A Study of PATAS Trifluoroacetate Using Single Ascending Doses in Healthy Volunteers

Inclusion criteria

• Part 1: Single Ascending Dose Inclusion criteria

• Healthy male and female subjects, 18 to 55 years of age, inclusive, at the time of signing the Informed Consent Form (ICF);
• Willing and able to give written informed consent for participation in the study prior to the initiation of any Screening or study-specific procedures;
• Body mass index (BMI) within the range of 20.0 to 35.0 kg/m2, inclusive, at Screening;
• In generally good health, as judged by the Investigator, based upon medical/surgical history and the results of physical examination, vital signs, clinical laboratory assessments, and 12-lead electrocardiogram (ECG) at Screening and at Check-In (Day -1);
• Female subjects must have a negative serum pregnancy test result at the Screening Visit and a negative urine pregnancy test at Check-In (Day -1) (prior to the first dose of study drug) and must not be pregnant, lactating, or planning a pregnancy from the Screening Visit to 90 days after the last dose of study drug;
• Negative test result for severe acute respiratory syndrome coronavirus 2 at Check-In (Day -1); and
• Willing to comply with all study procedures and requirements throughout the duration of the study.

Exclusion criteria

• Clinically significant history of asthma, eczema, or any other allergic condition or previous severe hypersensitivity; Note: Non-active hay fever is not exclusionary.
• Liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALP], total bilirubin) outside the following upper limits of normal (ULNs) at Screening or at Check-In (Day -1): a. For ALT and AST, measurements > ULN; b. For ALP, measurements >ULN; or c. For total bilirubin, measurements > ULN.
• Estimated glomerular filtration rate </= 90 mL/min/1.73 m2 based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at Screening or at Check-In (Day -1);
• Thyroid-stimulating hormone (TSH) outside of reference range (e.g., TSH <1 × lower limit of normal [LLN] or TSH >1 × ULN) at Screening; Note: Abnormal TSH results will reflex to a free thyroxine (T4) test.
• History of unexplained syncope, cardiac arrest, unexplained cardiac arrythmias or torsades de pointes, or structural heart disease;
• Personal or family history of long QT syndrome;
• Clinically significant history of any disease or disorder (i.e., gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric, or metabolic) deemed to be exclusionary, as judged by the Investigator;
• Abnormal pulse rate or blood pressure (BP) measurements at Screening, defined as: a. Pulse rate <40 bpm or >100 bpm; b. Systolic BP < 90 mmHg or >140 mmHg; or c. Diastolic BP < 50 mmHg or > 90 mmHg.
• Clinically significant ECG abnormalities at Screening or at Check-In (Day -1), defined as prolongation of the average QTcF interval > 450 ms for males and >470 ms for females, or other clinically significant ECG abnormalities per Investigator discretion;
• Positive for hepatitis B surface antigen, HIV antibody, or hepatitis C virus antibody at Screening;
• Receipt of any investigational product within 30 days prior to first study drug administration (90 days for investigational biologic agents) or 5 half-lives prior to first study drug administration, whichever is greater, or participation in >3 clinical studies within 12 months; 22. Known or suspected hypersensitivity to PATAS or any components of the formulation used (sodium hydroxide or mannitol);