Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06401213
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-04-22
Brief Title:
A First-in-Human Safety Trial of MTX-463
Sponsor:
Mediar Therapeutics
Organization:
Mediar Therapeutics
Study Overview
Official Title:
MTX-463-I101 A Phase 1 Randomized Double-Blind Dose-Escalating Study to Assess the Safety Tolerability and Pharmacokinetics of MTX-463 in Healthy Adults
Status:
RECRUITING
Status Verified Date:
2024-05
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:
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-463 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-463 administered in healthy adults
SAD Portion
The SAD portion of the study will consist of 4 planned dosing cohorts each comprising 8 healthy participants The starting dose will be 4 mgkg Cohort 1 with subsequent planned doses of 8 mgkg Cohort 2 16 mgkg Cohort 3 and 30 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
Within each cohort participants will be randomly assigned to receive MTX-463 or matched placebo The first 2 participants sentinel participants within each cohort will be randomized 11 to receive MTX-463 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 and Sponsors responsible medical officer SRMO the additional 6 participants will be randomized to study drug n5 MTX-463 n1 placebo
Each participant will undergo assessments at specified timepoints on Days 1 through 60 End-of-Study EOS procedures will be completed on Day 28 or upon early termination ET An End-of-Follow-up EOF assessment of PK and ADA will be completed on Day 60
MAD Portion
The MAD portion of the study will consist of 3 planned dosing cohorts Each cohort will comprise 8 healthy participants n6 MTX-463 n2 placebo The starting dose will be a 66 mgkg loading dose and 4 mgkg maintenance doses Cohort 1 with subsequent planned doses of a 13 mgkg loading dose and 8 mgkg maintenance doses Cohort 2 and a 27 mgkg loading dose and 16 mgkg maintenance doses Cohort 3 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-463 or matched placebo The randomized participants will receive a single loading dose on Day 1 followed by 2 maintenance doses of study drug on Day 8 and Day 22 Participants will be housed inpatient from Day -1 through post-dose observation on Day 8 and from Day 21 through assessments on Day 29 All other visits will be conducted in the outpatient setting Each participant will undergo assessments at specified timepoints on Days 1 through 82 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 82
Safety and tolerability of MTX-463 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 lower doses
SAD Portion
The SAD portion of the study will consist of 4 planned dosing cohorts each comprising 8 healthy participants The starting dose will be 4 mgkg Cohort 1 with subsequent planned doses of 8 mgkg Cohort 2 16 mgkg Cohort 3 and 30 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
Within each cohort participants will be randomly assigned to receive MTX-463 or matched placebo The first 2 participants sentinel participants within each cohort will be randomized 11 to receive MTX-463 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 and Sponsors responsible medical officer SRMO the additional 6 participants will be randomized to study drug n5 MTX-463 n1 placebo
Each participant will undergo assessments at specified timepoints on Days 1 through 60 End-of-Study EOS procedures will be completed on Day 28 or upon early termination ET An End-of-Follow-up EOF assessment of PK and ADA will be completed on Day 60
MAD Portion
The MAD portion of the study will consist of 3 planned dosing cohorts Each cohort will comprise 8 healthy participants n6 MTX-463 n2 placebo The starting dose will be a 66 mgkg loading dose and 4 mgkg maintenance doses Cohort 1 with subsequent planned doses of a 13 mgkg loading dose and 8 mgkg maintenance doses Cohort 2 and a 27 mgkg loading dose and 16 mgkg maintenance doses Cohort 3 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-463 or matched placebo The randomized participants will receive a single loading dose on Day 1 followed by 2 maintenance doses of study drug on Day 8 and Day 22 Participants will be housed inpatient from Day -1 through post-dose observation on Day 8 and from Day 21 through assessments on Day 29 All other visits will be conducted in the outpatient setting Each participant will undergo assessments at specified timepoints on Days 1 through 82 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 82
Safety and tolerability of MTX-463 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 lower doses
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