per minute	Standard Deviation 20.64
TBA-7371 100 mg QD	Change From Baseline in HR	Supine HR: Day 10	-2.1 Beats per minute	Standard Deviation 11.35
TBA-7371 100 mg QD	Change From Baseline in HR	Standing HR: Day 10	6.8 Beats per minute	Standard Deviation 28.37
TBA-7371 100 mg QD	Change From Baseline in HR	Supine HR: Day 14	-3.3 Beats per minute	Standard Deviation 10.49
TBA-7371 100 mg QD	Change From Baseline in HR	Standing HR: Day 14	3.1 Beats per minute	Standard Deviation 18.47
TBA-7371 100 mg BID	Change From Baseline in HR	Standing HR: Day 7	-3.9 Beats per minute	Standard Deviation 15.46
TBA-7371 100 mg BID	Change From Baseline in HR	Standing HR: Day 14	-0.4 Beats per minute	Standard Deviation 16.52
TBA-7371 100 mg BID	Change From Baseline in HR	Supine HR: Day 14	-0.9 Beats per minute	Standard Deviation 8.82
TBA-7371 100 mg BID	Change From Baseline in HR	Standing HR: Day 10	1.7 Beats per minute	Standard Deviation 10.39
TBA-7371 100 mg BID	Change From Baseline in HR	Supine HR: Day 4	4.2 Beats per minute	Standard Deviation 10.97
TBA-7371 100 mg BID	Change From Baseline in HR	Supine HR: Day 7	-1.0 Beats per minute	Standard Deviation 8.36
TBA-7371 100 mg BID	Change From Baseline in HR	Standing HR: Day 4	5.3 Beats per minute	Standard Deviation 13.4
TBA-7371 100 mg BID	Change From Baseline in HR	Supine HR: Day 10	1.3 Beats per minute	Standard Deviation 4.3
TBA-7371 200 mg QD	Change From Baseline in HR	Standing HR: Day 4	-1.8 Beats per minute	Standard Deviation 20.27
TBA-7371 200 mg QD	Change From Baseline in HR	Supine HR: Day 7	-5.8 Beats per minute	Standard Deviation 9.89
TBA-7371 200 mg QD	Change From Baseline in HR	Standing HR: Day 7	-0.4 Beats per minute	Standard Deviation 17.41
TBA-7371 200 mg QD	Change From Baseline in HR	Standing HR: Day 14	-3.2 Beats per minute	Standard Deviation 16.92
TBA-7371 200 mg QD	Change From Baseline in HR	Supine HR: Day 10	-6.0 Beats per minute	Standard Deviation 10.75
TBA-7371 200 mg QD	Change From Baseline in HR	Standing HR: Day 10	-6.0 Beats per minute	Standard Deviation 16.43
TBA-7371 200 mg QD	Change From Baseline in HR	Supine HR: Day 14	-6.4 Beats per minute	Standard Deviation 12.04
TBA-7371 200 mg QD	Change From Baseline in HR	Supine HR: Day 4	-0.3 Beats per minute	Standard Deviation 9.36
TBA-7371 100 mg TID	Change From Baseline in HR	Supine HR: Day 14	0.3 Beats per minute	Standard Deviation 10.26
TBA-7371 100 mg TID	Change From Baseline in HR	Standing HR: Day 10	-2.8 Beats per minute	Standard Deviation 14.57
TBA-7371 100 mg TID	Change From Baseline in HR	Supine HR: Day 10	-3.3 Beats per minute	Standard Deviation 8.19
TBA-7371 100 mg TID	Change From Baseline in HR	Supine HR: Day 4	0.6 Beats per minute	Standard Deviation 9.41
TBA-7371 100 mg TID	Change From Baseline in HR	Supine HR: Day 7	-3.9 Beats per minute	Standard Deviation 12.35
TBA-7371 100 mg TID	Change From Baseline in HR	Standing HR: Day 7	1.4 Beats per minute	Standard Deviation 14.36
TBA-7371 100 mg TID	Change From Baseline in HR	Standing HR: Day 14	2.1 Beats per minute	Standard Deviation 13.58
TBA-7371 100 mg TID	Change From Baseline in HR	Standing HR: Day 4	3.1 Beats per minute	Standard Deviation 10.28
TBA-7371 400 mg QD	Change From Baseline in HR	Standing HR: Day 14	-9.2 Beats per minute	Standard Deviation 12.8
TBA-7371 400 mg QD	Change From Baseline in HR	Supine HR: Day 4	-0.8 Beats per minute	Standard Deviation 10.09
TBA-7371 400 mg QD	Change From Baseline in HR	Supine HR: Day 10	-3.2 Beats per minute	Standard Deviation 10.39
TBA-7371 400 mg QD	Change From Baseline in HR	Standing HR: Day 10	-2.5 Beats per minute	Standard Deviation 13.69
TBA-7371 400 mg QD	Change From Baseline in HR	Standing HR: Day 4	2.7 Beats per minute	Standard Deviation 14.06
TBA-7371 400 mg QD	Change From Baseline in HR	Supine HR: Day 14	-6.7 Beats per minute	Standard Deviation 9.62
TBA-7371 400 mg QD	Change From Baseline in HR	Supine HR: Day 7	-3.5 Beats per minute	Standard Deviation 8.53
TBA-7371 400 mg QD	Change From Baseline in HR	Standing HR: Day 7	-4.6 Beats per minute	Standard Deviation 12.18
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in HR	Supine HR: Day 10	-8.5 Beats per minute	Standard Deviation 11.69
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in HR	Supine HR: Day 14	-7.1 Beats per minute	Standard Deviation 14.09
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in HR	Supine HR: Day 7	-9.8 Beats per minute	Standard Deviation 11.36
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in HR	Standing HR: Day 7	-10.1 Beats per minute	Standard Deviation 11.47
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in HR	Standing HR: Day 10	-11.4 Beats per minute	Standard Deviation 14.88
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in HR	Standing HR: Day 4	-1.5 Beats per minute	Standard Deviation 7.82
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in HR	Standing HR: Day 14	-10.2 Beats per minute	Standard Deviation 15.15
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in HR	Supine HR: Day 4	-3.7 Beats per minute	Standard Deviation 9.93

Secondary

Change From Baseline in HR as Measured by Electrocardiogram (ECG)

12-lead ECG was recorded after at least 10 minutes of supine rest to measure HR. Baseline was measured on Day 1 before the first dose of study medication was administered. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

Time frame: Baseline and at Day 15

Population: Safety Population. Only those participants with data available at the specified data points were analyzed

Arm	Measure	Value (MEAN)	Dispersion
TBA-7371 100 mg QD	Change From Baseline in HR as Measured by Electrocardiogram (ECG)	2.5 Beats per minute	Standard Deviation 11.17
TBA-7371 100 mg BID	Change From Baseline in HR as Measured by Electrocardiogram (ECG)	-1.1 Beats per minute	Standard Deviation 8.91
TBA-7371 200 mg QD	Change From Baseline in HR as Measured by Electrocardiogram (ECG)	-5.8 Beats per minute	Standard Deviation 9.28
TBA-7371 100 mg TID	Change From Baseline in HR as Measured by Electrocardiogram (ECG)	-2.0 Beats per minute	Standard Deviation 10.2
TBA-7371 400 mg QD	Change From Baseline in HR as Measured by Electrocardiogram (ECG)	-5.8 Beats per minute	Standard Deviation 11.37
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in HR as Measured by Electrocardiogram (ECG)	-6.0 Beats per minute	Standard Deviation 10.14

Secondary

Change From Baseline in SBP and DBP

SBP and DBP were measured twice as follows: after 10 minutes supine (manual, supine) and after 2 (±0.5) minutes standing (manual, 2-minute standing). Baseline was measured on Day 1 before the first dose of study medication was administered. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

Time frame: Baseline (Day 1) and at Day 4, Day 7, Day 10 and Day 14

Population: Safety Population. Only those participants with data available at the specified data points were analyzed

Arm	Measure	Group	Value (MEAN)	Dispersion
TBA-7371 100 mg QD	Change From Baseline in SBP and DBP	Standing SBP: Day 7	2.6 Millimeters of mercury (mmHg)	Standard Deviation 8.63
TBA-7371 100 mg QD	Change From Baseline in SBP and DBP	Standing DBP: Day 14	2.9 Millimeters of mercury (mmHg)	Standard Deviation 10.08
TBA-7371 100 mg QD	Change From Baseline in SBP and DBP	Supine SBP: Day 4	-1.3 Millimeters of mercury (mmHg)	Standard Deviation 9.5
TBA-7371 100 mg QD	Change From Baseline in SBP and DBP	Standing SBP: Day 4	-0.7 Millimeters of mercury (mmHg)	Standard Deviation 10.21
TBA-7371 100 mg QD	Change From Baseline in SBP and DBP	Supine SBP: Day 7	-1.7 Millimeters of mercury (mmHg)	Standard Deviation 10.7
TBA-7371 100 mg QD	Change From Baseline in SBP and DBP	Standing DBP: Day 7	5.1 Millimeters of mercury (mmHg)	Standard Deviation 7.25
TBA-7371 100 mg QD	Change From Baseline in SBP and DBP	Supine SBP: Day 10	-4.7 Millimeters of mercury (mmHg)	Standard Deviation 8.17
TBA-7371 100 mg QD	Change From Baseline in SBP and DBP	Standing SBP: Day 10	-2.3 Millimeters of mercury (mmHg)	Standard Deviation 11.73
TBA-7371 100 mg QD	Change From Baseline in SBP and DBP	Supine SBP: Day 14	-0.5 Millimeters of mercury (mmHg)	Standard Deviation 5.83
TBA-7371 100 mg QD	Change From Baseline in SBP and DBP	Standing SBP: Day 14	1.5 Millimeters of mercury (mmHg)	Standard Deviation 11.84
TBA-7371 100 mg QD	Change From Baseline in SBP and DBP	Supine DBP: Day 4	1.3 Millimeters of mercury (mmHg)	Standard Deviation 7.03
TBA-7371 100 mg QD	Change From Baseline in SBP and DBP	Standing DBP: Day 4	1.7 Millimeters of mercury (mmHg)	Standard Deviation 9.23
TBA-7371 100 mg QD	Change From Baseline in SBP and DBP	Supine DBP: Day 7	0.6 Millimeters of mercury (mmHg)	Standard Deviation 8.11
TBA-7371 100 mg QD	Change From Baseline in SBP and DBP	Supine DBP: Day 10	-1.5 Millimeters of mercury (mmHg)	Standard Deviation 5.97
TBA-7371 100 mg QD	Change From Baseline in SBP and DBP	Standing DBP: Day 10	2.8 Millimeters of mercury (mmHg)	Standard Deviation 9.56
TBA-7371 100 mg QD	Change From Baseline in SBP and DBP	Supine DBP: Day 14	0.8 Millimeters of mercury (mmHg)	Standard Deviation 6.17
TBA-7371 100 mg BID	Change From Baseline in SBP and DBP	Supine DBP: Day 14	0.1 Millimeters of mercury (mmHg)	Standard Deviation 7.07
TBA-7371 100 mg BID	Change From Baseline in SBP and DBP	Standing SBP: Day 14	5.2 Millimeters of mercury (mmHg)	Standard Deviation 9.84
TBA-7371 100 mg BID	Change From Baseline in SBP and DBP	Standing DBP: Day 14	2.9 Millimeters of mercury (mmHg)	Standard Deviation 6.66
TBA-7371 100 mg BID	Change From Baseline in SBP and DBP	Supine DBP: Day 4	-1.1 Millimeters of mercury (mmHg)	Standard Deviation 6.74
TBA-7371 100 mg BID	Change From Baseline in SBP and DBP	Standing SBP: Day 4	0.7 Millimeters of mercury (mmHg)	Standard Deviation 9.04
TBA-7371 100 mg BID	Change From Baseline in SBP and DBP	Supine SBP: Day 7	-3.1 Millimeters of mercury (mmHg)	Standard Deviation 10.78
TBA-7371 100 mg BID	Change From Baseline in SBP and DBP	Supine SBP: Day 10	-3.1 Millimeters of mercury (mmHg)	Standard Deviation 10.65
TBA-7371 100 mg BID	Change From Baseline in SBP and DBP	Standing SBP: Day 7	2.0 Millimeters of mercury (mmHg)	Standard Deviation 10.15
TBA-7371 100 mg BID	Change From Baseline in SBP and DBP	Standing DBP: Day 4	-1.5 Millimeters of mercury (mmHg)	Standard Deviation 4.82
TBA-7371 100 mg BID	Change From Baseline in SBP and DBP	Standing DBP: Day 10	-0.8 Millimeters of mercury (mmHg)	Standard Deviation 5.73
TBA-7371 100 mg BID	Change From Baseline in SBP and DBP	Supine DBP: Day 7	-2.0 Millimeters of mercury (mmHg)	Standard Deviation 8.68
TBA-7371 100 mg BID	Change From Baseline in SBP and DBP	Standing SBP: Day 10	3.2 Millimeters of mercury (mmHg)	Standard Deviation 8.07
TBA-7371 100 mg BID	Change From Baseline in SBP and DBP	Supine DBP: Day 10	-2.6 Millimeters of mercury (mmHg)	Standard Deviation 5.54
TBA-7371 100 mg BID	Change From Baseline in SBP and DBP	Standing DBP: Day 7	-0.1 Millimeters of mercury (mmHg)	Standard Deviation 11.48
TBA-7371 100 mg BID	Change From Baseline in SBP and DBP	Supine SBP: Day 14	-1.0 Millimeters of mercury (mmHg)	Standard Deviation 8.15
TBA-7371 100 mg BID	Change From Baseline in SBP and DBP	Supine SBP: Day 4	0.5 Millimeters of mercury (mmHg)	Standard Deviation 9.31
TBA-7371 200 mg QD	Change From Baseline in SBP and DBP	Supine SBP: Day 10	0.9 Millimeters of mercury (mmHg)	Standard Deviation 9.44
TBA-7371 200 mg QD	Change From Baseline in SBP and DBP	Supine DBP: Day 10	-1.7 Millimeters of mercury (mmHg)	Standard Deviation 9.68
TBA-7371 200 mg QD	Change From Baseline in SBP and DBP	Standing SBP: Day 14	-0.6 Millimeters of mercury (mmHg)	Standard Deviation 13
TBA-7371 200 mg QD	Change From Baseline in SBP and DBP	Supine SBP: Day 7	0.7 Millimeters of mercury (mmHg)	Standard Deviation 9.19
TBA-7371 200 mg QD	Change From Baseline in SBP and DBP	Standing SBP: Day 4	-0.4 Millimeters of mercury (mmHg)	Standard Deviation 8.09
TBA-7371 200 mg QD	Change From Baseline in SBP and DBP	Standing DBP: Day 14	0.9 Millimeters of mercury (mmHg)	Standard Deviation 11.7
TBA-7371 200 mg QD	Change From Baseline in SBP and DBP	Supine DBP: Day 14	-3.1 Millimeters of mercury (mmHg)	Standard Deviation 10.64
TBA-7371 200 mg QD	Change From Baseline in SBP and DBP	Supine SBP: Day 4	2.3 Millimeters of mercury (mmHg)	Standard Deviation 11.13
TBA-7371 200 mg QD	Change From Baseline in SBP and DBP	Supine DBP: Day 4	-3.0 Millimeters of mercury (mmHg)	Standard Deviation 12.18
TBA-7371 200 mg QD	Change From Baseline in SBP and DBP	Standing DBP: Day 7	-1.7 Millimeters of mercury (mmHg)	Standard Deviation 10.97
TBA-7371 200 mg QD	Change From Baseline in SBP and DBP	Standing DBP: Day 10	1.9 Millimeters of mercury (mmHg)	Standard Deviation 7.69
TBA-7371 200 mg QD	Change From Baseline in SBP and DBP	Standing SBP: Day 10	0.3 Millimeters of mercury (mmHg)	Standard Deviation 11.12
TBA-7371 200 mg QD	Change From Baseline in SBP and DBP	Supine SBP: Day 14	0.6 Millimeters of mercury (mmHg)	Standard Deviation 11.44
TBA-7371 200 mg QD	Change From Baseline in SBP and DBP	Supine DBP: Day 7	-0.5 Millimeters of mercury (mmHg)	Standard Deviation 9.01
TBA-7371 200 mg QD	Change From Baseline in SBP and DBP	Standing DBP: Day 4	-3.2 Millimeters of mercury (mmHg)	Standard Deviation 11.55
TBA-7371 200 mg QD	Change From Baseline in SBP and DBP	Standing SBP: Day 7	-3.7 Millimeters of mercury (mmHg)	Standard Deviation 11.2
TBA-7371 100 mg TID	Change From Baseline in SBP and DBP	Standing DBP: Day 4	-1.8 Millimeters of mercury (mmHg)	Standard Deviation 7.87
TBA-7371 100 mg TID	Change From Baseline in SBP and DBP	Supine DBP: Day 10	-3.0 Millimeters of mercury (mmHg)	Standard Deviation 7.39
TBA-7371 100 mg TID	Change From Baseline in SBP and DBP	Supine DBP: Day 7	1.2 Millimeters of mercury (mmHg)	Standard Deviation 10.1
TBA-7371 100 mg TID	Change From Baseline in SBP and DBP	Standing SBP: Day 7	-5.8 Millimeters of mercury (mmHg)	Standard Deviation 5.89
TBA-7371 100 mg TID	Change From Baseline in SBP and DBP	Standing DBP: Day 7	-1.5 Millimeters of mercury (mmHg)	Standard Deviation 7.15
TBA-7371 100 mg TID	Change From Baseline in SBP and DBP	Supine SBP: Day 10	-2.9 Millimeters of mercury (mmHg)	Standard Deviation 5.66
TBA-7371 100 mg TID	Change From Baseline in SBP and DBP	Supine SBP: Day 4	-4.2 Millimeters of mercury (mmHg)	Standard Deviation 7.06
TBA-7371 100 mg TID	Change From Baseline in SBP and DBP	Standing SBP: Day 10	-2.3 Millimeters of mercury (mmHg)	Standard Deviation 6.94
TBA-7371 100 mg TID	Change From Baseline in SBP and DBP	Supine SBP: Day 7	-2.2 Millimeters of mercury (mmHg)	Standard Deviation 12.08
TBA-7371 100 mg TID	Change From Baseline in SBP and DBP	Standing DBP: Day 14	-1.5 Millimeters of mercury (mmHg)	Standard Deviation 10.11
TBA-7371 100 mg TID	Change From Baseline in SBP and DBP	Supine SBP: Day 14	-5.3 Millimeters of mercury (mmHg)	Standard Deviation 10.29
TBA-7371 100 mg TID	Change From Baseline in SBP and DBP	Standing SBP: Day 4	-4.4 Millimeters of mercury (mmHg)	Standard Deviation 7.71
TBA-7371 100 mg TID	Change From Baseline in SBP and DBP	Standing SBP: Day 14	-5.1 Millimeters of mercury (mmHg)	Standard Deviation 8.63
TBA-7371 100 mg TID	Change From Baseline in SBP and DBP	Supine DBP: Day 4	-1.7 Millimeters of mercury (mmHg)	Standard Deviation 9.53
TBA-7371 100 mg TID	Change From Baseline in SBP and DBP	Standing DBP: Day 10	-1.7 Millimeters of mercury (mmHg)	Standard Deviation 8.76
TBA-7371 100 mg TID	Change From Baseline in SBP and DBP	Supine DBP: Day 14	-2.6 Millimeters of mercury (mmHg)	Standard Deviation 7.23
TBA-7371 400 mg QD	Change From Baseline in SBP and DBP	Standing DBP: Day 7	1.6 Millimeters of mercury (mmHg)	Standard Deviation 10.36
TBA-7371 400 mg QD	Change From Baseline in SBP and DBP	Supine SBP: Day 7	0.4 Millimeters of mercury (mmHg)	Standard Deviation 11.42
TBA-7371 400 mg QD	Change From Baseline in SBP and DBP	Standing SBP: Day 7	-0.3 Millimeters of mercury (mmHg)	Standard Deviation 10.54
TBA-7371 400 mg QD	Change From Baseline in SBP and DBP	Standing DBP: Day 10	-0.4 Millimeters of mercury (mmHg)	Standard Deviation 10.45
TBA-7371 400 mg QD	Change From Baseline in SBP and DBP	Supine SBP: Day 10	-4.5 Millimeters of mercury (mmHg)	Standard Deviation 10.46
TBA-7371 400 mg QD	Change From Baseline in SBP and DBP	Standing SBP: Day 10	-1.0 Millimeters of mercury (mmHg)	Standard Deviation 12.82
TBA-7371 400 mg QD	Change From Baseline in SBP and DBP	Supine SBP: Day 14	-1.2 Millimeters of mercury (mmHg)	Standard Deviation 8.65
TBA-7371 400 mg QD	Change From Baseline in SBP and DBP	Standing SBP: Day 14	1.7 Millimeters of mercury (mmHg)	Standard Deviation 9.95
TBA-7371 400 mg QD	Change From Baseline in SBP and DBP	Supine DBP: Day 4	-1.5 Millimeters of mercury (mmHg)	Standard Deviation 7.35
TBA-7371 400 mg QD	Change From Baseline in SBP and DBP	Supine DBP: Day 14	-0.7 Millimeters of mercury (mmHg)	Standard Deviation 5.68
TBA-7371 400 mg QD	Change From Baseline in SBP and DBP	Standing DBP: Day 4	0.4 Millimeters of mercury (mmHg)	Standard Deviation 10.53
TBA-7371 400 mg QD	Change From Baseline in SBP and DBP	Supine DBP: Day 7	-0.5 Millimeters of mercury (mmHg)	Standard Deviation 6.76
TBA-7371 400 mg QD	Change From Baseline in SBP and DBP	Standing SBP: Day 4	1.7 Millimeters of mercury (mmHg)	Standard Deviation 12.3
TBA-7371 400 mg QD	Change From Baseline in SBP and DBP	Supine DBP: Day 10	-2.1 Millimeters of mercury (mmHg)	Standard Deviation 6.1
TBA-7371 400 mg QD	Change From Baseline in SBP and DBP	Standing DBP: Day 14	2.0 Millimeters of mercury (mmHg)	Standard Deviation 10.62
TBA-7371 400 mg QD	Change From Baseline in SBP and DBP	Supine SBP: Day 4	-2.9 Millimeters of mercury (mmHg)	Standard Deviation 13.89
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in SBP and DBP	Standing DBP: Day 4	6.1 Millimeters of mercury (mmHg)	Standard Deviation 10.34
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in SBP and DBP	Standing SBP: Day 7	5.8 Millimeters of mercury (mmHg)	Standard Deviation 19.79
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in SBP and DBP	Supine DBP: Day 4	-0.4 Millimeters of mercury (mmHg)	Standard Deviation 5.54
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in SBP and DBP	Supine DBP: Day 10	-0.6 Millimeters of mercury (mmHg)	Standard Deviation 6.58
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in SBP and DBP	Supine SBP: Day 7	0.1 Millimeters of mercury (mmHg)	Standard Deviation 4.94
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in SBP and DBP	Standing DBP: Day 14	11.8 Millimeters of mercury (mmHg)	Standard Deviation 14.13
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in SBP and DBP	Standing SBP: Day 14	11.8 Millimeters of mercury (mmHg)	Standard Deviation 14.82
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in SBP and DBP	Supine SBP: Day 14	1.2 Millimeters of mercury (mmHg)	Standard Deviation 8.9
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in SBP and DBP	Standing SBP: Day 10	8.5 Millimeters of mercury (mmHg)	Standard Deviation 15.24
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in SBP and DBP	Standing DBP: Day 10	9.4 Millimeters of mercury (mmHg)	Standard Deviation 13.31
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in SBP and DBP	Standing SBP: Day 4	4.3 Millimeters of mercury (mmHg)	Standard Deviation 10.59
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in SBP and DBP	Supine SBP: Day 4	-1.3 Millimeters of mercury (mmHg)	Standard Deviation 6.53
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in SBP and DBP	Supine SBP: Day 10	-0.5 Millimeters of mercury (mmHg)	Standard Deviation 8.92
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in SBP and DBP	Standing DBP: Day 7	6.5 Millimeters of mercury (mmHg)	Standard Deviation 16.58
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in SBP and DBP	Supine DBP: Day 7	1.4 Millimeters of mercury (mmHg)	Standard Deviation 7.63
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in SBP and DBP	Supine DBP: Day 14	2.5 Millimeters of mercury (mmHg)	Standard Deviation 7.68

Secondary

Change From Baseline in SBP and DBP

Time frame: Baseline and at Day 28 and Day 42

Population: Safety Population. Only those participants with data available at the specified data points were analyzed

Arm	Measure	Group	Value (MEAN)	Dispersion
TBA-7371 100 mg QD	Change From Baseline in SBP and DBP	Supine DBP: Day 28	2.7 Millimeters of mercury (mmHg)	Standard Deviation 9.66
TBA-7371 100 mg QD	Change From Baseline in SBP and DBP	Standing SBP: Day 42	3.2 Millimeters of mercury (mmHg)	Standard Deviation 11.61
TBA-7371 100 mg QD	Change From Baseline in SBP and DBP	Supine SBP: Day 42	0.4 Millimeters of mercury (mmHg)	Standard Deviation 10.51
TBA-7371 100 mg QD	Change From Baseline in SBP and DBP	Standing DBP: Day 28	8.5 Millimeters of mercury (mmHg)	Standard Deviation 10.11
TBA-7371 100 mg QD	Change From Baseline in SBP and DBP	Supine DBP: Day 42	1.4 Millimeters of mercury (mmHg)	Standard Deviation 8.02
TBA-7371 100 mg QD	Change From Baseline in SBP and DBP	Standing DBP: Day 42	8.1 Millimeters of mercury (mmHg)	Standard Deviation 10.8
TBA-7371 100 mg QD	Change From Baseline in SBP and DBP	Supine SBP: Day 28	0.8 Millimeters of mercury (mmHg)	Standard Deviation 12.52
TBA-7371 100 mg QD	Change From Baseline in SBP and DBP	Standing SBP: Day 28	3.0 Millimeters of mercury (mmHg)	Standard Deviation 11
TBA-7371 100 mg BID	Change From Baseline in SBP and DBP	Standing SBP: Day 28	15.5 Millimeters of mercury (mmHg)	Standard Deviation 21.2
TBA-7371 100 mg BID	Change From Baseline in SBP and DBP	Standing DBP: Day 28	8.8 Millimeters of mercury (mmHg)	Standard Deviation 11.15
TBA-7371 100 mg BID	Change From Baseline in SBP and DBP	Supine SBP: Day 42	10.0 Millimeters of mercury (mmHg)	Standard Deviation 10.91
TBA-7371 100 mg BID	Change From Baseline in SBP and DBP	Supine SBP: Day 28	9.2 Millimeters of mercury (mmHg)	Standard Deviation 11.35
TBA-7371 100 mg BID	Change From Baseline in SBP and DBP	Standing DBP: Day 42	4.4 Millimeters of mercury (mmHg)	Standard Deviation 7.54
TBA-7371 100 mg BID	Change From Baseline in SBP and DBP	Supine DBP: Day 28	5.2 Millimeters of mercury (mmHg)	Standard Deviation 8.41
TBA-7371 100 mg BID	Change From Baseline in SBP and DBP	Standing SBP: Day 42	9.7 Millimeters of mercury (mmHg)	Standard Deviation 13.17
TBA-7371 100 mg BID	Change From Baseline in SBP and DBP	Supine DBP: Day 42	6.1 Millimeters of mercury (mmHg)	Standard Deviation 6.83
TBA-7371 200 mg QD	Change From Baseline in SBP and DBP	Standing SBP: Day 42	1.1 Millimeters of mercury (mmHg)	Standard Deviation 11.05
TBA-7371 200 mg QD	Change From Baseline in SBP and DBP	Supine DBP: Day 28	5.6 Millimeters of mercury (mmHg)	Standard Deviation 9.61
TBA-7371 200 mg QD	Change From Baseline in SBP and DBP	Standing DBP: Day 28	2.7 Millimeters of mercury (mmHg)	Standard Deviation 10.89
TBA-7371 200 mg QD	Change From Baseline in SBP and DBP	Standing SBP: Day 28	3.7 Millimeters of mercury (mmHg)	Standard Deviation 13.27
TBA-7371 200 mg QD	Change From Baseline in SBP and DBP	Supine DBP: Day 42	-1.3 Millimeters of mercury (mmHg)	Standard Deviation 11.04
TBA-7371 200 mg QD	Change From Baseline in SBP and DBP	Standing DBP: Day 42	-3.5 Millimeters of mercury (mmHg)	Standard Deviation 8.94
TBA-7371 200 mg QD	Change From Baseline in SBP and DBP	Supine SBP: Day 28	7.9 Millimeters of mercury (mmHg)	Standard Deviation 9.63
TBA-7371 200 mg QD	Change From Baseline in SBP and DBP	Supine SBP: Day 42	2.3 Millimeters of mercury (mmHg)	Standard Deviation 13.22
TBA-7371 100 mg TID	Change From Baseline in SBP and DBP	Supine SBP: Day 28	9.2 Millimeters of mercury (mmHg)	Standard Deviation 14.22
TBA-7371 100 mg TID	Change From Baseline in SBP and DBP	Standing DBP: Day 42	7.4 Millimeters of mercury (mmHg)	Standard Deviation 9.63
TBA-7371 100 mg TID	Change From Baseline in SBP and DBP	Supine DBP: Day 42	3.6 Millimeters of mercury (mmHg)	Standard Deviation 10.78
TBA-7371 100 mg TID	Change From Baseline in SBP and DBP	Supine SBP: Day 42	4.6 Millimeters of mercury (mmHg)	Standard Deviation 11.71
TBA-7371 100 mg TID	Change From Baseline in SBP and DBP	Supine DBP: Day 28	6.9 Millimeters of mercury (mmHg)	Standard Deviation 8.94
TBA-7371 100 mg TID	Change From Baseline in SBP and DBP	Standing DBP: Day 28	9.2 Millimeters of mercury (mmHg)	Standard Deviation 12.73
TBA-7371 100 mg TID	Change From Baseline in SBP and DBP	Standing SBP: Day 28	10.2 Millimeters of mercury (mmHg)	Standard Deviation 12.76
TBA-7371 100 mg TID	Change From Baseline in SBP and DBP	Standing SBP: Day 42	9.1 Millimeters of mercury (mmHg)	Standard Deviation 11.28
TBA-7371 400 mg QD	Change From Baseline in SBP and DBP	Standing SBP: Day 28	2.7 Millimeters of mercury (mmHg)	Standard Deviation 12.98
TBA-7371 400 mg QD	Change From Baseline in SBP and DBP	Supine SBP: Day 42	1.9 Millimeters of mercury (mmHg)	Standard Deviation 11.16
TBA-7371 400 mg QD	Change From Baseline in SBP and DBP	Supine DBP: Day 42	3.3 Millimeters of mercury (mmHg)	Standard Deviation 7.66
TBA-7371 400 mg QD	Change From Baseline in SBP and DBP	Standing DBP: Day 42	6.7 Millimeters of mercury (mmHg)	Standard Deviation 10.51
TBA-7371 400 mg QD	Change From Baseline in SBP and DBP	Supine SBP: Day 28	-0.1 Millimeters of mercury (mmHg)	Standard Deviation 11.95
TBA-7371 400 mg QD	Change From Baseline in SBP and DBP	Standing SBP: Day 42	5.3 Millimeters of mercury (mmHg)	Standard Deviation 14.14
TBA-7371 400 mg QD	Change From Baseline in SBP and DBP	Supine DBP: Day 28	2.5 Millimeters of mercury (mmHg)	Standard Deviation 6.91
TBA-7371 400 mg QD	Change From Baseline in SBP and DBP	Standing DBP: Day 28	6.1 Millimeters of mercury (mmHg)	Standard Deviation 8.93
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in SBP and DBP	Standing SBP: Day 28	15.7 Millimeters of mercury (mmHg)	Standard Deviation 17.6
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in SBP and DBP	Supine DBP: Day 42	2.4 Millimeters of mercury (mmHg)	Standard Deviation 8.05
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in SBP and DBP	Supine DBP: Day 28	6.3 Millimeters of mercury (mmHg)	Standard Deviation 10.27
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in SBP and DBP	Standing DBP: Day 28	11.8 Millimeters of mercury (mmHg)	Standard Deviation 15.13
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in SBP and DBP	Standing DBP: Day 42	10.1 Millimeters of mercury (mmHg)	Standard Deviation 12.16
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in SBP and DBP	Standing SBP: Day 42	11.9 Millimeters of mercury (mmHg)	Standard Deviation 17.51
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in SBP and DBP	Supine SBP: Day 28	6.9 Millimeters of mercury (mmHg)	Standard Deviation 12.61
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in SBP and DBP	Supine SBP: Day 42	6.0 Millimeters of mercury (mmHg)	Standard Deviation 10.24

Secondary

Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Time frame: Baseline and up to Day 15

Population: Safety Population. Only those participants with data available at the specified data points were analyzed

Arm	Measure	Group	Value (MEAN)	Dispersion
TBA-7371 100 mg QD	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Supine SBP	-3.0 Millimeters of mercury (mmHg)	Standard Deviation 16.13
TBA-7371 100 mg QD	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Standing SBP	2.0 Millimeters of mercury (mmHg)	Standard Deviation 13.41
TBA-7371 100 mg QD	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Supine DBP	0.3 Millimeters of mercury (mmHg)	Standard Deviation 10.69
TBA-7371 100 mg QD	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Standing DBP	4.9 Millimeters of mercury (mmHg)	Standard Deviation 8.9
TBA-7371 100 mg BID	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Supine DBP	0.1 Millimeters of mercury (mmHg)	Standard Deviation 7.18
TBA-7371 100 mg BID	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Standing SBP	2.7 Millimeters of mercury (mmHg)	Standard Deviation 13.85
TBA-7371 100 mg BID	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Supine SBP	0.4 Millimeters of mercury (mmHg)	Standard Deviation 8.79
TBA-7371 100 mg BID	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Standing DBP	2.1 Millimeters of mercury (mmHg)	Standard Deviation 9.4
TBA-7371 200 mg QD	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Standing DBP	4.5 Millimeters of mercury (mmHg)	Standard Deviation 10.99
TBA-7371 200 mg QD	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Supine DBP	1.0 Millimeters of mercury (mmHg)	Standard Deviation 10.65
TBA-7371 200 mg QD	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Standing SBP	0.6 Millimeters of mercury (mmHg)	Standard Deviation 10.54
TBA-7371 200 mg QD	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Supine SBP	2.1 Millimeters of mercury (mmHg)	Standard Deviation 9.74
TBA-7371 100 mg TID	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Supine SBP	-4.1 Millimeters of mercury (mmHg)	Standard Deviation 9.9
TBA-7371 100 mg TID	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Standing DBP	-0.1 Millimeters of mercury (mmHg)	Standard Deviation 7.85
TBA-7371 100 mg TID	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Standing SBP	-2.9 Millimeters of mercury (mmHg)	Standard Deviation 8.08
TBA-7371 100 mg TID	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Supine DBP	-1.8 Millimeters of mercury (mmHg)	Standard Deviation 10.89
TBA-7371 400 mg QD	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Supine DBP	-3.7 Millimeters of mercury (mmHg)	Standard Deviation 6.17
TBA-7371 400 mg QD	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Standing DBP	1.8 Millimeters of mercury (mmHg)	Standard Deviation 8.89
TBA-7371 400 mg QD	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Standing SBP	1.7 Millimeters of mercury (mmHg)	Standard Deviation 8.15
TBA-7371 400 mg QD	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Supine SBP	-4.1 Millimeters of mercury (mmHg)	Standard Deviation 9.52
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Standing SBP	15.7 Millimeters of mercury (mmHg)	Standard Deviation 16.77
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Supine DBP	2.5 Millimeters of mercury (mmHg)	Standard Deviation 12.59
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Standing DBP	10.4 Millimeters of mercury (mmHg)	Standard Deviation 16.19
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Supine SBP	2.5 Millimeters of mercury (mmHg)	Standard Deviation 11.14

Secondary

Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)

Urine samples were collected to measure urine pH. Baseline was defined as the last assessment at screening. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

Time frame: Baseline and at Day 3, Day 7 and Day 42

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
TBA-7371 100 mg QD	Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Day 42	0.3 Potential of Hydrogen (pH)	Standard Deviation 0.7
TBA-7371 100 mg QD	Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Day 3	0.5 Potential of Hydrogen (pH)	Standard Deviation 1.13
TBA-7371 100 mg QD	Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Day 7	0.6 Potential of Hydrogen (pH)	Standard Deviation 1.06
TBA-7371 100 mg BID	Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Day 7	0.3 Potential of Hydrogen (pH)	Standard Deviation 1.38
TBA-7371 100 mg BID	Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Day 42	-0.3 Potential of Hydrogen (pH)	Standard Deviation 1.45
TBA-7371 100 mg BID	Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Day 3	0.3 Potential of Hydrogen (pH)	Standard Deviation 1.18
TBA-7371 200 mg QD	Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Day 3	0.7 Potential of Hydrogen (pH)	Standard Deviation 1.22
TBA-7371 200 mg QD	Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Day 42	0.4 Potential of Hydrogen (pH)	Standard Deviation 0.74
TBA-7371 200 mg QD	Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Day 7	0.9 Potential of Hydrogen (pH)	Standard Deviation 1.06
TBA-7371 100 mg TID	Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Day 7	-0.1 Potential of Hydrogen (pH)	Standard Deviation 1.48
TBA-7371 100 mg TID	Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Day 3	0.0 Potential of Hydrogen (pH)	Standard Deviation 1.37
TBA-7371 100 mg TID	Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Day 42	-0.9 Potential of Hydrogen (pH)	Standard Deviation 1.22
TBA-7371 400 mg QD	Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Day 3	0.2 Potential of Hydrogen (pH)	Standard Deviation 1.66
TBA-7371 400 mg QD	Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Day 42	-0.4 Potential of Hydrogen (pH)	Standard Deviation 1.35
TBA-7371 400 mg QD	Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Day 7	0.4 Potential of Hydrogen (pH)	Standard Deviation 1.35
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Day 7	0.6 Potential of Hydrogen (pH)	Standard Deviation 0.85
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Day 42	0.1 Potential of Hydrogen (pH)	Standard Deviation 0.95
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)	Day 3	0.3 Potential of Hydrogen (pH)	Standard Deviation 0.98

Secondary

Change From Baseline in Urinalysis Parameter: Urine Specific Gravity

Urine samples were collected to measure urine specific gravity. Baseline was defined as the last assessment at screening. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

Time frame: Baseline and at Day 3, Day 7 and Day 42

Population: Safety Population.

Arm	Measure	Group	Value (MEAN)	Dispersion
TBA-7371 100 mg QD	Change From Baseline in Urinalysis Parameter: Urine Specific Gravity	Day 7	-0.003 Ratio	Standard Deviation 0.005
TBA-7371 100 mg QD	Change From Baseline in Urinalysis Parameter: Urine Specific Gravity	Day 3	-0.004 Ratio	Standard Deviation 0.006
TBA-7371 100 mg QD	Change From Baseline in Urinalysis Parameter: Urine Specific Gravity	Day 42	-0.001 Ratio	Standard Deviation 0.006
TBA-7371 100 mg BID	Change From Baseline in Urinalysis Parameter: Urine Specific Gravity	Day 7	-0.003 Ratio	Standard Deviation 0.008
TBA-7371 100 mg BID	Change From Baseline in Urinalysis Parameter: Urine Specific Gravity	Day 3	-0.006 Ratio	Standard Deviation 0.009
TBA-7371 100 mg BID	Change From Baseline in Urinalysis Parameter: Urine Specific Gravity	Day 42	-0.001 Ratio	Standard Deviation 0.008
TBA-7371 200 mg QD	Change From Baseline in Urinalysis Parameter: Urine Specific Gravity	Day 7	-0.004 Ratio	Standard Deviation 0.008
TBA-7371 200 mg QD	Change From Baseline in Urinalysis Parameter: Urine Specific Gravity	Day 3	-0.002 Ratio	Standard Deviation 0.008
TBA-7371 200 mg QD	Change From Baseline in Urinalysis Parameter: Urine Specific Gravity	Day 42	0.001 Ratio	Standard Deviation 0.006
TBA-7371 100 mg TID	Change From Baseline in Urinalysis Parameter: Urine Specific Gravity	Day 7	-0.002 Ratio	Standard Deviation 0.008
TBA-7371 100 mg TID	Change From Baseline in Urinalysis Parameter: Urine Specific Gravity	Day 3	-0.003 Ratio	Standard Deviation 0.008
TBA-7371 100 mg TID	Change From Baseline in Urinalysis Parameter: Urine Specific Gravity	Day 42	0.002 Ratio	Standard Deviation 0.006
TBA-7371 400 mg QD	Change From Baseline in Urinalysis Parameter: Urine Specific Gravity	Day 7	-0.004 Ratio	Standard Deviation 0.008
TBA-7371 400 mg QD	Change From Baseline in Urinalysis Parameter: Urine Specific Gravity	Day 3	-0.001 Ratio	Standard Deviation 0.008
TBA-7371 400 mg QD	Change From Baseline in Urinalysis Parameter: Urine Specific Gravity	Day 42	0.004 Ratio	Standard Deviation 0.008
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in Urinalysis Parameter: Urine Specific Gravity	Day 3	-0.003 Ratio	Standard Deviation 0.009
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in Urinalysis Parameter: Urine Specific Gravity	Day 42	0.001 Ratio	Standard Deviation 0.01
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in Urinalysis Parameter: Urine Specific Gravity	Day 7	-0.003 Ratio	Standard Deviation 0.008

Secondary

Change From Baseline in Visual Acuity Score

The visual acuity scores were converted to logMAR scale for analyzing change from Baseline. LogMar scale was computed as logMAR = -log(visual acuity score in decimal scale). In logMAR scale, lower scores corresponded to better vision, and as acuity became worse, the value of the logMAR increased. Worst logMAR score was defined to be the highest value of logMAR scores measured on left and right eyes at a given time point. The International Classification of Diseases 11 classification for distance vision impairment used was: Normal: Equal to or better than 20/40; Mild: Worse than 20/40 and equal to or better than 20/70; Moderate: Worse than 20/70 and equal to or better than 20/200; Severe: Worse than 20/200 and equal to or better than 20/400; Blindness: Worse than 20/400. Baseline was defined as the last assessment at screening. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

Time frame: Baseline and up to Day 42

Population: Safety Population.

Arm	Measure	Value (MEAN)	Dispersion
TBA-7371 100 mg QD	Change From Baseline in Visual Acuity Score	-0.007 Scores on a scale	Standard Deviation 0.0258
TBA-7371 100 mg BID	Change From Baseline in Visual Acuity Score	0.000 Scores on a scale	Standard Deviation 0.0302
TBA-7371 200 mg QD	Change From Baseline in Visual Acuity Score	-0.007 Scores on a scale	Standard Deviation 0.0458
TBA-7371 100 mg TID	Change From Baseline in Visual Acuity Score	-0.006 Scores on a scale	Standard Deviation 0.0429
TBA-7371 400 mg QD	Change From Baseline in Visual Acuity Score	0.000 Scores on a scale	Standard Deviation 0
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in Visual Acuity Score	0.000 Scores on a scale	Standard Deviation 0

Secondary

Change From Baseline in Visual Acuity Score

The visual acuity scores were converted to logarithm to the base 10 of the minimum angle of resolution (logMAR) scale for analyzing change from Baseline. LogMar scale was computed as logMAR = -log(visual acuity score in decimal scale). In logMAR scale, lower scores corresponded to better vision, and as acuity became worse, the value of the logMAR increased. Worst logMAR score was defined to be the highest value of logMAR scores measured on left and right eyes at a given time point. The International Classification of Diseases 11 for distance vision impairment used was: Normal: Equal to or better than 20/40; Mild: Worse than 20/40 and equal to or better than 20/70; Moderate: Worse than 20/70 and equal to or better than 20/200; Severe: Worse than 20/200 and equal to or better than 20/400; Blindness: Worse than 20/400. Baseline was defined as the last assessment at screening. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

Time frame: Baseline and up to Day 15

Population: Safety Population.

Arm	Measure	Value (MEAN)	Dispersion
TBA-7371 100 mg QD	Change From Baseline in Visual Acuity Score	-0.007 Scores on a scale	Standard Deviation 0.0258
TBA-7371 100 mg BID	Change From Baseline in Visual Acuity Score	0.008 Scores on a scale	Standard Deviation 0.0426
TBA-7371 200 mg QD	Change From Baseline in Visual Acuity Score	0.020 Scores on a scale	Standard Deviation 0.0414
TBA-7371 100 mg TID	Change From Baseline in Visual Acuity Score	0.011 Scores on a scale	Standard Deviation 0.0301
TBA-7371 400 mg QD	Change From Baseline in Visual Acuity Score	0.040 Scores on a scale	Standard Deviation 0.0828
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in Visual Acuity Score	0.000 Scores on a scale	Standard Deviation 0

Secondary

Change From Baseline in Visual Acuity Score

Time frame: Baseline, Day 1, Day 4, Day 7, Day 10 and Day 14

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
TBA-7371 100 mg QD	Change From Baseline in Visual Acuity Score	Day 10	-0.013 Scores on a scale	Standard Deviation 0.0352
TBA-7371 100 mg QD	Change From Baseline in Visual Acuity Score	Day 4	-0.007 Scores on a scale	Standard Deviation 0.0258
TBA-7371 100 mg QD	Change From Baseline in Visual Acuity Score	Day 1	-0.007 Scores on a scale	Standard Deviation 0.0258
TBA-7371 100 mg QD	Change From Baseline in Visual Acuity Score	Day 14	-0.014 Scores on a scale	Standard Deviation 0.0363
TBA-7371 100 mg QD	Change From Baseline in Visual Acuity Score	Day 7	-0.013 Scores on a scale	Standard Deviation 0.0352
TBA-7371 100 mg BID	Change From Baseline in Visual Acuity Score	Day 4	-0.012 Scores on a scale	Standard Deviation 0.0319
TBA-7371 100 mg BID	Change From Baseline in Visual Acuity Score	Day 10	0.007 Scores on a scale	Standard Deviation 0.0267
TBA-7371 100 mg BID	Change From Baseline in Visual Acuity Score	Day 1	-0.005 Scores on a scale	Standard Deviation 0.0431
TBA-7371 100 mg BID	Change From Baseline in Visual Acuity Score	Day 14	0.000 Scores on a scale	Standard Deviation 0.0392
TBA-7371 100 mg BID	Change From Baseline in Visual Acuity Score	Day 7	-0.007 Scores on a scale	Standard Deviation 0.0267
TBA-7371 200 mg QD	Change From Baseline in Visual Acuity Score	Day 4	-0.013 Scores on a scale	Standard Deviation 0.0352
TBA-7371 200 mg QD	Change From Baseline in Visual Acuity Score	Day 10	-0.007 Scores on a scale	Standard Deviation 0.0475
TBA-7371 200 mg QD	Change From Baseline in Visual Acuity Score	Day 14	0.007 Scores on a scale	Standard Deviation 0.0475
TBA-7371 200 mg QD	Change From Baseline in Visual Acuity Score	Day 7	-0.013 Scores on a scale	Standard Deviation 0.0352
TBA-7371 200 mg QD	Change From Baseline in Visual Acuity Score	Day 1	0.000 Scores on a scale	Standard Deviation 0.0378
TBA-7371 100 mg TID	Change From Baseline in Visual Acuity Score	Day 7	0.005 Scores on a scale	Standard Deviation 0.0194
TBA-7371 100 mg TID	Change From Baseline in Visual Acuity Score	Day 1	-0.006 Scores on a scale	Standard Deviation 0.0243
TBA-7371 100 mg TID	Change From Baseline in Visual Acuity Score	Day 4	0.011 Scores on a scale	Standard Deviation 0.0301
TBA-7371 100 mg TID	Change From Baseline in Visual Acuity Score	Day 10	-0.008 Scores on a scale	Standard Deviation 0.0426
TBA-7371 100 mg TID	Change From Baseline in Visual Acuity Score	Day 14	-0.013 Scores on a scale	Standard Deviation 0.0352
TBA-7371 400 mg QD	Change From Baseline in Visual Acuity Score	Day 10	0.000 Scores on a scale	Standard Deviation 0
TBA-7371 400 mg QD	Change From Baseline in Visual Acuity Score	Day 1	0.013 Scores on a scale	Standard Deviation 0.0352
TBA-7371 400 mg QD	Change From Baseline in Visual Acuity Score	Day 14	0.000 Scores on a scale	Standard Deviation 0
TBA-7371 400 mg QD	Change From Baseline in Visual Acuity Score	Day 4	0.000 Scores on a scale	Standard Deviation 0
TBA-7371 400 mg QD	Change From Baseline in Visual Acuity Score	Day 7	0.000 Scores on a scale	Standard Deviation 0
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in Visual Acuity Score	Day 1	0.000 Scores on a scale	Standard Deviation 0
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in Visual Acuity Score	Day 10	0.000 Scores on a scale	Standard Deviation 0
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in Visual Acuity Score	Day 4	-0.007 Scores on a scale	Standard Deviation 0.0258
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in Visual Acuity Score	Day 14	0.000 Scores on a scale	Standard Deviation 0
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Change From Baseline in Visual Acuity Score	Day 7	0.000 Scores on a scale	Standard Deviation 0

Secondary

Half-life (T1/2) After Administration of TBA7371

Blood samples were collected at indicated time points for pharmacokinetic analysis of TBA7371. PK parameters were analyzed using standard non-compartmental analysis.

Time frame: Days 1, 7 and 14

Population: PK Population. Only those participants with data available at the specified data points were analyzed

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
TBA-7371 100 mg QD	Half-life (T1/2) After Administration of TBA7371	Day 1	6.855 Hours	Geometric Coefficient of Variation 28.4
TBA-7371 100 mg QD	Half-life (T1/2) After Administration of TBA7371	Day 14	3.921 Hours	Geometric Coefficient of Variation 17.5
TBA-7371 100 mg QD	Half-life (T1/2) After Administration of TBA7371	Day 7	4.222 Hours	Geometric Coefficient of Variation 20.6
TBA-7371 100 mg BID	Half-life (T1/2) After Administration of TBA7371	Day 7	3.963 Hours	Geometric Coefficient of Variation 19
TBA-7371 100 mg BID	Half-life (T1/2) After Administration of TBA7371	Day 1	6.395 Hours	Geometric Coefficient of Variation 26.5
TBA-7371 100 mg BID	Half-life (T1/2) After Administration of TBA7371	Day 14	3.715 Hours	Geometric Coefficient of Variation 26.8
TBA-7371 200 mg QD	Half-life (T1/2) After Administration of TBA7371	Day 7	4.355 Hours	Geometric Coefficient of Variation 30.9
TBA-7371 200 mg QD	Half-life (T1/2) After Administration of TBA7371	Day 1	7.607 Hours	Geometric Coefficient of Variation 38.7
TBA-7371 200 mg QD	Half-life (T1/2) After Administration of TBA7371	Day 14	4.295 Hours	Geometric Coefficient of Variation 22.7
TBA-7371 100 mg TID	Half-life (T1/2) After Administration of TBA7371	Day 1	6.700 Hours	Geometric Coefficient of Variation 22.7
TBA-7371 100 mg TID	Half-life (T1/2) After Administration of TBA7371	Day 14	4.090 Hours	Geometric Coefficient of Variation 22
TBA-7371 100 mg TID	Half-life (T1/2) After Administration of TBA7371	Day 7	4.534 Hours	Geometric Coefficient of Variation 29
TBA-7371 400 mg QD	Half-life (T1/2) After Administration of TBA7371	Day 7	5.167 Hours	Geometric Coefficient of Variation 31.2
TBA-7371 400 mg QD	Half-life (T1/2) After Administration of TBA7371	Day 1	10.695 Hours	Geometric Coefficient of Variation 32.3
TBA-7371 400 mg QD	Half-life (T1/2) After Administration of TBA7371	Day 14	5.049 Hours	Geometric Coefficient of Variation 25

Secondary

Last Quantifiable Concentration (Clast) After Administration of TBA7371

Blood samples were collected at indicated time points for pharmacokinetic analysis of TBA7371. PK parameters were analyzed using standard non-compartmental analysis.

Time frame: Days 1, 7 and 14

Population: PK Population. Only those participants with data available at the specified data points were analyzed

Arm	Measure	Group	Value (MEAN)	Dispersion
TBA-7371 100 mg QD	Last Quantifiable Concentration (Clast) After Administration of TBA7371	Day 7	545.313 Nanograms per milliliter (ng/mL)	Standard Deviation 336.06
TBA-7371 100 mg QD	Last Quantifiable Concentration (Clast) After Administration of TBA7371	Day 1	730.077 Nanograms per milliliter (ng/mL)	Standard Deviation 713.708
TBA-7371 100 mg QD	Last Quantifiable Concentration (Clast) After Administration of TBA7371	Day 14	609.215 Nanograms per milliliter (ng/mL)	Standard Deviation 481.42
TBA-7371 100 mg BID	Last Quantifiable Concentration (Clast) After Administration of TBA7371	Day 14	913.244 Nanograms per milliliter (ng/mL)	Standard Deviation 599.243
TBA-7371 100 mg BID	Last Quantifiable Concentration (Clast) After Administration of TBA7371	Day 7	993.427 Nanograms per milliliter (ng/mL)	Standard Deviation 560.48
TBA-7371 100 mg BID	Last Quantifiable Concentration (Clast) After Administration of TBA7371	Day 1	1443.136 Nanograms per milliliter (ng/mL)	Standard Deviation 611.087
TBA-7371 200 mg QD	Last Quantifiable Concentration (Clast) After Administration of TBA7371	Day 14	1043.355 Nanograms per milliliter (ng/mL)	Standard Deviation 562.379
TBA-7371 200 mg QD	Last Quantifiable Concentration (Clast) After Administration of TBA7371	Day 1	1323.935 Nanograms per milliliter (ng/mL)	Standard Deviation 969.233
TBA-7371 200 mg QD	Last Quantifiable Concentration (Clast) After Administration of TBA7371	Day 7	1240.299 Nanograms per milliliter (ng/mL)	Standard Deviation 1059.177
TBA-7371 100 mg TID	Last Quantifiable Concentration (Clast) After Administration of TBA7371	Day 1	2341.459 Nanograms per milliliter (ng/mL)	Standard Deviation 710.626
TBA-7371 100 mg TID	Last Quantifiable Concentration (Clast) After Administration of TBA7371	Day 14	2148.453 Nanograms per milliliter (ng/mL)	Standard Deviation 850.006
TBA-7371 100 mg TID	Last Quantifiable Concentration (Clast) After Administration of TBA7371	Day 7	2445.429 Nanograms per milliliter (ng/mL)	Standard Deviation 1248.061
TBA-7371 400 mg QD	Last Quantifiable Concentration (Clast) After Administration of TBA7371	Day 14	2510.091 Nanograms per milliliter (ng/mL)	Standard Deviation 1103.997
TBA-7371 400 mg QD	Last Quantifiable Concentration (Clast) After Administration of TBA7371	Day 7	2942.279 Nanograms per milliliter (ng/mL)	Standard Deviation 1752.8
TBA-7371 400 mg QD	Last Quantifiable Concentration (Clast) After Administration of TBA7371	Day 1	3675.478 Nanograms per milliliter (ng/mL)	Standard Deviation 1882.844

Secondary

Maximum Observed Serum Concentration (Cmax) After Administration of TBA7371

Blood samples were collected at indicated time points for pharmacokinetic analysis of TBA7371. PK parameters were analyzed using standard non-compartmental analysis.

Time frame: Days 1, 7 and 14

Population: Pharmacokinetic (PK) Population: included all participants who received at least one dose of TBA-7371 and had at least one pair of pre- and post-dose blood samples with measurable concentrations. Only those participants with data available at the specified data points were analyzed

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
TBA-7371 100 mg QD	Maximum Observed Serum Concentration (Cmax) After Administration of TBA7371	Day 1	4913.52 Nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 16.2
TBA-7371 100 mg QD	Maximum Observed Serum Concentration (Cmax) After Administration of TBA7371	Day 14	5323.33 Nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 16.5
TBA-7371 100 mg QD	Maximum Observed Serum Concentration (Cmax) After Administration of TBA7371	Day 7	5198.53 Nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 17.6
TBA-7371 100 mg BID	Maximum Observed Serum Concentration (Cmax) After Administration of TBA7371	Day 7	5457.19 Nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 17.4
TBA-7371 100 mg BID	Maximum Observed Serum Concentration (Cmax) After Administration of TBA7371	Day 1	4868.80 Nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 8.5
TBA-7371 100 mg BID	Maximum Observed Serum Concentration (Cmax) After Administration of TBA7371	Day 14	5351.36 Nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 17.7
TBA-7371 200 mg QD	Maximum Observed Serum Concentration (Cmax) After Administration of TBA7371	Day 7	8523.96 Nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 18.4
TBA-7371 200 mg QD	Maximum Observed Serum Concentration (Cmax) After Administration of TBA7371	Day 1	9629.97 Nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 11.8
TBA-7371 200 mg QD	Maximum Observed Serum Concentration (Cmax) After Administration of TBA7371	Day 14	8671.52 Nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 12.4
TBA-7371 100 mg TID	Maximum Observed Serum Concentration (Cmax) After Administration of TBA7371	Day 1	5061.16 Nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 21.9
TBA-7371 100 mg TID	Maximum Observed Serum Concentration (Cmax) After Administration of TBA7371	Day 14	6060.03 Nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 18.3
TBA-7371 100 mg TID	Maximum Observed Serum Concentration (Cmax) After Administration of TBA7371	Day 7	6461.33 Nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 20.7
TBA-7371 400 mg QD	Maximum Observed Serum Concentration (Cmax) After Administration of TBA7371	Day 7	16877.34 Nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 13
TBA-7371 400 mg QD	Maximum Observed Serum Concentration (Cmax) After Administration of TBA7371	Day 1	16769.92 Nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 14.5
TBA-7371 400 mg QD	Maximum Observed Serum Concentration (Cmax) After Administration of TBA7371	Day 14	15599.81 Nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 15.3

Secondary

Mean Number of Days With ≥25% Decrease in SBP and Decrease in DBP From Baseline

SBP and DBP were measured twice as follows: after 10 minutes supine (manual, supine) and after 2 (±0.5) minutes standing (manual, 2-minute standing). Mean number of days with ≥25% decrease in SBP and decrease in DBP from Baseline is presented.

Time frame: Baseline (Day 1) and up to Day 15

Population: Safety Population. Only those participants with data available at the specified data points were analyzed

Arm	Measure	Group	Value (MEAN)	Dispersion
TBA-7371 100 mg QD	Mean Number of Days With ≥25% Decrease in SBP and Decrease in DBP From Baseline	≥25% decrease in supine SBP	1.0 Days	—
TBA-7371 100 mg QD	Mean Number of Days With ≥25% Decrease in SBP and Decrease in DBP From Baseline	≥25% decrease in supine DBP	1.3 Days	Standard Deviation 0.5
TBA-7371 100 mg QD	Mean Number of Days With ≥25% Decrease in SBP and Decrease in DBP From Baseline	≥25% decrease in standing DBP	1.3 Days	Standard Deviation 0.82
TBA-7371 100 mg QD	Mean Number of Days With ≥25% Decrease in SBP and Decrease in DBP From Baseline	≥25% decrease in standing SBP	1.3 Days	Standard Deviation 0.5
TBA-7371 100 mg BID	Mean Number of Days With ≥25% Decrease in SBP and Decrease in DBP From Baseline	≥25% decrease in standing DBP	2.0 Days	Standard Deviation 1.41
TBA-7371 100 mg BID	Mean Number of Days With ≥25% Decrease in SBP and Decrease in DBP From Baseline	≥25% decrease in standing SBP	1.0 Days	—
TBA-7371 100 mg BID	Mean Number of Days With ≥25% Decrease in SBP and Decrease in DBP From Baseline	≥25% decrease in supine DBP	1.0 Days	Standard Deviation 0
TBA-7371 200 mg QD	Mean Number of Days With ≥25% Decrease in SBP and Decrease in DBP From Baseline	≥25% decrease in supine DBP	8.0 Days	Standard Deviation 9.9
TBA-7371 200 mg QD	Mean Number of Days With ≥25% Decrease in SBP and Decrease in DBP From Baseline	≥25% decrease in supine SBP	1.0 Days	Standard Deviation 0
TBA-7371 200 mg QD	Mean Number of Days With ≥25% Decrease in SBP and Decrease in DBP From Baseline	≥25% decrease in standing SBP	4.0 Days	—
TBA-7371 200 mg QD	Mean Number of Days With ≥25% Decrease in SBP and Decrease in DBP From Baseline	≥25% decrease in standing DBP	2.0 Days	Standard Deviation 0.82
TBA-7371 100 mg TID	Mean Number of Days With ≥25% Decrease in SBP and Decrease in DBP From Baseline	≥25% decrease in standing DBP	1.9 Days	Standard Deviation 1.21
TBA-7371 100 mg TID	Mean Number of Days With ≥25% Decrease in SBP and Decrease in DBP From Baseline	≥25% decrease in supine DBP	2.5 Days	Standard Deviation 1.73
TBA-7371 100 mg TID	Mean Number of Days With ≥25% Decrease in SBP and Decrease in DBP From Baseline	≥25% decrease in standing SBP	1.3 Days	Standard Deviation 0.58
TBA-7371 400 mg QD	Mean Number of Days With ≥25% Decrease in SBP and Decrease in DBP From Baseline	≥25% decrease in supine DBP	2.3 Days	Standard Deviation 1.15
TBA-7371 400 mg QD	Mean Number of Days With ≥25% Decrease in SBP and Decrease in DBP From Baseline	≥25% decrease in standing SBP	1.5 Days	Standard Deviation 0.71
TBA-7371 400 mg QD	Mean Number of Days With ≥25% Decrease in SBP and Decrease in DBP From Baseline	≥25% decrease in standing DBP	1.4 Days	Standard Deviation 0.55
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Mean Number of Days With ≥25% Decrease in SBP and Decrease in DBP From Baseline	≥25% decrease in standing DBP	1.3 Days	Standard Deviation 0.5
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Mean Number of Days With ≥25% Decrease in SBP and Decrease in DBP From Baseline	≥25% decrease in standing SBP	1.0 Days	Standard Deviation 0
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Mean Number of Days With ≥25% Decrease in SBP and Decrease in DBP From Baseline	≥25% decrease in supine DBP	2.0 Days	Standard Deviation 0

Secondary

Mean Number of Days With ≥25% Increase in HR From Baseline

HR was measured twice as follows: after 10 minutes supine (manual, supine) and after 2 (±0.5) minutes standing (manual, 2-minute standing). Mean number of days with ≥25% increase in HR from Baseline is presented.

Time frame: Baseline (Day 1) and up to Day 15

Population: Safety Population. Only those participants with data available at the specified data points were analyzed

Arm	Measure	Group	Value (MEAN)	Dispersion
TBA-7371 100 mg QD	Mean Number of Days With ≥25% Increase in HR From Baseline	≥25% increase in supine HR	2.3 Days	Standard Deviation 1.41
TBA-7371 100 mg QD	Mean Number of Days With ≥25% Increase in HR From Baseline	≥25% increase in standing HR	5.4 Days	Standard Deviation 6.48
TBA-7371 100 mg BID	Mean Number of Days With ≥25% Increase in HR From Baseline	≥25% increase in supine HR	4.0 Days	Standard Deviation 2.88
TBA-7371 100 mg BID	Mean Number of Days With ≥25% Increase in HR From Baseline	≥25% increase in standing HR	4.3 Days	Standard Deviation 4.8
TBA-7371 200 mg QD	Mean Number of Days With ≥25% Increase in HR From Baseline	≥25% increase in supine HR	3.0 Days	Standard Deviation 2.07
TBA-7371 200 mg QD	Mean Number of Days With ≥25% Increase in HR From Baseline	≥25% increase in standing HR	6.1 Days	Standard Deviation 4.6
TBA-7371 100 mg TID	Mean Number of Days With ≥25% Increase in HR From Baseline	≥25% increase in supine HR	1.8 Days	Standard Deviation 1.39
TBA-7371 100 mg TID	Mean Number of Days With ≥25% Increase in HR From Baseline	≥25% increase in standing HR	3.9 Days	Standard Deviation 3.26
TBA-7371 400 mg QD	Mean Number of Days With ≥25% Increase in HR From Baseline	≥25% increase in supine HR	4.4 Days	Standard Deviation 4.47
TBA-7371 400 mg QD	Mean Number of Days With ≥25% Increase in HR From Baseline	≥25% increase in standing HR	3.9 Days	Standard Deviation 2.7
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Mean Number of Days With ≥25% Increase in HR From Baseline	≥25% increase in supine HR	4.8 Days	Standard Deviation 5.5
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Mean Number of Days With ≥25% Increase in HR From Baseline	≥25% increase in standing HR	1.0 Days	Standard Deviation 0

Secondary

Minimum Observed Plasma Concentration (Cmin) After Administration of TBA7371

Blood samples were collected at indicated time points for pharmacokinetic analysis of TBA7371. PK parameters were analyzed using standard non-compartmental analysis. Mean and standard deviation for Cmin could not be calculated due to high proportion of NQ values (\>30% of values were imputed)

Time frame: Days 7 and 14

Population: PK Population. Only those participants with data available at the specified data points were analyzed

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
TBA-7371 100 mg QD	Minimum Observed Plasma Concentration (Cmin) After Administration of TBA7371	Day 14	NA Nanograms per milliliter (ng/mL)	—
TBA-7371 100 mg QD	Minimum Observed Plasma Concentration (Cmin) After Administration of TBA7371	Day 7	NA Nanograms per milliliter (ng/mL)	—
TBA-7371 100 mg BID	Minimum Observed Plasma Concentration (Cmin) After Administration of TBA7371	Day 14	715.138 Nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 55.6
TBA-7371 100 mg BID	Minimum Observed Plasma Concentration (Cmin) After Administration of TBA7371	Day 7	756.809 Nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 50.5
TBA-7371 200 mg QD	Minimum Observed Plasma Concentration (Cmin) After Administration of TBA7371	Day 14	NA Nanograms per milliliter (ng/mL)	—
TBA-7371 200 mg QD	Minimum Observed Plasma Concentration (Cmin) After Administration of TBA7371	Day 7	NA Nanograms per milliliter (ng/mL)	—
TBA-7371 100 mg TID	Minimum Observed Plasma Concentration (Cmin) After Administration of TBA7371	Day 7	1777.999 Nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 45.5
TBA-7371 100 mg TID	Minimum Observed Plasma Concentration (Cmin) After Administration of TBA7371	Day 14	1736.179 Nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 28.8
TBA-7371 400 mg QD	Minimum Observed Plasma Concentration (Cmin) After Administration of TBA7371	Day 14	NA Nanograms per milliliter (ng/mL)	—
TBA-7371 400 mg QD	Minimum Observed Plasma Concentration (Cmin) After Administration of TBA7371	Day 7	NA Nanograms per milliliter (ng/mL)	—

Secondary

Number of Participants Experiencing AEs Related to Study Intervention

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with use of a study intervention, whether or not considered related to study intervention. An AE is considered related to study intervention if there was a reasonable possibility that the study intervention contributed to the AE.

Time frame: Up to Day 15

Population: Safety Population

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
TBA-7371 100 mg QD	Number of Participants Experiencing AEs Related to Study Intervention	5 Participants
TBA-7371 100 mg BID	Number of Participants Experiencing AEs Related to Study Intervention	3 Participants
TBA-7371 200 mg QD	Number of Participants Experiencing AEs Related to Study Intervention	7 Participants
TBA-7371 100 mg TID	Number of Participants Experiencing AEs Related to Study Intervention	9 Participants
TBA-7371 400 mg QD	Number of Participants Experiencing AEs Related to Study Intervention	15 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants Experiencing AEs Related to Study Intervention	7 Participants

Secondary

Number of Participants Reporting AEs (Presented by Severity)

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants reporting Reporting AEs is presented by Severity: Mild- Grade 1 (An event that is usually transient in nature and generally does not interfere with normal activities), Moderate-Grade 2 (An AE that is sufficiently discomforting to interfere with normal activities) and Severe- ≥Grade 3 (An AE that is incapacitating and prevents normal activities). The higher the grade, the more severe the symptoms.

Time frame: Up to Day 15

Population: Safety Population

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
TBA-7371 100 mg QD	Number of Participants Reporting AEs (Presented by Severity)	Grade 2	5 Participants
TBA-7371 100 mg QD	Number of Participants Reporting AEs (Presented by Severity)	Grade 1	6 Participants
TBA-7371 100 mg QD	Number of Participants Reporting AEs (Presented by Severity)	>=Grade 3	0 Participants
TBA-7371 100 mg BID	Number of Participants Reporting AEs (Presented by Severity)	Grade 2	2 Participants
TBA-7371 100 mg BID	Number of Participants Reporting AEs (Presented by Severity)	Grade 1	11 Participants
TBA-7371 100 mg BID	Number of Participants Reporting AEs (Presented by Severity)	>=Grade 3	1 Participants
TBA-7371 200 mg QD	Number of Participants Reporting AEs (Presented by Severity)	Grade 2	5 Participants
TBA-7371 200 mg QD	Number of Participants Reporting AEs (Presented by Severity)	Grade 1	7 Participants
TBA-7371 200 mg QD	Number of Participants Reporting AEs (Presented by Severity)	>=Grade 3	1 Participants
TBA-7371 100 mg TID	Number of Participants Reporting AEs (Presented by Severity)	Grade 2	4 Participants
TBA-7371 100 mg TID	Number of Participants Reporting AEs (Presented by Severity)	Grade 1	6 Participants
TBA-7371 100 mg TID	Number of Participants Reporting AEs (Presented by Severity)	>=Grade 3	2 Participants
TBA-7371 400 mg QD	Number of Participants Reporting AEs (Presented by Severity)	Grade 2	12 Participants
TBA-7371 400 mg QD	Number of Participants Reporting AEs (Presented by Severity)	Grade 1	3 Participants
TBA-7371 400 mg QD	Number of Participants Reporting AEs (Presented by Severity)	>=Grade 3	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants Reporting AEs (Presented by Severity)	Grade 1	8 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants Reporting AEs (Presented by Severity)	>=Grade 3	3 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants Reporting AEs (Presented by Severity)	Grade 2	0 Participants

Secondary

Number of Participants Reporting Any Adverse Events (AEs)

Time frame: Up to Day 15

Population: Safety Population

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
TBA-7371 100 mg QD	Number of Participants Reporting Any Adverse Events (AEs)	11 Participants
TBA-7371 100 mg BID	Number of Participants Reporting Any Adverse Events (AEs)	14 Participants
TBA-7371 200 mg QD	Number of Participants Reporting Any Adverse Events (AEs)	13 Participants
TBA-7371 100 mg TID	Number of Participants Reporting Any Adverse Events (AEs)	12 Participants
TBA-7371 400 mg QD	Number of Participants Reporting Any Adverse Events (AEs)	15 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants Reporting Any Adverse Events (AEs)	11 Participants

Secondary

Number of Participants Reporting Grade >=3 AEs by Preferred Term

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Clinical signs and symptoms that constitute AEs were classified by the investigator as mild (Grade 1), moderate (Grade 2), severe (Grade 3), potentially life threatening (Grade 4), death (Grade 5). Number of participants who experienced grade \>=3 AEs by preferred term is presented.

Time frame: Up to Day 15

Population: Safety Population

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
TBA-7371 100 mg QD	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Alanine aminotransferase increased	0 Participants
TBA-7371 100 mg QD	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Glycosuria	0 Participants
TBA-7371 100 mg QD	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Aspartate aminotransferase increased	0 Participants
TBA-7371 100 mg QD	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Orchitis	0 Participants
TBA-7371 100 mg QD	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Hypoalbuminaemia	0 Participants
TBA-7371 100 mg QD	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Orthostatic hypertension	0 Participants
TBA-7371 100 mg QD	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Colitis	0 Participants
TBA-7371 100 mg BID	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Colitis	0 Participants
TBA-7371 100 mg BID	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Hypoalbuminaemia	0 Participants
TBA-7371 100 mg BID	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Glycosuria	0 Participants
TBA-7371 100 mg BID	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Orchitis	1 Participants
TBA-7371 100 mg BID	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Alanine aminotransferase increased	0 Participants
TBA-7371 100 mg BID	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Aspartate aminotransferase increased	0 Participants
TBA-7371 100 mg BID	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Orthostatic hypertension	0 Participants
TBA-7371 200 mg QD	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Aspartate aminotransferase increased	0 Participants
TBA-7371 200 mg QD	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Hypoalbuminaemia	1 Participants
TBA-7371 200 mg QD	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Orthostatic hypertension	0 Participants
TBA-7371 200 mg QD	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Orchitis	0 Participants
TBA-7371 200 mg QD	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Glycosuria	0 Participants
TBA-7371 200 mg QD	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Alanine aminotransferase increased	0 Participants
TBA-7371 200 mg QD	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Colitis	1 Participants
TBA-7371 100 mg TID	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Aspartate aminotransferase increased	0 Participants
TBA-7371 100 mg TID	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Colitis	0 Participants
TBA-7371 100 mg TID	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Orchitis	0 Participants
TBA-7371 100 mg TID	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Alanine aminotransferase increased	0 Participants
TBA-7371 100 mg TID	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Hypoalbuminaemia	0 Participants
TBA-7371 100 mg TID	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Glycosuria	1 Participants
TBA-7371 100 mg TID	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Orthostatic hypertension	1 Participants
TBA-7371 400 mg QD	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Alanine aminotransferase increased	0 Participants
TBA-7371 400 mg QD	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Orchitis	0 Participants
TBA-7371 400 mg QD	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Orthostatic hypertension	0 Participants
TBA-7371 400 mg QD	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Colitis	0 Participants
TBA-7371 400 mg QD	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Glycosuria	0 Participants
TBA-7371 400 mg QD	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Aspartate aminotransferase increased	0 Participants
TBA-7371 400 mg QD	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Hypoalbuminaemia	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Orthostatic hypertension	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Hypoalbuminaemia	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Alanine aminotransferase increased	3 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Orchitis	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Glycosuria	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Colitis	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants Reporting Grade >=3 AEs by Preferred Term	Aspartate aminotransferase increased	1 Participants

Secondary

Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time

HR, SBP and DBP were measured twice as follows: after 10 minutes supine (manual, supine) and after 2 (±0.5) minutes standing (manual, 2-minute standing). Number of participants with ≥25% intraday increase in HR, ≥25% intraday decrease in SBP, ≥25% intraday decrease in DBP at any intraday time is presented.

Time frame: Day 1 and up to Day 15

Population: Safety Population. Only those participants with data available at the specified data points were analyzed

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
TBA-7371 100 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in supine DBP at any intraday time: Day 1	0 Participants
TBA-7371 100 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% increase in supine HR at any intraday time: Day 1	5 Participants
TBA-7371 100 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in standing SBP at any intraday time: Day 15	0 Participants
TBA-7371 100 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in standing DBP at any intraday time: Day 15	0 Participants
TBA-7371 100 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% increase in standing HR at any intraday time: Day 1	5 Participants
TBA-7371 100 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in standing DBP at any intraday time: Day 1	1 Participants
TBA-7371 100 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% increase in standing HR at any intraday time: Day 15	2 Participants
TBA-7371 100 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in supine SBP at any intraday time: Day 1	0 Participants
TBA-7371 100 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in supine DBP at any intraday time: Day 15	1 Participants
TBA-7371 100 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in supine SBP at any intraday time: Day 15	1 Participants
TBA-7371 100 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% increase in supine HR at any intraday time: Day 15	0 Participants
TBA-7371 100 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in standing SBP at any intraday time: Day 1	0 Participants
TBA-7371 100 mg BID	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in supine SBP at any intraday time: Day 15	0 Participants
TBA-7371 100 mg BID	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in standing SBP at any intraday time: Day 1	0 Participants
TBA-7371 100 mg BID	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in supine DBP at any intraday time: Day 1	0 Participants
TBA-7371 100 mg BID	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% increase in supine HR at any intraday time: Day 15	1 Participants
TBA-7371 100 mg BID	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in supine SBP at any intraday time: Day 1	0 Participants
TBA-7371 100 mg BID	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% increase in standing HR at any intraday time: Day 15	1 Participants
TBA-7371 100 mg BID	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% increase in supine HR at any intraday time: Day 1	4 Participants
TBA-7371 100 mg BID	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in standing SBP at any intraday time: Day 15	0 Participants
TBA-7371 100 mg BID	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in standing DBP at any intraday time: Day 1	1 Participants
TBA-7371 100 mg BID	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% increase in standing HR at any intraday time: Day 1	2 Participants
TBA-7371 100 mg BID	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in standing DBP at any intraday time: Day 15	1 Participants
TBA-7371 100 mg BID	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in supine DBP at any intraday time: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in standing DBP at any intraday time: Day 1	0 Participants
TBA-7371 200 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% increase in standing HR at any intraday time: Day 1	4 Participants
TBA-7371 200 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in supine DBP at any intraday time: Day 1	1 Participants
TBA-7371 200 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% increase in standing HR at any intraday time: Day 15	1 Participants
TBA-7371 200 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in standing DBP at any intraday time: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in supine DBP at any intraday time: Day 15	1 Participants
TBA-7371 200 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in standing SBP at any intraday time: Day 1	0 Participants
TBA-7371 200 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in standing SBP at any intraday time: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in supine SBP at any intraday time: Day 1	0 Participants
TBA-7371 200 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% increase in supine HR at any intraday time: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% increase in supine HR at any intraday time: Day 1	4 Participants
TBA-7371 200 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in supine SBP at any intraday time: Day 15	0 Participants
TBA-7371 100 mg TID	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in standing SBP at any intraday time: Day 15	0 Participants
TBA-7371 100 mg TID	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% increase in supine HR at any intraday time: Day 1	3 Participants
TBA-7371 100 mg TID	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% increase in supine HR at any intraday time: Day 15	0 Participants
TBA-7371 100 mg TID	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% increase in standing HR at any intraday time: Day 1	9 Participants
TBA-7371 100 mg TID	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% increase in standing HR at any intraday time: Day 15	3 Participants
TBA-7371 100 mg TID	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in supine SBP at any intraday time: Day 1	0 Participants
TBA-7371 100 mg TID	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in supine SBP at any intraday time: Day 15	0 Participants
TBA-7371 100 mg TID	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in standing SBP at any intraday time: Day 1	1 Participants
TBA-7371 100 mg TID	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in supine DBP at any intraday time: Day 1	1 Participants
TBA-7371 100 mg TID	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in supine DBP at any intraday time: Day 15	1 Participants
TBA-7371 100 mg TID	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in standing DBP at any intraday time: Day 1	2 Participants
TBA-7371 100 mg TID	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in standing DBP at any intraday time: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in supine SBP at any intraday time: Day 1	0 Participants
TBA-7371 400 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% increase in standing HR at any intraday time: Day 1	4 Participants
TBA-7371 400 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% increase in supine HR at any intraday time: Day 1	5 Participants
TBA-7371 400 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in standing DBP at any intraday time: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in standing DBP at any intraday time: Day 1	1 Participants
TBA-7371 400 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% increase in standing HR at any intraday time: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% increase in supine HR at any intraday time: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in supine DBP at any intraday time: Day 1	1 Participants
TBA-7371 400 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in supine DBP at any intraday time: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in standing SBP at any intraday time: Day 1	1 Participants
TBA-7371 400 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in standing SBP at any intraday time: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in supine SBP at any intraday time: Day 15	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in standing SBP at any intraday time: Day 15	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in supine SBP at any intraday time: Day 1	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in supine DBP at any intraday time: Day 1	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% increase in standing HR at any intraday time: Day 15	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in standing DBP at any intraday time: Day 15	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in supine DBP at any intraday time: Day 15	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% increase in standing HR at any intraday time: Day 1	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% increase in supine HR at any intraday time: Day 15	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in standing DBP at any intraday time: Day 1	2 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% increase in supine HR at any intraday time: Day 1	3 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in standing SBP at any intraday time: Day 1	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time	≥25% decrease in supine SBP at any intraday time: Day 15	0 Participants

Secondary

Number of Participants With Any New Eye Symptom in One or Both Eyes

Eye symptoms were assessed by non-leading questions delivered by trained staff based on a standardized script. A participant with multiple eye symptoms within a preferred term was counted once. Number of participants with any new eye symptom in one or both eyes is presented. All the eye symptoms have been included in the adverse events section of this study.

Time frame: Up to Day 15

Population: Safety Population

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
TBA-7371 100 mg QD	Number of Participants With Any New Eye Symptom in One or Both Eyes	2 Participants
TBA-7371 100 mg BID	Number of Participants With Any New Eye Symptom in One or Both Eyes	5 Participants
TBA-7371 200 mg QD	Number of Participants With Any New Eye Symptom in One or Both Eyes	6 Participants
TBA-7371 100 mg TID	Number of Participants With Any New Eye Symptom in One or Both Eyes	3 Participants
TBA-7371 400 mg QD	Number of Participants With Any New Eye Symptom in One or Both Eyes	10 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Any New Eye Symptom in One or Both Eyes	1 Participants

Secondary

Number of Participants With Color Vision Abnormality in One or Both Eyes

Color vision abnormality was defined as the most severe of protan, deutan, or tritan color deficiency in one or both eyes at a given time point. The degree of severity of color vision deficiency was graded as mild, moderate, severe. The severity of color vision abnormality was assigned to the highest degree of severity of the 3 color vision deficits. Number of participants with color vision abnormality in one or both eyes is presented.

Time frame: Up to Day 42

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
TBA-7371 100 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Moderate	0 Participants
TBA-7371 100 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Mild	0 Participants
TBA-7371 100 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Severe	0 Participants
TBA-7371 100 mg BID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Moderate	0 Participants
TBA-7371 100 mg BID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Mild	0 Participants
TBA-7371 100 mg BID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Severe	0 Participants
TBA-7371 200 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Moderate	0 Participants
TBA-7371 200 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Mild	0 Participants
TBA-7371 200 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Severe	0 Participants
TBA-7371 100 mg TID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Moderate	0 Participants
TBA-7371 100 mg TID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Mild	0 Participants
TBA-7371 100 mg TID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Severe	0 Participants
TBA-7371 400 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Moderate	0 Participants
TBA-7371 400 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Mild	0 Participants
TBA-7371 400 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Severe	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Color Vision Abnormality in One or Both Eyes	Mild	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Color Vision Abnormality in One or Both Eyes	Severe	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Color Vision Abnormality in One or Both Eyes	Moderate	0 Participants

Secondary

Number of Participants With Color Vision Abnormality in One or Both Eyes

Time frame: Day 1, Day 4, Day 7, Day 10 and Day 14

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
TBA-7371 100 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 7: Severe	0 Participants
TBA-7371 100 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 4: Severe	0 Participants
TBA-7371 100 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 14: Severe	0 Participants
TBA-7371 100 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 7: Moderate	0 Participants
TBA-7371 100 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 7: Mild	1 Participants
TBA-7371 100 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 14: Moderate	0 Participants
TBA-7371 100 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 1: Moderate	0 Participants
TBA-7371 100 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 1: Mild	0 Participants
TBA-7371 100 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 14: Mild	1 Participants
TBA-7371 100 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 1: Severe	0 Participants
TBA-7371 100 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 10: Severe	0 Participants
TBA-7371 100 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 4: Mild	0 Participants
TBA-7371 100 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 10: Moderate	0 Participants
TBA-7371 100 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 10: Mild	0 Participants
TBA-7371 100 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 4: Moderate	0 Participants
TBA-7371 100 mg BID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 7: Severe	0 Participants
TBA-7371 100 mg BID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 1: Severe	0 Participants
TBA-7371 100 mg BID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 4: Severe	0 Participants
TBA-7371 100 mg BID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 7: Moderate	0 Participants
TBA-7371 100 mg BID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 10: Moderate	0 Participants
TBA-7371 100 mg BID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 7: Mild	0 Participants
TBA-7371 100 mg BID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 4: Moderate	0 Participants
TBA-7371 100 mg BID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 14: Moderate	0 Participants
TBA-7371 100 mg BID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 4: Mild	0 Participants
TBA-7371 100 mg BID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 1: Mild	0 Participants
TBA-7371 100 mg BID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 1: Moderate	0 Participants
TBA-7371 100 mg BID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 14: Severe	0 Participants
TBA-7371 100 mg BID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 14: Mild	0 Participants
TBA-7371 100 mg BID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 10: Mild	0 Participants
TBA-7371 100 mg BID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 10: Severe	0 Participants
TBA-7371 200 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 7: Moderate	0 Participants
TBA-7371 200 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 1: Severe	0 Participants
TBA-7371 200 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 1: Mild	1 Participants
TBA-7371 200 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 1: Moderate	0 Participants
TBA-7371 200 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 4: Mild	0 Participants
TBA-7371 200 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 4: Moderate	0 Participants
TBA-7371 200 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 4: Severe	0 Participants
TBA-7371 200 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 7: Mild	0 Participants
TBA-7371 200 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 7: Severe	0 Participants
TBA-7371 200 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 10: Mild	0 Participants
TBA-7371 200 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 10: Moderate	0 Participants
TBA-7371 200 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 10: Severe	0 Participants
TBA-7371 200 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 14: Mild	0 Participants
TBA-7371 200 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 14: Moderate	0 Participants
TBA-7371 200 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 14: Severe	0 Participants
TBA-7371 100 mg TID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 4: Mild	0 Participants
TBA-7371 100 mg TID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 14: Severe	0 Participants
TBA-7371 100 mg TID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 1: Moderate	0 Participants
TBA-7371 100 mg TID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 10: Moderate	0 Participants
TBA-7371 100 mg TID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 7: Mild	0 Participants
TBA-7371 100 mg TID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 10: Severe	0 Participants
TBA-7371 100 mg TID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 1: Severe	0 Participants
TBA-7371 100 mg TID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 7: Severe	0 Participants
TBA-7371 100 mg TID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 4: Severe	0 Participants
TBA-7371 100 mg TID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 14: Moderate	0 Participants
TBA-7371 100 mg TID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 14: Mild	0 Participants
TBA-7371 100 mg TID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 7: Moderate	0 Participants
TBA-7371 100 mg TID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 1: Mild	2 Participants
TBA-7371 100 mg TID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 10: Mild	0 Participants
TBA-7371 100 mg TID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 4: Moderate	0 Participants
TBA-7371 400 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 1: Severe	0 Participants
TBA-7371 400 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 7: Moderate	0 Participants
TBA-7371 400 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 4: Moderate	0 Participants
TBA-7371 400 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 7: Severe	0 Participants
TBA-7371 400 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 4: Mild	0 Participants
TBA-7371 400 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 10: Mild	1 Participants
TBA-7371 400 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 10: Moderate	0 Participants
TBA-7371 400 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 10: Severe	0 Participants
TBA-7371 400 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 1: Moderate	0 Participants
TBA-7371 400 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 14: Mild	0 Participants
TBA-7371 400 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 1: Mild	1 Participants
TBA-7371 400 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 14: Severe	0 Participants
TBA-7371 400 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 4: Severe	0 Participants
TBA-7371 400 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 14: Moderate	0 Participants
TBA-7371 400 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 7: Mild	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 4: Mild	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 7: Moderate	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 14: Mild	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 1: Mild	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 14: Moderate	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 4: Moderate	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 7: Severe	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 1: Moderate	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 14: Severe	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 10: Moderate	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 4: Severe	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 10: Severe	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 7: Mild	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 10: Mild	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Color Vision Abnormality in One or Both Eyes	Day 1: Severe	0 Participants

Secondary

Number of Participants With Color Vision Abnormality in One or Both Eyes

Time frame: Up to Day 15

Population: Safety Population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
TBA-7371 100 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Moderate	0 Participants
TBA-7371 100 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Mild	2 Participants
TBA-7371 100 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Severe	0 Participants
TBA-7371 100 mg BID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Moderate	0 Participants
TBA-7371 100 mg BID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Mild	0 Participants
TBA-7371 100 mg BID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Severe	0 Participants
TBA-7371 200 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Moderate	0 Participants
TBA-7371 200 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Mild	1 Participants
TBA-7371 200 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Severe	0 Participants
TBA-7371 100 mg TID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Moderate	0 Participants
TBA-7371 100 mg TID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Mild	2 Participants
TBA-7371 100 mg TID	Number of Participants With Color Vision Abnormality in One or Both Eyes	Severe	0 Participants
TBA-7371 400 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Moderate	0 Participants
TBA-7371 400 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Mild	3 Participants
TBA-7371 400 mg QD	Number of Participants With Color Vision Abnormality in One or Both Eyes	Severe	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Color Vision Abnormality in One or Both Eyes	Mild	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Color Vision Abnormality in One or Both Eyes	Severe	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Color Vision Abnormality in One or Both Eyes	Moderate	0 Participants

Secondary

Number of Participants With New Eye Symptoms in Any Eye

Eye symptoms were assessed by non-leading questions delivered by trained staff based on a standardized script. A participant with multiple eye symptoms within a preferred term was counted once. Severe eye symptoms were events with grade 3 intensity or greater. Number of participants with new eye symptoms in any eye including: any, severe and serious is presented.

Time frame: Day 1, Day 4, Day 7, Day 10, Day 14 and 15

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
TBA-7371 100 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 1	0 Participants
TBA-7371 100 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 15	0 Participants
TBA-7371 100 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 4	0 Participants
TBA-7371 100 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 4	0 Participants
TBA-7371 100 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 4	0 Participants
TBA-7371 100 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 15	0 Participants
TBA-7371 100 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 15	0 Participants
TBA-7371 100 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 14	0 Participants
TBA-7371 100 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 7	0 Participants
TBA-7371 100 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 1	0 Participants
TBA-7371 100 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 14	0 Participants
TBA-7371 100 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 14	0 Participants
TBA-7371 100 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 10	0 Participants
TBA-7371 100 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 1	1 Participants
TBA-7371 100 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 10	0 Participants
TBA-7371 100 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 10	1 Participants
TBA-7371 100 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 7	0 Participants
TBA-7371 100 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 7	0 Participants
TBA-7371 100 mg BID	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 1	0 Participants
TBA-7371 100 mg BID	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 1	0 Participants
TBA-7371 100 mg BID	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 4	0 Participants
TBA-7371 100 mg BID	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 7	0 Participants
TBA-7371 100 mg BID	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 1	0 Participants
TBA-7371 100 mg BID	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 4	4 Participants
TBA-7371 100 mg BID	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 4	0 Participants
TBA-7371 100 mg BID	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 7	0 Participants
TBA-7371 100 mg BID	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 7	0 Participants
TBA-7371 100 mg BID	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 10	1 Participants
TBA-7371 100 mg BID	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 10	0 Participants
TBA-7371 100 mg BID	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 10	0 Participants
TBA-7371 100 mg BID	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 14	0 Participants
TBA-7371 100 mg BID	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 14	0 Participants
TBA-7371 100 mg BID	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 14	0 Participants
TBA-7371 100 mg BID	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 15	0 Participants
TBA-7371 100 mg BID	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 15	0 Participants
TBA-7371 100 mg BID	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 4	0 Participants
TBA-7371 200 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 4	4 Participants
TBA-7371 200 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 10	0 Participants
TBA-7371 200 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 10	0 Participants
TBA-7371 200 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 10	0 Participants
TBA-7371 200 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 1	0 Participants
TBA-7371 200 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 4	0 Participants
TBA-7371 200 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 7	0 Participants
TBA-7371 200 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 7	1 Participants
TBA-7371 200 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 14	0 Participants
TBA-7371 200 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 14	0 Participants
TBA-7371 200 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 7	0 Participants
TBA-7371 200 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 1	0 Participants
TBA-7371 200 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 1	4 Participants
TBA-7371 200 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 14	0 Participants
TBA-7371 100 mg TID	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 4	2 Participants
TBA-7371 100 mg TID	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 7	0 Participants
TBA-7371 100 mg TID	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 7	0 Participants
TBA-7371 100 mg TID	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 7	0 Participants
TBA-7371 100 mg TID	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 1	0 Participants
TBA-7371 100 mg TID	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 15	0 Participants
TBA-7371 100 mg TID	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 10	0 Participants
TBA-7371 100 mg TID	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 10	0 Participants
TBA-7371 100 mg TID	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 10	0 Participants
TBA-7371 100 mg TID	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 1	1 Participants
TBA-7371 100 mg TID	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 14	0 Participants
TBA-7371 100 mg TID	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 14	0 Participants
TBA-7371 100 mg TID	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 14	0 Participants
TBA-7371 100 mg TID	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 15	0 Participants
TBA-7371 100 mg TID	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 15	0 Participants
TBA-7371 100 mg TID	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 4	0 Participants
TBA-7371 100 mg TID	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 1	0 Participants
TBA-7371 100 mg TID	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 4	0 Participants
TBA-7371 400 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 4	2 Participants
TBA-7371 400 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 14	1 Participants
TBA-7371 400 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 7	0 Participants
TBA-7371 400 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 1	0 Participants
TBA-7371 400 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 14	0 Participants
TBA-7371 400 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 7	0 Participants
TBA-7371 400 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 14	0 Participants
TBA-7371 400 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 7	1 Participants
TBA-7371 400 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 4	0 Participants
TBA-7371 400 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 1	0 Participants
TBA-7371 400 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 10	0 Participants
TBA-7371 400 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 1	8 Participants
TBA-7371 400 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 10	2 Participants
TBA-7371 400 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 4	0 Participants
TBA-7371 400 mg QD	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 10	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 10	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 1	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 7	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 4	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 10	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 14	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 1	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 15	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 7	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 4	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 15	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 14	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 4	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 7	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With New Eye Symptoms in Any Eye	Severe: Day 10	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 1	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With New Eye Symptoms in Any Eye	Any: Day 15	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With New Eye Symptoms in Any Eye	Serious: Day 14	0 Participants

Secondary

Number of Participants With Shift From Baseline in Clinical Chemistry Parameters

Blood samples were collected from participants for analysis of following hematology parameters; Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Creatinine, Urea Nitrogen, Sodium and Potassium. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, were recorded in the 'To Normal or No Change' category. Baseline was defined as the last assessment at screening. Only the abnormal values were reported where normal to high and normal to low changes were reported.

Time frame: Day 3, Day 7, Day 15 and Day 42

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to High: Day 15	1 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to Low: Day 15	1 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to High: Day 7	2 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to High: Day 3	1 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to Low: Day 7	3 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to Low: Day 3	1 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to High: Day 42	1 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to Low: Day 42	3 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to High: Day 15	5 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to High: Day 3	3 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to High: Day 3	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to Low: Day 3	2 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to High: Day 42	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to Low: Day 42	1 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to High: Day 15	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to Low: Day 15	1 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to High: Day 42	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to High: Day 7	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to Low: Day 7	2 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to High: Day 3	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to High: Day 42	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to High: Day 7	2 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to High: Day 15	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to High: Day 7	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to High: Day 15	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to Low: Day 7	1 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to High: Day 3	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to High: Day 15	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to High: Day 7	4 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to High: Day 42	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to High: Day 15	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to Low: Day 15	1 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to High: Day 3	4 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to High: Day 7	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to Low: Day 7	1 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to High: Day 3	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to High: Day 42	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to Low: Day 15	1 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to High: Day 42	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to Low: Day 42	1 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to High: Day 15	3 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to High: Day 7	2 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to High: Day 3	1 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to High: Day 7	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to High: Day 42	1 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to High: Day 7	2 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to High: Day 42	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to High: Day 15	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to High: Day 7	2 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to High: Day 15	2 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to High: Day 42	2 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to High: Day 3	2 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to High: Day 15	1 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to Low: Day 42	2 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to High: Day 42	1 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to High: Day 3	1 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to High: Day 7	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to High: Day 15	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to High: Day 42	1 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to High: Day 3	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to High: Day 7	3 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to High: Day 15	2 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to High: Day 42	1 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to High: Day 3	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to High: Day 7	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to Low: Day 15	1 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to High: Day 15	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to High: Day 42	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to High: Day 3	1 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to High: Day 7	1 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to High: Day 15	1 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to Low: Day 42	2 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to High: Day 3	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to High: Day 7	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to High: Day 42	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to Low: Day 3	3 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to High: Day 3	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to Low: Day 7	1 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to High: Day 7	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to Low: Day 15	1 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to High: Day 15	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to Low: Day 42	1 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to High: Day 42	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to High: Day 3	4 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to Low: Day 15	3 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to Low: Day 3	3 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to Low: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to High: Day 7	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to Low: Day 7	2 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to Low: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to Low: Day 3	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to High: Day 7	3 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to High: Day 3	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to Low: Day 3	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to High: Day 42	3 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to High: Day 42	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to Low: Day 7	1 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to Low: Day 42	1 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to High: Day 15	2 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to Low: Day 42	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to Low: Day 42	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to High: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to High: Day 7	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to High: Day 3	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to High: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to Low: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to Low: Day 42	2 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to High: Day 3	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to High: Day 15	1 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to High: Day 15	1 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to High: Day 3	2 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to High: Day 7	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to High: Day 7	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to Low: Day 7	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to Low: Day 3	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to Low: Day 3	4 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to Low: Day 7	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to Low: Day 3	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to Low: Day 15	1 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to High: Day 7	1 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to Low: Day 7	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to Low: Day 42	4 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to High: Day 42	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to High: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to Low: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to Low: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to High: Day 42	2 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to High: Day 7	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to High: Day 42	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to Low: Day 7	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to Low: Day 7	2 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to High: Day 15	1 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to Low: Day 7	3 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to High: Day 3	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to Low: Day 3	1 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to High: Day 3	1 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to High: Day 42	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to Low: Day 42	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to Low: Day 3	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to High: Day 3	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to Low: Day 42	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to High: Day 7	3 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to High: Day 42	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to High: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to High: Day 42	1 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to High: Day 3	3 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to Low: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to High: Day 3	1 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to High: Day 42	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to High: Day 3	2 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to High: Day 7	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to High: Day 7	2 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to High: Day 15	3 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to High: Day 42	2 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to High: Day 42	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to Low: Day 3	1 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to Low: Day 15	3 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to High: Day 3	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to Low: Day 7	3 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to High: Day 7	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to Low: Day 15	1 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to High: Day 15	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to High: Day 15	3 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to Low: Day 42	1 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to High: Day 15	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to High: Day 42	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to High: Day 3	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to Low: Day 7	1 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to High: Day 7	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to Low: Day 15	1 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to High: Day 7	2 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to Low: Day 42	1 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to High: Day 15	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to Low: Day 42	1 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to High: Day 42	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to Low: Day 3	1 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to High: Day 3	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to High: Day 3	3 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to Low: Day 7	3 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to High: Day 7	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to High: Day 42	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to High: Day 15	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to Low: Day 42	2 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to High: Day 42	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to Low: Day 3	3 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to High: Day 15	5 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to Low: Day 42	1 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to High: Day 3	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to High: Day 42	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to High: Day 15	1 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to High: Day 3	1 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to High: Day 7	3 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to High: Day 7	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to Low: Day 15	1 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to Low: Day 7	4 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to Low: Day 3	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to High: Day 7	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to High: Day 7	1 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to High: Day 7	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to High: Day 42	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to Low: Day 15	1 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to Low: Day 3	1 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to Low: Day 3	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to High: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to Low: Day 42	1 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to Low: Day 42	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to Low: Day 42	3 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to High: Day 3	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to High: Day 42	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to High: Day 42	1 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to Low: Day 3	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to Low: Day 7	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to High: Day 15	1 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to High: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to High: Day 3	3 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to High: Day 3	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to High: Day 7	3 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to Low: Day 7	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to High: Day 42	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to Low: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to High: Day 7	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to Low: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to High: Day 7	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to Low: Day 7	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to Low: Day 15	1 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to High: Day 3	5 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to High: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to Low: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to High: Day 42	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to Low: Day 42	3 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to High: Day 42	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to High: Day 7	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to Low: Day 7	1 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to Low: Day 42	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to Low: Day 3	4 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to High: Day 3	1 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to High: Day 15	3 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to Low: Day 3	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to High: Day 7	1 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to Low: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to High: Day 15	2 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to Low: Day 42	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to High: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to Low: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to Low: Day 42	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to Low: Day 7	3 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to Low: Day 15	1 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to Low: Day 3	1 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to High: Day 42	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to High: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to Low: Day 7	3 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to Low: Day 3	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to High: Day 42	1 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to High: Day 3	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to High: Day 3	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to Low: Day 42	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to Low: Day 7	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to High: Day 3	3 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to Low: Day 7	2 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to Low: Day 42	3 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to High: Day 3	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to High: Day 42	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to High: Day 7	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to High: Day 7	3 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to Low: Day 42	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to Low: Day 42	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to High: Day 42	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to Low: Day 7	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to Low: Day 15	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to High: Day 15	2 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to High: Day 42	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to Low: Day 3	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to Low: Day 3	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to Low: Day 7	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to High: Day 15	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to Low: Day 42	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to Low: Day 3	2 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to Low: Day 42	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to High: Day 7	3 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to Low: Day 7	2 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to Low: Day 42	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to Low: Day 7	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to High: Day 42	2 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to Low: Day 3	2 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to Low: Day 3	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to High: Day 42	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to Low: Day 42	2 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to High: Day 15	3 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to High: Day 3	2 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to High: Day 7	3 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to High: Day 3	3 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to High: Day 15	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to High: Day 15	5 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to Low: Day 15	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to Low: Day 3	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to High: Day 3	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to High: Day 3	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to Low: Day 3	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to High: Day 7	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to High: Day 42	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to Low: Day 7	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to Low: Day 7	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to High: Day 15	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alkaline Phosphatase: Normal to Low: Day 15	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to High: Day 42	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to Low: Day 7	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to Low: Day 15	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to High: Day 7	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to High: Day 3	2 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to Low: Day 15	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to High: Day 7	2 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to Low: Day 3	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to High: Day 7	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to Low: Day 15	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to High: Day 3	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Potassium: Normal to High: Day 42	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to Low: Day 7	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Creatinine: Normal to High: Day 3	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Urea Nitrogen: Normal to High: Day 15	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Bilirubin: Normal to High: Day 15	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Alanine Aminotransferase: Normal to Low: Day 42	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Aspartate Aminotransferase: Normal to Low: Day 15	2 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Sodium: Normal to Low: Day 15	1 Participants

Secondary

Number of Participants With Shift From Baseline in Hematology Parameters

Blood samples were collected from participants for analysis of following hematology parameters: Erythrocytes, Hemoglobin, Hematocrit, Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelets. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, were recorded in the 'To Normal or No Change' category. Baseline was defined as the last assessment at screening. Only the abnormal values were reported where normal to high and normal to low changes were reported.

Time frame: Day 3, Day 7, Day 15 and Day 42

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to Low: Day 42	1 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to High: Day 42	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to High: Day 3	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to Low: Day 7	2 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to High: Day 3	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to High: Day 15	1 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to Low: Day 7	3 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to High: Day 42	1 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to High: Day 3	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to High: Day 7	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to High: Day 7	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to High: Day 15	1 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to High: Day 7	2 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to High: Day 42	3 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to Low: Day 15	2 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to High: Day 15	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to High: Day 3	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to High: Day 42	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to High: Day 15	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to Low: Day 3	1 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to High: Day 15	3 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to High: Day 15	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to High: Day 42	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to High: Day 15	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to High: Day 7	2 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to High: Day 7	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to High: Day 42	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to Low: Day 3	3 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to High: Day 42	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to High: Day 3	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to High: Day 3	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to High: Day 7	2 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to High: Day 3	1 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to Low: Day 15	1 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to Low: Day 42	1 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to Low: Day 7	3 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to High: Day 7	3 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to High: Day 15	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to High: Day 15	1 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to High: Day 7	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to High: Day 3	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to High: Day 42	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to Low: Day 15	1 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to High: Day 42	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to High: Day 7	2 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to Low: Day 15	2 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to High: Day 3	2 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to High: Day 15	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to Low: Day 3	3 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to High: Day 7	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to High: Day 3	2 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to High: Day 42	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to High: Day 3	3 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to High: Day 42	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to High: Day 42	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to Low: Day 3	1 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to High: Day 42	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to High: Day 7	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to High: Day 15	2 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to Low: Day 7	1 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to High: Day 7	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to High: Day 7	2 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to High: Day 3	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to Low: Day 7	1 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to High: Day 15	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to High: Day 3	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to High: Day 42	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to High: Day 7	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to High: Day 42	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to Low: Day 15	1 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to High: Day 3	1 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to High: Day 15	1 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to High: Day 15	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to High: Day 7	1 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to Low: Day 42	1 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to High: Day 3	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to High: Day 3	1 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to High: Day 42	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to High: Day 42	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to High: Day 3	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to High: Day 15	1 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to Low: Day 7	1 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to High: Day 7	3 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to High: Day 7	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to High: Day 42	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to High: Day 15	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to Low: Day 42	2 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to High: Day 15	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to High: Day 42	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to High: Day 7	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to Low: Day 3	1 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to Low: Day 3	1 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to High: Day 3	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to High: Day 42	1 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to Low: Day 7	1 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to High: Day 15	1 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to High: Day 7	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to High: Day 7	1 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to High: Day 3	1 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to Low: Day 7	1 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to High: Day 3	2 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to High: Day 15	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to High: Day 15	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to Low: Day 3	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to Low: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to High: Day 42	1 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to Low: Day 3	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to Low: Day 7	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to High: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to Low: Day 42	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to Low: Day 3	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to High: Day 3	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to Low: Day 7	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to High: Day 7	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to Low: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to High: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to Low: Day 42	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to High: Day 42	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to Low: Day 3	2 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to High: Day 3	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to Low: Day 7	1 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to High: Day 7	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to Low: Day 15	1 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to High: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to Low: Day 42	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to High: Day 42	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to Low: Day 3	2 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to High: Day 3	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to Low: Day 7	2 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to High: Day 7	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to Low: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to High: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to Low: Day 7	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to Low: Day 42	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to High: Day 42	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to Low: Day 3	1 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to High: Day 3	2 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to Low: Day 7	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to High: Day 7	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to High: Day 7	1 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to Low: Day 15	1 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to Low: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to High: Day 15	1 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to Low: Day 42	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to High: Day 42	1 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to High: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to Low: Day 42	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to Low: Day 3	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to High: Day 3	1 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to Low: Day 7	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to High: Day 7	1 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to Low: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to High: Day 15	1 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to Low: Day 42	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to High: Day 42	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to Low: Day 3	1 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to High: Day 3	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to Low: Day 7	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to High: Day 7	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to Low: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to High: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to Low: Day 42	1 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to High: Day 42	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to Low: Day 3	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to High: Day 3	6 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to Low: Day 7	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to High: Day 7	3 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to High: Day 15	2 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to Low: Day 42	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to High: Day 42	1 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to Low: Day 3	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to High: Day 3	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to Low: Day 7	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to High: Day 7	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to Low: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to High: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to Low: Day 42	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to High: Day 42	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to High: Day 3	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to High: Day 7	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to Low: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to High: Day 42	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to Low: Day 3	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to High: Day 3	2 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to High: Day 3	2 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to High: Day 7	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to High: Day 15	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to High: Day 15	2 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to High: Day 15	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to High: Day 7	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to Low: Day 42	1 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to High: Day 42	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to High: Day 15	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to High: Day 3	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to High: Day 3	3 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to High: Day 42	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to High: Day 42	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to High: Day 42	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to High: Day 42	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to Low: Day 7	7 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to Low: Day 42	2 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to High: Day 15	3 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to Low: Day 3	3 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to High: Day 7	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to High: Day 3	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to High: Day 7	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to High: Day 3	2 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to High: Day 15	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to Low: Day 7	2 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to High: Day 7	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to High: Day 15	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to Low: Day 3	5 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to High: Day 7	4 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to High: Day 3	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to Low: Day 42	1 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to High: Day 42	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to High: Day 3	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to High: Day 3	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to Low: Day 7	3 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to Low: Day 15	3 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to Low: Day 3	1 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to High: Day 7	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to Low: Day 3	7 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to High: Day 3	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to High: Day 15	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to High: Day 42	1 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to High: Day 7	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to Low: Day 7	1 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to High: Day 42	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to High: Day 7	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to High: Day 42	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to High: Day 15	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to High: Day 3	3 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to High: Day 7	1 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to High: Day 15	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to High: Day 42	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to Low: Day 15	2 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to Low: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to Low: Day 7	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to High: Day 42	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to Low: Day 3	1 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to High: Day 42	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to High: Day 3	3 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to Low: Day 15	3 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to Low: Day 7	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to High: Day 7	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to High: Day 7	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to High: Day 7	1 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to Low: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to Low: Day 7	3 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to Low: Day 3	3 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to High: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to High: Day 3	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to Low: Day 42	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to High: Day 42	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to Low: Day 3	3 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to Low: Day 3	1 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to Low: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to High: Day 3	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to Low: Day 7	1 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to High: Day 42	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to High: Day 3	2 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to High: Day 7	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to Low: Day 42	2 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to Low: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to High: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to High: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to High: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to Low: Day 42	3 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to Low: Day 15	4 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to High: Day 42	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to Low: Day 3	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to High: Day 3	5 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to High: Day 7	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to Low: Day 42	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to Low: Day 7	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to High: Day 7	1 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to Low: Day 7	3 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to High: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to Low: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to High: Day 3	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to High: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to High: Day 15	1 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to Low: Day 42	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to Low: Day 3	4 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to High: Day 42	1 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to High: Day 42	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to Low: Day 3	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to High: Day 42	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to High: Day 3	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to Low: Day 42	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to Low: Day 7	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to High: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to High: Day 7	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to High: Day 7	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to Low: Day 3	1 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to Low: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to Low: Day 15	3 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to High: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to Low: Day 42	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to High: Day 7	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to Low: Day 3	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to High: Day 42	1 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to Low: Day 3	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to Low: Day 7	3 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to High: Day 3	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to High: Day 7	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to Low: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to Low: Day 7	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to High: Day 3	4 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to High: Day 3	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to High: Day 15	2 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to Low: Day 42	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to Low: Day 7	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to High: Day 42	1 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to Low: Day 42	2 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to Low: Day 42	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to High: Day 15	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to High: Day 15	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to High: Day 7	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to High: Day 7	3 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to High: Day 15	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to Low: Day 15	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to Low: Day 3	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to High: Day 15	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to High: Day 7	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to Low: Day 15	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to Low: Day 7	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to Low: Day 15	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to Low: Day 42	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to High: Day 7	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to Low: Day 42	2 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to Low: Day 42	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to High: Day 15	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to High: Day 7	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to High: Day 3	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to Low: Day 7	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to Low: Day 15	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to Low: Day 42	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to High: Day 42	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to Low: Day 7	2 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to High: Day 42	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to High: Day 3	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to Low: Day 15	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to High: Day 42	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to Low: Day 3	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to Low: Day 15	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to Low: Day 3	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to High: Day 15	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to Low: Day 3	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to Low: Day 3	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to High: Day 42	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to Low: Day 3	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to Low: Day 42	2 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to High: Day 7	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to High: Day 3	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to Low: Day 7	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to High: Day 3	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to High: Day 15	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to High: Day 42	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to High: Day 3	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to High: Day 42	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to Low: Day 15	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to High: Day 7	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to High: Day 7	2 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to High: Day 15	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to Low: Day 42	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to Low: Day 3	2 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to Low: Day 7	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to Low: Day 7	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Neutrophils: Normal to Low: Day 15	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to Low: Day 42	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to High: Day 3	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to Low: Day 7	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to High: Day 3	3 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to High: Day 3	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to High: Day 7	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to High: Day 42	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to High: Day 42	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to Low: Day 7	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to High: Day 7	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Platelets: Normal to Low: Day 15	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to Low: Day 3	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Monocytes: Normal to Low: Day 3	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to Low: Day 42	2 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to High: Day 3	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to High: Day 42	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to Low: Day 3	2 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to High: Day 3	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Leukocytes: Normal to High: Day 15	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Hemoglobin: Normal to Low: Day 15	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Basophils: Normal to High: Day 42	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Lymphocytes: Normal to Low: Day 42	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to Low: Day 7	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Eosinophils: Normal to Low: Day 7	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Erythrocytes: Normal to High: Day 15	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Hematology Parameters	Hematocrit: Normal to Low: Day 42	2 Participants

Secondary

Number of Participants With Shift From Baseline in Serum Coagulation Parameters

Blood samples were collected from participants for analysis of following serum coagulation: Prothrombin time, Activated Partial Thromboplastin Time and Prothrombin International Normalized Ratio. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, were recorded in the 'To Normal or No Change' category. Baseline was defined as the last assessment at screening. Only the abnormal values were reported where normal to high and normal to low changes were reported.

Time frame: Day 3, Day 7, Day 15 and Day 42

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to High: Day 7	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to High: Day 42	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to High: Day 15	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to High: Day 15	2 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to High: Day 7	1 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to High: Day 3	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to High: Day 3	1 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time: Normal to High: Day 42	1 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time: Normal to Low: Day 42	2 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time: Normal to High: Day 15	1 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time: Normal to Low: Day 15	3 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to High: Day 42	0 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time : Normal to High: Day 7	1 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time : Normal to Low: Day 7	2 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time : Normal to High: Day 3	1 Participants
TBA-7371 100 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time : Normal to Low: Day 3	2 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to High: Day 3	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to High: Day 15	2 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to High: Day 3	3 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to High: Day 7	1 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to High: Day 15	3 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to High: Day 42	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time : Normal to Low: Day 3	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time : Normal to High: Day 3	2 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time : Normal to Low: Day 7	1 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time : Normal to High: Day 7	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time: Normal to Low: Day 15	2 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time: Normal to High: Day 15	3 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time: Normal to Low: Day 42	3 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time: Normal to High: Day 42	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to High: Day 7	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg BID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to High: Day 42	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time: Normal to Low: Day 42	2 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time : Normal to High: Day 7	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to Low: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to Low: Day 42	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time: Normal to High: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time: Normal to Low: Day 15	3 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to Low: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to High: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time : Normal to Low: Day 3	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to Low: Day 3	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to High: Day 7	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to High: Day 42	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to High: Day 7	1 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time : Normal to High: Day 3	2 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to High: Day 42	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to Low: Day 7	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to High: Day 3	1 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to Low: Day 42	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to Low: Day 3	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time : Normal to Low: Day 7	2 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to High: Day 15	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to High: Day 3	3 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time: Normal to High: Day 42	0 Participants
TBA-7371 200 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to High: Day 15	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to High: Day 42	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time : Normal to High: Day 3	1 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time : Normal to Low: Day 7	3 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time : Normal to High: Day 7	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time: Normal to Low: Day 15	2 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time: Normal to High: Day 15	1 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to High: Day 3	1 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time: Normal to Low: Day 42	3 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time: Normal to High: Day 42	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to Low: Day 42	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time : Normal to Low: Day 3	1 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to High: Day 3	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to Low: Day 7	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to Low: Day 3	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to High: Day 7	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to High: Day 42	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to Low: Day 15	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to High: Day 15	1 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to High: Day 7	0 Participants
TBA-7371 100 mg TID	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to Low: Day 42	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time: Normal to High: Day 42	5 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to High: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to High: Day 7	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to High: Day 42	1 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time : Normal to Low: Day 3	1 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to Low: Day 42	3 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to High: Day 3	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to High: Day 7	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to Low: Day 3	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time: Normal to Low: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to Low: Day 3	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to High: Day 3	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to High: Day 42	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time : Normal to High: Day 3	2 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to Low: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time: Normal to High: Day 15	2 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to Low: Day 7	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time : Normal to Low: Day 7	1 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time : Normal to High: Day 7	1 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to High: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to Low: Day 15	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time: Normal to Low: Day 42	1 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to Low: Day 7	0 Participants
TBA-7371 400 mg QD	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to Low: Day 42	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to Low: Day 42	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time: Normal to High: Day 42	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to Low: Day 15	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to Low: Day 3	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to Low: Day 3	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to Low: Day 15	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time : Normal to High: Day 3	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to High: Day 3	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to High: Day 42	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to Low: Day 42	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to Low: Day 7	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time : Normal to Low: Day 3	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to High: Day 15	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to High: Day 7	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time : Normal to Low: Day 7	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to High: Day 3	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to High: Day 7	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time: Normal to Low: Day 15	2 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time : Normal to High: Day 7	1 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to Low: Day 7	2 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time: Normal to High: Day 15	2 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin time: Normal to High: Day 42	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Prothrombin International Normalized Ratio: Normal to High: Day 15	0 Participants
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Number of Participants With Shift From Baseline in Serum Coagulation Parameters	Activated Partial Thromboplastin Time: Normal to Low: Day 42	0 Participants

Secondary

Time at Last Quantifiable Concentration (Tlast) After Administration of TBA7371

Blood samples were collected at indicated time points for pharmacokinetic analysis of TBA7371. PK parameters were analyzed using standard non-compartmental analysis.

Time frame: Days 1, 7 and 14

Population: PK Population. Only those participants with data available at the specified data points were analyzed

Arm	Measure	Group	Value (MEDIAN)
TBA-7371 100 mg QD	Time at Last Quantifiable Concentration (Tlast) After Administration of TBA7371	Day 7	16.450 Hours
TBA-7371 100 mg QD	Time at Last Quantifiable Concentration (Tlast) After Administration of TBA7371	Day 1	23.933 Hours
TBA-7371 100 mg QD	Time at Last Quantifiable Concentration (Tlast) After Administration of TBA7371	Day 14	16.417 Hours
TBA-7371 100 mg BID	Time at Last Quantifiable Concentration (Tlast) After Administration of TBA7371	Day 14	11.917 Hours
TBA-7371 100 mg BID	Time at Last Quantifiable Concentration (Tlast) After Administration of TBA7371	Day 1	11.917 Hours
TBA-7371 100 mg BID	Time at Last Quantifiable Concentration (Tlast) After Administration of TBA7371	Day 7	11.917 Hours
TBA-7371 200 mg QD	Time at Last Quantifiable Concentration (Tlast) After Administration of TBA7371	Day 1	23.900 Hours
TBA-7371 200 mg QD	Time at Last Quantifiable Concentration (Tlast) After Administration of TBA7371	Day 7	16.417 Hours
TBA-7371 200 mg QD	Time at Last Quantifiable Concentration (Tlast) After Administration of TBA7371	Day 14	16.450 Hours
TBA-7371 100 mg TID	Time at Last Quantifiable Concentration (Tlast) After Administration of TBA7371	Day 7	6.917 Hours
TBA-7371 100 mg TID	Time at Last Quantifiable Concentration (Tlast) After Administration of TBA7371	Day 1	6.917 Hours
TBA-7371 100 mg TID	Time at Last Quantifiable Concentration (Tlast) After Administration of TBA7371	Day 14	6.917 Hours
TBA-7371 400 mg QD	Time at Last Quantifiable Concentration (Tlast) After Administration of TBA7371	Day 1	23.917 Hours
TBA-7371 400 mg QD	Time at Last Quantifiable Concentration (Tlast) After Administration of TBA7371	Day 14	16.500 Hours
TBA-7371 400 mg QD	Time at Last Quantifiable Concentration (Tlast) After Administration of TBA7371	Day 7	16.500 Hours

Secondary

Time at Maximum Plasma Concentration (Tmax) After Administration of TBA7371

Blood samples were collected at indicated time points for pharmacokinetic analysis of TBA7371. PK parameters were analyzed using standard non-compartmental analysis.

Time frame: Days 1, 7 and 14

Population: PK Population. Only those participants with data available at the specified data points were analyzed

Arm	Measure	Group	Value (MEDIAN)
TBA-7371 100 mg QD	Time at Maximum Plasma Concentration (Tmax) After Administration of TBA7371	Day 1	1.000 Hours
TBA-7371 100 mg QD	Time at Maximum Plasma Concentration (Tmax) After Administration of TBA7371	Day 14	1.000 Hours
TBA-7371 100 mg QD	Time at Maximum Plasma Concentration (Tmax) After Administration of TBA7371	Day 7	1.000 Hours
TBA-7371 100 mg BID	Time at Maximum Plasma Concentration (Tmax) After Administration of TBA7371	Day 7	0.983 Hours
TBA-7371 100 mg BID	Time at Maximum Plasma Concentration (Tmax) After Administration of TBA7371	Day 1	1.000 Hours
TBA-7371 100 mg BID	Time at Maximum Plasma Concentration (Tmax) After Administration of TBA7371	Day 14	0.500 Hours
TBA-7371 200 mg QD	Time at Maximum Plasma Concentration (Tmax) After Administration of TBA7371	Day 7	1.000 Hours
TBA-7371 200 mg QD	Time at Maximum Plasma Concentration (Tmax) After Administration of TBA7371	Day 1	1.000 Hours
TBA-7371 200 mg QD	Time at Maximum Plasma Concentration (Tmax) After Administration of TBA7371	Day 14	1.000 Hours
TBA-7371 100 mg TID	Time at Maximum Plasma Concentration (Tmax) After Administration of TBA7371	Day 1	1.000 Hours
TBA-7371 100 mg TID	Time at Maximum Plasma Concentration (Tmax) After Administration of TBA7371	Day 14	1.000 Hours
TBA-7371 100 mg TID	Time at Maximum Plasma Concentration (Tmax) After Administration of TBA7371	Day 7	1.000 Hours
TBA-7371 400 mg QD	Time at Maximum Plasma Concentration (Tmax) After Administration of TBA7371	Day 7	1.000 Hours
TBA-7371 400 mg QD	Time at Maximum Plasma Concentration (Tmax) After Administration of TBA7371	Day 1	1.000 Hours
TBA-7371 400 mg QD	Time at Maximum Plasma Concentration (Tmax) After Administration of TBA7371	Day 14	1.000 Hours

Secondary

Total Number of Days With New Eye Symptoms in One or Both Eyes

Any day that a participant reported an eye symptom in one or both eyes after screening was counted toward the number of days of having eye symptoms in the study for that participant. Total Number of Days with New Eye Symptoms in One or Both Eyes is presented.

Time frame: Up to Day 15

Population: Safety Population. Only those participants with data available at the specified data points were analyzed

Arm	Measure	Value (MEDIAN)
TBA-7371 100 mg QD	Total Number of Days With New Eye Symptoms in One or Both Eyes	0.51 Days
TBA-7371 100 mg BID	Total Number of Days With New Eye Symptoms in One or Both Eyes	0.50 Days
TBA-7371 200 mg QD	Total Number of Days With New Eye Symptoms in One or Both Eyes	0.13 Days
TBA-7371 100 mg TID	Total Number of Days With New Eye Symptoms in One or Both Eyes	3.00 Days
TBA-7371 400 mg QD	Total Number of Days With New Eye Symptoms in One or Both Eyes	0.08 Days
Isoniazid [H] / Rifampicin [R] / Pyrazinamide [Z] / Ethambutol [E] (HRZE)	Total Number of Days With New Eye Symptoms in One or Both Eyes	78.00 Days

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Early Bactericidal Activity of TBA-7371 in Pulmonary Tuberculosis

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Average Change Per Day (Slope) of Log Colony Forming Units (CFU) Counts From Day 0 to Day 14 (BACFU [0-14]) to Assess Bactericidal Activity

Number of Participants Reporting ≥Grade 3 Adverse Events (AEs) and Serious Adverse Events (SAEs)

Accumulation Ratio After Administration of TBA7371

Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 Extrapolated to Infinity (AUCinf) After Administration of TBA7371

Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Last Quantifiable Concentration (AUClast) After Administration of TBA7371

Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Tau (AUCtau) After Administration of TBA7371

Average Change Per Day (Slope) of Log CFU Counts From Day 0 to Day 2 (BACFU [0-2]) and From Day 2 to Day 14 (BACFU [2-14]) to Assess Bactericidal Activity

Average Change Per Day (Slope) of the log10 Sputum Lipoarabinomannan (LAM) Measurements From Day 0 to Day 14 (BALAM [0-14]), From Day 0 to Day 2 (BALAM [0-2]) and From Day 2 to Day 14 (BALAM [2-14]) to Assess Bactericidal Activity

Average Change Per Day(Slope)of Time to Sputum Culture Positivity(TTP) in Mycobacteria Growth Indicator Tube (MGIT) System From Day0 to Day14 (BATTP[0-14]),From Day0 to Day2(BATTP[0-2]), and From Day2 to Day14(BATTP [2-14]) to Assess Bactericidal Activity

Average Duration of New Eye Symptom in One or Both Eyes

Change From Baseline in Electrocardiogram (ECG) Parameters

Change From Baseline in Heart Rate (HR)

Change From Baseline in HR

Change From Baseline in HR

Change From Baseline in HR as Measured by Electrocardiogram (ECG)

Change From Baseline in SBP and DBP

Change From Baseline in SBP and DBP

Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)

Change From Baseline in Urinalysis Parameter: Urine Specific Gravity

Change From Baseline in Visual Acuity Score

Change From Baseline in Visual Acuity Score

Change From Baseline in Visual Acuity Score

Half-life (T1/2) After Administration of TBA7371

Last Quantifiable Concentration (Clast) After Administration of TBA7371

Maximum Observed Serum Concentration (Cmax) After Administration of TBA7371

Mean Number of Days With ≥25% Decrease in SBP and Decrease in DBP From Baseline

Mean Number of Days With ≥25% Increase in HR From Baseline

Minimum Observed Plasma Concentration (Cmin) After Administration of TBA7371

Number of Participants Experiencing AEs Related to Study Intervention

Number of Participants Reporting AEs (Presented by Severity)

Number of Participants Reporting Any Adverse Events (AEs)

Number of Participants Reporting Grade >=3 AEs by Preferred Term

Number of Participants With ≥25% Intraday Increase in HR, ≥25% Intraday Decrease in SBP, ≥25% Intraday Decrease in DBP at Any Intraday Time

Number of Participants With Any New Eye Symptom in One or Both Eyes

Number of Participants With Color Vision Abnormality in One or Both Eyes

Number of Participants With Color Vision Abnormality in One or Both Eyes

Number of Participants With Color Vision Abnormality in One or Both Eyes

Number of Participants With New Eye Symptoms in Any Eye

Number of Participants With Shift From Baseline in Clinical Chemistry Parameters

Number of Participants With Shift From Baseline in Hematology Parameters

Number of Participants With Shift From Baseline in Serum Coagulation Parameters

Time at Last Quantifiable Concentration (Tlast) After Administration of TBA7371

Time at Maximum Plasma Concentration (Tmax) After Administration of TBA7371

Total Number of Days With New Eye Symptoms in One or Both Eyes