Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of NO-13065 in Healthy and Obese Adult Subjects

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of NO-13065 When Administered Orally to Healthy and Obese Adult Subjects

This clinical trial is the first-in-human study of NO-13065. The purpose of this phase 1 study is to assess the safety and tolerability of single and multiple ascending oral doses and food effect of NO-13065 in healthy and obese adult subjects.

Inclusion Criteria:

1. Healthy adult male and/or female (non-childbearing potential only), 19 to 55 years of age
2. Continuous non-smoker
3. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or safety ECGs.
4. Women of non-childbearing potential only
5. Able to understand and sign a written informed consent form prior to initiation of study procedures.

Exclusion Criteria:

1. Subject is mentally or legally incapacitated or has significant emotional problems
2. History or presence of clinically significant medical or psychiatric condition or disease
3. History or presence : Familial hyperlipidemia, Diabetes, Bleeding disorder(s), including relevant familial history, Thromboembolic disease, Bleeding in the gastrointestinal tract or CNS, Hepatobillary disease, Gilbert's syndrome
4. History or presence of alcohol or drug abuse.
5. Has liver function test(s) including ALT, AST, GGT, and/or ALP or total bilirubin that are > ULN at screening or check-in.
6. Positive urine drug or alcohol results.