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

96 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) with Single and Multiple Ascending Oral Doses of MT-501 in Healthy Adults.

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.

How does the drug MT-501 differ from other treatments for this condition?

MT-501 is unique because it is being tested for safety in healthy subjects, which suggests it may have a novel mechanism or application compared to existing treatments. The research does not provide specific details about MT-501, but it is distinct from other platinum-based drugs like malonatoplatinum, which have been studied for their effects on advanced tumors. ^{1 2 3 4 5}

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

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]

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]

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]

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]

Citations

1. Germany pubmed.ncbi.nlm.nih.gov

Preclinical and phase I studies of malonatoplatinum. [2019]

2. England 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. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of cis-malonato[(4R,5R)-4,5-bis(aminomethyl)-2-isopropyl-1, 3-dioxolane]platinum(II) in rats. [2003]

4. Ireland pubmed.ncbi.nlm.nih.gov

Phase I/II dose finding study of paclitaxel and carboplatin in advanced non-small cell lung cancer. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Noninvasive measurements for studying the tumoral pharmacokinetics of platinum anticancer drugs in solid tumors. [2019]