MTR-601 for Muscle Spasticity

Overseen By Kristen Signs

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Motric Bio

Must not be taking: St. John's wort

Disqualifiers: Endocrine, Neurological, Cardiovascular, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines MTR-601, a new treatment for muscle spasticity. The main goal is to assess the safety and tolerability of this treatment and its behavior in the body, both in the blood and urine. Researchers are also evaluating how MTR-601 affects muscle strength and its presence in muscle tissue. Healthy volunteers who do not smoke, have no significant health issues, and are willing to follow study rules might be suitable candidates for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment 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?

Yes, you will need to stop taking any prescription or nonprescription medications, herbal remedies, or supplements (except for paracetamol/acetaminophen) at least 14 days before the study and throughout its duration.

Is there any evidence suggesting that MTR-601 is likely to be safe for humans?

Research shows that MTR-601 is undergoing its first human trials, so specific safety information from these trials is not yet available. However, prior studies suggested the drug could be safe for humans. These studies were crucial in determining MTR-601's potential for human use.

As this trial is in its early phase, the primary goal is to assess the drug's safety and tolerability. The trial will evaluate how the drug functions in the body and its impact on muscle strength. Detailed information on side effects and tolerability is not yet available, as these aspects remain under investigation.

In summary, the trial seeks to determine MTR-601's safety for humans, but specific results are pending. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for muscle spasticity, like baclofen or tizanidine, work by affecting nerve signaling to relax muscles. But MTR-601 is different; it directly targets the fast twitch myosin 2 ATPase, a key enzyme involved in muscle contraction. This unique mechanism could mean more precise control over muscle stiffness and fewer side effects related to the central nervous system. Researchers are excited because MTR-601's targeted approach might offer a safer, more effective way to manage spasticity compared to existing options.

What evidence suggests that MTR-601 might be an effective treatment for muscle spasticity?

Research has shown that MTR-601, which participants in this trial may receive, is under study as a treatment for muscle stiffness, with promising early results. Initial findings suggest it could reduce muscle spasms and improve patient outcomes. MTR-601 targets specific muscle fibers responsible for quick and powerful movements, blocking a specific enzyme to reduce involuntary muscle contractions. Although human studies provide limited information, the treatment shows potential based on its mechanism. Additionally, treatments in this area often successfully progress through early trial stages. ^{2 3 4 5 6}

Who Is on the Research Team?

Alan Hand, MD

Principal Investigator

Worldwide Clinical Trials

Are You a Good Fit for This Trial?

Healthy non-smokers aged 18-45 with a BMI <33 kg/m2 can join this trial. They must not have used tobacco for 3 months, be in good health based on various medical tests, and agree to use contraception if applicable. People with cardiovascular diseases, positive drug/alcohol screens, recent surgeries that affect drug absorption or metabolism, or those who've been hospitalized recently cannot participate.

Inclusion Criteria

Willing to adhere to study procedures and provide written informed consent prior to the start of any study procedures

I weigh at least 50 kg and my BMI is less than 33.

I am using birth control or cannot become pregnant/beget children.

Exclusion Criteria

I haven't received blood products, donated blood, or consumed certain foods recently.

I haven't taken any medications that affect drug processing in the last 30 days.

I have no significant health issues apart from my current condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD)

Participants receive single ascending doses of MTR-601, with safety evaluations after each dose level

Approximately 1 week per dose level

Multiple visits for dosing and safety evaluation

Multiple Ascending Dose (MAD)

Participants receive multiple ascending doses of MTR-601 over 14 continuous days

14 days

Daily visits for dosing

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MTR-601

Trial Overview The study is testing MTR-601's safety and how the body processes it under different conditions (with food or without). It will also look at how MTR-601 affects muscle strength and its accumulation in muscles through biopsies and other markers.

How Is the Trial Designed?

Group I: MTR-601 Experimental Treatment 1 Intervention

Safety and tolerability of oral MTR-601, a highly selective fast twitch myosin 2 ATPase inhibitor in normal healthy volunteers

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Motric Bio

Lead Sponsor

Trials

2

Recruited

170+

Citations

1. trialx.com trialx.com/clinical-trials/listings/251215/single-and-multiple-ascending-dose-study-of-mtr-601-in-healthy-individuals/

Single and Multiple Ascending Dose Study of MTR-601 ... To evaluate the pharmacodynamic (PD) effects of MTR-601 on muscle strength and muscle accumulation of MTR-601 by muscle biopsy and other ...

2. ctv.veeva.com ctv.veeva.com/study/single-and-multiple-ascending-dose-study-of-mtr-601-in-healthy-individuals

Single and Multiple Ascending Dose Study of MTR-601 in ... To assess the safety and tolerability of single and multiple doses of MTR-601 in normal healthy volunteers under fed and fasted conditions.

3. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/mtr-601-motric-bio-muscle-spasticity-likelihood-of-approval/

MTR-601 by Motric Bio for Muscle Spasticity: Likelihood of ... According to GlobalData, Phase I drugs for Muscle Spasticity have a 71% phase transition success rate (PTSR) indication benchmark for progressing into Phase II.

4. trial.medpath.com trial.medpath.com/drug/report/0a7ab4076c42ea9b

MTR-601 | Advanced Drug Monograph - MedPath MTR-601 is positioned to address a significant unmet need in the treatment of cervical dystonia and other spasticity-related disorders. The ...

5. withpower.com withpower.com/trial/phase-1-muscle-spasticity-8-2023-c4d60

MTR-601 for Muscle Spasticity · Info for Participants What data supports the effectiveness of the drug MTR-601 for muscle spasticity? ... effective in reducing muscle spasms and improving patient-reported outcomes.

6. motricbio.com motricbio.com/mtr-601

MTR-601 | Motric Bio | Relieving Muscle Spasticity Our team has completed a range of Investigational New Drug (IND)-enabling studies to generate the safety data that will enabled us to complete the first human ...