TuberculosisPhase 1NCT04865536
Study to Evaluate Safety, Tolerability, and the PK Profile of TBI-223 in Healthy Subjects
A Phase 1 study testing TBI-223 1800 mg and TBI-223 2400mg in people with Tuberculosis and Tuberculosis, Pulmonary, run by Global Alliance for TB Drug Development at 1 site in United States.
Trial summary
A Phase 1, Partially-Blinded, Placebo-Controlled, Randomized, Multiple Ascending Dose Study to Include A Single Dose Food-Effect Study to Evaluate the Safety, Tolerability, and the PK Profile of TBI-223 in Healthy Subjects Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis, Tuberculosis, Pulmonary
- What is being tested?
- TBI-223 1800 mg and TBI-223 2400mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2021to 17 May 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All volunteers must satisfy the following criteria to be considered for study participation:
- Is a healthy adult male or female, 19 to 50 years of age (inclusive) at the time of screening.
- Has a body mass index (BMI) ≥18.5 and ≤32.0 (kg/m2) and a body weight of no less than 50.0 kg.
- Is medically healthy with no clinically significant screening results (e.g., laboratory profiles normal or up to Grade 1 per Division of Microbiology and Infectious Diseases Toxicity Tables), as deemed by the Investigator.
- Has not used tobacco- or nicotine-containing products (including smoking cessation products), for a minimum of 6 months before dosing.
- If assigned to receive study drug under fed conditions, is willing and able to consume the entire high-calorie, high-fat breakfast meal in the timeframe required.
Who cannot join
- History or presence of clinically significant cardiovascular (heart murmur), pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
- Any presence of musculoskeletal toxicity (severe tenderness with marked impairment of activity, or frank necrosis).
- Has a positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV at screening.
- QTcF interval >450 msec for males or >470 msec for females at screening, Day -1, or Day 1 (predose), or history of prolonged QT syndrome. For the triplicate 12-lead ECGs taken at screening and on Day -1, the average QTcF interval of the three 12-lead ECG recordings were used to determine qualification.
- Family history of long-QT syndrome or sudden death without a preceding diagnosis of a condition that was causative of sudden death (such as known coronary artery disease, congestive heart failure, or terminal cancer).
- History of any of the following:
Show all 13Show fewer
- Serotonin syndrome
- Seizures or seizure disorders, other than childhood febrile seizures
- Brain surgery
- History of head injury in the last 5 years
- Any serious disorder of the nervous system particularly one that lowered the seizure threshold.
- Lactose intolerant.
- History of sensitivity or contraindication to use of linezolid, tedizolid, or any study investigational products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Partially-Blinded, Placebo-Controlled, Randomized, Multiple Ascending Dose Study to Include A Single Dose Food-Effect Study to Evaluate the Safety, Tolerability, and the PK Profile of TBI-223 in Healthy Subjects
A Phase 1, Partially-Blinded, Placebo-Controlled, Randomized, Multiple Ascending Dose Study to Include A Single Dose Food-Effect Study to Evaluate the Safety, Tolerability, and the PK Profile of TBI-223 in Healthy Subjects
Read the detailed description
This study was a partially-blinded, placebo-controlled, randomized multiple ascending dose (MAD) study conducted at one study center. Cohorts 1 (1800 mg) and 2 (2400mg) began dosing of TBI-223 or placebo on Day 1 under fasted conditions, followed by a 3-day washout period and then by multiple doses of TBI-223 administered after a high-calorie, high-fat meal (Fed) from Day 4 through Day 17 (total of 14 days). Cohort 1 subjects only received slow-release formulations (SR1) tablets and Cohort 2 subjects received a combination of SR1 tablets with one immediate-release (IR) tablet. Cohort 3 with higher doses was planned in the protocol but as allowed by the protocol, a decision was made to halt the study after the second cohort due to mean Cmax and AUC0-24 after 14 days of dosing at 2400 mg in the second cohort exceeded values that were predicted to be achieved at 3000 mg in the third cohort.
Safety was assessed throughout the study for all subjects. Safety assessments included physical and detailed neurological examinations, vital signs (blood pressure (BP), pulse rate (PR), respiration rate, temperature, and pulse oximetry), 12-lead electrocardiograms (12-lead ECGs), cardiac monitoring, adverse events (AEs), and clinical laboratory tests (including hematology, serology, serum chemistry, coagulation, and urinalysis).
- Conditions
- Tuberculosis, Tuberculosis, Pulmonary
- Being tested
- TBI-223 1800 mg, TBI-223 2400mg, TBI-223 Placebo
- Keywords
- TB, Tuberculosis, TBI-223, Pulmonary Tuberculosis
- Medical subject headings
- Tuberculosis, Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TBI-223 1800 mgDrug
3 x 600 mg SR1 tablets
TBI-223 2400mgDrug
3 x 600 mg SR1 tablets and 1 x 600 mg IR tablets
TBI-223 PlaceboDrug
Placebo SR and IR tablets for TBI-223
| Study group | Role | What they receive |
|---|---|---|
| TBI-223 1800 mg | Active comparator | Cohort 1, 3 x 600 mg slow release (SR1) tablets. Administered on Day 1 under fasted conditions, followed by a 3-day washout period and then by multiple doses of TBI-223 administered after a high-calorie, high-fat meal (Fed) from Day 4 through Day 17 (total of 14 days), (n=9) Receives: Drug: TBI-223 1800 mg |
| TBI-223 2400mg | Active comparator | Cohort 2, 3 x 600 mg SR1 tablets and 1 x 600 mg immediate release (IR) tablets. Administered on Day 1 under fasted conditions, followed by a 3-day washout period and then by multiple doses of TBI-223 administered after a high-calorie, high-fat meal (Fed) from Day 4 through Day 17 (total of 14 days), (n=13) Receives: Drug: TBI-223 2400mg |
| TBI-223 Placebo | Placebo comparator | Dose matching placebo tablets. Administered on Day 1 under fasted conditions, followed by a 3-day washout period and then by multiple doses of dose matched placebo administered after a high-calorie, high-fat meal (Fed) from Day 4 through Day 17 (total of 14 days), (n=6) Receives: Drug: TBI-223 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessment Vital Signs - Blood pressure
Blood pressure measured.
Measured: through study completion, 12 weeks.
Safety assessment Vital Signs - Pulse rate
Pulse rate measured.
Measured: through study completion, 12 weeks.
Safety assessment Vital Signs - Respiration rate
Respiration rate measured.
Measured: through study completion, 12 weeks.
Safety assessment Vital Signs - Temperature
Temperature measured.
Measured: through study completion, 12 weeks.
Safety assessment Vital Signs - Pulse oximetry
Pulse oximetry measured.
Measured: through study completion, 12 weeks.
Safety assessment - Cardiac monitoring
Safety 12-lead ECGs including ECG QT interval will be recorded and printed for on-site review by the Principal Investigator or designee.
Measured: through study completion, 12 weeks.
Safety assessment - Adverse Events (AEs)
AEs recorded.
Measured: through study completion, 12 weeks.
Safety assessment Clinical Laboratory Tests - Hematology
Hematology recorded: hemoglobin, hematocrit, total and differential leukocyte count, red blood cell count (RBC), and platelet count.
Measured: through study completion, 12 weeks.
Safety assessment Clinical Laboratory Tests - Serology
Serology tests recorded: hepatitis B surface antigen, hepatitis C antibody, and HIV.
Measured: through study completion, 12 weeks.
Safety assessment Clinical Laboratory Tests - Serum Chemistry
Serum chemistry recorded: albumin, blood urea nitrogen (BUN), creatinine, total bilirubin, alkaline phosphatase (ALP), aspartate transaminase (AST), alanine transaminase (ALT), sodium (Na+), potassium (K+), chloride (Cl-), lactate dehydrogenase (LDH), calcium (Ca), uric acid, glucose, gamma-glutamyltransferase (GGT), and magnesium.
Measured: through study completion, 12 weeks.
Safety assessment Clinical Laboratory Tests - Coagulation
Coagulation recorded: prothrombin time (PT), partial thromboplastin time (PTT), and international normalized ratio (INR).
Measured: through study completion, 12 weeks.
Safety assessment Clinical Laboratory Tests - Urinalysis
Urinalysis recorded.
Measured: through study completion, 12 weeks.
Safety assessment - Serum Pregnancy Testing
Blood collection from female subjects for serum pregnancy testing.
Measured: through study completion, 12 weeks.
Safety assessment - Follicle-stimulating hormone (FSH) Levels
Blood collection from postmenopausal women to measure FSH levels.
Measured: through study completion, 12 weeks.
Pharmacokinetics, non-food-effect cohorts - AUCtau
AUCtau measured.
Measured: Day 1
Pharmacokinetics, non-food-effect cohorts - Cmax
Cmax measured.
Measured: Day 1
Pharmacokinetics, non-food-effect cohorts - C24
C24 measured.
Measured: Day 1
Pharmacokinetics, non-food-effect cohorts - Cavg
Cavg measured.
Measured: Day 1
Pharmacokinetics, non-food-effect cohorts - Tmax
Tmax measured.
Measured: Day 1
Pharmacokinetics, non-food-effect cohorts - AUCinf
AUCinf measured if AUCtau ≥ 70% of AUCinf.
Measured: Day 1
Pharmacokinetics, non-food-effect cohorts - AUCextrap
AUCextrap measured if AUCtau ≥ 70% of AUCinf.
Measured: Day 1
Pharmacokinetics, non-food-effect cohorts - CL/F
CL/F measured if AUCtau ≥ 70% of AUCinf.
Measured: Day 1
Pharmacokinetics, non-food-effect cohorts - Vz/F
Vz/F measured if AUCtau ≥ 70% of AUCinf.
Measured: Day 1
Pharmacokinetics, non-food-effect cohorts - lambaZ
lambaZ measured if AUCtau ≥ 70% of AUCinf.
Measured: Day 1
Pharmacokinetics, non-food-effect cohorts - t1/2
t1/2 measured if AUCtau ≥ 70% of AUCinf.
Measured: Day 1
Pharmacokinetics, non-food-effect cohorts - AUCtau
AUCtau measured.
Measured: Day 14
Pharmacokinetics, non-food-effect cohorts - Cmax
Cmax measured.
Measured: Day 14
Pharmacokinetics, non-food-effect cohorts - Cmin
Cmin measured.
Measured: Day 14
Pharmacokinetics, non-food-effect cohorts - Ctrough
Ctrough (i.e., C0) measured.
Measured: Day 14
Pharmacokinetics, non-food-effect cohorts - C24
C24 measured.
Measured: Day 14
Pharmacokinetics, non-food-effect cohorts - Cavg
Cavg measured.
Measured: Day 14
Pharmacokinetics, non-food-effect cohorts - Tmax
Tmax measured.
Measured: Day 14
Pharmacokinetics, non-food-effect cohorts - CL/F
CL/F measured.
Measured: Day 14
Pharmacokinetics, non-food-effect cohorts - Vz/F
Vz/F measured.
Measured: Day 14
Pharmacokinetics, non-food-effect cohorts - lambaZ
lambaZ measured.
Measured: Day 14
Pharmacokinetics, non-food-effect cohorts - t1/2
t1/2 measured.
Measured: Day 14
Pharmacokinetics, non-food-effect cohorts - RAUC
RAUC measured.
Measured: Day 14
Pharmacokinetics, non-food-effect cohorts - RCmax measured.
RCmax measured.
Measured: Day 14
Pharmacokinetics, food-effect cohorts - AUCtau
AUCtau measured.
Measured: Day 1
Pharmacokinetics, food-effect cohorts - AUCextrap
AUCextrap measured.
Measured: Day 1
Pharmacokinetics, food-effect cohorts - AUCinf
AUCinf measured.
Measured: Day 1
Pharmacokinetics, food-effect cohorts - Cmax
Cmax measured.
Measured: Day 1
Pharmacokinetics, food-effect cohorts - C24
C24 measured
Measured: Day 1
Pharmacokinetics, food-effect cohorts - Clast
Clast measured.
Measured: Day 1
Pharmacokinetics, food-effect cohorts - Tmax
Tmax measured.
Measured: Day 1
Pharmacokinetics, food-effect cohorts - Tlast
Tlast measured.
Measured: Day 1
Pharmacokinetics, food-effect cohorts - CL/F
CL/F measured.
Measured: Day 1
Pharmacokinetics, food-effect cohorts - Vz/F
Vz/F measured.
Measured: Day 1
Pharmacokinetics, food-effect cohorts - lambaZ
lambaZ measured.
Measured: Day 1
Pharmacokinetics, food-effect cohorts - t1/2
t1/2 measured.
Measured: Day 1
Pharmacokinetics, food-effect cohorts - AUCtau
AUCtau measured. lambaZ, t1/2 should be included if AUCtau ≥ 70% of AUCinf
Measured: Day 4
Pharmacokinetics, food-effect cohorts - Cmax
Cmax measured.
Measured: Day 4
Pharmacokinetics, food-effect cohorts - C24
C24 measured.
Measured: Day 4
Pharmacokinetics, food-effect cohorts - Cavg
Cavg measured.
Measured: Day 4
Pharmacokinetics, food-effect cohorts - Tmax
Tmax measured.
Measured: Day 4
Pharmacokinetics, food-effect cohorts - AUCinf
AUCinf measured if AUCtau ≥ 70% of AUCinf.
Measured: Day 4
Pharmacokinetics, food-effect cohorts - AUCextrap
AUCextrap measured if AUCtau ≥ 70% of AUCinf.
Measured: Day 4
Pharmacokinetics, food-effect cohorts - CL/F
CL/F measured if AUCtau ≥ 70% of AUCinf.
Measured: Day 4
Pharmacokinetics, food-effect cohorts - Vz/F
Vz/F measured if AUCtau ≥ 70% of AUCinf.
Measured: Day 4
Pharmacokinetics, food-effect cohorts - lambaZ
lambaZ measured if AUCtau ≥ 70% of AUCinf.
Measured: Day 4
Pharmacokinetics, food-effect cohorts - t1/2
t1/2 measured if AUCtau ≥ 70% of AUCinf.
Measured: Day 4
Pharmacokinetics, food-effect cohorts - AUCtau
AUCtau measured.
Measured: Day 17
Pharmacokinetics, food-effect cohorts - Cmax
Cmax measured.
Measured: Day 17
Pharmacokinetics, food-effect cohorts - Cmin
Cmin measured.
Measured: Day 17
Pharmacokinetics, food-effect cohorts - Ctrough
Ctrough (i.e., C0) measured.
Measured: Day 17
Pharmacokinetics, food-effect cohorts - C24
C24 measured.
Measured: Day 17
Pharmacokinetics, food-effect cohorts - Cavg
Cavg measured.
Measured: Day 17
Pharmacokinetics, food-effect cohorts - Tmax
Tmax measured.
Measured: Day 17
Pharmacokinetics, food-effect cohorts - CL/F
CL/F measured.
Measured: Day 17
Pharmacokinetics, food-effect cohorts - Vz/F
Vz/F measured.
Measured: Day 17
Pharmacokinetics, food-effect cohorts - lambaZ
lambaZ measured.
Measured: Day 17
Pharmacokinetics, food-effect cohorts - t1/2
t1/2 measured.
Measured: Day 17
Pharmacokinetics, food-effect cohorts - RAUC
RAUC measured.
Measured: Day 17
Pharmacokinetics, food-effect cohorts - RCmax
RCmax measured.
Measured: Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start3 Feb 2021
- Primary completion17 May 2021
- Study completion17 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Global Alliance for TB Drug Development
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jerry Nedelman, Study chair, Global Alliance for TB Drug Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865536
- Sponsor's protocol ID
- TBI-223-CL-002
- Status last verified
- Jun 2025
- First submitted
- 22 Feb 2021
- Last updated
- 5 Jun 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Lombardi A, Pappas F, Bruinenberg P, Nedelman J, Taneja R, Hickman D, Beumont M, Sun E. Pharmacokinetics, tolerability, and safety of TBI-223, a novel oxazolidinone, in healthy participants. Antimicrob Agents Chemother. 2025 Apr 2;69(4):e0154224. doi: 10.1128/aac.01542-24. Epub 2025 Mar 11.
PubMed 40067046
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Partially-Blinded, Placebo-Controlled, Randomized, Multiple Ascending Dose Study to Include A Single Dose Food-Effect Study to Evaluate the Safety, Tolerability, and the PK Profile of TBI-223 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04865536
- Acronym / sponsor ID
- TBI-223-CL-002
- Conditions
- Tuberculosis, Tuberculosis, Pulmonary
- Keywords
- TB, Tuberculosis, TBI-223, Pulmonary Tuberculosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Global Alliance for TB Drug DevelopmentUniversity, hospital or other
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 17 May 2021 (actual)
- Study completion
- 17 May 2022 (actual)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1, Partially-Blinded, Placebo-Controlled, Randomized, Multiple Ascending Dose Study to Include A Single Dose Food-Effect Study to Evaluate the Safety, Tolerability, and the PK Profile of TBI-223 in Healthy Subjects
Detailed description
This study was a partially-blinded, placebo-controlled, randomized multiple ascending dose (MAD) study conducted at one study center. Cohorts 1 (1800 mg) and 2 (2400mg) began dosing of TBI-223 or placebo on Day 1 under fasted conditions, followed by a 3-day washout period and then by multiple doses of TBI-223 administered after a high-calorie, high-fat meal (Fed) from Day 4 through Day 17 (total of 14 days). Cohort 1 subjects only received slow-release formulations (SR1) tablets and Cohort 2 subjects received a combination of SR1 tablets with one immediate-release (IR) tablet. Cohort 3 with higher doses was planned in the protocol but as allowed by the protocol, a decision was made to halt the study after the second cohort due to mean Cmax and AUC0-24 after 14 days of dosing at 2400 mg in the second cohort exceeded values that were predicted to be achieved at 3000 mg in the third cohort.
Safety was assessed throughout the study for all subjects. Safety assessments included physical and detailed neurological examinations, vital signs (blood pressure (BP), pulse rate (PR), respiration rate, temperature, and pulse oximetry), 12-lead electrocardiograms (12-lead ECGs), cardiac monitoring, adverse events (AEs), and clinical laboratory tests (including hematology, serology, serum chemistry, coagulation, and urinalysis).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TBI-223 1800 mg | Active comparator | Drug: TBI-223 1800 mgCohort 1, 3 x 600 mg slow release (SR1) tablets. Administered on Day 1 under fasted conditions, followed by a 3-day washout period and then by multiple doses of TBI-223 administered after a high-calorie, high-fat meal (Fed) from Day 4 through Day 17 (total of 14 days), (n=9) |
| TBI-223 2400mg | Active comparator | Drug: TBI-223 2400mgCohort 2, 3 x 600 mg SR1 tablets and 1 x 600 mg immediate release (IR) tablets. Administered on Day 1 under fasted conditions, followed by a 3-day washout period and then by multiple doses of TBI-223 administered after a high-calorie, high-fat meal (Fed) from Day 4 through Day 17 (total of 14 days), (n=13) |
| TBI-223 Placebo | Placebo comparator | Drug: TBI-223 PlaceboDose matching placebo tablets. Administered on Day 1 under fasted conditions, followed by a 3-day washout period and then by multiple doses of dose matched placebo administered after a high-calorie, high-fat meal (Fed) from Day 4 through Day 17 (total of 14 days), (n=6) |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- All volunteers must satisfy the following criteria to be considered for study participation:
- Is a healthy adult male or female, 19 to 50 years of age (inclusive) at the time of screening.
- Has a body mass index (BMI) ≥18.5 and ≤32.0 (kg/m2) and a body weight of no less than 50.0 kg.
- Is medically healthy with no clinically significant screening results (e.g., laboratory profiles normal or up to Grade 1 per Division of Microbiology and Infectious Diseases Toxicity Tables), as deemed by the Investigator.
- Has not used tobacco- or nicotine-containing products (including smoking cessation products), for a minimum of 6 months before dosing.
Key exclusion criteria (13 listed)
- History or presence of clinically significant cardiovascular (heart murmur), pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
- Any presence of musculoskeletal toxicity (severe tenderness with marked impairment of activity, or frank necrosis).
- Has a positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV at screening.
- QTcF interval >450 msec for males or >470 msec for females at screening, Day -1, or Day 1 (predose), or history of prolonged QT syndrome. For the triplicate 12-lead ECGs taken at screening and on Day -1, the average QTcF interval of the three 12-lead ECG recordings were used to determine qualification.
- Family history of long-QT syndrome or sudden death without a preceding diagnosis of a condition that was causative of sudden death (such as known coronary artery disease, congestive heart failure, or terminal cancer).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TBI-223 1800 mg3 x 600 mg SR1 tablets | Drug | TBI-223 1800 mg |
| TBI-223 2400mg3 x 600 mg SR1 tablets and 1 x 600 mg IR tablets | Drug | TBI-223 2400mg |
| TBI-223 PlaceboPlacebo SR and IR tablets for TBI-223 | Drug | TBI-223 Placebo |
Primary outcome
Safety assessment Vital Signs - Blood pressure
Time frame: through study completion, 12 weeks.
Blood pressure measured.
Safety assessment Vital Signs - Pulse rate
Time frame: through study completion, 12 weeks.
Pulse rate measured.
Safety assessment Vital Signs - Respiration rate
Time frame: through study completion, 12 weeks.
Respiration rate measured.
Safety assessment Vital Signs - Temperature
Time frame: through study completion, 12 weeks.
Temperature measured.
Safety assessment Vital Signs - Pulse oximetry
Time frame: through study completion, 12 weeks.
Pulse oximetry measured.
Safety assessment - Cardiac monitoring
Time frame: through study completion, 12 weeks.
Safety 12-lead ECGs including ECG QT interval will be recorded and printed for on-site review by the Principal Investigator or designee.
Safety assessment - Adverse Events (AEs)
Time frame: through study completion, 12 weeks.
AEs recorded.
Safety assessment Clinical Laboratory Tests - Hematology
Time frame: through study completion, 12 weeks.
Hematology recorded: hemoglobin, hematocrit, total and differential leukocyte count, red blood cell count (RBC), and platelet count.
Safety assessment Clinical Laboratory Tests - Serology
Time frame: through study completion, 12 weeks.
Serology tests recorded: hepatitis B surface antigen, hepatitis C antibody, and HIV.
Safety assessment Clinical Laboratory Tests - Serum Chemistry
Time frame: through study completion, 12 weeks.
Serum chemistry recorded: albumin, blood urea nitrogen (BUN), creatinine, total bilirubin, alkaline phosphatase (ALP), aspartate transaminase (AST), alanine transaminase (ALT), sodium (Na+), potassium (K+), chloride (Cl-), lactate dehydrogenase (LDH), calcium (Ca), uric acid, glucose, gamma-glutamyltransferase (GGT), and magnesium.
Safety assessment Clinical Laboratory Tests - Coagulation
Time frame: through study completion, 12 weeks.
Coagulation recorded: prothrombin time (PT), partial thromboplastin time (PTT), and international normalized ratio (INR).
Safety assessment Clinical Laboratory Tests - Urinalysis
Time frame: through study completion, 12 weeks.
Urinalysis recorded.
Safety assessment - Serum Pregnancy Testing
Time frame: through study completion, 12 weeks.
Blood collection from female subjects for serum pregnancy testing.
Safety assessment - Follicle-stimulating hormone (FSH) Levels
Time frame: through study completion, 12 weeks.
Blood collection from postmenopausal women to measure FSH levels.
Pharmacokinetics, non-food-effect cohorts - AUCtau
Time frame: Day 1
AUCtau measured.
Pharmacokinetics, non-food-effect cohorts - Cmax
Time frame: Day 1
Cmax measured.
Pharmacokinetics, non-food-effect cohorts - C24
Time frame: Day 1
C24 measured.
Pharmacokinetics, non-food-effect cohorts - Cavg
Time frame: Day 1
Cavg measured.
Pharmacokinetics, non-food-effect cohorts - Tmax
Time frame: Day 1
Tmax measured.
Pharmacokinetics, non-food-effect cohorts - AUCinf
Time frame: Day 1
AUCinf measured if AUCtau ≥ 70% of AUCinf.
Pharmacokinetics, non-food-effect cohorts - AUCextrap
Time frame: Day 1
AUCextrap measured if AUCtau ≥ 70% of AUCinf.
Pharmacokinetics, non-food-effect cohorts - CL/F
Time frame: Day 1
CL/F measured if AUCtau ≥ 70% of AUCinf.
Pharmacokinetics, non-food-effect cohorts - Vz/F
Time frame: Day 1
Vz/F measured if AUCtau ≥ 70% of AUCinf.
Pharmacokinetics, non-food-effect cohorts - lambaZ
Time frame: Day 1
lambaZ measured if AUCtau ≥ 70% of AUCinf.
Pharmacokinetics, non-food-effect cohorts - t1/2
Time frame: Day 1
t1/2 measured if AUCtau ≥ 70% of AUCinf.
Pharmacokinetics, non-food-effect cohorts - AUCtau
Time frame: Day 14
AUCtau measured.
Pharmacokinetics, non-food-effect cohorts - Cmax
Time frame: Day 14
Cmax measured.
Pharmacokinetics, non-food-effect cohorts - Cmin
Time frame: Day 14
Cmin measured.
Pharmacokinetics, non-food-effect cohorts - Ctrough
Time frame: Day 14
Ctrough (i.e., C0) measured.
Pharmacokinetics, non-food-effect cohorts - C24
Time frame: Day 14
C24 measured.
Pharmacokinetics, non-food-effect cohorts - Cavg
Time frame: Day 14
Cavg measured.
Pharmacokinetics, non-food-effect cohorts - Tmax
Time frame: Day 14
Tmax measured.
Pharmacokinetics, non-food-effect cohorts - CL/F
Time frame: Day 14
CL/F measured.
Pharmacokinetics, non-food-effect cohorts - Vz/F
Time frame: Day 14
Vz/F measured.
Pharmacokinetics, non-food-effect cohorts - lambaZ
Time frame: Day 14
lambaZ measured.
Pharmacokinetics, non-food-effect cohorts - t1/2
Time frame: Day 14
t1/2 measured.
Pharmacokinetics, non-food-effect cohorts - RAUC
Time frame: Day 14
RAUC measured.
Pharmacokinetics, non-food-effect cohorts - RCmax measured.
Time frame: Day 14
RCmax measured.
Pharmacokinetics, food-effect cohorts - AUCtau
Time frame: Day 1
AUCtau measured.
Pharmacokinetics, food-effect cohorts - AUCextrap
Time frame: Day 1
AUCextrap measured.
Pharmacokinetics, food-effect cohorts - AUCinf
Time frame: Day 1
AUCinf measured.
Pharmacokinetics, food-effect cohorts - Cmax
Time frame: Day 1
Cmax measured.
Pharmacokinetics, food-effect cohorts - C24
Time frame: Day 1
C24 measured
Pharmacokinetics, food-effect cohorts - Clast
Time frame: Day 1
Clast measured.
Pharmacokinetics, food-effect cohorts - Tmax
Time frame: Day 1
Tmax measured.
Pharmacokinetics, food-effect cohorts - Tlast
Time frame: Day 1
Tlast measured.
Pharmacokinetics, food-effect cohorts - CL/F
Time frame: Day 1
CL/F measured.
Pharmacokinetics, food-effect cohorts - Vz/F
Time frame: Day 1
Vz/F measured.
Pharmacokinetics, food-effect cohorts - lambaZ
Time frame: Day 1
lambaZ measured.
Pharmacokinetics, food-effect cohorts - t1/2
Time frame: Day 1
t1/2 measured.
Pharmacokinetics, food-effect cohorts - AUCtau
Time frame: Day 4
AUCtau measured. lambaZ, t1/2 should be included if AUCtau ≥ 70% of AUCinf
Pharmacokinetics, food-effect cohorts - Cmax
Time frame: Day 4
Cmax measured.
Pharmacokinetics, food-effect cohorts - C24
Time frame: Day 4
C24 measured.
Pharmacokinetics, food-effect cohorts - Cavg
Time frame: Day 4
Cavg measured.
Pharmacokinetics, food-effect cohorts - Tmax
Time frame: Day 4
Tmax measured.
Pharmacokinetics, food-effect cohorts - AUCinf
Time frame: Day 4
AUCinf measured if AUCtau ≥ 70% of AUCinf.
Pharmacokinetics, food-effect cohorts - AUCextrap
Time frame: Day 4
AUCextrap measured if AUCtau ≥ 70% of AUCinf.
Pharmacokinetics, food-effect cohorts - CL/F
Time frame: Day 4
CL/F measured if AUCtau ≥ 70% of AUCinf.
Pharmacokinetics, food-effect cohorts - Vz/F
Time frame: Day 4
Vz/F measured if AUCtau ≥ 70% of AUCinf.
Pharmacokinetics, food-effect cohorts - lambaZ
Time frame: Day 4
lambaZ measured if AUCtau ≥ 70% of AUCinf.
Pharmacokinetics, food-effect cohorts - t1/2
Time frame: Day 4
t1/2 measured if AUCtau ≥ 70% of AUCinf.
Pharmacokinetics, food-effect cohorts - AUCtau
Time frame: Day 17
AUCtau measured.
Pharmacokinetics, food-effect cohorts - Cmax
Time frame: Day 17
Cmax measured.
Pharmacokinetics, food-effect cohorts - Cmin
Time frame: Day 17
Cmin measured.
Pharmacokinetics, food-effect cohorts - Ctrough
Time frame: Day 17
Ctrough (i.e., C0) measured.
Pharmacokinetics, food-effect cohorts - C24
Time frame: Day 17
C24 measured.
Pharmacokinetics, food-effect cohorts - Cavg
Time frame: Day 17
Cavg measured.
Pharmacokinetics, food-effect cohorts - Tmax
Time frame: Day 17
Tmax measured.
Pharmacokinetics, food-effect cohorts - CL/F
Time frame: Day 17
CL/F measured.
Pharmacokinetics, food-effect cohorts - Vz/F
Time frame: Day 17
Vz/F measured.
Pharmacokinetics, food-effect cohorts - lambaZ
Time frame: Day 17
lambaZ measured.
Pharmacokinetics, food-effect cohorts - t1/2
Time frame: Day 17
t1/2 measured.
Pharmacokinetics, food-effect cohorts - RAUC
Time frame: Day 17
RAUC measured.
Pharmacokinetics, food-effect cohorts - RCmax
Time frame: Day 17
RCmax measured.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Results publication: PubMed 40067046Lombardi A, Pappas F, Bruinenberg P, Nedelman J, Taneja R, Hickman D, Beumont M, Sun E. Pharmacokinetics, tolerability, and safety of TBI-223, a novel oxazolidinone, in healthy participants. Antimicrob Agents Chemother. 2025 Apr 2;69(4):e0154224. doi: 10.1128/aac.01542-24. Epub 2025 Mar 11.
Related trials for Tuberculosis
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
RecruitingObservational study
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Tuberculosis
Active, not recruitingPhase 3
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Tuberculosis, MDR
Not yet recruitingPhase 2
Re-evaluating the Duration in Children of TB Treatment
Tuberculosis
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerry Nedelman study chair
Global Alliance for TB Drug Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TBI-223 1800 mg and TBI-223 2400mg in people with Tuberculosis and Tuberculosis, Pulmonary, run by Global Alliance for TB Drug Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessment Vital Signs - Blood pressure (time frame: through study completion, 12 weeks.). The study lists 74 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04865536, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.