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

Launched by TIXIMED, INC. · Jan 28, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new medication called TIX100 to see how safe it is, how well it can be tolerated, and how the body processes it. The study is being conducted with healthy adults aged 18 to 70 years. To participate, individuals must be in good health and not have any significant medical issues or recent surgeries. Both men and women can join, but women of childbearing age need to have a negative pregnancy test and use reliable birth control during the study.

Participants in this trial can expect to take TIX100 or a placebo (a pill with no active medication) in a controlled setting. They will be monitored closely by medical professionals to ensure their safety and to gather information about how the medication works in the body. This study is a first step in understanding TIX100, which could lead to more information about its use in future treatments. If you are interested and meet the eligibility criteria, this could be a great opportunity to contribute to medical research.

Gender

ALL

Eligibility criteria

• Inclusion 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%
• Exclusion Criteria:
• • 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.