Pulmonary DiseasePhase 1NCT04493671

Evaluate Safety, Tolerability, PK of TBAJ-876 in Healthy Adults

A Phase 1 study testing TBAJ-876 suspension, TBAJ-876 100 mg tablet and TBAJ-876 25 mg tablet in people with Pulmonary Disease and Tuberculosis, Pulmonary, run by Global Alliance for TB Drug Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

A Phase 1, Partially Blind, Placebo Controlled, Randomized, Combined Single Ascending Dose (SAD) with a Food Effect Cohort (Part 1), Multiple Ascending Dose (MAD) (Part 2), and Relative Bioavailability (rBA) (Part 3) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBAJ-876 in Healthy Adult Subjects Read more about this study

Who is it for?: Ages 19 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Pulmonary Disease, Tuberculosis, Pulmonary, Tuberculosis
What is being tested?: TBAJ-876 suspension, TBAJ-876 100 mg tablet and TBAJ-876 25 mg tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 137 participants
Where: 1 siteUnited States
Study dates: 8 Jun 2020to 15 Nov 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 DMID 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.
Current or history of prolonged QT syndrome15. Family history of long-QT syndrome or sudden death without a preceding diagnosis of a condition that could be causative of sudden death (such as known coronary artery disease, congestive heart failure, or terminal cancer).
If assigned to the fasted/fed cohort, is lactose intolerant.

Trial locations and contacts

1 site in 1 country.

United States1 site

Worldwide Clinical Trials
San Antonio, Texas, 78217

Other trials in United States

About this study

Official title: A Phase 1, Partially Blind, Placebo Controlled, Randomized, Combined Single Ascending Dose With a Food Effect Cohort, Multiple Ascending Dose, and Relative Bioavailability Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBAJ-876 in Healthy Adult Subjects

Read the detailed description

This study is a three-part, partially blinded, placebo controlled, combined single ascending dose with food-effect, multiple ascending dose study, and a single dose relative bioavailability study conducted at one study center in the United States.

Safety will be assessed throughout the study for all subjects. Safety assessments will include physical examinations, vital signs, serial ECGs, cardiac monitoring, adverse events (AEs), and clinical laboratory tests (including hematology, serum chemistry, coagulation, and urinalysis).

Conditions: Pulmonary Disease, Tuberculosis, Pulmonary, Tuberculosis, Multi Drug Resistant Tuberculosis, Drug Sensitive Tuberculosis, Drug-resistant Tuberculosis
Being tested: TBAJ-876 suspension, Placebo suspension, TBAJ-876 100 mg tablet, TBAJ-876 25 mg tablet
Keywords: TBAJ-876, Diarylquinoline, DARQ
Medical subject headings: Lung Diseases, Tuberculosis, Pulmonary, Tuberculosis, Tuberculosis, Multidrug-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TBAJ-876 suspensionDrug
TBAJ-876 oral suspension, orally administered
Placebo suspensionDrug
Placebo for TBAJ-876 oral Suspension; orally administered
TBAJ-876 100 mg tabletDrug
TBAJ-876 100 mg tablets, orally administered
TBAJ-876 25 mg tabletDrug
TBAJ-876 25 mg tablets, orally administered

Study groups in NCT04493671
Study group	Role	What they receive
TBAJ-876 10mg SAD	Active comparator	Cohort 1 single dose of 10 mg TBAJ-876 (n=6) under fasted conditions Receives: Drug: TBAJ-876 suspension
TBAJ-876 25mg SAD	Active comparator	Cohort 2, Single dose of 25 mg TBAJ-876 (n=6) under fasted conditions Receives: Drug: TBAJ-876 suspension
TBAJ-876 50mg SAD	Active comparator	Cohort 3 single dose of 50 mg TBAJ-876 (n=6) under fasted conditions Receives: Drug: TBAJ-876 suspension
TBAJ-876 100mg fasted SAD	Active comparator	Cohort 4, single dose of 100 mg TBAJ-876 (n=9) under fasted conditions Receives: Drug: TBAJ-876 suspension
TBAJ-876 100mg fed SAD	Active comparator	Cohort 4, dose of 100 mg TBAJ-876 (n=10) under fed conditions Receives: Drug: TBAJ-876 suspension
TBAJ-876 200mg SAD	Active comparator	Cohort 5 single dose of 200 mg TBAJ-876 (n=6) under fasted conditions Receives: Drug: TBAJ-876 suspension
TBAJ-876 400mg SAD	Active comparator	Cohort 6, single dose of 400 mg TBAJ-876) (n=6) under fasted conditions Receives: Drug: TBAJ-876 suspension
TBAJ-876 800mg SAD	Active comparator	Cohort 7, Single dose of 800 mg TBAJ-876 (n=6) under fasted conditions Receives: Drug: TBAJ-876 suspension
TBAJ-876 Placebo SAD	Placebo comparator	Single dose matching placebo for TBAJ-876 under fasted conditions (n=13) Receives: Drug: Placebo suspension
TBAJ-876 25mg MAD	Active comparator	25 mg TBAJ-876 (n=9) for 14 days under fed conditions Receives: Drug: TBAJ-876 suspension
TBAJ-876 75mg MAD	Active comparator	75 mg TBAJ-876) (n=9) for 14 days under fed conditions Receives: Drug: TBAJ-876 suspension
TBAJ-876 200mg MAD	Active comparator	200 mg TBAJ-876 (n=9) for 14 days under fed conditions Receives: Drug: TBAJ-876 suspension
TBAJ-876 Placebo MAD	Placebo comparator	Matching placebo for TBAJ-876 for 14 days under fed conditions (n=12) Receives: Drug: Placebo suspension
TBAJ-876 1x100 mg rBA fasted	Active comparator	Single dose TBAJ-876 of 100 mg (1 x 100 mg tablet) (n=10) under fasted conditions Receives: Drug: TBAJ-876 100 mg tablet
TBAJ-876 1x100 mg rBA fed	Active comparator	Single dose TBAJ-876 of 100 mg (1 x 100 mg tablet) (n=10) under fed conditions Receives: Drug: TBAJ-876 100 mg tablet
TBAJ-876 4x25 mg rBA fasted	Active comparator	Single dose TBAJ-876 of 100 mg (4 x 25 mg tablets) (n=10) under fasted conditions Receives: Drug: TBAJ-876 25 mg tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants with Treatment-Related Adverse Events in Part 1, Single Ascending Dose
Subjects will be monitored for any adverse events from the signing of the consent form until the end-of-study visit. The Investigator or a Sub-Investigator will assess its relationship to the study drug.
Measured: Day 1 to Day 28
Number of Participants with Treatment-Related Adverse Events in Part 2, Multiple Ascending Dose
Subjects will be monitored for any adverse events from the signing of the consent form until the end-of-study visit. The Investigator or a Sub-Investigator will assess its relationship to the study drug.
Measured: Day 1 to Day 133
Number of Participants with Treatment-Related Adverse Events in Part 3, Relative Bioavailability Study
Subjects will be monitored for any adverse events from the signing of the consent form until the end-of-study visit. The Investigator or a Sub-Investigator will assess its relationship to the study drug.
Measured: Day 1 to Day 21

Secondary outcomes (16)

AUCExtrap [Pharmacokinetic Analysis]
PK parameters will be calculated from plasma concentrations of TBAJ-876 TBAJ-876, M2, and M3. AUCExtrap is the percentage of AUCinf based on extrapolation.
Measured: Days 1 - 28
AUCinf [Pharmacokinetic Analysis]
PK parameters will be calculated from plasma concentrations of TBAJ-876 TBAJ-876, M2, and M3. AUCinf is area under the concentration-time curve from time-zero extrapolated to infinity.
Measured: Days 1 - 28
AUClast [Pharmacokinetic Analysis]
PK parameters will be calculated from plasma concentrations of TBAJ-876 TBAJ-876, M2, and M3. AUClast area under the concentration-time curve from time-zero to the time of the last quantifiable concentration; calculated using the linear trapezoidal rule.
Measured: Days 1 - 28
AUCtau [Pharmacokinetic Analysis]
PK parameters will be calculated from plasma concentrations of TBAJ-876 TBAJ-876, M2, and M3. AUCtau is area under the concentration-time curve during the dosing interval; calculated using the linear trapezoidal rule.
Measured: Days 1 - 28
Cavg [Pharmacokinetic Analysis]
PK parameters will be calculated from plasma concentrations of TBAJ-876 TBAJ-876, M2, and M3. Cavg is average concentration during the dosing interval.
Measured: Days 1 - 28
Clast [Pharmacokinetic Analysis]
PK parameters will be calculated from plasma concentrations of TBAJ-876 TBAJ-876, M2, and M3. Clast is the last quantifiable concentration determined directly from individual concentration-time data.
Measured: Days 1 - 28
CL/F [Pharmacokinetic Analysis]
PK parameters will be calculated from plasma concentrations of TBAJ-876 TBAJ-876, M2, and M3. CL/F is apparent total clearance after single administration.
Measured: Days 1 - 28
CLss/F [Pharmacokinetic Analysis]
PK parameters will be calculated from plasma concentrations of TBAJ-876 TBAJ-876, M2, and M3. CLss/F is apparent total clearance after multiple administration.
Measured: Days 1 - 28
Cmax [Pharmacokinetic Analysis]
PK parameters will be calculated from plasma concentrations of TBAJ-876 TBAJ-876, M2, and M3. Cmax is maximum concentration, determined directly from individual concentration-time data.
Measured: Days 1 - 28
RAUC [Pharmacokinetic Analysis]
PK parameters will be calculated from plasma concentrations of TBAJ-876 TBAJ-876, M2, and M3. RAUC is accumulation factor during multiple dosing, based on AUCtau.
Measured: Days 1 - 28
RCmax [Pharmacokinetic Analysis]
PK parameters will be calculated from plasma concentrations of TBAJ-876 TBAJ-876, M2, and M3. RCmax is accumulation factor during multiple dosing, based on Cmax.
Measured: Days 1 - 28
Tlast [Pharmacokinetic Analysis]
PK parameters will be calculated from plasma concentrations of TBAJ-876 TBAJ-876, M2, and M3. Tlast is time of the last quantifiable concentration.
Measured: Days 1 - 28
Tmax [Pharmacokinetic Analysis]
PK parameters will be calculated from plasma concentrations of TBAJ-876 TBAJ-876, M2, and M3. Tmax is time of the maximum concentration.
Measured: Days 1 - 28
T1/2 [Pharmacokinetic Analysis]
PK parameters will be calculated from plasma concentrations of TBAJ-876 TBAJ-876, M2, and M3. T1/2 is the observed terminal half-life.
Measured: Days 1 - 28
Vz/F [Pharmacokinetic Analysis]
PK parameters will be calculated from plasma concentrations of TBAJ-876 TBAJ-876, M2, and M3. Vz/F is apparent volume of distribution in the terminal phase.
Measured: Days 1 - 28
λz [Pharmacokinetic Analysis]
PK parameters will be calculated from plasma concentrations of TBAJ-876 TBAJ-876, M2, and M3. λz is the observed terminal rate constant; estimated by linear regression through at least 3 data points in the terminal phase of the log concentration-time profile.
Measured: Days 1 - 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jun 202015 Nov 2022

First posted30 Jul 2020
Study start8 Jun 2020
Primary completion16 Jun 2022
Study completion15 Nov 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 Pulmonary DiseaseStudies 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: 137 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04493671
Sponsor's protocol ID: TBAJ-876-CL-001
Status last verified: May 2025
First submitted: 22 Jul 2020
Last updated: 4 Jun 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Lombardi A, Pappas F, Nedelman J, Hickman D, Jaw-Tsai S, Olugbosi M, Bruinenberg P, Beumont M, Sun E. Pharmacokinetics and safety of TBAJ-876, a novel antimycobacterial diarylquinoline, in healthy subjects. Antimicrob Agents Chemother. 2024 Oct 8;68(10):e0061324. doi: 10.1128/aac.00613-24. Epub 2024 Aug 28.
PubMed 39194204

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Partially Blind, Placebo Controlled, Randomized, Combined Single Ascending Dose With a Food Effect Cohort, Multiple Ascending Dose, and Relative Bioavailability Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBAJ-876 in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT04493671
Acronym / sponsor ID: TBAJ-876-CL-001
Conditions: Pulmonary Disease, Tuberculosis, Pulmonary, Tuberculosis, Multi Drug Resistant Tuberculosis, Drug Sensitive Tuberculosis, Drug-resistant Tuberculosis
Keywords: TBAJ-876, Diarylquinoline, DARQ
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 137 participants (actual)
Lead sponsor: Global Alliance for TB Drug DevelopmentUniversity, hospital or other
Study start: 8 Jun 2020 (actual)
Primary completion: 16 Jun 2022 (actual)
Study completion: 15 Nov 2022 (actual)
First posted: 30 Jul 2020 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 16

Arm	Type	Receives
TBAJ-876 10mg SAD	Active comparator	Drug: TBAJ-876 suspensionCohort 1 single dose of 10 mg TBAJ-876 (n=6) under fasted conditions
TBAJ-876 25mg SAD	Active comparator	Drug: TBAJ-876 suspensionCohort 2, Single dose of 25 mg TBAJ-876 (n=6) under fasted conditions
TBAJ-876 50mg SAD	Active comparator	Drug: TBAJ-876 suspensionCohort 3 single dose of 50 mg TBAJ-876 (n=6) under fasted conditions
TBAJ-876 100mg fasted SAD	Active comparator	Drug: TBAJ-876 suspensionCohort 4, single dose of 100 mg TBAJ-876 (n=9) under fasted conditions
TBAJ-876 100mg fed SAD	Active comparator	Drug: TBAJ-876 suspensionCohort 4, dose of 100 mg TBAJ-876 (n=10) under fed conditions
TBAJ-876 200mg SAD	Active comparator	Drug: TBAJ-876 suspensionCohort 5 single dose of 200 mg TBAJ-876 (n=6) under fasted conditions
TBAJ-876 400mg SAD	Active comparator	Drug: TBAJ-876 suspensionCohort 6, single dose of 400 mg TBAJ-876) (n=6) under fasted conditions
TBAJ-876 800mg SAD	Active comparator	Drug: TBAJ-876 suspensionCohort 7, Single dose of 800 mg TBAJ-876 (n=6) under fasted conditions
TBAJ-876 Placebo SAD	Placebo comparator	Drug: Placebo suspensionSingle dose matching placebo for TBAJ-876 under fasted conditions (n=13)
TBAJ-876 25mg MAD	Active comparator	Drug: TBAJ-876 suspension25 mg TBAJ-876 (n=9) for 14 days under fed conditions
TBAJ-876 75mg MAD	Active comparator	Drug: TBAJ-876 suspension75 mg TBAJ-876) (n=9) for 14 days under fed conditions
TBAJ-876 200mg MAD	Active comparator	Drug: TBAJ-876 suspension200 mg TBAJ-876 (n=9) for 14 days under fed conditions
TBAJ-876 Placebo MAD	Placebo comparator	Drug: Placebo suspensionMatching placebo for TBAJ-876 for 14 days under fed conditions (n=12)
TBAJ-876 1x100 mg rBA fasted	Active comparator	Drug: TBAJ-876 100 mg tabletSingle dose TBAJ-876 of 100 mg (1 x 100 mg tablet) (n=10) under fasted conditions
TBAJ-876 1x100 mg rBA fed	Active comparator	Drug: TBAJ-876 100 mg tabletSingle dose TBAJ-876 of 100 mg (1 x 100 mg tablet) (n=10) under fed conditions
TBAJ-876 4x25 mg rBA fasted	Active comparator	Drug: TBAJ-876 25 mg tabletSingle dose TBAJ-876 of 100 mg (4 x 25 mg tablets) (n=10) under fasted conditions

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 DMID 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 (5 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.
Current or history of prolonged QT syndrome15. Family history of long-QT syndrome or sudden death without a preceding diagnosis of a condition that could be causative of sudden death (such as known coronary artery disease, congestive heart failure, or terminal cancer).
If assigned to the fasted/fed cohort, is lactose intolerant.

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
TBAJ-876 suspensionTBAJ-876 oral suspension, orally administered	Drug	TBAJ-876 100mg fasted SAD, TBAJ-876 100mg fed SAD, TBAJ-876 10mg SAD, TBAJ-876 200mg MAD, TBAJ-876 200mg SAD, TBAJ-876 25mg MAD, TBAJ-876 25mg SAD, TBAJ-876 400mg SAD, TBAJ-876 50mg SAD, TBAJ-876 75mg MAD, TBAJ-876 800mg SAD
Placebo suspensionPlacebo for TBAJ-876 oral Suspension; orally administered	Drug	TBAJ-876 Placebo MAD, TBAJ-876 Placebo SAD
TBAJ-876 100 mg tabletTBAJ-876 100 mg tablets, orally administered	Drug	TBAJ-876 1x100 mg rBA fasted, TBAJ-876 1x100 mg rBA fed
TBAJ-876 25 mg tabletTBAJ-876 25 mg tablets, orally administered	Drug	TBAJ-876 4x25 mg rBA fasted

Primary outcome

Number of Participants with Treatment-Related Adverse Events in Part 1, Single Ascending Dose
Time frame: Day 1 to Day 28
Subjects will be monitored for any adverse events from the signing of the consent form until the end-of-study visit. The Investigator or a Sub-Investigator will assess its relationship to the study drug.
Number of Participants with Treatment-Related Adverse Events in Part 2, Multiple Ascending Dose
Time frame: Day 1 to Day 133
Subjects will be monitored for any adverse events from the signing of the consent form until the end-of-study visit. The Investigator or a Sub-Investigator will assess its relationship to the study drug.
Number of Participants with Treatment-Related Adverse Events in Part 3, Relative Bioavailability Study
Time frame: Day 1 to Day 21
Subjects will be monitored for any adverse events from the signing of the consent form until the end-of-study visit. The Investigator or a Sub-Investigator will assess its relationship to the study drug.

16 secondary outcomes

AUCExtrap [Pharmacokinetic Analysis]
Time frame: Days 1 - 28
AUCinf [Pharmacokinetic Analysis]
Time frame: Days 1 - 28
AUClast [Pharmacokinetic Analysis]
Time frame: Days 1 - 28
AUCtau [Pharmacokinetic Analysis]
Time frame: Days 1 - 28
Cavg [Pharmacokinetic Analysis]
Time frame: Days 1 - 28
Clast [Pharmacokinetic Analysis]
Time frame: Days 1 - 28
CL/F [Pharmacokinetic Analysis]
Time frame: Days 1 - 28
CLss/F [Pharmacokinetic Analysis]
Time frame: Days 1 - 28
Cmax [Pharmacokinetic Analysis]
Time frame: Days 1 - 28
RAUC [Pharmacokinetic Analysis]
Time frame: Days 1 - 28
RCmax [Pharmacokinetic Analysis]
Time frame: Days 1 - 28
Tlast [Pharmacokinetic Analysis]
Time frame: Days 1 - 28
Tmax [Pharmacokinetic Analysis]
Time frame: Days 1 - 28
T1/2 [Pharmacokinetic Analysis]
Time frame: Days 1 - 28
Vz/F [Pharmacokinetic Analysis]
Time frame: Days 1 - 28
λz [Pharmacokinetic Analysis]
Time frame: Days 1 - 28

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 4 Jun 2025.
Results publication: PubMed 39194204Lombardi A, Pappas F, Nedelman J, Hickman D, Jaw-Tsai S, Olugbosi M, Bruinenberg P, Beumont M, Sun E. Pharmacokinetics and safety of TBAJ-876, a novel antimycobacterial diarylquinoline, in healthy subjects. Antimicrob Agents Chemother. 2024 Oct 8;68(10):e0061324. doi: 10.1128/aac.00613-24. Epub 2024 Aug 28.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Antonio Lombardi, MD 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?

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 5 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 4 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?

Number of Participants with Treatment-Related Adverse Events in Part 1, Single Ascending Dose (time frame: Day 1 to Day 28). The study lists 3 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 NCT04493671, 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 4 Jun 2025.