A Trial in Healthy Adult Participants to Evaluate the Safety, Tolerability, and Behavior in the Body of TBD11

March 25, 2026 updated by: Gates Medical Research Institute

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Nebraska
      • Lincoln, Nebraska, United States, 68502
        • Celerion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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:

    1. Systolic blood pressure (SBP) >= 100 millimeters of Mercury (mmHg) and <= 140 mmHg
    2. Diastolic blood pressure (DBP) >= 60 mmHg and <= 90 mmHg
    3. 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:

    1. 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,
    2. 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants in Part 1 (cohorts 1-5 and cohort 7) and Part 2 will receive placebos matched to TBD11
Placebo will be administered orally.
Experimental: TBD11

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

Placebo will be administered orally.
TBD11 will be administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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
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
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].
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: Maximum plasma drug concentration (Cmax) of TBD11 in treated participants
Time Frame: Day 1
Blood samples are collected at indicated time points for pharmacokinetic (PK) analysis of TBD11. PK parameters are analyzed using standard non-compartmental analysis.
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
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
Day 1 through Day 7
Part 1: Time to maximal concentration (Tmax) of TBD11 in treated participants
Time Frame: Day 1
Day 1
Part 2: Cmax of TBD11 in treated participants
Time Frame: Day 1 and Day 14
Day 1 and Day 14
Part 2: Tmax of TBD11 in treated participants
Time Frame: Day 1 and Day 14
Day 1 and Day 14
Part 2: Minimum plasma drug concentration (Cmin) of TBD11 in treated participants
Time Frame: Day 14
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
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
Day 1
Part 2: AUC last of TBD11 in treated participants
Time Frame: Day 1 and Day 14
Day 1 and 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
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
Day 1 through last day of washout of the treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2024

Primary Completion (Actual)

February 27, 2026

Study Completion (Actual)

February 27, 2026

Study Registration Dates

First Submitted

November 24, 2024

First Submitted That Met QC Criteria

November 24, 2024

First Posted (Actual)

November 27, 2024

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • Gates MRI-TBD11-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

This will be done within 12 months of the study completion date Access Criteria: Anonymized participant level data may be shared with external researchers in accordance with the trial participants' written and executed informed consent document and any local or applicable regulations on data sharing. Qualified researchers may submit a request for anonymized participant level data along with a research proposal to Gates MRI for review. The types of supporting information that could be shared with external researchers include: the Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, and analytic code. A data sharing agreement must be in place before any clinical trial data are shared. There are additional circumstances that may prevent the sharing of data with external researchers, including but not limited to contractual obligations to existing partners and any restrictions imposed by regulatory bodies.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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