A Trial in Healthy Adult Participants to Evaluate the Safety, Tolerability, and Behavior in the Body of TBD11
- Registration Number
- NCT06707142
- Lead Sponsor
- Bill & Melinda Gates Medical Research Institute
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 108
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Is healthy as determined by the Investigator via medical history and clinical examination before enrolment in the trial.
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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.
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Can complete all Screening period evaluations and stay in the clinical research facility for the duration of the inpatient periods of the trial.
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Has BMI between 18 and 32 kilograms per meter square (kg/m2), inclusive, and body weight not less than 50 kg at Screening.
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Has resting vital signs within the following ranges:
- Systolic blood pressure (SBP) >= 100 millimeters of Mercury (mmHg) and <= 140 mmHg
- Diastolic blood pressure (DBP) >= 60 mmHg and <= 90 mmHg
- Heart rate between 50 and 100 beats per minute (bpm)
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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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description TBD11 TBD11 In Part 1 double-blind phase of the trial (SAD), cohorts 1 to 5 and an optional 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 will be randomized (3:1) to receive TBD11 or placebo in Cohorts 1-3 TBD11 Placebo In Part 1 double-blind phase of the trial (SAD), cohorts 1 to 5 and an optional 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 will be randomized (3:1) to receive TBD11 or placebo in Cohorts 1-3 Placebo Placebo Participants in in Part 1 (cohorts 1-5 and optional cohort 7) and Part 2 will receive placebos matched to TBD11
- Primary Outcome Measures
Name Time Method Incidence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) after administration of single doses or multiple doses in healthy adult participants Part 1 (Cohorts 1-5 and Cohort 7): Day 1 through Day 7; Part 1 (Cohort 6), Periods 1-3: Day 1 through last day of washout period for first, second and third dosing period; Part 2(Cohorts 1-3): Day 1 through Day 19 Number of participants with clinically significant changes from Baseline in clinical laboratory values Part 1 (Cohorts 1-5 and Cohort 7): Day 1 through Day 7; Part 1 (Cohort 6), Periods 1-3: Day 1 through last day of washout period for first, second and third dosing period; Part 2(Cohorts 1-3): Day 1 through Day 19 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 Part 1 (Cohorts 1-5 and Cohort 7): Day 1 through Day 7; Part 1 (Cohort 6), Periods 1-3: Day 1 through last day of washout period for first, second and third dosing period; Part 2(Cohorts 1-3): Day 1 through Day 19 Number of participants with clinically significant changes from Baseline in Electrocardiogram (ECG) parameters Part 1 (Cohorts 1-5 and Cohort 7): Day 1 through Day 7; Part 1 (Cohort 6), Periods 1-3: Day 1 through last day of washout period for first, second and third dosing period; Part 2(Cohorts 1-3): Day 1 through Day 19 ECG parameters include heart rate, RR interval, PR interval, QRS duration, QT interval, and QT interval corrected by Fridericia's formula \[QTcF\].
- Secondary Outcome Measures
Name Time Method Part 2: Accumulation ratio (area under plasma concentration-time curve over dosing interval [AUCtau] / AUC0-24) of TBD11 in treated participants Day 14 Part 2: AUC last of TBD11 in treated participants Day 1 and Day 14 Part 2: Minimum plasma drug concentration (Cmin) of TBD11 in treated participants Day 14 Part 1: Maximum plasma drug concentration (Cmax) of TBD11 in treated participants 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.
Part 1: Area under the concentration-time curve calculated to last quantifiable observed sample (AUClast) of TBD11 in treated participants Day 1 through Day 7 Part 1: Terminal elimination half-life (t1/2) of TBD11 in treated participants Day 1 through Day 7 Part 1: Time to maximal concentration (Tmax) of TBD11 in treated participants Day 1 Part 2: Cmax of TBD11 in treated participants Day 1 and Day 14 Part 2: Tmax of TBD11 in treated participants 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 Day 1
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Trial Locations
- Locations (1)
Celerion
🇺🇸Lincoln, Nebraska, United States