Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06535841
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
A First-in-Human Safety Trial of MTX-474
Sponsor:
None
Organization:
None
Study Overview
Official Title:
MTX-474-S101 A Phase 1 Randomized Double-Blind Dose-Escalating Study to Assess the Safety Tolerability and Pharmacokinetics of MTX-474 in Healthy Adults
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A randomized double-blind placebo-controlled single ascending dose SAD and multiple ascending dose MAD study to assess the safety tolerability and PK of single and multiple ascending doses of MTX-474 administered in healthy adults
Detailed Description:
This is a randomized double-blind placebo-controlled single ascending dose SAD and multiple ascending dose MAD study to assess the safety tolerability and PK of single and multiple ascending doses of MTX-474 administered in healthy adults
SAD Portion
The SAD portion of the study will consist of 6 planned dosing cohorts each comprising 8 healthy participants The starting dose will be 0125 mgkg Cohort 1 with subsequent planned doses of 025 mgkg Cohort 2 05 mgkg Cohort 3 1 mgkg Cohort 4 2 mgkg Cohort 5 and 4 mgkg Cohort 6 Planned doses may be adjusted in response to the data Additional participants andor additional dosing cohorts may be added as needed based on the data
Within each cohort participants will be randomly assigned to receive MTX-474 or matched placebo The first 2 participants sentinel participants within each cohort will be randomized 11 to receive MTX-474 or placebo on Day 1 These participants will be monitored for 24 hours and after review of the safety data from both participants and approval by the study Investigator the additional 6 participants will be randomized to study drug n5 MTX-474 n1 placebo
Each participant will undergo assessments at specified timepoints on Days 1 through 29 End-of-Study EOS procedures will be completed on Day 29 or upon early termination ET An End-of-Follow-up EOF assessment of PK and ADA will be completed on Day 29
MAD Portion
The MAD portion of the study will consist of 4 planned dosing cohorts Each cohort will comprise 8 healthy participants n6 MTX-474 n2 placebo The starting dose will be 05 mgkg Cohort 1 with subsequent planned doses of 1 mgkg Cohort 2 2 mgkg Cohort 3 and 4 mgkg Cohort 4 Planned doses may be adjusted in response to the data Additional participants andor additional dosing cohorts may be added as needed based on the data
On Day 1 participants will be randomized to receive either MTX-474 or matched placebo The randomized participants will receive a dose of study drug on Days 1 8 15 and 22 Participants will be housed inpatient from Day -1 through Day 2 Days 7 through 9 14 through 16 and 21 through 23 All other visits will be conducted in the outpatient setting Each participant will undergo assessments at specified timepoints on Days 1 through 50 End-of-study procedures will be completed on Day 50 or upon ET An EOF assessment of PK and ADA will be completed on Day 50
Safety and tolerability of MTX-474 will be reviewed through Day 29 by the study Investigator and SRMO to inform dose escalation decisions for the next dose cohort
Additional cohorts for the SAD and MAD portions of the study may be added as needed to potentially explore alternative doses
SAD Portion
The SAD portion of the study will consist of 6 planned dosing cohorts each comprising 8 healthy participants The starting dose will be 0125 mgkg Cohort 1 with subsequent planned doses of 025 mgkg Cohort 2 05 mgkg Cohort 3 1 mgkg Cohort 4 2 mgkg Cohort 5 and 4 mgkg Cohort 6 Planned doses may be adjusted in response to the data Additional participants andor additional dosing cohorts may be added as needed based on the data
Within each cohort participants will be randomly assigned to receive MTX-474 or matched placebo The first 2 participants sentinel participants within each cohort will be randomized 11 to receive MTX-474 or placebo on Day 1 These participants will be monitored for 24 hours and after review of the safety data from both participants and approval by the study Investigator the additional 6 participants will be randomized to study drug n5 MTX-474 n1 placebo
Each participant will undergo assessments at specified timepoints on Days 1 through 29 End-of-Study EOS procedures will be completed on Day 29 or upon early termination ET An End-of-Follow-up EOF assessment of PK and ADA will be completed on Day 29
MAD Portion
The MAD portion of the study will consist of 4 planned dosing cohorts Each cohort will comprise 8 healthy participants n6 MTX-474 n2 placebo The starting dose will be 05 mgkg Cohort 1 with subsequent planned doses of 1 mgkg Cohort 2 2 mgkg Cohort 3 and 4 mgkg Cohort 4 Planned doses may be adjusted in response to the data Additional participants andor additional dosing cohorts may be added as needed based on the data
On Day 1 participants will be randomized to receive either MTX-474 or matched placebo The randomized participants will receive a dose of study drug on Days 1 8 15 and 22 Participants will be housed inpatient from Day -1 through Day 2 Days 7 through 9 14 through 16 and 21 through 23 All other visits will be conducted in the outpatient setting Each participant will undergo assessments at specified timepoints on Days 1 through 50 End-of-study procedures will be completed on Day 50 or upon ET An EOF assessment of PK and ADA will be completed on Day 50
Safety and tolerability of MTX-474 will be reviewed through Day 29 by the study Investigator and SRMO to inform dose escalation decisions for the next dose cohort
Additional cohorts for the SAD and MAD portions of the study may be added as needed to potentially explore alternative doses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None