Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT06117020
Brief 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.
Study:
NCT06117020
Study Brief:
Protocol Section:
NCT06117020