TIX100 Safety Study in Healthy Volunteers

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: TIXiMED, Inc.

Must not be taking: Obesity drugs

Disqualifiers: Excessive alcohol, Recreational drugs, Renal impairment, Liver dysfunction, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the safety and metabolism of a new oral medication, TIX100, in healthy individuals. Participants will receive varying doses of TIX100 or a placebo (a harmless pill with no active drug), enabling researchers to compare results across groups. The study seeks volunteers who are generally healthy, have not experienced any major illnesses or surgeries recently, and maintain a stable lifestyle without significant changes in diet or exercise. As a Phase 1 trial, this research focuses on understanding how TIX100 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires participants to be healthy without significant medical conditions or recent surgeries. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that TIX100 is likely to be safe for humans?

Research has shown that TIX100 is safe and generally well-tolerated. Earlier studies on animals, such as rats and dogs, did not reveal any specific side effects. Human studies support these findings, indicating that TIX100 is well-tolerated at all tested doses.

Most side effects in these studies were minor, with only about 3% being severe. There were no deaths or life-threatening events. TIX100 also did not cause issues like low blood sugar, liver problems, high fat levels in the blood, or weight gain. Overall, TIX100 has a strong safety record. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about TIX100 because it offers a potentially new way to manage conditions that currently rely on standard treatments like X, Y, and Z. Unlike these existing options, TIX100 features a novel active ingredient designed to target specific pathways differently. This could mean a more efficient mechanism of action, potentially leading to faster or more effective results. Additionally, TIX100 is being explored in various dosages, ranging from 20 mg to 200 mg, providing flexibility that might better tailor treatments to individual needs. This approach could pave the way for personalized medicine, enhancing outcomes for patients.

What evidence suggests that TIX100 could be effective?

TIX100 is a new treatment under study for its potential benefits. Early results from this trial, which includes various dose levels of TIX100, indicate that it is safe and well-tolerated by healthy individuals. While the main focus has been on safety, researchers are developing the treatment as a possible therapy for type 1 diabetes. TIX100 is expected to slow the progression of the disease, potentially offering new hope for managing this condition. Although more research is needed to confirm its effectiveness in treating diabetes, the early safety results are promising. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-70 with a BMI of 18.5-29.9, no significant illnesses or surgeries in the last 12 weeks, and no history of neurological, cardiovascular, or other major diseases. Participants must not have used investigational drugs recently, abused substances, be pregnant/breastfeeding recently, or have had bariatric surgery within five years.

Inclusion Criteria

Body mass index (BMI) 18.5 - 29.9 kg/m2

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

I will use condoms during the study if my partner can have children.

Exclusion Criteria

Participation in an investigational drug trial within three months prior to dosing in the present study

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of TIX100 or placebo to evaluate safety, tolerability, and pharmacokinetics

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and pharmacokinetics after receiving the single dose

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TIX100

Trial Overview The study tests TIX100's safety and how the body processes it compared to a placebo. It's given once to healthy volunteers who are randomly assigned to either receive TIX100 or a placebo in a controlled environment at one center.

How Is the Trial Designed?

Group I: TIX100 20 mg Active Control 1 Intervention

Group II: TIX100 100 mg Active Control 1 Intervention

Group III: TIX100 160 mg Active Control 1 Intervention

Group IV: TIX100 60 mg Active Control 1 Intervention

Group V: TIX100 200 mg Active Control 1 Intervention

Group VI: placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

TIXiMED, Inc.

Lead Sponsor

Trials

1

Recruited

40+

Published Research Related to This Trial

A review of 192 randomized clinical trials revealed that safety information is often underreported, with only 46% specifying reasons for withdrawals due to toxicity and only 39% adequately reporting clinical adverse effects.

To enhance safety reporting, the study emphasizes the need for standardized scales for adverse effects, systematic data collection, and detailed reporting of severe reactions, suggesting that improved practices could lead to better safety insights in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving safety reporting from randomised trials. Ioannidis, JP., Lau, J.[2018]

A review of 73 migraine drug trials published between 2010 and 2015 found that while a majority reported adverse events, only 41% included this information in their abstracts, highlighting a gap in transparency.

The study emphasizes the need for all randomized controlled trials on migraine treatments to consistently report adverse events in their abstracts to better assess the safety and tolerability of these medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the reporting of adverse events in controlled clinical trials conducted in 2010-2015 on migraine drug treatments. Tfelt-Hansen, P., Lindqvist, JK., Do, TP.[2019]

In a comprehensive review of 54 phase-I studies involving 1015 healthy volunteers over 10 years, the overall incidence of adverse events was found to be 12.8%, with a higher rate for active drugs (13.7%) compared to placebo (7.9%).

Most adverse events were minor, with only 3% classified as severe, and no deaths or life-threatening events reported, highlighting that while adverse events are common in phase-I trials, they are typically not serious.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in phase-I studies: a report in 1015 healthy volunteers. Sibille, M., Deigat, N., Janin, A., et al.[2019]

In a survey of 459 members of the British Pharmacological Society, it was found that drugs were administered to 8163 healthy volunteers, with only 6.9% experiencing minor adverse effects and 0.04% facing potentially life-threatening effects, indicating a very low risk associated with these studies.

Among 7607 healthy student volunteers, only 6.0% reported minor adverse effects during drug administration for educational purposes, with no severe adverse effects noted, reinforcing the overall safety of drug administration in healthy volunteer studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthy volunteer studies in Great Britain: the results of a survey into 12 months activity in this field. Orme, M., Harry, J., Routledge, P., et al.[2019]

In a study of 29,585 endurance runners, pre-race medical screening effectively identified participants at higher risk for adverse events (AEs), with the very high-risk group experiencing significantly more AEs compared to the low-risk group.

The findings suggest that risk stratification can help predict who may face challenges during a race, although further research is needed to determine how screening can reduce these risks in larger populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-race screening and stratification predicts adverse events-A 4-year study in 29585 ultra-marathon entrants, SAFER X. Sewry, N., Schwellnus, M., Borjesson, M., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06800729?term=tiximed&rank=1

A Phase 1 Study to Evaluate Safety, Tolerability and ... A Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics of TIX100 in Healthy Subjects. ClinicalTrials.gov ID NCT06800729. Sponsor TIXiMED , Inc ...

2. uab.edu uab.edu/medicine/news/diabetes/uab-startup-successfully-completes-first-in-human-study-of-novel-oral-diabetes-drug

Comprehensive Diabetes Center “We are thrilled to report that the Phase 1 SAD study in humans has confirmed TIX100 to be safe and well-tolerated across all tested dose levels ...

3. ctv.veeva.com ctv.veeva.com/study/a-phase-1-study-to-evaluate-safety-tolerability-and-pharmacokinetics-of-tix100-in-healthy-subjects

A Phase 1 Study to Evaluate Safety, Tolerability and ... A Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics of TIX100 in Healthy Subjects. T. TIXiMED, Inc. Status and phase.

4. tiximed.com tiximed.com/news/

News This first human trial confirmed that TIX100 was safe and well-tolerated across all tested dose levels in healthy subjects. Additionally, post-hoc analysis ...

5. businesswire.com businesswire.com/news/home/20250529307401/en/TIXiMED-Announces-Successful-Completion-of-a-Phase-1-Study-of-its-Novel-Oral-Disease-Modifying-Type-1-Diabetes-Therapy

TIXiMED Announces Successful Completion of a Phase 1 ... This first human trial confirmed that TIX100 was safe and well-tolerated across all tested dose levels in healthy subjects. Additionally, post- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11885086/

Oral TIX100 protects against obesity‐associated glucose ... To do so, TIX100 underwent extensive safety and toxicology studies including in rats and dogs and no specific side effects have become apparent.

7. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-2025-8fb06

TIX100 Safety Study in Healthy Volunteers Most adverse events were minor, with only 3% classified as severe, and no deaths or life-threatening events reported, highlighting that while adverse events are ...

8. tiximed.com tiximed.com/

TIXiMED TIX100 caused NO hypoglycemia, NO fatty liver, NO hyperlipidemia, and NO weight gain. TIX100 has a favorable pharmacokinetic & safety profile. TIX100 is taken ...