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

89 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new drug, MTR-601, in healthy volunteers to see if it is safe. Researchers will measure how the drug behaves in the body and its effects on muscle strength.

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.

What data supports the effectiveness of the drug MTR-601 for muscle spasticity?

Research shows that botulinum toxin A, a component often used in spasticity management, is effective in reducing muscle spasms and improving patient-reported outcomes. Additionally, tizanidine, another drug used for spasticity, has shown significant reduction in muscle spasms in clinical trials. ^{1 2 3 4 5}

Research Team

Alan Hand, MD

Principal Investigator

Worldwide Clinical Trials

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Sweden pubmed.ncbi.nlm.nih.gov

Longitudinal goal attainment with integrated upper limb spasticity management including repeat injections of botulinum toxin A: Findings from the prospective, observational Upper Limb International Spasticity (ULIS-III) cohort study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Safety and self-reported efficacy of botulinum toxin for adult spasticity in current clinical practice: a prospective observational study. [2019]

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

Tizanidine treatment of spasticity caused by multiple sclerosis: results of a double-blind, placebo-controlled trial. US Tizanidine Study Group. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Inter-rater reliability of the Modified Modified Ashworth Scale in assessing lower limb muscle spasticity. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Measurement of the effect of a bolus dose of intrathecal baclofen by a repetitive movement test. [2019]