TrialPath
Recruiting

A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects

NCT07675590 · TIXiMED, Inc.
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
A Single Center, Multiple Dose, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects
About this study
Randomized, Placebo-controlled Study to determine the safety and tolerability of multiple oral doses of TIX100 administered daily for 28 days to otherwise healthy overweight/obese subjects.
Eligibility criteria
Inclusion Criteria: 1. Subjects aged 18-70 years, both genders. 2. Healthy as determined by the Investigator, 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 oral contraceptives, 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. bilateral tubal ligation (BTL), bilateral tubal occlusion (BTO), bilateral salpingectomy, hysterectomy, partial hysterectomy, bilateral oophorectomy, or postmenopausal, defined as no menses for 12 months without an alternative medical cause). 6. Body mass index (BMI) 25 - 34.9 kg/m2 7. HbA1c \<6.5% 8. Willingness to fully comply with protocol. 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 routines 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 mL/min/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 prescription medications during screening and duration of the trial. 11. Use of drugs approved for the treatment of obesity. 12. Any clinically significant abnormality following the Investigator's review of the physical examination and clinical laboratory tests. 13. A baseline prolongation of QT/QTcF interval after repeated measurements of \>450 ms for men and \>470 for women; a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of LQTS. 14. Participation in an investigational drug trial within three months prior to dosing in the present study.
Study design
Enrollment target: 18 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2026-06-22
Estimated completion: 2026-12
Last updated: 2026-06-30
Interventions
Drug: TIX100Drug: Placebo
Primary outcomes
  • Safety and Tolerability (Day 1 to Day 35)
Sponsor
TIXiMED, Inc. · industry
Contacts & investigators
ContactGloria Keopuhiwa · contact · gloria.keopuhiwa@prosciento.com · 619-799-4818
ContactMoises Hernandez · contact · Moises.Hernandez@prosciento.com · 619-845-3039
InvestigatorAnath Shalev, MD · principal_investigator, TIXiMED, Inc.
All locations (1)
ProSciento, INCRecruiting
Chula Vista, California, United States
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects · TrialPath