Healthy Adult ParticipantsPhase 1NCT07883226
A Phase 1 Multiple Dose Trial in Healthy Adult Participants to Evaluate the Safety, Tolerability, Drug-Drug Interactions, and Pharmacokinetics of TBD11
A Phase 1 study testing TBD11 (300 mg), Itraconazole (200 mg) and Rifampicin 600mg in people with Healthy Adult Participants, run by Gates Medical Research Institute at 1 site in South Africa.
Trial summary
This is a Phase 1, randomized, double-blind, placebo-controlled, multiple dose trial of TBD11 in healthy adults. It includes a dedicated open-label cohort in which TBD11 will be administered as a single dose with either a strong cytochrome P450 3A (CYP3A) inhibitor (itraconazole) or a strong CYP3A inducer (rifampicin)… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- TBD11 (300 mg), Itraconazole (200 mg) and Rifampicin 600mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteSouth Africa
- Study dates
- 21 Oct 2026to 30 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 55 years of age, inclusive.
- Healthy, as determined by the Investigator through medical history and clinical examination before enrolment.
- Able to understand and comply with trial and site procedures, understand study risks, and provide written informed consent before any trial-specific procedure.
- Able to complete all Screening evaluations and remain in the clinical research facility for required inpatient periods.
- BMI between 18 and 32 kg/m², inclusive, and body weight of at least 50 kg at Screening.
- Resting vital signs within protocol-defined ranges at Screening and Day -1.
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- 12-lead ECG consistent with normal cardiac conduction and function at Screening.
- Non-smoker within the previous 90 days, with negative urine cotinine at Screening and no use of tobacco- or nicotine-containing products.
- Screening clinical chemistry, coagulation, complete blood count, and urinalysis within laboratory reference ranges, unless assessed as not clinically significant by the Investigator/designee.
- Negative HBsAg and HCV antibody at Screening.
- Negative IGRA test for TB infection.
- Negative HIV antibody test at Screening.
- Negative urine drug screen and urine alcohol screen at Screening and Day -1.
- For participants assigned female sex at birth: negative urine and serum pregnancy tests at Screening and non-childbearing potential as defined in the protocol.
- For participants assigned male sex at birth who are not sterilized and sexually active with a female partner of childbearing potential: agreement to use condoms from Day -1 through 90 days after the last dose and not donate sperm during the trial and for 90 days after the last dose.
Who cannot join
- Current or past clinically significant cardiovascular, cerebrovascular, respiratory, gastrointestinal, haematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease.
- Current or past condition expected to require treatment during the trial with medication known to inhibit or induce CYP3A4.
- Clinically relevant cardiovascular disorder or symptoms suggestive of such disorder.
- Prior history of TB infection or TB disease.
- Current cough lasting more than 2 weeks, fever, night sweats, or unexplained weight loss.
- Close household or repeated living/workspace contact with an individual with active TB in the preceding 12 months.
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- Active malignancy within 5 years of Screening, except basal cell or squamous cell skin cancers; any history of breast cancer or melanoma is exclusionary.
- History of drug abuse within 1 year before Screening or use of specified hard drugs within 1 year before Screening, unless limited to prescribed opioid or amphetamine medication not currently being taken.
- Surgical or medical condition that may alter absorption, metabolism, or excretion of trial treatment.
- Use of prohibited medications, vitamins, dietary supplements, herbal products, or vaccination within the protocol-defined windows.
- Contraindication to trial interventions or excipients, or clinically significant allergic/anaphylactic reaction to any medication.
- Participation in another investigational drug, vaccine, or device study within 30 days or 5 half-lives, whichever is longer, before Screening and during this trial.
- Any condition that may interfere with informed consent, compliance, interpretation of results, or place the participant at undue risk.
- Blood donation within 2 months before Screening or planned blood donation during the trial or within 12 weeks after the final visit.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa1 site, 1 recruiting
- Recruiting
FARMOVS (Pty) Ltd
Bloemfontein, 9301
Riana Fourie, Dip HIV Man (SA), MBChB, +27 51 410 3060, Riana.Fourie@farmovs.com
Lizette Herbst, +27 51 410-3004
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Dose Trial in Healthy Adult Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBD11 With Up to 84-day Period of Fixed Daily Dosing, With an Evaluation of Drug-Drug Interactions
This is a Phase 1, randomized, double-blind, placebo-controlled, multiple dose trial of TBD11 in healthy adults. It includes a dedicated open-label cohort in which TBD11 will be administered as a single dose with either a strong cytochrome P450 3A (CYP3A) inhibitor (itraconazole) or a strong CYP3A inducer (rifampicin) in 2 trial periods to evaluate DDI. The trial will consist of 3 cohorts; Cohort 1 will occur prior to Cohort 2 and Cohort 3. Cohort 2 and Cohort 3 will start after completion of Cohort 1 and will run in parallel. Cohort 1 will be double-blind and participants will receive 300 mg TBD11 or placebo once daily for 14 days. Cohort 2 will be the open-label DDI cohort. Cohort 3 will be double-blind and participants will receive TBD11 or placebo once daily for 84 days.
- Conditions
- Healthy Adult Participants
- Being tested
- TBD11 (300 mg), Placebo, Itraconazole (200 mg), Rifampicin 600mg, TBD11 (50 mg)
- Keywords
- Mycobacterium tuberculosis, TBD11, Rifampicin, Itraconazole, Multiple Dose, Drug-Drug Interactions, Fixed Daily Dosing, Safety, Tolerability, Pharmacokinetics, DDI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TBD11 (300 mg)Drug
TBD11: TBD11 administered orally at 300 mg
PlaceboDrug
Matching placebo administered orally according to the cohort-specific dosing schedule.
Itraconazole (200 mg)Drug
Itraconazole 200 mg orally once daily, with a 400 mg loading dose on the first day of administration.
Rifampicin 600mgDrug
Rifampicin 600 mg orally once daily.
TBD11 (50 mg)Drug
TBD11: TBD11 administered orally at 50 mg
TBD11 (up to 300 mg)Drug
TBD11: TBD11 administered orally at up to 300 mg
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (TBD11 or placebo) | Experimental | Participants randomized 3:1 to receiveTBD11 300 mg or matching placebo once daily for up to 14 days Receives: Drug: TBD11 (300 mg); Drug: Placebo |
| Cohort 2 Arm A | Experimental | Participants receive TBD11 50 mg single dose alone and in combination with itraconazole 200 mg BID loading dose followed by 200 mg QD. Receives: Drug: Itraconazole (200 mg); Drug: TBD11 (50 mg) |
| Cohort 2 Arm B | Experimental | Participants receive TBD11 up to 300 mg single dose alone and in combination with rifampicin 600 mg QD. Receives: Drug: Rifampicin 600mg; Drug: TBD11 (up to 300 mg) |
| Cohort 3 (TBD11 or placebo) | Experimental | Participants randomized 2:1 to receive TBD11 up to 300 mg or matching placebo once daily for up to 84 days Receives: Drug: Placebo; Drug: TBD11 (up to 300 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events
Number of participants with one or more treatment-emergent adverse events, summarized overall and by severity, Investigator-assessed relationship to trial intervention, System Organ Class, and Preferred Term.
Measured: Cohort 1: Day 1 through Day 19. Cohort 2 Arm A: Period 1, Day 1 through Day 8; Period 2, Day -4 through Day 16. Cohort 2 Arm B: Period 1, Day 1 through Day 8; Period 2, Day -10 through Day 8. Cohort 3: Day 1 through Day 92.
Number of Participants With Serious Adverse Events
Number of participants with one or more serious adverse events, summarized overall and by severity, Investigator-assessed relationship to trial intervention, System Organ Class, and Preferred Term.
Measured: Cohort 1: Day 1 through Day 19. Cohort 2 Arm A: Period 1, Day 1 through Day 8; Period 2, Day -4 through Day 16. Cohort 2 Arm B: Period 1, Day 1 through Day 8; Period 2, Day -10 through Day 8. Cohort 3: Day 1 through Day 92.
Number of Participants With Adverse Events Leading to Trial Intervention Interruption
Number of participants with one or more adverse events resulting in temporary interruption of trial intervention, summarized overall and by severity, Investigator-assessed relationship to trial intervention, System Organ Class, and Preferred Term.
Measured: Cohort 1: Day 1 through Day 19. Cohort 2 Arm A: Period 1, Day 1 through Day 8; Period 2, Day -4 through Day 16. Cohort 2 Arm B: Period 1, Day 1 through Day 8; Period 2, Day -10 through Day 8. Cohort 3: Day 1 through Day 92.
Number of Participants With Adverse Events Leading to Trial Intervention Discontinuation
Number of participants with one or more adverse events resulting in permanent discontinuation of trial intervention, summarized overall and by severity, Investigator-assessed relationship to trial intervention, System Organ Class, and Preferred Term.
Measured: Cohort 1: Day 1 through Day 19. Cohort 2 Arm A: Period 1, Day 1 through Day 8; Period 2, Day -4 through Day 16. Cohort 2 Arm B: Period 1, Day 1 through Day 8; Period 2, Day -10 through Day 8. Cohort 3: Day 1 through Day 92.
Number of Participants With Treatment-Emergent Clinical Chemistry Abnormalities
Number of participants with treatment-emergent clinical chemistry abnormalities, summarized by visit, worst post-baseline grade, and grade shift from baseline using the protocol-specified toxicity grading criteria.
Measured: Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92.
Number of Participants With Treatment-Emergent Hematology Abnormalities
Number of participants with treatment-emergent hematology abnormalities, summarized by visit, worst post-baseline grade, and grade shift from baseline using the protocol-specified toxicity grading criteria.
Measured: Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92.
Number of Participants With Treatment-Emergent Coagulation Abnormalities
Number of participants with treatment-emergent coagulation abnormalities, summarized by visit, worst post-baseline grade, and grade shift from baseline using the protocol-specified toxicity grading criteria.
Measured: Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92.
Number of Participants With Treatment-Emergent Urinalysis Abnormalities
Number of participants with treatment-emergent urinalysis abnormalities, summarized by visit, worst post-baseline grade, and grade shift from baseline using the protocol-specified toxicity grading criteria.
Measured: Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92.
Number of Participants With Treatment-Emergent Lipid Profile Abnormalities
Number of Cohort 3 participants with treatment-emergent lipid profile abnormalities, summarized by visit, worst post-baseline grade, and grade shift from baseline.
Measured: Baseline and scheduled post-baseline assessments from Day 1 through Day 92 for Cohort 3.
Change From Baseline in Systolic Blood Pressure
Change from baseline in systolic blood pressure, measured in millimeters of mercury (mmHg).
Measured: Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92.
Change From Baseline in Diastolic Blood Pressure
Change from baseline in diastolic blood pressure, measured in millimeters of mercury (mmHg)
Measured: Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92.
Change From Baseline in Heart Rate
Change from baseline in heart rate, measured in beats per minute (bpm)
Measured: Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92.
Change From Baseline in Body Temperature
Change from baseline in body temperature, measured in degrees Celsius (°C)
Measured: Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92.
Change From Baseline in 12-Lead ECG Heart Rate
Change From Baseline in 12-Lead ECG Heart Rate Change from baseline in 12-lead ECG heart rate, measured in beats per minute (bpm)
Measured: Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92.
Change From Baseline in RR Interval
Change From Baseline in RR Interval Change from baseline in RR interval, measured in milliseconds (ms).
Measured: Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92.
Change From Baseline in PR Interval
Change From Baseline in PR Interval Change from baseline in PR interval, measured in milliseconds (ms).
Measured: Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92.
Change From Baseline in QRS Duration
Change From Baseline in QRS Duration Change from baseline in QRS duration, measured in milliseconds (ms).
Measured: Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92.
Change From Baseline in QT Interval
Change From Baseline in QT Interval Change from baseline in QT interval, measured in milliseconds (ms).
Measured: Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92.
Change From Baseline in QTcF Interval
Change from baseline in QT interval corrected for heart rate using Fridericia's formula (QTcF), measured in milliseconds (ms).
Measured: Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92.
Secondary outcomes (10)
Maximum Observed Plasma Concentration of TBD11
Maximum observed plasma concentration (Cmax) of TBD11 following single-dose and multiple-dose administration, measured in nanograms per milliliter (ng/mL).
Measured: Cohort 1: Day 1 and Day 14. Cohort 3: Day 1 and Day 84.
Time to Maximum Observed Plasma Concentration of TBD11
Time to reach the maximum observed plasma concentration (Tmax) of TBD11, measured in hours (h).
Measured: Cohort 1: Day 1 and Day 14. Cohort 3: Day 1 and Day 84.
Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours for TBD11
Area under the plasma concentration-time curve from time zero to 24 hours (AUC0-24), measured in hour-nanograms per milliliter (h·ng/mL).
Measured: Cohort 1: Day 1. Cohort 3: Day 1
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration for TBD11
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration (AUClast), measured in hour-nanograms per milliliter (h·ng/mL).
Measured: Cohort 1: Day 14. Cohort 3: Day 84.
Minimum Plasma Concentration of TBD11
Minimum plasma concentration (Cmin) of TBD11 after multiple-dose administration, measured in nanograms per milliliter (ng/mL).
Measured: Cohort 1: Day 14. Cohort 3: Day 84
Accumulation Ratio for TBD11 Based on AUC Over the Dosing Interval
Accumulation ratio calculated as AUCtau following multiple-dose administration divided by AUC0-24 following the Day 1 dose.
Measured: Cohort 1: Day 14 compared with Day 1. Cohort 3: Day 84 compared with Day 1.
Geometric Mean Ratio of TBD11 Cmax With and Without Itraconazole
Geometric mean ratio and corresponding two-sided 90% confidence interval for TBD11 Cmax, where Test is TBD11 co-administered with itraconazole and Reference is TBD11 administered alone.
Measured: Cmax derived from plasma PK samples collected from pre-dose through 12 hours after TBD11 administration on Day 1 of Period 1 and Day 1 of Period 2.
Geometric Mean Ratio of TBD11 AUC0-inf With and Without Itraconazole
Geometric mean ratio and corresponding two-sided 90% confidence interval for TBD11 area under the plasma concentration-time curve from time zero extrapolated to infinity, where Test is TBD11 co-administered with itraconazole and Reference is TBD11 administered alone.
Measured: AUC0-inf derived from plasma PK samples collected from pre-dose through 168 hours after TBD11 administration in Period 1 and through 360 hours after TBD11 administration in Period 2.
Geometric Mean Ratio of TBD11 Cmax With and Without Rifampicin
Geometric mean ratio and corresponding two-sided 90% confidence interval for TBD11 Cmax, where Test is TBD11 co-administered with rifampicin and Reference is TBD11 administered alone.
Measured: Cmax derived from plasma PK samples collected from pre-dose through 12 hours after TBD11 administration on Day 1 of Period 1 and Day 1 of Period 2.
Geometric Mean Ratio of TBD11 AUC0-inf With and Without Rifampicin
Geometric mean ratio and corresponding two-sided 90% confidence interval for TBD11 area under the plasma concentration-time curve from time zero extrapolated to infinity, where Test is TBD11 co-administered with rifampicin and Reference is TBD11 administered alone.
Measured: AUC0-inf derived from plasma PK samples collected from pre-dose through 168 hours after TBD11 administration in each treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start21 Oct 2026
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies 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
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gates Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- IQVIA RDS Inc.
- Responsible party
- Sponsor
- Investigators
- Gates MRI, Study director, Gates Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883226
- Sponsor's protocol ID
- Gates MRI-TBD11-104
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Dose Trial in Healthy Adult Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBD11 With Up to 84-day Period of Fixed Daily Dosing, With an Evaluation of Drug-Drug Interactions
- ClinicalTrials.gov ID
- NCT07883226
- Acronym / sponsor ID
- Gates MRI-TBD11-104
- Conditions
- Healthy Adult Participants
- Keywords
- Mycobacterium tuberculosis, TBD11, Rifampicin, Itraconazole, Multiple Dose, Drug-Drug Interactions, Fixed Daily Dosing, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Gates Medical Research InstituteUniversity, hospital or other
- Collaborators
- IQVIA RDS Inc.
- Study start
- 21 Oct 2026 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 20 Oct 2026 (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.
This is a Phase 1, randomized, double-blind, placebo-controlled, multiple dose trial of TBD11 in healthy adults. It includes a dedicated open-label cohort in which TBD11 will be administered as a single dose with either a strong cytochrome P450 3A (CYP3A) inhibitor (itraconazole) or a strong CYP3A inducer (rifampicin) in 2 trial periods to evaluate DDI. The trial will consist of 3 cohorts; Cohort 1 will occur prior to Cohort 2 and Cohort 3. Cohort 2 and Cohort 3 will start after completion of Cohort 1 and will run in parallel. Cohort 1 will be double-blind and participants will receive 300 mg TBD11 or placebo once daily for 14 days. Cohort 2 will be the open-label DDI cohort. Cohort 3 will be double-blind and participants will receive TBD11 or placebo once daily for 84 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (TBD11 or placebo) | Experimental | Drug: TBD11 (300 mg), Drug: PlaceboParticipants randomized 3:1 to receiveTBD11 300 mg or matching placebo once daily for up to 14 days |
| Cohort 2 Arm A | Experimental | Drug: Itraconazole (200 mg), Drug: TBD11 (50 mg)Participants receive TBD11 50 mg single dose alone and in combination with itraconazole 200 mg BID loading dose followed by 200 mg QD. |
| Cohort 2 Arm B | Experimental | Drug: Rifampicin 600mg, Drug: TBD11 (up to 300 mg)Participants receive TBD11 up to 300 mg single dose alone and in combination with rifampicin 600 mg QD. |
| Cohort 3 (TBD11 or placebo) | Experimental | Drug: Placebo, Drug: TBD11 (up to 300 mg)Participants randomized 2:1 to receive TBD11 up to 300 mg or matching placebo once daily for up to 84 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 18 to 55 years of age, inclusive.
- Healthy, as determined by the Investigator through medical history and clinical examination before enrolment.
- Able to understand and comply with trial and site procedures, understand study risks, and provide written informed consent before any trial-specific procedure.
- Able to complete all Screening evaluations and remain in the clinical research facility for required inpatient periods.
- BMI between 18 and 32 kg/m², inclusive, and body weight of at least 50 kg at Screening.
Key exclusion criteria (14 listed)
- Current or past clinically significant cardiovascular, cerebrovascular, respiratory, gastrointestinal, haematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease.
- Current or past condition expected to require treatment during the trial with medication known to inhibit or induce CYP3A4.
- Clinically relevant cardiovascular disorder or symptoms suggestive of such disorder.
- Prior history of TB infection or TB disease.
- Current cough lasting more than 2 weeks, fever, night sweats, or unexplained weight loss.
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 |
|---|---|---|
| TBD11 (300 mg)TBD11: TBD11 administered orally at 300 mg | Drug | Cohort 1 (TBD11 or placebo) |
| PlaceboMatching placebo administered orally according to the cohort-specific dosing schedule. | Drug | Cohort 1 (TBD11 or placebo), Cohort 3 (TBD11 or placebo) |
| Itraconazole (200 mg)Itraconazole 200 mg orally once daily, with a 400 mg loading dose on the first day of administration. | Drug | Cohort 2 Arm A |
| Rifampicin 600mgRifampicin 600 mg orally once daily. | Drug | Cohort 2 Arm B |
| TBD11 (50 mg)TBD11: TBD11 administered orally at 50 mg | Drug | Cohort 2 Arm A |
| TBD11 (up to 300 mg)TBD11: TBD11 administered orally at up to 300 mg | Drug | Cohort 2 Arm B, Cohort 3 (TBD11 or placebo) |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events
Time frame: Cohort 1: Day 1 through Day 19. Cohort 2 Arm A: Period 1, Day 1 through Day 8; Period 2, Day -4 through Day 16. Cohort 2 Arm B: Period 1, Day 1 through Day 8; Period 2, Day -10 through Day 8. Cohort 3: Day 1 through Day 92.
Number of participants with one or more treatment-emergent adverse events, summarized overall and by severity, Investigator-assessed relationship to trial intervention, System Organ Class, and Preferred Term.
Number of Participants With Serious Adverse Events
Time frame: Cohort 1: Day 1 through Day 19. Cohort 2 Arm A: Period 1, Day 1 through Day 8; Period 2, Day -4 through Day 16. Cohort 2 Arm B: Period 1, Day 1 through Day 8; Period 2, Day -10 through Day 8. Cohort 3: Day 1 through Day 92.
Number of participants with one or more serious adverse events, summarized overall and by severity, Investigator-assessed relationship to trial intervention, System Organ Class, and Preferred Term.
Number of Participants With Adverse Events Leading to Trial Intervention Interruption
Time frame: Cohort 1: Day 1 through Day 19. Cohort 2 Arm A: Period 1, Day 1 through Day 8; Period 2, Day -4 through Day 16. Cohort 2 Arm B: Period 1, Day 1 through Day 8; Period 2, Day -10 through Day 8. Cohort 3: Day 1 through Day 92.
Number of participants with one or more adverse events resulting in temporary interruption of trial intervention, summarized overall and by severity, Investigator-assessed relationship to trial intervention, System Organ Class, and Preferred Term.
Number of Participants With Adverse Events Leading to Trial Intervention Discontinuation
Time frame: Cohort 1: Day 1 through Day 19. Cohort 2 Arm A: Period 1, Day 1 through Day 8; Period 2, Day -4 through Day 16. Cohort 2 Arm B: Period 1, Day 1 through Day 8; Period 2, Day -10 through Day 8. Cohort 3: Day 1 through Day 92.
Number of participants with one or more adverse events resulting in permanent discontinuation of trial intervention, summarized overall and by severity, Investigator-assessed relationship to trial intervention, System Organ Class, and Preferred Term.
Number of Participants With Treatment-Emergent Clinical Chemistry Abnormalities
Time frame: Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92.
Number of participants with treatment-emergent clinical chemistry abnormalities, summarized by visit, worst post-baseline grade, and grade shift from baseline using the protocol-specified toxicity grading criteria.
Number of Participants With Treatment-Emergent Hematology Abnormalities
Time frame: Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92.
Number of participants with treatment-emergent hematology abnormalities, summarized by visit, worst post-baseline grade, and grade shift from baseline using the protocol-specified toxicity grading criteria.
Number of Participants With Treatment-Emergent Coagulation Abnormalities
Time frame: Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92.
Number of participants with treatment-emergent coagulation abnormalities, summarized by visit, worst post-baseline grade, and grade shift from baseline using the protocol-specified toxicity grading criteria.
Number of Participants With Treatment-Emergent Urinalysis Abnormalities
Time frame: Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92.
Number of participants with treatment-emergent urinalysis abnormalities, summarized by visit, worst post-baseline grade, and grade shift from baseline using the protocol-specified toxicity grading criteria.
Number of Participants With Treatment-Emergent Lipid Profile Abnormalities
Time frame: Baseline and scheduled post-baseline assessments from Day 1 through Day 92 for Cohort 3.
Number of Cohort 3 participants with treatment-emergent lipid profile abnormalities, summarized by visit, worst post-baseline grade, and grade shift from baseline.
Change From Baseline in Systolic Blood Pressure
Time frame: Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92.
Change from baseline in systolic blood pressure, measured in millimeters of mercury (mmHg).
Change From Baseline in Diastolic Blood Pressure
Time frame: Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92.
Change from baseline in diastolic blood pressure, measured in millimeters of mercury (mmHg)
Change From Baseline in Heart Rate
Time frame: Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92.
Change from baseline in heart rate, measured in beats per minute (bpm)
Change From Baseline in Body Temperature
Time frame: Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92.
Change from baseline in body temperature, measured in degrees Celsius (°C)
Change From Baseline in 12-Lead ECG Heart Rate
Time frame: Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92.
Change From Baseline in 12-Lead ECG Heart Rate Change from baseline in 12-lead ECG heart rate, measured in beats per minute (bpm)
Change From Baseline in RR Interval
Time frame: Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92.
Change From Baseline in RR Interval Change from baseline in RR interval, measured in milliseconds (ms).
Change From Baseline in PR Interval
Time frame: Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92.
Change From Baseline in PR Interval Change from baseline in PR interval, measured in milliseconds (ms).
Change From Baseline in QRS Duration
Time frame: Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92.
Change From Baseline in QRS Duration Change from baseline in QRS duration, measured in milliseconds (ms).
Change From Baseline in QT Interval
Time frame: Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92.
Change From Baseline in QT Interval Change from baseline in QT interval, measured in milliseconds (ms).
Change From Baseline in QTcF Interval
Time frame: Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92.
Change from baseline in QT interval corrected for heart rate using Fridericia's formula (QTcF), measured in milliseconds (ms).
10 secondary outcomes
Maximum Observed Plasma Concentration of TBD11
Time frame: Cohort 1: Day 1 and Day 14. Cohort 3: Day 1 and Day 84.
Time to Maximum Observed Plasma Concentration of TBD11
Time frame: Cohort 1: Day 1 and Day 14. Cohort 3: Day 1 and Day 84.
Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours for TBD11
Time frame: Cohort 1: Day 1. Cohort 3: Day 1
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration for TBD11
Time frame: Cohort 1: Day 14. Cohort 3: Day 84.
Minimum Plasma Concentration of TBD11
Time frame: Cohort 1: Day 14. Cohort 3: Day 84
Accumulation Ratio for TBD11 Based on AUC Over the Dosing Interval
Time frame: Cohort 1: Day 14 compared with Day 1. Cohort 3: Day 84 compared with Day 1.
Geometric Mean Ratio of TBD11 Cmax With and Without Itraconazole
Time frame: Cmax derived from plasma PK samples collected from pre-dose through 12 hours after TBD11 administration on Day 1 of Period 1 and Day 1 of Period 2.
Geometric Mean Ratio of TBD11 AUC0-inf With and Without Itraconazole
Time frame: AUC0-inf derived from plasma PK samples collected from pre-dose through 168 hours after TBD11 administration in Period 1 and through 360 hours after TBD11 administration in Period 2.
Geometric Mean Ratio of TBD11 Cmax With and Without Rifampicin
Time frame: Cmax derived from plasma PK samples collected from pre-dose through 12 hours after TBD11 administration on Day 1 of Period 1 and Day 1 of Period 2.
Geometric Mean Ratio of TBD11 AUC0-inf With and Without Rifampicin
Time frame: AUC0-inf derived from plasma PK samples collected from pre-dose through 168 hours after TBD11 administration in each treatment period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Yes
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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.
Gates MRI study director
Gates Medical Research Institute
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 TBD11 (300 mg), Itraconazole (200 mg) and Rifampicin 600mg in people with Healthy Adult Participants, run by Gates Medical Research Institute at 1 site in South Africa.
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 15 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. 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 South Africa. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gates MRI (+1-857-702-2108, Clinical.trials@gatesmri.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (time frame: Cohort 1: Day 1 through Day 19. Cohort 2 Arm A: Period 1, Day 1 through Day 8; Period 2, Day -4 through Day 16. Cohort 2 Arm B: Period 1, Day 1 through Day 8; Period 2, Day -10 through Day 8. Cohort 3: Day 1 through Day 92.). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2026.