NCT07675590 A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects
| NCT ID | NCT07675590 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | TIXiMED, Inc. |
| Condition | Health Adult Subjects |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2026-06-22 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 18 participants in total. It began in 2026-06-22 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Contact & Investigator
Anath Shalev, MD
PRINCIPAL INVESTIGATOR
TIXiMED, Inc.
Frequently Asked Questions
Who can join the NCT07675590 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Health Adult Subjects. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07675590 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07675590 currently recruiting?
Yes, NCT07675590 is actively recruiting participants. Contact the research team at gloria.keopuhiwa@prosciento.com for enrollment information.
Where is the NCT07675590 trial being conducted?
This trial is being conducted at Chula Vista, United States.
Who is sponsoring the NCT07675590 clinical trial?
NCT07675590 is sponsored by TIXiMED, Inc.. The principal investigator is Anath Shalev, MD at TIXiMED, Inc.. The trial plans to enroll 18 participants.