A Phase 1a Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of ABX-002 in Healthy Adult Subjects

2. Male or female * 18 to * 55 years of age at the time of the Screening Visit.
7. In good health based on medical history, physical examination (including
neurological examination), vital sign measurements, and laboratory safety tests
obtained at Screening.
8. No clinically significant abnormality on the single ECG performed at
Screening and the triplicate ECG performed prior to the first administration of
study drug. Single ECG performed at Screening may be repeated once.

3. Estimated creatinine clearance of * 90 mL/min based on the Chronic Kidney
Disease Epidemiology Collaboration (CKD-EPI) equation (Levey 2009).
6. History or evidence of any of the following: myocardial infarction; cardiac
valvulopathy; cardiac surgery revascularization (coronary artery bypass
grafting or percutaneous transluminal coronary angioplasty); unstable angina;
cerebrovascular accident, stroke, or transient ischemic attack; pacemaker;
atrial fibrillation, flutter, or nonsustained or sustained VT; pulmonary
arterial hypertension; sick sinus syndrome, second- or third-degree
atrioventricular (AV) block; uncontrolled hypertension; congestive heart
failure; personal or family history of sudden death or long QT syndrome;
unexplained syncope or syncope within the last 3 years regardless of etiology;
or history of hypokalemia.
8. Screening Holter monitor (24 hours) shows nonsustained VT, SVT lasting > 10
beats in a run or > 4 runs, atrial fibrillation, atrial flutter, or a pause > 4
seconds.
9. Mean pulse < 50 or > 100 bpm, mean systolic blood pressure >140 mm Hg, or
mean diastolic blood pressure > 90 mm Hg at Screening measured in duplicate
using a calibrated digital device. If the mean blood pressure exceeds the
limits above, an additional set of blood pressure measurements will be
obtained, and the subject may be included if pulse and BP parameters are within
the permitted boundaries.
11. Troponin T out of the normal laboratory range at time of the Screening
Visit.
18. Consumption of excessive amounts of caffeine, defined as > 4 servings of
coffee, tea, cola, or other caffeinated beverages per day (1 serving is
approximately 120 mg of caffeine). Refusal to abstain from caffeine-containing
foods or caffeinated beverages (eg, coffee, tea, cola, energy drinks) 24 hours
prior to Day -1 through discharge from the CRU after the final administration
of study drug.
19. Refusal to abstain from grapefruit-containing foods or beverages or Seville
orange-containing foods or beverages 14 days prior to Day -1 through the
Follow-Up Visit
20. Refusal to abstain from consumption of cruciferous vegetables (eg, kale,
broccoli, watercress, collard greens, kohlrabi, brussels sprouts, mustard
greens) or charbroiled meats (meat grilled over any heat source with black
marks) * 7 days prior to Day -1 through the Follow-Up Visit
25. Abnormal thyroid function tests (thyroid-stimulating hormone [TSH],
triiodothyronine, free thyroxine [FT4]) out of the normal laboratory value
ranges at the time of the Screening Visit.
26. Aspartate aminotransferase, alanine aminotransferase, or gamma-glutamyl
transferase > 1.5 times the upper limit of normal at the time of the Screening
Visit and at Day -1.
30. Personal history of epilepsy or familial history of epilepsy in a primary
relative (eg, sibling, parent, child) as documented by medical records or by
the history provided to the Investigator by the subject. Individuals with a
personal history of febrile seizures or seizures related to medication,
intoxication, or withdrawal.