Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05790382
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-30
First Post:
2023-03-06
Brief Title:
Single and Multiple Ascending Dose Study to Assess Safety Tolerability and Pharmacokinetics of NM-101
Sponsor:
Neuramedy Co Ltd
Organization:
Neuramedy Co Ltd
Study Overview
Official Title:
A Phase I Study to Assess the Safety Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of NM-101 in Healthy Male and Female Subjects
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-03
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:
This is a Phase I double-blind randomised two-part single-ascending dose Part 1 and multiple-ascending dose Part 2 study of NM-101 in healthy males and healthy females of non-childbearing potential
Detailed Description:
NM-101 is an anti-TLR2 antibody which may have clinical efficacy in Parkinsons disease patients This Phase I study aims to assess the safety tolerability and pharmacokinetics PK of single and multiple ascending doses of NM-101 in healthy males and healthy females of non-childbearing potential A total of 56 subjects 8 per cohort are planned to be enrolled
Subjects will be randomly assigned to recieve NM-101 or placebo in a 31 ratio The study will be in 2 parts Part 1 will consist of 3 single-dose cohorts Part 2 will consist of 4 multiple-dose cohorts
In Part 1 sentinel dosing will be applied In each cohort 1 subject will be randomised to receive NM-101 and 1 subject will be randomised to receive placebo ahead of dosing in the remaining 6 subjects The dose for Cohort 1 is 20 mgkg NN-101 The predicted doses for Cohorts 2 and 3 are 40 mgkg and 60 mgkg NM-101 respectively dependent on a blinded interim review of the safety tolerability and PK data Blood samples will be collected at regular intervals for PK analysis and safety from Day 1 until Day 42
In Part 2 sentinel dosing will not be applied Each subject will receive 4 doses of NM-101 or placebo over the course of 3 months Dosing may occur in parallel to the conduct of Part 1 The doses administered will be selected based on emerging safety tolerability and PK data from preceding groups in Part 1 The predicted NM-101 doses are 10 mgkg for Cohort 4 20 mgkg for Cohort 5 40 mgkg for Cohort 6 60 mgkg for Cohort 7 In Cohorts 5 to 7 subjects will undergo a lumbar puncture to assess NM-101 concentrations in the cerebrospinal fluid Blood samples will be collected at regular intervals for PK analysis and safety from Day 1 until Day 127
Subjects will be randomly assigned to recieve NM-101 or placebo in a 31 ratio The study will be in 2 parts Part 1 will consist of 3 single-dose cohorts Part 2 will consist of 4 multiple-dose cohorts
In Part 1 sentinel dosing will be applied In each cohort 1 subject will be randomised to receive NM-101 and 1 subject will be randomised to receive placebo ahead of dosing in the remaining 6 subjects The dose for Cohort 1 is 20 mgkg NN-101 The predicted doses for Cohorts 2 and 3 are 40 mgkg and 60 mgkg NM-101 respectively dependent on a blinded interim review of the safety tolerability and PK data Blood samples will be collected at regular intervals for PK analysis and safety from Day 1 until Day 42
In Part 2 sentinel dosing will not be applied Each subject will receive 4 doses of NM-101 or placebo over the course of 3 months Dosing may occur in parallel to the conduct of Part 1 The doses administered will be selected based on emerging safety tolerability and PK data from preceding groups in Part 1 The predicted NM-101 doses are 10 mgkg for Cohort 4 20 mgkg for Cohort 5 40 mgkg for Cohort 6 60 mgkg for Cohort 7 In Cohorts 5 to 7 subjects will undergo a lumbar puncture to assess NM-101 concentrations in the cerebrospinal fluid Blood samples will be collected at regular intervals for PK analysis and safety from Day 1 until Day 127
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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