Health Adult SubjectsPhase 1NCT07675590
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects
A Phase 1 study testing TIX100 in people with Health Adult Subjects and Obesity & Overweight, run by TIXiMED, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Adult Subjects, Obesity & Overweight
- What is being tested?
- TIX100
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2026to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects aged 18-70 years, both genders.
- 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:
- 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 oral contraceptives, hormonal implant or hormonal or non-hormonal intrauterine device, and the secondary (barrier) method of contraception with condom and/or with spermicide.
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- 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).
- Body mass index (BMI) 25 - 34.9 kg/m2
- HbA1c <6.5%
- Willingness to fully comply with protocol.
Who cannot join
- 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 routines within the preceding three months.
- Evidence of eating disorders.
- >5% weight change in the past three months.
- Bariatric surgery within the past five years.
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- Significant renal impairment (eGFR <60 mL/min/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 prescription medications during screening and duration of the trial.
- 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/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.
- Participation in an investigational drug trial within three months prior to dosing in the present study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
ProSciento, INC
Chula Vista, California, 91911
About this study
Official title: A Single Center, Multiple Dose, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects
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.
- Conditions
- Health Adult Subjects, Obesity & Overweight
- Being tested
- TIX100, Placebo
- Keywords
- inhibitor of thioredoxin-interacting protein, TXNIP, TIX100, TIXiMED, Type 1 Diabetes
- Medical subject headings
- Obesity, Overweight, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIX100Drug
oral administration over 28 days
PlaceboDrug
oral administration over 28 days
| Study group | Role | What they receive |
|---|---|---|
| TIX100 40mg BID | Active comparator | oral administration over 28 days Receives: Drug: TIX100 |
| TIX100 80mg BID | Active comparator | oral administration over 28 days Receives: Drug: TIX100 |
| TIX100 120MG BID | Active comparator | oral administration over 28 days Receives: Drug: TIX100 |
| Placebo | Placebo comparator | oral administration over 28 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
- Number of subjects with Treatment-Emergent Adverse Events (TEAEs)
- Number of subjects with clinically significant TEAEs (Physical Examination, Vital Signs, ECG)
Measured: Day 1 to Day 35
Secondary outcomes (1)
Pharmacokinetic: Area Under Concentration (AUC)
To determine the area under concentration (AUC) of multiple oral doses of TIX100 in otherwise healthy overweight/obese subjects
Measured: Day 1 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start22 Jun 2026
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Adult SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TIXiMED, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anath Shalev, MD, Principal investigator, TIXiMED, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07675590
- Sponsor's protocol ID
- TIX100-02
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Phase 1 healthy volunteer study
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Multiple Dose, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07675590
- Acronym / sponsor ID
- TIX100-02
- Conditions
- Health Adult Subjects, Obesity & Overweight
- Keywords
- inhibitor of thioredoxin-interacting protein, TXNIP, TIX100, TIXiMED, Type 1 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- TIXiMED, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Jun 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TIX100 40mg BID | Active comparator | Drug: TIX100oral administration over 28 days |
| TIX100 80mg BID | Active comparator | Drug: TIX100oral administration over 28 days |
| TIX100 120MG BID | Active comparator | Drug: TIX100oral administration over 28 days |
| Placebo | Placebo comparator | Drug: Placebooral administration over 28 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects aged 18-70 years, both genders.
- 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:
- 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 oral contraceptives, 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. 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).
Key exclusion criteria (14 listed)
- 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 routines within the preceding three months.
- Evidence of eating disorders.
- >5% weight change in the past three months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TIX100oral administration over 28 days | Drug | TIX100 120MG BID, TIX100 40mg BID, TIX100 80mg BID |
| Placebooral administration over 28 days | Drug | Placebo |
Primary outcome
Safety and Tolerability
Time frame: Day 1 to Day 35
* Number of subjects with Treatment-Emergent Adverse Events (TEAEs) * Number of subjects with clinically significant TEAEs (Physical Examination, Vital Signs, ECG)
1 secondary outcome
Pharmacokinetic: Area Under Concentration (AUC)
Time frame: Day 1 and Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No. Phase 1 healthy volunteer study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anath Shalev, MD principal investigator
TIXiMED, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TIX100 in people with Health Adult Subjects and Obesity & Overweight, run by TIXiMED, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gloria Keopuhiwa (619-799-4818, gloria.keopuhiwa@prosciento.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: Day 1 to Day 35). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.