Evaluating the safety and tolerability of TIX100 in healthy individuals

A Single Center, Single Dose, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects

This study is testing a new oral medication called TIX100 in healthy people to see if it is safe and how it affects their bodies.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: TIXiMED, Inc. (Industry-sponsored)
• Locations: 1 site (Chula Vista, California)
• Trial ID: NCT06800729 on ClinicalTrials.gov

What this trial studies

This study is designed to assess the safety, tolerability, and pharmacokinetics of TIX100, an orally administered inhibitor of thioredoxin-interacting protein, in healthy subjects. It is a single-center, randomized, placebo-controlled trial where participants will receive either TIX100 or a placebo. The study will involve monitoring participants' health through medical examinations, vital signs, and laboratory tests to ensure their well-being throughout the trial.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18-70 years without significant medical histories.

Not a fit: Patients with significant medical conditions or recent surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a better understanding of TIX100's safety profile, paving the way for future studies in patients with conditions related to thioredoxin-interacting protein.

How similar studies have performed: While this approach is focused on a specific pharmacological agent, similar studies evaluating the safety of new compounds in healthy subjects have shown success in the past.

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.

Where this trial is running

Chula Vista, California

• ProSciento, Inc. — Chula Vista, California, United States (Recruiting)

Conditions Healthy; TIX100; TIXiMED; inhibitor of thioredoxin-interacting protein