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

TIXiMED, Inc.

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: TIX100, an orally available inhibitor of thioredoxin-interacting protein; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06800729

TIX100-01

Details and patient eligibility

About

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

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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35 participants in 6 patient groups, including a placebo group

TIX100 20 mg

Active Comparator group

Treatment:

Drug: TIX100, an orally available inhibitor of thioredoxin-interacting protein

TIX100 60 mg

Active Comparator group

Treatment:

Drug: TIX100, an orally available inhibitor of thioredoxin-interacting protein

TIX100 100 mg

Active Comparator group

Treatment:

Drug: TIX100, an orally available inhibitor of thioredoxin-interacting protein

TIX100 160 mg

Active Comparator group

Treatment:

Drug: TIX100, an orally available inhibitor of thioredoxin-interacting protein

TIX100 200 mg

Active Comparator group

Treatment:

Drug: TIX100, an orally available inhibitor of thioredoxin-interacting protein

placebo

Placebo Comparator group

Treatment:

Drug: Placebo