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MTR-601 for Muscle Spasticity

Phase 1
Recruiting
Led By Alan Hand, MD
Research Sponsored by Motric Bio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Weight ≥50 kg and BMI <33 kg/m2
Aged 18-45 years and in good physical health based on medical history, physical examination, vital signs, laboratory, ECG, Echocardiography, muscle strength, and spirometry test values
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to day 18.
Awards & highlights

Study Summary

This trial tests the safety and effects of a drug, measuring effects on strength and how it's absorbed in different conditions.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones may include reactions at the injection site, fatigue, headache, nausea. The trial aims to identify any potential side effects from single or multiple doses of MTR-601.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I weigh at least 50 kg and my BMI is less than 33.
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I am between 18-45 years old and in good health.
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My vital signs are normal and my lung function is good.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to day 18.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to day 18. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence, severity and relatedness of Treatment-emergent adverse events (TEAEs). TEAE severity will be measured as mild, moderate or severe, and relatedness will be either related or not related.
Secondary outcome measures
Maximum plasma concentration (Cmax) of MTR-601
Pharmacodynamic of MTR-601-Forearm extension and flexion strength by dynamometry
Pharmacodynamic of MTR-601-Grip strength by dynamometry
+6 more
Other outcome measures
Exploratory biomarkers of MTR-601 activity.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MTR-601Experimental Treatment1 Intervention
Safety and tolerability of oral MTR-601, a highly selective fast twitch myosin 2 ATPase inhibitor in normal healthy volunteers
Group II: PlaceboPlacebo Group1 Intervention

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Motric BioLead Sponsor
Alan Hand, MDPrincipal InvestigatorWorldwide Clinical Trials

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what degree could MTR-601 pose a hazard to humans?

"With limited clinical data pertaining to safety and efficacy, MTR-601 was assigned a score of 1."

Answered by AI

Does this research program extend to elderly participants older than seventy-five years of age?

"This trial, intended for the age cohort of 18 to 45 year olds, has a total enrollment goal of 262 participants. For those aged under 18 and over 65 there are 1715 additional clinical trials available."

Answered by AI

How many individuals are engaged in this trial's experimentation?

"Affirmative. From the information hosted on clinicaltrials.gov, it is evident that this medical trial which was initially made visible on September 11th 2023 continues to actively recruit participants. 80 patients are needed from one site for successful completion of the study."

Answered by AI

To whom is the recruitment of this experiment open?

"For admittance to this study, applicants need to have muscle spasms and be within the age bracket of 18-45. This trial is seeking about 80 participants in total."

Answered by AI

Are there any openings left for participants in this examination?

"Affirmative. Clinicaltrials.gov's information attests to this trial actively seeking participants, which was initially posted on September 11th 2023 and has since been amended on October 31st 2023. 80 individuals are needed for the single-site study."

Answered by AI

Who else is applying?

What site did they apply to?
Worldwide Clinical Trials
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Single and Multiple Ascending Dose Study of MTR-601 in Healthy Individuals
2023. "Single and Multiple Ascending Dose Study of MTR-601 in Healthy Individuals". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06117020.
All > Dystonia > Cerebral Palsy
~51 spots leftby Apr 2025
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