A Study to Assess the Safety, Tolerability and Pharmacokinetics of TCMCB07 in Single and Multiple Ascending Doses in Health Subjects

Overseen By Chief Commercialization Officer

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Endevica Bio

Disqualifiers: Hypersensitivity, Covid-19, Abnormal labs, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

76 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called TCMCB07 to help cancer patients who are experiencing severe weight loss and weakness due to cachexia. The drug aims to improve their appetite and energy levels, making them feel stronger and healthier.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinator or your doctor.

What safety data exists for the treatment known as TCMCB07 or mibefradil?

Mibefradil, also known as TCMCB07, was tested for safety in patients with heart failure and angina, showing no worsening of heart function, though some patients reported adverse events. It was withdrawn from the market due to drug interactions but is being studied again for cancer treatment. ^{1 2 3 4 5}

Research Team

Maria Bermudez, MD, CPI

Principal Investigator

Quotient Sciences

Eligibility Criteria

Inclusion Criteria

Body mass index 18.0 to 30.0 kg/m2 as measured at Screening or, if outside this range, considered not clinically significant by the investigator.

Weight ≥ 50 kg at Screening

Healthy males and females (WONCBP), aged 18 to 55 years inclusive, at time of signing informed consent.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive once daily subcutaneous injections of TCMCB07 or placebo

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• TCMCB07

Participant Groups

Group I: TCMCB07 Experimental Treatment 1 Intervention

once daily subcutaneous injection

Group II: Placebo Placebo Group 1 Intervention

once daily subcutaneous injection

Who Is Running the Clinical Trial?

Endevica Bio

Lead Sponsor

Trials

1

Recruited

80+

Findings from Research

In a study involving 45 patients with mild-to-moderate chronic congestive heart failure, short-term oral dosing of mibefradil did not worsen cardiac function or clinical variables, indicating its safety in this population.

While 23.3% of patients taking mibefradil reported adverse events compared to 13.3% in the placebo group, the incidence of these events was not related to the dose, suggesting that mibefradil may be well-tolerated at various levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the safety of mibefradil, a selective T-type calcium antagonist, in patients with chronic congestive heart failure. van der Vring, JA., Bernink, PJ., van der Wall, EE., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Adding the new calcium antagonist mibefradil to patients receiving long-term beta-blocker therapy results in improved antianginal and antiischemic efficacy. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

CCT128930 is a novel and potent antagonist of TRPM7 channel. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Effects of the calcium channel antagonist mibefradil on haemodynamic and morphological parameters in myocardial infarction-induced cardiac failure in rats. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

T-type Ca2+ Channels: T for Targetable. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluating the safety of mibefradil, a selective T-type calcium antagonist, in patients with chronic congestive heart failure. [2019]