Muscle SpasticityPhase 1NCT06117020

Single and Multiple Ascending Dose Study of MTR-601 in Healthy Individuals

A Phase 1 study testing MTR-601 in people with Muscle Spasticity and Hypertonia, Muscle, run by Motric Bio at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To assess the safety and tolerability of single and multiple doses of MTR-601 in normal healthy volunteers under fed and fasted conditions. To evaluate the plasma and urine pharmacokinetics (PK) of MTR-601. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Muscle Spasticity, Hypertonia, Muscle, Cerebral Palsy
What is being tested?: MTR-601
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 89 participants
Where: 1 siteUnited States
Study dates: 11 Sep 2023to 16 Oct 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Willing to adhere to study procedures and provide written informed consent prior to the start of any study procedures.
18-45 years of age at the time of consent and in good physical health based on medical history, physical examination including vital signs, as well as laboratory, electrocardiogram (ECG), Echocardiography (LVEF in the normal range of 50-70%), normal muscle strength upon physical examination, and spirometry test values in the normal range.
Weight ≥50 kg and body mass index (BMI) <33 kg/m2.
Females or males with female partners must use a medically accepted contraceptive regimen (i.e., condoms with spermicide, abstinence, nonhormonal intrauterine device (IUD), Essure procedure, or diaphragm with spermicide) from at least 30 days prior to first dose through 90 days after the last dose OR females must be of non-childbearing potential, defined as:
Have been surgically sterilized (bilateral oophorectomy) or hysterectomized at least 6 months prior to screening. Surgical sterilization procedures or hysterectomy must be supported with clinical documentation/medical records and noted in the Relevant Medical History/Current Medical Condition section of the electronic case report form (eCRF).
Be postmenopausal (i.e., must have no regular menstrual bleeding for at least 2 years prior to inclusion). Menopause will be confirmed by a plasma follicle-stimulating hormone (FSH) level of >40 IU/L.

Show all 10Show fewer

Non-smoker and must not have used any tobacco products within 3 months prior to screening.
In good physical and mental health as determined by past medical history, physical examination, psychiatric examination, 12-lead ECG, Echocardiography, spirometry, urinary system ultrasound, vital sign measurements, and clinical laboratory evaluations and calculations(e.g., eGFR greater than 90 ml/1.73 m2) at screening or check-in to the clinical research unit (CRU) on Day -1, as assessed by the Investigator (or designee). Congenital nonhemolytic hyperbilirubinemia; or suspicion of Gilbert's syndrome based on total and direct bilirubin is not acceptable.
Has clinical laboratory test results within the reference ranges of the testing laboratory, except for results outside reference ranges that are deemed not clinically significant by the Investigator (or designee) at screening and check-in to the CRU on Day -1.
Vital signs are within normal limits and FVC (after 3 minutes resting in supine position, will be measured in the seated position) is greater than 90% of the predicted value for gender, age and height with good expiratory effort.

Who cannot join

Subjects who meet any of the following exclusion criteria will be excluded from participation in the study:
History of, or physical examination findings indicating, clinically significant endocrine, neurological, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or muscle abnormalities or diseases that, in the opinion of the Investigator, would render the subject being unsuitable for the study.
Unwilling or unable to refrain from strenuous exercise for 3 days prior to check-in and during study.
Unwilling to discontinue coffee (containing caffeine) and other caffeine-containing beverages (e.g., sodas, energy drinks) for at least 72 hours before check-in and throughout the entirety of the study.
Use of tobacco- or nicotine-containing products (including but not limited to cigarettes, electronic cigarettes, pipes, cigars, chewing tobacco, nicotine patch, or nicotine gum) within 3 months prior to check-in to the CRU on Day -1 and throughout the entirety of the study (urine cotinine levels will be measured during screening for all subjects; subjects with cotinine values greater than 500 ng/mL will be excluded).
Requires prescription or nonprescription medications/herbal remedies/supplements of any kind (with the exception of paracetamol/acetaminophen 2 g/day for up to 3 consecutive days) from 14 days prior to check-in (Day -1) and throughout the entirety of the study; uses or intends to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing.

Show all 37Show fewer

History or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, urinary, hematological, pulmonary, gastrointestinal, neurological, psychiatric, respiratory, or endocrine disorder, unless determined by the Investigator (or designee) and agreed by the Medical Monitor to be not clinically significant.
Active or history of metabolic, cardiovascular, or cerebrovascular disease, including hypertension, angina, ischemic heart disease, transient ischemic attacks, bundle branch block, evidence of myocardial ischemia, stroke, and peripheral arterial disease sufficient to cause symptoms and/or require therapy to maintain stable status.
History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
Active neoplastic disease or history of any neoplastic disease within 5 years of screening (except for basal or squamous cell carcinoma of the skin or carcinoma in situ that has been definitively treated with standard of care).
Active infection (e.g., sepsis, pneumonia, abscess) or a serious infection (e.g., resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to dosing.
History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
Any of the following at screening and/or pre-dose:
QT interval corrected for heart rate using Fridericia's formula (QTcF), QRS duration, PR interval outside of normal limits confirmed by repeat measurement, unless deemed non-clinically significant by PI and agreed by Medical Monitor
Findings which would make QTc measurements difficult or QTc data uninterpretable
History of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome)
History of alcoholism or drug/chemical abuse.
Unwilling to abstain from alcohol consumption within 24 hours of check-in to the CRU on Day -1 throughout the study.
Positive urine alcohol screen or positive urine drug screen (including cannabinoids, amphetamines, cocaine, opiates benzodiazepines, or barbiturates), including cotinine (confirmed by repeat) at screening or check-in to the CRU on Day -1.
Positive hepatitis panel and/or positive human immunodeficiency virus test at screening.
Any of the following hematology values at screening or check-in to the CRU on Day -1, as confirmed by 1 repeat if necessary:
Hemoglobin <11 g/dL for females, and <12 g/dL for males
Absolute neutrophil count (ANC) <1.5 × 109/L (<1500/μL).
Aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), or total bilirubin >1.5 × upper limit of normal (ULN) at screening or check-in to the CRU on Day -1, confirmed by 1 repeat if necessary.
Participation in a clinical study involving administration of an investigational drug (new chemical entity) or medical device within the last 90 days or 5 half-lives of the investigational medication, whichever is longer, prior to dosing.
Use or intention to use any prescription or nonprescription medications/products within 14 days or 5 half-lives of the medication/product, whichever is longer, prior to check-in to the CRU on Day -1 (hormone replacement therapy or intrauterine contraceptives are acceptable).
Receipt of blood products within 2 months prior to check-in to the CRU on Day -1.
Donation of blood (>400 mL) or comparable blood loss (>350 mL) from 3 months prior to screening, plasma donation from 2 weeks prior to screening, or platelets donation from 6 weeks prior to screening.
Poor peripheral venous access.
Consumption of any foods or beverages containing Seville-type oranges, grapefruit, or poppy seeds within 7 days prior to check-in to the CRU on Day -1.
Subjects who, in the opinion of the Investigator (or designee; including input from subjects' general practitioner, as applicable), should not participate in this study.
Subject hospitalized for any reason in a period of 30 days before the start of the study.
Diagnosis with a primary muscle disorder.
The presence of any medical device which may interfere with or be impacted by magnetic stimulation.
History of any suicidal behavior in lifetime or suicidal ideation within the last 2 years, with or without a plan at screening or check-in (Day -1).
Subjects who are investigational site staff members or directly involved in the conduct of the study and their family members or subjects who are employed by the Sponsor.
An IPSS score equal to or greater than 6 at baseline.

Trial locations and contacts

1 site in 1 country.

United States1 site

Worldwide Clinical Trials
San Antonio, Texas, 78217

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, First-in-Human, Single and Multiple Ascending Dose Study of MTR-601 in Healthy Volunteers.

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

To evaluate the plasma and urine pharmacokinetics (PK) 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 potential mechanistic, predictive and PD markers of MTR-601.

Read the detailed description

This randomized, placebo-controlled, first-in-human (FIH) study of MTR-601 in normal healthy volunteers will consist of 3 single ascending dose (SAD) level cohorts, 1 SAD Level 2, Two-Dose cohort, 3 multiple ascending dose (MAD) level cohorts, and 1 optional MAD level cohort, each comprised of 8 subjects (6 MTR-601; 2 placebo). The total sample size will be up to 80 subjects to accommodate withdrawal of consent or replacement for other non-treatment-emergent adverse events (non-TEAE) reasons.

SAD Levels 1-4 dosing:

Each of the SAD dose level cohorts will have 2 sentinel subjects followed at least 72 hours later by the remaining 6 subjects in 1 or more groups in a staggered fashion. Both sentinel subjects will be evaluated for 72 hours by the Investigator for safety prior to dosing the cohort's remaining 6 subjects.
Dosing will begin at dose Level 1 (10 mg).
Subjects in SAD Levels 1,3 and 4 will be dosed in a fed state (standard non-high-fat breakfast).
Subjects in the SAD Level 2, Two-Dose (20 mg) will be dosed in a fasting state on Day 1 with a subsequent 4-day washout period, followed by dosing in a fed state (standard not- high fat breakfast) on Day 6.
SAD Level 4 (80 mg) dosing is optional and may be adjusted based upon PK and safety results from earlier cohorts.

MAD Levels 1-2 dosing:

The MAD portion of the study will commence at MAD Level 1 (10 mg) after the safe completion of the subjects in at least the SAD Level 2 Two-Dose cohort.
Subjects in MAD Levels 1-2 (no more than 20mg) will be dosed in a fed state (standard non-high-fat breakfast) over 14 continuous days of dosing.
MAD cohorts may be enrolled in small groups to accommodate clinic scheduling, with subjects dosed in a staggered fashion.

Conditions: Muscle Spasticity, Hypertonia, Muscle, Cerebral Palsy, Multiple Sclerosis, Stroke, Hereditary Spastic Paraplegia
Being tested: MTR-601
Keywords: Fast twitch type 2 myosin ATPase
Medical subject headings: Muscle Spasticity, Muscle Hypertonia, Cerebral Palsy, Multiple Sclerosis, Stroke, Spastic Paraplegia, Hereditary, Dystonia, Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06117020
Study group	Role	What they receive
MTR-601	Experimental	Safety and tolerability of oral MTR-601, a highly selective fast twitch myosin 2 ATPase inhibitor in normal healthy volunteers Receives: Drug: MTR-601
Placebo	Placebo comparator	Not described Receives: Drug: MTR-601

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
To assess the safety and tolerability of single and multiple doses of MTR-601 in normal healthy volunteers under fed and fasted conditions.
Measured: From baseline to last follow-up visit (Day 7 for SAD Dose Levels 1, 3, and 4, Day 12 for SAD Dose Level 2, Day 20 MAD Dose Levels 1-6)

Secondary outcomes (35)

Maximum Plasma Concentration (Cmax) of MTR-601 In Single Ascending Doses
To evaluate the plasma and urine pharmacokinetics (PK) of MTR-601
Measured: Day 1
Maximum Plasma Concentration (Cmax) of MTR-601 in Multiple Ascending Doses
To evaluate the plasma pharmacokinetics (PK) of MTR-601 in Multiple Ascending Doses on Day 1
Measured: Day 1
Maximum Plasma Concentration (Cmax) of MTR-601 in Multiple Ascending Doses
To evaluate the plasma pharmacokinetics (PK) of MTR-601 in Multiple Ascending Doses on Day 7
Measured: Day 7
Maximum Plasma Concentration at Steady State (Cmax, ss) of MTR-601 in Multiple Ascending Doses
To evaluate the plasma pharmacokinetics (PK) of MTR-601 in Multiple Ascending Doses on Day 14
Measured: Day 14
Time to Maximum Plasma Concentration (Tmax) of MTR-601 in Single Ascending Doses
To evaluate the plasma and urine pharmacokinetics (PK) of MTR-601
Measured: Day 1
Time to Maximum Plasma Concentration (Tmax) of MTR-601 in Multiple Ascending Doses
To evaluate the plasma pharmacokinetics (PK) of MTR-601 in Multiple Ascending Doses on Day 1
Measured: Day 1
Time to Maximum Plasma Concentration (Tmax) of MTR-601 in Multiple Ascending Doses
To evaluate the plasma pharmacokinetics (PK) of MTR-601 in Multiple Ascending Doses on Day 7
Measured: Day 7
Time to Maximum Plasma Concentration at Steady State (Tmax, ss) of MTR-601 in Multiple Ascending Doses
To Evaluate the Time to Maximum Plasma Concentration at Steady State (Tmax, ss) of MTR-601 in Multiple Ascending Doses on Day 14
Measured: Day 14
Plasma Area Under the Curve Through 24 Hours (AUC0-24) of MTR-601 in Single Ascending Doses
To evaluate the Plasma area under the curve (AUC0-24) of MTR-601 in Single Ascending Doses to 24 Hours
Measured: 0-24 Hours
Plasma Area Under the Curve to Infinity (AUCinf) of MTR-601 in Single Ascending Dose
To extraplolate the plasma Area Under the Curve to infinite time of MTR-601 in Single Ascending Doses
Measured: 0-96 hours
Plasma Half-life (T1/2) of MTR-601 in Single Ascending Doses
To evaluate the plasma pharmacokinetics (PK) of MTR-601 in Single Ascending Doses
Measured: 0-96 Hours
Plasma Concentration Corresponding to the Time of Last Measurable Observation (Clast)
To evaluate the plasma concentration corresponding to the time of last measurable observation of MTR-601 in Single Ascending Doses
Measured: 0-96 Hours
Plasma Clearance of Drug After Extravascular Administration (CL/F) in Single Ascending Doses
To evaluate the plasma pharmacokinetics (PK) of MTR-601 in Single Ascending Doses
Measured: 0-96 Hours
Volume of Distribution After Extravascular Administration (Vz/F) of MTR-901 in Single Ascending Doses
To evaluate the volume of distribution after extravascular administration (Vz/F) of MTR-901 in Single Ascending Doses
Measured: 0-96 Hours
Maximum Plasma Concentration at 24 Hours (C24) of MTR-601 in Multiple Ascending Doses
To evaluate the plasma pharmacokinetics (PK) of MTR-601 in Multiple Ascending Doses on Day 1
Measured: Day 1
Maximum Plasma Concentration at 24 Hours (C24) of MTR-601 in Multiple Ascending Doses
To evaluate the plasma pharmacokinetics (PK) of MTR-601 in Multiple Ascending Doses on Day 7
Measured: Day 7
Maximum Plasma Concentration at 24 Hours (C24) of MTR-601 in Multiple Ascending Doses
To evaluate the plasma pharmacokinetics (PK) of MTR-601 in Multiple Ascending Doses on Day 14
Measured: Day 14
Area Under the Curve Over the Dosing Interval (AUCtau) of MTR-601 in Multiple Ascending Doses
To evaluate the Area Under the Curve over the Dosing Interval (AUCtau) of MTR-601 in Multiple Ascending Doses on Day 1
Measured: Day 1
Area Under the Curve Over the Dosing Interval (AUCtau) of MTR-601 in Multiple Ascending Doses
To evaluate the Area Under the Curve over the Dosing Interval (AUCtau) of MTR-601 in Multiple Ascending Doses on Day 7
Measured: Day 7
Area Under the Curve at Steady State Over the Dosing Interval (AUCtau) of MTR-601 in Multiple Ascending Doses
To evaluate the Area Under the Curve at Steady State over the Dosing Interval (AUCtau) of MTR-601 in Multiple Ascending Doses on Day 14
Measured: Day 14
Average Plasma Drug Concentration of MTR-601 in Multiple Ascending Doses
To evaluate the Average plasma drug concentration of MTR-601 in Multiple Ascending Doses on Day 14
Measured: Day 14
Volume of Distribution After Extravascular Administration (Vz/F) of MTR-901 in Multiple Ascending Doses
To evaluate the Volume of Distribution After Extravascular Administration (Vz/F) of MTR-901 in Multiple Ascending Doses on Day 14
Measured: Day 14
Accumulation Ratio of Maximum Plasma Concentration (AR_Cmax) of MTR-901 in Multiple Ascending Doses
To evaluate the Accumulation Ratio of Maximum Plasma Concentration (AR_Cmax) of MTR-901 in Multiple Ascending Doses on Day 14
Measured: Day 14
Maximum Accumulation Concentration of Area Under the Curve (AR_AUC0-24, qd) of MTR-901 in Multiple Ascending Doses
To evaluate the Maximum Accumulation Concentration of Area Under the Curve (AR_AUC0-24, qd) of MTR-901 in Multiple Ascending Doses on Day 14
Measured: Day 14
Plasma Clearance of Drug After Extravascular Administration (CL/F) of MTR-601 in Multiple Ascending Doses
To evaluate the Plasma Clearance of Drug After Extravascular Administration (CL/F) of MTR-601 in Multiple Ascending Doses on Day 14
Measured: Day 14
Cumulative Amount of MTR-601 Excreted Unchanged in Urine (Ae) in Single Ascending Doses
To evaluate the Cumulative amount of MTR-601 Excreted Unchanged in Urine in Single Ascending Doses
Measured: Up to 96 Hours
Fraction of Dose of MTR-601 Excreted Unchanged in Urine (Fe) in Single Ascending Doses
To evaluate theFraction of Dose of MTR-601 Excreted Unchanged in Urine in Single Ascending Doses
Measured: Up to 96 Hours
Renal Clearance (Clr) of MTR-601 in Single Ascending Doses
To evaluate the Renal Clearance (Clr) of MTR-601 in Single Ascending Doses in Single Ascending Doses
Measured: Up to 96 Hours
Cumulative Amount of MTR-601 Excreted Unchanged in Urine (Ae) In Multiple Ascending Doses
To evaluate the Cumulative amount of MTR-601 Excreted Unchanged in Urine in Multiple Ascending Doses
Measured: Day 1
Fraction of Dose of MTR-601 Excreted Unchanged in Urine (Fe) in Multiple Ascending Doses
To evaluate theFraction of Dose of MTR-601 Excreted Unchanged in Urine in Multiple Ascending Doses
Measured: Day 1
Cumulative Amount of MTR-601 Excreted Unchanged in Urine (Ae) In Multiple Ascending Doses
To evaluate the Cumulative amount of MTR-601 Excreted Unchanged in Urine in Multiple Ascending Doses
Measured: Day 7
Fraction of Dose of MTR-601 Excreted Unchanged in Urine (Fe) in Multiple Ascending Doses
To evaluate theFraction of Dose of MTR-601 Excreted Unchanged in Urine in Multiple Ascending Doses
Measured: Day 7
Cumulative Amount of MTR-601 Excreted Unchanged in Urine (Ae) In Multiple Ascending Doses
To evaluate the Cumulative amount of MTR-601 Excreted Unchanged in Urine in Multiple Ascending Doses
Measured: Day 14
Fraction of Dose of MTR-601 Excreted Unchanged in Urine (Fe) in Multiple Ascending Doses
To evaluate theFraction of Dose of MTR-601 Excreted Unchanged in Urine in Multiple Ascending Doses
Measured: Day 14
Renal Clearance (Clr) of MTR-601 in Multiple Ascending Doses
To evaluate the Renal Clearance (Clr) of MTR-601 in Multiple Ascending Doses
Measured: Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Sep 202316 Oct 2024

First posted3 Nov 2023
Study start11 Sep 2023
Primary completion16 Oct 2024
Study completion16 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Muscle SpasticityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: This randomized, placebo-controlled, first-in-human (FIH) study of MTR-601 in normal healthy volunteers will consist of 3 single ascending dose (SAD) level cohorts, 1 SAD Level 2, Two-Dose cohort, 3 multiple ascending dose (MAD) level cohorts, and 1 optional MAD level cohort, each comprised of 8 subjects (6 MTR-601; 2 placebo).
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06117020
Sponsor's protocol ID: MTR-601-NHV-101
Status last verified: May 2026
First submitted: 17 Oct 2023
Last updated: 5 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Gyimesi M, Horvath AI, Turos D, Suthar SK, Penzes M, Kurdi C, Canon L, Kikuti C, Ruppel KM, Trivedi DV, Spudich JA, Lorincz I, Rauscher AA, Kovacs M, Pal E, Komoly S, Houdusse A, Malnasi-Csizmadia A. Single Residue Variation in Skeletal Muscle Myosin Enables Direct and Selective Drug Targeting for Spasticity and Muscle Stiffness. Cell. 2020 Oct 15;183(2):335-346.e13. doi: 10.1016/j.cell.2020.08.050. Epub 2020 Oct 8.
PubMed 33035452

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
RecruitingPhase 4
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)
Not yet recruitingObservational study
Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
Cerebral Palsy Infantile, Upper Limb Spasticity
Not yet recruitingEarly Phase 1
Early Botulinum Toxin for Muscle Stiffness Reduction in First-Time Stroke Patients: Improving Recovery and Independence
Spasticity, Stroke

All Muscle Spasticity trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, First-in-Human, Single and Multiple Ascending Dose Study of MTR-601 in Healthy Volunteers.
ClinicalTrials.gov ID: NCT06117020
Acronym / sponsor ID: MTR-601-NHV-101
Conditions: Muscle Spasticity, Hypertonia, Muscle, Cerebral Palsy, Multiple Sclerosis, Stroke, Hereditary Spastic Paraplegia
Keywords: Fast twitch type 2 myosin ATPase
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: Motric BioIndustry (pharma, biotech, devices)
Study start: 11 Sep 2023 (actual)
Primary completion: 16 Oct 2024 (actual)
Study completion: 16 Oct 2024 (actual)
First posted: 3 Nov 2023 (actual)
Results: Posted 5 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

SAD Levels 1-4 dosing:

Each of the SAD dose level cohorts will have 2 sentinel subjects followed at least 72 hours later by the remaining 6 subjects in 1 or more groups in a staggered fashion. Both sentinel subjects will be evaluated for 72 hours by the Investigator for safety prior to dosing the cohort's remaining 6 subjects.
Dosing will begin at dose Level 1 (10 mg).
Subjects in SAD Levels 1,3 and 4 will be dosed in a fed state (standard non-high-fat breakfast).
Subjects in the SAD Level 2, Two-Dose (20 mg) will be dosed in a fasting state on Day 1 with a subsequent 4-day washout period, followed by dosing in a fed state (standard not- high fat breakfast) on Day 6.
SAD Level 4 (80 mg) dosing is optional and may be adjusted based upon PK and safety results from earlier cohorts.

MAD Levels 1-2 dosing:

The MAD portion of the study will commence at MAD Level 1 (10 mg) after the safe completion of the subjects in at least the SAD Level 2 Two-Dose cohort.
Subjects in MAD Levels 1-2 (no more than 20mg) will be dosed in a fed state (standard non-high-fat breakfast) over 14 continuous days of dosing.
MAD cohorts may be enrolled in small groups to accommodate clinic scheduling, with subjects dosed in a staggered fashion.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: This randomized, placebo-controlled, first-in-human (FIH) study of MTR-601 in normal healthy volunteers will consist of 3 single ascending dose (SAD) level cohorts, 1 SAD Level 2, Two-Dose cohort, 3 multiple ascending dose (MAD) level cohorts, and 1 optional MAD level cohort, each comprised of 8 subjects (6 MTR-601; 2 placebo).

Arm	Type	Receives
MTR-601	Experimental	Drug: MTR-601Safety and tolerability of oral MTR-601, a highly selective fast twitch myosin 2 ATPase inhibitor in normal healthy volunteers
Placebo	Placebo comparator	Drug: MTR-601

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Willing to adhere to study procedures and provide written informed consent prior to the start of any study procedures.
18-45 years of age at the time of consent and in good physical health based on medical history, physical examination including vital signs, as well as laboratory, electrocardiogram (ECG), Echocardiography (LVEF in the normal range of 50-70%), normal muscle strength upon physical examination, and spirometry test values in the normal range.
Weight ≥50 kg and body mass index (BMI) <33 kg/m2.
Females or males with female partners must use a medically accepted contraceptive regimen (i.e., condoms with spermicide, abstinence, nonhormonal intrauterine device (IUD), Essure procedure, or diaphragm with spermicide) from at least 30 days prior to first dose through 90 days after the last dose OR females must be of non-childbearing potential, defined as:
Non-smoker and must not have used any tobacco products within 3 months prior to screening.

Key exclusion criteria (37 listed)

Subjects who meet any of the following exclusion criteria will be excluded from participation in the study:
History of, or physical examination findings indicating, clinically significant endocrine, neurological, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or muscle abnormalities or diseases that, in the opinion of the Investigator, would render the subject being unsuitable for the study.
Unwilling or unable to refrain from strenuous exercise for 3 days prior to check-in and during study.
Unwilling to discontinue coffee (containing caffeine) and other caffeine-containing beverages (e.g., sodas, energy drinks) for at least 72 hours before check-in and throughout the entirety of the study.
Use of tobacco- or nicotine-containing products (including but not limited to cigarettes, electronic cigarettes, pipes, cigars, chewing tobacco, nicotine patch, or nicotine gum) within 3 months prior to check-in to the CRU on Day -1 and throughout the entirety of the study (urine cotinine levels will be measured during screening for all subjects; subjects with cotinine values greater than 500 ng/mL will be excluded).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MTR-601Also: PlaceboSafety and tolerability of oral MTR-601, a highly selective fast twitch myosin 2 ATPase inhibitor in normal healthy volunteers	Drug	MTR-601, Placebo

Primary outcome

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.
Time frame: From baseline to last follow-up visit (Day 7 for SAD Dose Levels 1, 3, and 4, Day 12 for SAD Dose Level 2, Day 20 MAD Dose Levels 1-6)
To assess the safety and tolerability of single and multiple doses of MTR-601 in normal healthy volunteers under fed and fasted conditions.

35 secondary outcomes

Maximum Plasma Concentration (Cmax) of MTR-601 In Single Ascending Doses
Time frame: Day 1
Maximum Plasma Concentration (Cmax) of MTR-601 in Multiple Ascending Doses
Time frame: Day 1
Maximum Plasma Concentration (Cmax) of MTR-601 in Multiple Ascending Doses
Time frame: Day 7
Maximum Plasma Concentration at Steady State (Cmax, ss) of MTR-601 in Multiple Ascending Doses
Time frame: Day 14
Time to Maximum Plasma Concentration (Tmax) of MTR-601 in Single Ascending Doses
Time frame: Day 1
Time to Maximum Plasma Concentration (Tmax) of MTR-601 in Multiple Ascending Doses
Time frame: Day 1
Time to Maximum Plasma Concentration (Tmax) of MTR-601 in Multiple Ascending Doses
Time frame: Day 7
Time to Maximum Plasma Concentration at Steady State (Tmax, ss) of MTR-601 in Multiple Ascending Doses
Time frame: Day 14
Plasma Area Under the Curve Through 24 Hours (AUC0-24) of MTR-601 in Single Ascending Doses
Time frame: 0-24 Hours
Plasma Area Under the Curve to Infinity (AUCinf) of MTR-601 in Single Ascending Dose
Time frame: 0-96 hours
Plasma Half-life (T1/2) of MTR-601 in Single Ascending Doses
Time frame: 0-96 Hours
Plasma Concentration Corresponding to the Time of Last Measurable Observation (Clast)
Time frame: 0-96 Hours
Plasma Clearance of Drug After Extravascular Administration (CL/F) in Single Ascending Doses
Time frame: 0-96 Hours
Volume of Distribution After Extravascular Administration (Vz/F) of MTR-901 in Single Ascending Doses
Time frame: 0-96 Hours
Maximum Plasma Concentration at 24 Hours (C24) of MTR-601 in Multiple Ascending Doses
Time frame: Day 1
Maximum Plasma Concentration at 24 Hours (C24) of MTR-601 in Multiple Ascending Doses
Time frame: Day 7
Maximum Plasma Concentration at 24 Hours (C24) of MTR-601 in Multiple Ascending Doses
Time frame: Day 14
Area Under the Curve Over the Dosing Interval (AUCtau) of MTR-601 in Multiple Ascending Doses
Time frame: Day 1
Area Under the Curve Over the Dosing Interval (AUCtau) of MTR-601 in Multiple Ascending Doses
Time frame: Day 7
Area Under the Curve at Steady State Over the Dosing Interval (AUCtau) of MTR-601 in Multiple Ascending Doses
Time frame: Day 14
Average Plasma Drug Concentration of MTR-601 in Multiple Ascending Doses
Time frame: Day 14
Volume of Distribution After Extravascular Administration (Vz/F) of MTR-901 in Multiple Ascending Doses
Time frame: Day 14
Accumulation Ratio of Maximum Plasma Concentration (AR_Cmax) of MTR-901 in Multiple Ascending Doses
Time frame: Day 14
Maximum Accumulation Concentration of Area Under the Curve (AR_AUC0-24, qd) of MTR-901 in Multiple Ascending Doses
Time frame: Day 14
Plasma Clearance of Drug After Extravascular Administration (CL/F) of MTR-601 in Multiple Ascending Doses
Time frame: Day 14
Cumulative Amount of MTR-601 Excreted Unchanged in Urine (Ae) in Single Ascending Doses
Time frame: Up to 96 Hours
Fraction of Dose of MTR-601 Excreted Unchanged in Urine (Fe) in Single Ascending Doses
Time frame: Up to 96 Hours
Renal Clearance (Clr) of MTR-601 in Single Ascending Doses
Time frame: Up to 96 Hours
Cumulative Amount of MTR-601 Excreted Unchanged in Urine (Ae) In Multiple Ascending Doses
Time frame: Day 1
Fraction of Dose of MTR-601 Excreted Unchanged in Urine (Fe) in Multiple Ascending Doses
Time frame: Day 1
Cumulative Amount of MTR-601 Excreted Unchanged in Urine (Ae) In Multiple Ascending Doses
Time frame: Day 7
Fraction of Dose of MTR-601 Excreted Unchanged in Urine (Fe) in Multiple Ascending Doses
Time frame: Day 7
Cumulative Amount of MTR-601 Excreted Unchanged in Urine (Ae) In Multiple Ascending Doses
Time frame: Day 14
Fraction of Dose of MTR-601 Excreted Unchanged in Urine (Fe) in Multiple Ascending Doses
Time frame: Day 14
Renal Clearance (Clr) of MTR-601 in Multiple Ascending Doses
Time frame: Day 14

Results and safety

Results posted to the registry on 5 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Ascending Dose Level 1 - Active MTR-601	6	6
Single Ascending Dose Level 2 - Active MTR-601	6	6
Single Ascending Dose Level 3 - Active MTR-601	6	6
Single Ascending Dose Level 4 - Active MTR-601	6	6
Single Ascending Dose Level 5 - Active MTR-601	6	6
Multiple Ascending Dose Level 1 - Active MTR-601	6	6
Multiple Ascending Dose Level 2 - Active MTR-601	6	6
Multiple Ascending Dose Level 3 - Active MTR-601	6	6
Multiple Ascending Dose Level 4 - Active MTR-601	7	6
Multiple Ascending Dose Level 5 - Active MTR-601	6	6
Multiple Ascending Dose Level 6 - Active MTR-601	6	6
Single Ascending Dose - Placebo	10	10
Multiple Ascending Dose - Placebo	12	11

Primary outcome: 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.

Time frame: From baseline to last follow-up visit (Day 7 for SAD Dose Levels 1, 3, and 4, Day 12 for SAD Dose Level 2, Day 20 MAD Dose Levels 1-6). Number. Unit: Number of events

Measure	Single Ascending Dose Level 1 - Active MTR-601 n = 6	Single Ascending Dose Level 2 - Active MTR-601 (Fast) n = 6	Single Ascending Dose Level 2 - Active MTR-601 (Fed) n = 6	Single Ascending Dose Level 3 - Active MTR-601 n = 6	Single Ascending Dose Level 4 - Active MTR-601 n = 6	Single Ascending Dose Level 5 - Active MTR-601 n = 6	Multiple Ascending Dose Level 1 - Active MTR-601 n = 6	Multiple Ascending Dose Level 2 - Active MTR-601 n = 6	Multiple Ascending Dose Level 3 - Active MTR-601 n = 6	Multiple Ascending Dose Level 4 - Active MTR-601 n = 7	Multiple Ascending Dose Level 5 - Active MTR-601 n = 6	Multiple Ascending Dose Level 6 - Active MTR-601 n = 6	Single Ascending Dose - Placebo n = 10	Multiple Ascending Dose - Placebo n = 12
Value	1	0	1	3	2	8	8	6	12	23	10	15	8	28

Population analysed: The number of participants and events analyzed does not differ from the number of participants or events assigned to the arm or placebo group.

35 secondary outcomes are reported in the full results.

Adverse events

Time frame: All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single Ascending Dose Level 1 - Active MTR-601	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Single Ascending Dose Level 2 - Active MTR-601 (Fast)	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Single Ascending Dose Level 2 - Active MTR-601 (Fed)	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Single Ascending Dose Level 3 - Active MTR-601	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Single Ascending Dose Level 4 - Active MTR-601	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Single Ascending Dose Level 5 - Active MTR-601	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Multiple Ascending Dose Level 1 - Active MTR-601	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Multiple Ascending Dose Level 2 - Active MTR-601	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Multiple Ascending Dose Level 3 - Active MTR-601	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Multiple Ascending Dose Level 4 - Active MTR-601	0 of 7 (0%)	7 of 7 (100%)	0 of 7
Multiple Ascending Dose Level 5 - Active MTR-601	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Multiple Ascending Dose Level 6 - Active MTR-601	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Single Ascending Dose - Placebo	0 of 10 (0%)	4 of 10 (40%)	0 of 10
Multiple Ascending Dose - Placebo	0 of 12 (0%)	9 of 12 (75%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 33035452Gyimesi M, Horvath AI, Turos D, Suthar SK, Penzes M, Kurdi C, Canon L, Kikuti C, Ruppel KM, Trivedi DV, Spudich JA, Lorincz I, Rauscher AA, Kovacs M, Pal E, Komoly S, Houdusse A, Malnasi-Csizmadia A. Single Residue Variation in Skeletal Muscle Myosin Enables Direct and Selective Drug Targeting for Spasticity and Muscle Stiffness. Cell. 2020 Oct 15;183(2):335-346.e13. doi: 10.1016/j.cell.2020.08.050. Epub 2020 Oct 8.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Muscle Spasticity

Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
RecruitingPhase 4
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)
Not yet recruitingObservational study
Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
Cerebral Palsy Infantile, Upper Limb Spasticity
Not yet recruitingEarly Phase 1
Early Botulinum Toxin for Muscle Stiffness Reduction in First-Time Stroke Patients: Improving Recovery and Independence
Spasticity, Stroke

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alan Hand, MD principal investigator

Worldwide Clinical Trials

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MTR-601 in people with Muscle Spasticity and Hypertonia, Muscle, run by Motric Bio at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: From baseline to last follow-up visit (Day 7 for SAD Dose Levels 1, 3, and 4, Day 12 for SAD Dose Level 2, Day 20 MAD Dose Levels 1-6)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06117020, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.