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

Inclusion criteria

• Subjects aged 18-70 years, both genders.
• 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:

• Absence of clinically significant illness or surgery within the preceding 12 weeks.
• Absence of clinically significant history of neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and/or metabolic disease.
• Male subjects with female partners of childbearing potential must agree to utilize condoms for the duration of the study.
• 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.
• Female subjects of non-child-bearing potential (i.e. tubal ligation, hysterectomy, or postmenopausal).
• Body mass index (BMI) 18.5 - 29.9 kg/m2
• HbA1c <6.0%

Exclusion criteria

• 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.
• Pregnant or breastfeeding within six months of screening assessment.
• Substantial changes in eating habits or exercise routine within the preceding three months.
• Evidence of eating disorders.
• >5% weight change in the past three months.
• Bariatric surgery within the past five years.
• Significant renal impairment (eGFR <60 mg/mL/1.73m2).
• Liver function tests (i.e., ALT, AST, alkaline phosphatase) greater than twice the upper limit of normal upon repeated measurements.
• Diseases interfering with metabolism and/or ingestive behavior (e.g., myxedema, Cushing's disease, schizophrenia, major psychoses, unmanaged depression).
• Use of drugs approved for the treatment of obesity.
• Any clinically significant abnormality following the Investigator's review of the physical examination and clinical laboratory tests.
• 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.
• Participation in an investigational drug trial within three months prior to dosing in the present study.