The purpose of this study is to assess the safety, tolerability and pharmacokinetics (i.e. how study drug is taken up by the body) of TBN in healthy participants.
Male or non-childbearing potential female, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), ≥ 18 and ≤ 50 years of age, with BMI > 18.0 and < 30.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
The absence of clinically significant illness and surgery within 4 weeks prior to the first dosing. Subjects vomiting within 24 hours pre-dose will be carefully evaluated for upcoming illness/disease. Inclusion pre-dosing is at the discretion of the Investigator.
The absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
Post-menopausal female (absence of menses for 12 months prior to the first study drug administration, bilateral oophorectomy or hysterectomy with bilateral oophorectomy at least 6 months prior to the first study drug administration);
Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results or positive test for hepatitis B, hepatitis C, or HIV found during medical screening.
Positive urine drug screen, alcohol breath test, or urine cotinine test at screening.
History of allergic reactions to TBN or other related drugs, or to any excipient in the formulation.
Positive pregnancy test at screening.
Sequential
Tetramethylpyrazine nitrone (TBN) tablet / Placebo
DrugSubjects will be administered multiple oral doses of TBN or matching placebo tablets twice a day for 6 consecutive days and a last dose in the morning of Day 7.
Number of participants with Adverse Events (AEs)
The number and severity of AEs will be graded according to criteria from the NCI-CTCAE (i.e., seriousness, severity, relationship to the study medication, outcome, duration, and management).
Assessment of physical examination.
Physical examination will be assessed on Day-1, Day4, and check-out (Day8), follow-up visit (Day14±2).
Assessment of vital signs.
Vital signs, including orthostatic blood pressure and heart rate, respiratory rate and oral temperature, will be evaluated from Day-1 to check-out (Day8), and at follow-up visit (Day14±2).
Assessment of 12 lead-ECG.
12 lead-ECG will be assessed on Day-1, Day4, Day 7 and at check-out (Day8), follow-up visit (Day14±2).
Maximum observed concentration (Cmax) of TBN and its metabolite.
Plasma concentrations of TBN and its metabolite \[Time point: pre-dose, 1, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12 (prior to the second dose)\], and derived pharmacokinetic parameters Cmax.
Time of occurrence of Cmax (Tmax) of TBN and its metabolite.
Plasma concentrations of TBN and its metabolite \[Time point: pre-dose, 1, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12 (prior to the second dose)\], and derived pharmacokinetic parameters Tmax.
Area under the concentration-time curve from time zero to time 12 hours (AUC0-12) of TBN and its metabolite.
Plasma concentrations of TBN and its metabolite \[Time point: pre-dose, 1, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12 (prior to the second dose)\], and derived pharmacokinetic parameters AUC0-12.
Lowest concentration before the next dose is administered (Ctrough) of TBN and its metabolite.
Time point: pre-morning dose of Day2, Day3, Day4, Day5 and Day6.
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