MT-501 for Safety in Healthy Subjects

Overseen By Toll-Free Number

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Mirador Therapeutics, Inc.

Disqualifiers: Organ disease, Abnormal labs, Drug abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and tolerability of a new drug, MT-501, in healthy adults. Researchers will assess how the body processes the drug with both single and multiple doses. The trial seeks healthy non-smokers who haven't used tobacco or nicotine products in the last three months. Participants should also be in good general health without any major medical issues. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding how it works in people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications, but it does mention that you should not have used any investigational drugs or devices within 30 days before starting the study.

Is there any evidence suggesting that MT-501 is likely to be safe for humans?

Research has shown that MT-501 is undergoing its first tests in healthy individuals, meaning no prior data exists on its effects in humans. The primary goal is to assess its safety and tolerability. As this is the initial human study, it aims to understand how the body processes the treatment and its effects.

Since MT-501 is in early testing stages, its safety is still under evaluation. Researchers closely monitor for any side effects or reactions. Although specific data is not yet available, testing in healthy volunteers suggests some initial confidence in its safety. However, participants should be aware of the unknowns, given this is the first human trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

MT-501 is unique because it offers a novel approach to treatment with its single and multiple ascending dose strategy in healthy subjects. Unlike many conventional treatments that often involve stable, fixed dosing, MT-501's regimen focuses on gradually increasing doses, which may help to better understand its safety profile and optimize its effectiveness. Researchers are excited because this method could lead to a more tailored and potentially more effective treatment approach, minimizing side effects while maximizing benefits, a significant advancement over the standard one-size-fits-all dosing methods.

What evidence suggests that MT-501 could be effective?

MT-501 is a new treatment undergoing its first test in healthy individuals. This trial consists of two parts: a Single Ascending Dose arm and a Multiple Ascending Dose arm, both evaluating the safety and tolerability of MT-501 following oral administration. Currently, no human studies demonstrate its effectiveness for any specific health problem. Due to limited information, researchers are examining how the treatment functions and how the body responds to it. The primary goal is to determine its safety and tolerability. Future studies will likely assess its effectiveness for specific health issues. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy adults who can participate in a study to test the safety and effects of a new medication, MT-501. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not be taking conflicting medications.

Inclusion Criteria

I am between 19 and 55 years old and cannot become pregnant or get someone pregnant.

I am a woman who cannot have children and have been sterilized at least 6 months ago.

Able to provide written informed consent and understand and comply with the requirements of the study

Exclusion Criteria

History of alcohol or drug abuse within the past 24 months

Current use or history of regular tobacco, or nicotine-containing products within 3 months prior to screening

Administration or use of any investigational drug or device within 30 days preceding the first does of study drug administration

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose

Participants receive single oral doses of MT-501 to assess safety and tolerability

1 day

Multiple Ascending Dose

Participants receive multiple oral doses of MT-501 to assess safety and tolerability

8 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 days

What Are the Treatments Tested in This Trial?

Interventions

• MT-501

Trial Overview MT-501 is being tested in this first-in-human study. It involves giving volunteers either a single dose or multiple doses over time to see how safe it is, how well tolerated it is, and what happens to the drug in the body (PK) as well as its effects on the body (PD).

How Is the Trial Designed?

Group I: Part 2 - Multiple Ascending Dose Experimental Treatment 1 Intervention

To assess the safety and tolerability of multiple doses of MT-501 following oral administration.

Group II: Part 1 - Single Ascending Dose Experimental Treatment 1 Intervention

To assess the safety and tolerability of single doses of MT-501 following oral administration.

Who Is Running the Clinical Trial?

Mirador Therapeutics, Inc.

Lead Sponsor

Trials

1

Recruited

100+

Published Research Related to This Trial

A new noninvasive method using the radionuclide 195mPt allows for the imaging and quantification of cisplatin or carboplatin at solid tumor sites, which can help tailor drug regimens based on individual pharmacokinetics.

Preliminary studies in both animals and humans demonstrate that this method can effectively estimate the concentration of platinated drugs in tumors, potentially optimizing treatment efficacy for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive measurements for studying the tumoral pharmacokinetics of platinum anticancer drugs in solid tumors. Dowell, JA., Sancho, AR., Anand, D., et al.[2019]

Cis-malonato[(4R,5R)-4,5-bis(aminomethyl)-2-isopropyl-1,3-dioxolane]platinum(II) (SKI 2053R) shows a biexponential decline in blood concentration after intravenous administration, with a rapid initial half-life of about 0.4 hours and a much longer terminal half-life of approximately 68 hours, indicating prolonged presence in the body.

The compound is distributed extensively in tissues, primarily accumulating in the gastrointestinal tract and organs of elimination, with high cumulative recoveries of radioactivity in urine and feces (around 94% in males and 96% in females), suggesting effective excretion and low central nervous system penetration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of cis-malonato[(4R,5R)-4,5-bis(aminomethyl)-2-isopropyl-1, 3-dioxolane]platinum(II) in rats. Cho, YB., Kim, DK., Kim, KH., et al.[2003]

The maximum tolerated dose (MTD) for the carboplatin and paclitaxel combination was established at 235 mg/m2 and 375 mg/m2, respectively, showing a good safety profile with minimal neutropenia and no thrombocytopenia in 50 patients with advanced non-small cell lung cancer.

The treatment resulted in an overall response rate of 38%, with a median overall survival time of 51.81 weeks and a 1-year survival rate of 49%, indicating that this combination therapy is both effective and well tolerated in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I/II dose finding study of paclitaxel and carboplatin in advanced non-small cell lung cancer. Scagliotti, GV., Crinó, L., Pozzi, E., et al.[2019]

The maximum-tolerated dose (MTD) of E6201 was determined to be 320 mg/m2 administered once weekly, based on a phase 1 study involving 55 patients with advanced solid tumors, including melanoma.

E6201 was found to be reasonably well-tolerated, with some adverse events like QT prolongation, and showed clinical efficacy with partial responses in patients, particularly those with BRAF-mutated melanoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, pharmacokinetics, and preliminary efficacy of E6201 in patients with advanced solid tumours, including melanoma: results of a phase 1 study. Tibes, R., Borad, MJ., Dutcus, CE., et al.[2019]

In a phase I trial of malonatoplatinum involving advanced-tumor patients, mild hematologic toxicity was observed, and the study faced challenges due to the drug's poor solubility.

Notably, three patients who were previously resistant to traditional platinum-based chemotherapy (cisdichlorodiammino-platinum) experienced tumor regressions, suggesting potential efficacy of malonatoplatinum in difficult-to-treat cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical and phase I studies of malonatoplatinum. Ribaud, P., Kelsen, DP., Alcock, N., et al.[2019]

Citations

1. trial.medpath.com trial.medpath.com/clinical-trial/ed4c7917d2fd5067/nct06762457-mt-501-safety-tolerability-pharmacokinetics-healthy-volunteers

A First-in-Human Single and Multiple Ascending Dose Study ... This study is the first administration of MT-501 in healthy volunteers (HV). The purpose of the study is to evaluate the safety, tolerability, ...

2. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-11-2024-26a90

MT-501 for Safety in Healthy Subjects The treatment resulted in an overall response rate of 38%, with a median overall survival time of 51.81 weeks and a 1-year survival rate of 49%, indicating that ...

3. trialstoday.org trialstoday.org/trial/NCT06762457

A First-in-Human Single and Multiple Ascending Dose ... This study is the first administration of MT-501 in healthy volunteers (HV). The purpose of the study is to evaluate the safety, tolerability ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10183667/

Phase I NT-501 Ciliary Neurotrophic Factor Implant Trial for ... The primary outcome was ocular safety after NT-501 implantation. A comprehensive eye examination included slit lamp and fundus examination, measurement of ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03650114

Study Details | NCT03650114 | Long-term Safety, ... The purpose of this study is to collect long-term safety, tolerability, effectiveness and health outcomes data in eligible subjects who have participated in ...

6. ctv.veeva.com ctv.veeva.com/study/a-first-in-human-single-and-multiple-ascending-dose-study-of-mt501

A First-in-Human Single and Multiple Ascending Dose Study ... This study is the first administration of MT-501 in healthy volunteers (HV). The purpose of the study is to evaluate the safety, ...

7. clinicaltrials.eu clinicaltrials.eu/trial/study-of-mt-501-in-patients-with-active-crohns-disease-or-ulcerative-colitis-a-phase-2-safety-and-effectiveness-trial/

Study of MT-501 in patients with active Crohn's Disease or ... The main goal of this research is to determine if MT-501 is safe and effective for people with moderate to severe forms of these digestive ...

8. ichgcp.net ichgcp.net/amp/clinical-trials-registry/NCT06762457

Clinical Trial on MT-501 - Clinical Trials Registry - ICH GCP This study is the first administration of MT-501 in healthy volunteers (HV). The purpose of the study is to evaluate the safety, tolerability, ...