HealthyPhase 1NCT06800729
A Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics of TIX100 in Healthy Subjects
A Phase 1 study testing TIX100, an orally available inhibitor of thioredoxin-interacting protein in people with Healthy, run by TIXiMED, Inc. at 1 site in United States.
Trial summary
A Single Center, Single Dose, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TIX100, an orally available inhibitor of thioredoxin-interacting protein
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2025to May 2025
- 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 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.
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- 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%
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 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.
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- 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.
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
Clinic Answering Service, 619-427-1300, hello@myproscientostudy.com
About this study
Official title: A Single Center, Single Dose, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects
A Single Center, Single Dose, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects
- Conditions
- Healthy
- Being tested
- TIX100, an orally available inhibitor of thioredoxin-interacting protein, Placebo
- Keywords
- TIX100, TIXiMED, inhibitor of thioredoxin-interacting protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIX100, an orally available inhibitor of thioredoxin-interacting proteinDrug
TIX100, an orally available inhibitor of thioredoxin-interacting protein
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| TIX100 20 mg | Active comparator | Not described Receives: Drug: TIX100, an orally available inhibitor of thioredoxin-interacting protein |
| TIX100 60 mg | Active comparator | Not described Receives: Drug: TIX100, an orally available inhibitor of thioredoxin-interacting protein |
| TIX100 100 mg | Active comparator | Not described Receives: Drug: TIX100, an orally available inhibitor of thioredoxin-interacting protein |
| TIX100 160 mg | Active comparator | Not described Receives: Drug: TIX100, an orally available inhibitor of thioredoxin-interacting protein |
| TIX100 200 mg | Active comparator | Not described Receives: Drug: TIX100, an orally available inhibitor of thioredoxin-interacting protein |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: Day 7
Number of participants with laboratory analyte results above upper limit of normal.
Measured: Day 7
Number of participants with vital sign results considered clinically significant by the investigator
Measured: Day 7
Number of participants with ECG results considered clinically significant by the investigator
Measured: Day 7
Number of participants with physical examination findings considered clinically significant by the investigator
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study startJan 2025 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TIXiMED, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800729
- Sponsor's protocol ID
- TIX100-01
- Status last verified
- Jan 2025
- First submitted
- 23 Jan 2025
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Single Dose, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06800729
- Acronym / sponsor ID
- TIX100-01
- Conditions
- Healthy
- Keywords
- TIX100, TIXiMED, inhibitor of thioredoxin-interacting protein
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- TIXiMED, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2025 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 30 Jan 2025 (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.
A Single Center, Single Dose, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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).
Key exclusion criteria (13 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 routine 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 |
|---|---|---|
| TIX100, an orally available inhibitor of thioredoxin-interacting proteinTIX100, an orally available inhibitor of thioredoxin-interacting protein | Drug | TIX100 100 mg, TIX100 160 mg, TIX100 20 mg, TIX100 200 mg, TIX100 60 mg |
| Placeboplacebo | Drug | placebo |
Primary outcome
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
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 30 Jan 2025.
- 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.
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, an orally available inhibitor of thioredoxin-interacting protein in people with Healthy, 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 9 inclusion and 13 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 30 Jan 2025. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (time frame: Day 7). The study lists 5 primary outcomes in all. 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 30 Jan 2025.