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

NCT06800729 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: TIX100-01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

TIX100; TIXiMED; inhibitor of thioredoxin-interacting protein

Outcome Measures

Primary Outcomes (5)

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  Day 7

• Number of participants with laboratory analyte results above upper limit of normal.

  Day 7

• Number of participants with vital sign results considered clinically significant by the investigator

  Day 7

• Number of participants with ECG results considered clinically significant by the investigator

  Day 7

• Number of participants with physical examination findings considered clinically significant by the investigator

  Day 7

Study Arms (6)

TIX100 20 mg

ACTIVE COMPARATOR

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

TIX100 60 mg

ACTIVE COMPARATOR

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

TIX100 100 mg

ACTIVE COMPARATOR

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

TIX100 160 mg

ACTIVE COMPARATOR

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

TIX100 200 mg

ACTIVE COMPARATOR

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

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TIX100, an orally available inhibitor of thioredoxin-interacting protein DRUG

TIX100, an orally available inhibitor of thioredoxin-interacting protein

TIX100 100 mg; TIX100 160 mg; TIX100 20 mg; TIX100 200 mg; TIX100 60 mg

Placebo DRUG

placebo

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• TIXiMED, Inc.: lead

Study Sites (1)

ProSciento, Inc.

Chula Vista, California, 91911, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 30, 2025
• Study Start: January 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)