Celerion
Lincoln, Nebraska, 68502, United States
NCT Number: NCT06707142
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).
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Notify Me19 year–55 year
All sexes
Interventional
Phase 1
Lincoln, Nebraska, 68502, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Additional inclusion/exclusion criteria are defined in the protocol.
TBD11 will be administered orally.
Placebo will be administered orally.
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
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.
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
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].
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.
Time frame: Day 1 through Day 7
Time frame: Day 1 through Day 7
Time frame: Day 1
Time frame: Day 1 and Day 14
Time frame: Day 1 and Day 14
Time frame: Day 1
Time frame: Day 1 and Day 14
Time frame: Day 14
Time frame: Day 14
Time frame: Day 1 through last day of washout of the treatment period
Time frame: Day 1 through last day of washout of the treatment period
Gates Medical Research Institute
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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