Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06117020
Status:
RECRUITING
Last Update Posted:
2023-11-03
First Post:
2023-10-17
Brief Title:
Single and Multiple Ascending Dose Study of MTR-601 in Healthy Individuals
Sponsor:
Motric Bio
Organization:
Motric Bio
Study Overview
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
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 cohorts remaining 6 subjects
Dosing will begin at dose Level 1 10 mg
Subjects in SAD Levels 13 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
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 cohorts remaining 6 subjects
Dosing will begin at dose Level 1 10 mg
Subjects in SAD Levels 13 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None