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.