NCT06117020

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Motric Bio · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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. 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.

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
• Dystonia
• Spinal Cord Injuries

Interventions

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

Timeline

• Start date: 2023-09-11
• Primary completion: 2024-10-16
• Completion: 2024-10-16
• First posted: 2023-11-03
• Last updated: 2025-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study