A Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics of TIX100 in Healthy Subjects

Eligibility Criteria

• 1. Subjects aged 18-70 years, both genders.
• 2. Healthy as determined by a physician, based on history, medical examination, vital signs, laboratory tests, cardiac monitoring and respiratory function. History must comply with the following:
• 1. Absence of clinically significant illness or surgery within the preceding 12 weeks.
• 2. Absence of clinically significant history of neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and/or metabolic disease.
• 3. Male subjects with female partners of childbearing potential must agree to utilize condoms for the duration of the study.
• 4. Female subjects of child-bearing potential with negative urine pregnancy tests and who agree to use double-barrier contraception during the study. The primary contraception may be either hormonal implant or hormonal or non-hormonal intrauterine device, and the secondary (barrier) method of contraception with condom and/or with spermicide.
• 5. Female subjects of non-child-bearing potential (i.e. tubal ligation, hysterectomy, or postmenopausal).
• 6. Body mass index (BMI) 18.5 - 29.9 kg/m2
• 7. HbA1c \<6.0%
• 1. History of excessive alcohol use (defined as \>21 drinks per week for males and \>14 drinks per week for females), recreational drug use or drugs of abuse within the past three months, or failure on urinary drug screen.
• 2. Pregnant or breastfeeding within six months of screening assessment.
• 3. Substantial changes in eating habits or exercise routine within the preceding three months.
• 4. Evidence of eating disorders.
• 5. \>5% weight change in the past three months.
• 6. Bariatric surgery within the past five years.
• 7. Significant renal impairment (eGFR \<60 mg/mL/1.73m2).
• 8. Liver function tests (i.e., ALT, AST, alkaline phosphatase) greater than twice the upper limit of normal upon repeated measurements.
• 9. Diseases interfering with metabolism and/or ingestive behavior (e.g., myxedema, Cushing's disease, schizophrenia, major psychoses, unmanaged depression).
• 10. Use of drugs approved for the treatment of obesity.
• 11. Any clinically significant abnormality following the Investigator's review of the physical examination and clinical laboratory tests.
• 12. A baseline prolongation of QT/QTc interval after repeated measurements of \>450 ms; a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of LQTS.
• 13. Participation in an investigational drug trial within three months prior to dosing in the present study.