Healthy Adult ParticipantsPhase 1NCT06707142
A Trial in Healthy Adult Participants to Evaluate the Safety, Tolerability, and Behavior in the Body of TBD11
A Phase 1 study testing TBD11 in people with Healthy Adult Participants, run by Gates Medical Research Institute at 1 site in United States.
Trial summary
This is a randomized, double-blind, placebo controlled First in human (FIH) trial of TBD11, administered to healthy adults. The trial will be conducted in two parts. Part 1 will consist of single ascending dose (SAD) and Food effect (FE) cohorts, and Part 2 will consist of multiple ascending dose (MAD) cohorts and… Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- TBD11
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2024to 27 Feb 2026
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is healthy as determined by the Investigator via medical history and clinical examination before enrollment in the trial.
- Can understand and comply with the trial and site procedures, understand the risks involved in the trial, and provide written informed consent before the first trial-specific procedure.
- Can complete all Screening period evaluations and stay in the clinical research facility for the duration of the inpatient periods of the trial.
- Has Body Mass Index (BMI) between 18 and 32 kilograms per meter square (kg/m2), inclusive, and body weight not less than 50 kg at Screening.
- Has resting vital signs within the following ranges at Screening and Day -1:
- Systolic blood pressure (SBP) >= 100 millimeters of Mercury (mmHg) and <= 140 mmHg
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- Diastolic blood pressure (DBP) >= 60 mmHg and <= 90 mmHg
- Heart rate between 50 and 100 beats per minute (bpm)
- If individual's assigned sex at birth is female, they must have negative urine and serum pregnancy tests at Screening, and be of non-childbearing potential based on either of the following:
- Is post-menopausal defined as amenorrhea for at least 12 months in absence of any exogenous hormonal treatments and follicle stimulating hormone (FSH) levels in the laboratory-defined postmenopausal range, or,
- Reports being surgically sterilized (ie, tubal ligation, hysterectomy, bilateral oophorectomy/salpingectomy), and provides written documentation [(ie, medical record(s)], where feasible, to document such procedure(s) to the Principal Investigator. The site must make documented attempts to obtain medical records. If records cannot be retrieved, a participant may be enrolled at the Principal Investigator's discretion.
Who cannot join
- Has current or past history of a clinically significant cardiovascular, cerebrovascular, respiratory, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease, as determined by the Investigator.
- Has history of or has clinically relevant cardiovascular disorder, such as heart failure, coronary artery disease, controlled or uncontrolled hypertension, arrhythmia, tachyarrhythmia, prolonged QT syndrome, or presence of symptom(s) strongly suggestive of such a problem, such as exertional chest pressure/pain or unexplained syncope.
- Had an active malignancy within 5 years from Screening, except basal cell or squamous cell skin cancers. Any history of breast cancer or melanoma will be exclusionary.
- Has history of any drug abuse within 1 year prior to Screening or has used any hard drugs (such as cocaine, phencyclidine [PCP], natural and synthetic opiates, and amphetamine derivatives) within 1 year prior to Screening. Individuals that have taken an opioid or amphetamine medication within the previous year prior to Screening that was prescribed by a healthcare provider will not be excluded unless they are currently taking the medication at the time of Screening.
- Had any surgical or medical condition or history that, in the opinion of the Investigator, may potentially alter the absorption, metabolism, or excretion of study treatment, such as, but not limited to, gastric bypass, sleeve, banding surgery, or gastric or duodenal ulcers.
- Additional inclusion/exclusion criteria are defined in the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose and Multiple Ascending Dose Trial in Healthy Adult Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBD11 With an Open Label (Single Dose) Food Effect Panel
This is a randomized, double-blind, placebo controlled First in human (FIH) trial of TBD11, administered to healthy adults. The trial will be conducted in two parts. Part 1 will consist of single ascending dose (SAD) and Food effect (FE) cohorts, and Part 2 will consist of multiple ascending dose (MAD) cohorts and tablet formulation evaluation (Part 2, Cohort 4).
- Conditions
- Healthy Adult Participants
- Being tested
- TBD11, Placebo
- Keywords
- Single Ascending Dose, Multiple Ascending Dose, TBD11, Food Effect, Safety, Tolerability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TBD11Drug
TBD11 will be administered orally.
PlaceboDrug
Placebo will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| TBD11 | Experimental | In Part 1 double-blind phase of the trial (SAD), cohorts 1 to 5 and cohort 7 will receive doses of TBD11; 8 participants in each cohort will be randomized (6:2) to receive TBD11 or placebo.
The FE component of Part 1 (cohort 6) is open-label and 12 participants will receive TBD11 to evaluate the food effect.
In Part 2, double blind phase of the trial, MAD, 48 participants will be randomized (3:1) to receive TBD11 or placebo in Cohorts 1-3.
In Part 2 (Cohort 4), all participants will receive open-label TBD11 Receives: Drug: TBD11; Drug: Placebo |
| Placebo | Placebo comparator | Participants in Part 1 (cohorts 1-5 and cohort 7) and Part 2 will receive placebos matched to TBD11 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) after administration of single doses or multiple doses in healthy adult participants
Measured: Part (Pt.) 1 (Cohorts 1-5, 7):Day 1-7; Pt. 1 (Cohort 6, Periods [Pds.] 1-3):Day 1 through the washout of each respective Pd.; Pt. 2 (Cohorts 1-3):Day 1-19; Pt. 2 (Cohort 4): Pd.1: Day 1 through last day of washout; Pd.2: Day 1 through last day of washout
Number of participants with clinically significant changes from Baseline in clinical laboratory values
Blood samples will be collected for the analysis of clinical laboratory measures including clinical chemistry, hematology, coagulation, and urinalysis.
Measured: Part (Pt.) 1 (Cohorts 1-5, 7):Day 1-7; Pt. 1 (Cohort 6, Periods [Pds.] 1-3):Day 1 through the washout of each respective Pd.; Pt. 2 (Cohorts 1-3):Day 1-19; Pt. 2 (Cohort 4): Pd.1: Day 1 through last day of washout; Pd.2: Day 1 through last day of washout
Number of participants with clinically significant changes from Baseline in vital signs
Measured: Part (Pt.) 1 (Cohorts 1-5, 7):Day 1-7; Pt. 1 (Cohort 6, Periods [Pds.] 1-3):Day 1 through the washout of each respective Pd.; Pt. 2 (Cohorts 1-3):Day 1-19; Pt. 2 (Cohort 4): Pd.1: Day 1 through last day of washout; Pd.2: Day 1 through last day of washout
Number of participants with clinically significant changes from Baseline in Electrocardiogram (ECG) parameters
ECG parameters include heart rate, RR interval, PR interval, QRS duration, QT interval, and QT interval corrected by Fridericia's formula [QTcF].
Measured: Part (Pt.) 1 (Cohorts 1-5, 7):Day 1-7; Pt. 1 (Cohort 6, Periods [Pds.] 1-3):Day 1 through the washout of each respective Pd.; Pt. 2 (Cohorts 1-3):Day 1-19; Pt. 2 (Cohort 4): Pd.1: Day 1 through last day of washout; Pd.2: Day 1 through last day of washout
Secondary outcomes (12)
Part 1: Maximum plasma drug concentration (Cmax) of TBD11 in treated participants
Blood samples are collected at indicated time points for pharmacokinetic (PK) analysis of TBD11. PK parameters are analyzed using standard non-compartmental analysis.
Measured: Day 1
Part 1: Area under the concentration-time curve calculated to last quantifiable observed sample (AUClast) of TBD11 in treated participants
Measured: Day 1 through Day 7
Part 1: Terminal elimination half-life (t1/2) of TBD11 in treated participants
Measured: Day 1 through Day 7
Part 1: Time to maximal concentration (Tmax) of TBD11 in treated participants
Measured: Day 1
Part 2: Cmax of TBD11 in treated participants
Measured: Day 1 and Day 14
Part 2: Tmax of TBD11 in treated participants
Measured: Day 1 and Day 14
Part 2: Area Under the concentration time curve from Zero to 24 hours (AUC 0-24) of TBD11 in treated participants
Measured: Day 1
Part 2: AUC last of TBD11 in treated participants
Measured: Day 1 and Day 14
Part 2: Minimum plasma drug concentration (Cmin) of TBD11 in treated participants
Measured: Day 14
Part 2: Accumulation ratio (area under plasma concentration-time curve over dosing interval [AUCtau] / AUC0-24) of TBD11 in treated participants
Measured: Day 14
Part 2, Cohort 4: Geometric mean ratio (GMR) Cmax,capsules / Cmax,tablets in treated participants
Measured: Day 1 through last day of washout of the treatment period
Part 2: Cohort 4: GMR AUC (0-infinity) capsules / AUC(0-inf) tablets
Measured: Day 1 through last day of washout of the treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start5 Dec 2024
- Primary completion27 Feb 2026
- Study completion27 Feb 2026
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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gates Medical Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707142
- Sponsor's protocol ID
- Gates MRI-TBD11-101
- Status last verified
- Mar 2026
- First submitted
- 24 Nov 2024
- Last updated
- 30 Mar 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 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose and Multiple Ascending Dose Trial in Healthy Adult Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBD11 With an Open Label (Single Dose) Food Effect Panel
- ClinicalTrials.gov ID
- NCT06707142
- Acronym / sponsor ID
- Gates MRI-TBD11-101
- Conditions
- Healthy Adult Participants
- Keywords
- Single Ascending Dose, Multiple Ascending Dose, TBD11, Food Effect, Safety, Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Gates Medical Research InstituteUniversity, hospital or other
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 27 Feb 2026 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 27 Nov 2024 (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 randomized, double-blind, placebo controlled First in human (FIH) trial of TBD11, administered to healthy adults. The trial will be conducted in two parts. Part 1 will consist of single ascending dose (SAD) and Food effect (FE) cohorts, and Part 2 will consist of multiple ascending dose (MAD) cohorts and tablet formulation evaluation (Part 2, Cohort 4).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TBD11 | Experimental | Drug: TBD11, Drug: PlaceboIn Part 1 double-blind phase of the trial (SAD), cohorts 1 to 5 and cohort 7 will receive doses of TBD11; 8 participants in each cohort will be randomized (6:2) to receive TBD11 or placebo. The FE component of Part 1 (cohort 6) is open-label and 12 participants will receive TBD11 to evaluate the food effect. In Part 2, double blind phase of the trial, MAD, 48 participants will be randomized (3:1) to receive TBD11 or placebo in Cohorts 1-3. In Part 2 (Cohort 4), all participants will receive open-label TBD11 |
| Placebo | Placebo comparator | Drug: PlaceboParticipants in Part 1 (cohorts 1-5 and cohort 7) and Part 2 will receive placebos matched to TBD11 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Is healthy as determined by the Investigator via medical history and clinical examination before enrollment in the trial.
- Can understand and comply with the trial and site procedures, understand the risks involved in the trial, and provide written informed consent before the first trial-specific procedure.
- Can complete all Screening period evaluations and stay in the clinical research facility for the duration of the inpatient periods of the trial.
- Has Body Mass Index (BMI) between 18 and 32 kilograms per meter square (kg/m2), inclusive, and body weight not less than 50 kg at Screening.
- Has resting vital signs within the following ranges at Screening and Day -1:
Key exclusion criteria (6 listed)
- Has current or past history of a clinically significant cardiovascular, cerebrovascular, respiratory, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease, as determined by the Investigator.
- Has history of or has clinically relevant cardiovascular disorder, such as heart failure, coronary artery disease, controlled or uncontrolled hypertension, arrhythmia, tachyarrhythmia, prolonged QT syndrome, or presence of symptom(s) strongly suggestive of such a problem, such as exertional chest pressure/pain or unexplained syncope.
- Had an active malignancy within 5 years from Screening, except basal cell or squamous cell skin cancers. Any history of breast cancer or melanoma will be exclusionary.
- Has history of any drug abuse within 1 year prior to Screening or has used any hard drugs (such as cocaine, phencyclidine [PCP], natural and synthetic opiates, and amphetamine derivatives) within 1 year prior to Screening. Individuals that have taken an opioid or amphetamine medication within the previous year prior to Screening that was prescribed by a healthcare provider will not be excluded unless they are currently taking the medication at the time of Screening.
- Had any surgical or medical condition or history that, in the opinion of the Investigator, may potentially alter the absorption, metabolism, or excretion of study treatment, such as, but not limited to, gastric bypass, sleeve, banding surgery, or gastric or duodenal ulcers.
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 |
|---|---|---|
| TBD11TBD11 will be administered orally. | Drug | TBD11 |
| PlaceboPlacebo will be administered orally. | Drug | Placebo, TBD11 |
Primary outcome
Incidence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) after administration of single doses or multiple doses in healthy adult participants
Time frame: Part (Pt.) 1 (Cohorts 1-5, 7):Day 1-7; Pt. 1 (Cohort 6, Periods [Pds.] 1-3):Day 1 through the washout of each respective Pd.; Pt. 2 (Cohorts 1-3):Day 1-19; Pt. 2 (Cohort 4): Pd.1: Day 1 through last day of washout; Pd.2: Day 1 through last day of washout
Number of participants with clinically significant changes from Baseline in clinical laboratory values
Time frame: Part (Pt.) 1 (Cohorts 1-5, 7):Day 1-7; Pt. 1 (Cohort 6, Periods [Pds.] 1-3):Day 1 through the washout of each respective Pd.; Pt. 2 (Cohorts 1-3):Day 1-19; Pt. 2 (Cohort 4): Pd.1: Day 1 through last day of washout; Pd.2: Day 1 through last day of washout
Blood samples will be collected for the analysis of clinical laboratory measures including clinical chemistry, hematology, coagulation, and urinalysis.
Number of participants with clinically significant changes from Baseline in vital signs
Time frame: Part (Pt.) 1 (Cohorts 1-5, 7):Day 1-7; Pt. 1 (Cohort 6, Periods [Pds.] 1-3):Day 1 through the washout of each respective Pd.; Pt. 2 (Cohorts 1-3):Day 1-19; Pt. 2 (Cohort 4): Pd.1: Day 1 through last day of washout; Pd.2: Day 1 through last day of washout
Number of participants with clinically significant changes from Baseline in Electrocardiogram (ECG) parameters
Time frame: Part (Pt.) 1 (Cohorts 1-5, 7):Day 1-7; Pt. 1 (Cohort 6, Periods [Pds.] 1-3):Day 1 through the washout of each respective Pd.; Pt. 2 (Cohorts 1-3):Day 1-19; Pt. 2 (Cohort 4): Pd.1: Day 1 through last day of washout; Pd.2: Day 1 through last day of washout
ECG parameters include heart rate, RR interval, PR interval, QRS duration, QT interval, and QT interval corrected by Fridericia's formula [QTcF].
12 secondary outcomes
Part 1: Maximum plasma drug concentration (Cmax) of TBD11 in treated participants
Time frame: Day 1
Part 1: Area under the concentration-time curve calculated to last quantifiable observed sample (AUClast) of TBD11 in treated participants
Time frame: Day 1 through Day 7
Part 1: Terminal elimination half-life (t1/2) of TBD11 in treated participants
Time frame: Day 1 through Day 7
Part 1: Time to maximal concentration (Tmax) of TBD11 in treated participants
Time frame: Day 1
Part 2: Cmax of TBD11 in treated participants
Time frame: Day 1 and Day 14
Part 2: Tmax of TBD11 in treated participants
Time frame: Day 1 and Day 14
Part 2: Area Under the concentration time curve from Zero to 24 hours (AUC 0-24) of TBD11 in treated participants
Time frame: Day 1
Part 2: AUC last of TBD11 in treated participants
Time frame: Day 1 and Day 14
Part 2: Minimum plasma drug concentration (Cmin) of TBD11 in treated participants
Time frame: Day 14
Part 2: Accumulation ratio (area under plasma concentration-time curve over dosing interval [AUCtau] / AUC0-24) of TBD11 in treated participants
Time frame: Day 14
Part 2, Cohort 4: Geometric mean ratio (GMR) Cmax,capsules / Cmax,tablets in treated participants
Time frame: Day 1 through last day of washout of the treatment period
Part 2: Cohort 4: GMR AUC (0-infinity) capsules / AUC(0-inf) tablets
Time frame: Day 1 through last day of washout of the treatment period
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 30 Mar 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Healthy Adult Participants, run by Gates Medical Research Institute 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 11 inclusion and 6 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 30 Mar 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 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?
Incidence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) after administration of single doses or multiple doses in healthy adult participants (time frame: Part (Pt.) 1 (Cohorts 1-5, 7):Day 1-7; Pt. 1 (Cohort 6, Periods [Pds.] 1-3):Day 1 through the washout of each respective Pd.; Pt. 2 (Cohorts 1-3):Day 1-19; Pt. 2 (Cohort 4): Pd.1: Day 1 through last day of washout; Pd.2: Day 1 through last day of washout). The study lists 4 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 30 Mar 2026.