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Recruiting NCT06800729

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

Phase I Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TIX100, an orally available inhibitor of thioredoxin-interacting protein, Placebo.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug TIX100, an orally available inhibitor of thioredoxin-interacting protein
    TIX100, an orally available inhibitor of thioredoxin-interacting protein
  • Drug Placebo
    placebo

Primary outcome measures

  • Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Time frame: Day 7]
  • Number of participants with laboratory analyte results above upper limit of normal. [Time frame: Day 7]
  • Number of participants with vital sign results considered clinically significant by the investigator [Time frame: Day 7]
  • Number of participants with ECG results considered clinically significant by the investigator [Time frame: Day 7]
  • Number of participants with physical examination findings considered clinically significant by the investigator [Time frame: Day 7]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Single group
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • ProSciento, Inc. — Chula Vista

Identifiers

NCT: NCT06800729 · TIX100-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗