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

Stroke Clinical Trial

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

Status Recruiting

Clinical 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. 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cerebral Palsy
• Dystonia
• Hereditary Spastic Paraplegia
• Hypertonia, Muscle
• Multiple Sclerosis
• Muscle Hypertonia
• Muscle Spasticity
• Paraplegia
• Spastic Paraplegia, Hereditary
• Spinal Cord Injuries
• Stroke

• NCT number: NCT06117020
• Study type: Interventional
• Source: Motric Bio
• Contact: Dan Meyers, MD
• Phone: 510-227-2102
• Email: dan.meyers@aditumbio.com
• Status: Recruiting
• Phase: Phase 1
• Start date: September 11, 2023
• Completion date: May 2024