RECRUITING

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

Conditions

Healthy TIX100 TIXiMED inhibitor of thioredoxin-interacting protein

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-01

Study Completion:2025-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06800729

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Locations (Sites)

ProSciento, Inc.

Chula Vista, California, 91911

United States

Collaborators and Investigators

Sponsor: TIXiMED, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01

Study Completion Date2025-05

Study Record Updates

Study Start Date2025-01

Study Completion Date2025-05

Terms related to this study

Keywords Provided by Researchers

TIX100
TIXiMED
inhibitor of thioredoxin-interacting protein

Additional Relevant MeSH Terms

Healthy