Study of AC0058TA in Healthy Male and Female Subjects

This is a 2-part, randomized, double-blind, placebo-controlled, single-dose-escalation (Part 1) and multiple-dose-escalation (Part 2) study to evaluate the safety, tolerability, PK, and PD of AC0058TA administered orally to healthy subjects. Part 1 of the study will also to evaluate the effect of food on the pharmacokinetics of a single oral dose of AC0058TA.

Inclusion criteria

• Male or female, of any ethnic origin, age ≥18 and ≤65 years of age;
• BMI ≥18.5 and ≤32.0 kg/m2;
• Medical history without major pathology and determined to be in good health with no clinically significant findings as assessed by the Investigator;
• All clinical laboratory tests of blood and urine are within the normal range or show no clinically relevant deviations as judged by the Investigator;
• A female must be

• postmenopausal (ie, have spontaneous amenorrhea for ≥12 consecutive months with follicle stimulating hormone (FSH) ≥40 mIU/mL at Screening, and be of an appropriate age) or
• surgically sterile (ie, hysterectomy, bilateral salpingectomy, bilateral oophorectomy, tubal occlusion) for at least 90 days prior to Screening;
• Male subjects must agree to use at least 2 methods of contraception with a female partner of childbearing potential, with at least 1 method being a highly effective method of contraception (as defined in Section 5.5), to refrain from sperm donation, and to refrain from unprotected sexual intercourse with a female who is pregnant or breastfeeding during the study from the time of signing the informed consent or 10 days prior to Check-in (Day -1) until 90 days after the last administration of study medication or discontinuation;
• Able to comprehend and abide by the study restrictions, and willing to sign an Informed Consent Form (ICF)

Exclusion criteria

• Has a significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, immune suppressive/defective, or psychiatric disorder as determined by the Investigator;
• Has a history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator;
• Has a history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (a subject who has had an appendectomy or hernia repair may be enrolled in the study);
• Has a history of congenital nonhemolytic hyperbilirubinaemia (eg, Gilbert's syndrome);
• Has a history of alcoholism or drug addiction within 1 year prior to Check-in;
• Has a positive test for selected drugs of abuse at Screening (not including alcohol) or Check-in (including alcohol);
• Has a positive hepatitis panel and/or positive human immunodeficiency virus (HIV) antibody screens;
• Has a positive pregnancy test result at Screening or Check-in (females only);
• Has clinically significant findings as determined by the Investigator (eg, medical history, 12-lead ECG, vital signs, or clinical laboratory evaluations;
• Has participated in any other investigational drug trial in which receipt of an investigational drug (new chemical entity) occurred within 5 half-lives of the respective study drug or 30 days prior to Check-in, whichever is longer;
• Has used any medications/products, including St. John's Wort, known to alter drug absorption or elimination processes within 30 days prior to Check-in, unless deemed acceptable by the Investigator;
• Has used any prescription medications/products not discussed in another exclusion criterion within 14 days prior to Check-in, unless deemed acceptable by the Investigator;
• Has used slow-release medications/products considered to still be active within 14 days prior to Check-in, unless deemed acceptable by the Investigator; 14. Has used any over-the-counter, nonprescription medications/products not discussed in another exclusion criterion (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days prior to Check-in, unless deemed acceptable by the Investigator;
• Has donated blood within 30 days prior to Screening, plasma within 2 weeks prior to Screening, or platelets within 6 weeks prior to Screening;
• Has received blood products within 2 months prior to Check-in;
• Has poor peripheral venous access;
• Who, in the opinion of the Investigator, should not participate in this study.