Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06617546
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
SAD and MAD Study of FTX-101 in Healthy Male Subjects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled First-in-Human Nested Bioavailability Study to Assess Safety Tolerability Pharmacokinetics and Immunogenicity of Single and Multiple Ascending Doses of FTX-101 After Subcutaneous Injection of FTX-101 in Healthy Male Subjects
Status:
RECRUITING
Status Verified Date:
2024-10
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:
This is a Phase 1 first-in-human FIH single-center randomized double-blind placebo-controlled study in healthy male subjects The study will include the following 2 parts
Part A Single Ascending Dose SAD with a nested absolute bioavailability cohort in healthy male subjects
Part B Multiple Ascending Dose MAD in healthy male subjects
Part A Single Ascending Dose SAD with a nested absolute bioavailability cohort in healthy male subjects
Part B Multiple Ascending Dose MAD in healthy male subjects
Detailed Description:
Study Rationale
FTX-101 is a first-in-class synthetic peptide with a novel mechanism of action designed to promote the self-repair of myelin FTX-101 is a highly selective modulator of the PlexinA1Neuropilin 1 receptor system and displays no significant activity on any other target FTX-101 interferes with the heterodimerization of the coreceptor system and ultimately with the activation of second messenger signaling pathways shown to inhibit both the differentiation and migration of oligodendrocyte precursor cells OPCs and oligodendrocytes OLs Through this mechanism FTX-101 disinhibits both the differentiation of OPCs to OLs and migration of OPCs into lesions favorably promoting the remyelination process The study is designed to evaluate the safety tolerability and pharmacokinetic profile of single ascending doses and multiple ascending doses of FTX-101 subcutaneous injection and intravenous infusion in healthy male subjects The study will characterize the pharmacokinetics of FTX-101 following SAD and MAD SC injection and IV infusion of FTX-101 and determine the absolute bioavailability of FTX-101 following SC injection relative to IV infusion The study will also evaluate the immunogenic potential of FTX-101 and will also explore the relationship between FTX-101 concentration and the change from baseline corrected QT interval
Detailed Description
This is a Phase 1 first-in-human FIH single-center randomized double-blind placebo-controlled study in healthy male subjects The study will include the following 2 parts
Part A SAD with a nested absolute bioavailability cohort in healthy male subjects
Part B MAD in healthy male subjects
Part A - SAD with a nested absolute bioavailability cohort
Part A consists of 5 planned cohorts A1 to A5 of 8 healthy adult male subjects each An additional SAD intermediate lower or equivalent dose cohort A6 of 8 male subjects may be added at the discretion of the Sponsor In each cohort subjects will be randomized to receive a single subcutaneous SC dose as 1 or 2 injections of either FTX-101 or placebo in a 31 FTX-101 placebo ratio to have a total of 6 subjects receiving FTX-101 and 2 subjects receiving placebo An absolute bioavailability assessment will be integrated into one of the SAD cohorts Cohort A2 Cohort A3 or Cohort A4 The absolute bioavailability cohort will receive an IV dose of the assigned study treatment in Period 2 The selection of the SAD cohort and dose level for absolute bioavailability assessment will be determined based on interim safety tolerability and available PK data of previous cohorts
Part B - MAD
Part B consists of 3 planned cohorts B1 to B3 of 8 healthy adult male subjects each An additional MAD cohort B4 of 8 male subjects may be added at the discretion of the Sponsor depending on emerging safety and plasma PK data from the previous cohorts The proposed dosing regimen dose level and frequency for the first cohort B1 in Part B MAD will be based on available safety tolerability and PK data from Part A SAD The dosing regimens for each subsequent cohort in Part B will be determined based on the available blinded safety tolerability and PK data from Part A and any previous cohorts in Part B In each cohort subjects will be randomized to receive multiple SC doses of either FTX-101 or placebo in a 31 FTX-101 placebo ratio to have a total of 6 subjects receiving FTX-101 and 2 subjects receiving placebo
FTX-101 is a first-in-class synthetic peptide with a novel mechanism of action designed to promote the self-repair of myelin FTX-101 is a highly selective modulator of the PlexinA1Neuropilin 1 receptor system and displays no significant activity on any other target FTX-101 interferes with the heterodimerization of the coreceptor system and ultimately with the activation of second messenger signaling pathways shown to inhibit both the differentiation and migration of oligodendrocyte precursor cells OPCs and oligodendrocytes OLs Through this mechanism FTX-101 disinhibits both the differentiation of OPCs to OLs and migration of OPCs into lesions favorably promoting the remyelination process The study is designed to evaluate the safety tolerability and pharmacokinetic profile of single ascending doses and multiple ascending doses of FTX-101 subcutaneous injection and intravenous infusion in healthy male subjects The study will characterize the pharmacokinetics of FTX-101 following SAD and MAD SC injection and IV infusion of FTX-101 and determine the absolute bioavailability of FTX-101 following SC injection relative to IV infusion The study will also evaluate the immunogenic potential of FTX-101 and will also explore the relationship between FTX-101 concentration and the change from baseline corrected QT interval
Detailed Description
This is a Phase 1 first-in-human FIH single-center randomized double-blind placebo-controlled study in healthy male subjects The study will include the following 2 parts
Part A SAD with a nested absolute bioavailability cohort in healthy male subjects
Part B MAD in healthy male subjects
Part A - SAD with a nested absolute bioavailability cohort
Part A consists of 5 planned cohorts A1 to A5 of 8 healthy adult male subjects each An additional SAD intermediate lower or equivalent dose cohort A6 of 8 male subjects may be added at the discretion of the Sponsor In each cohort subjects will be randomized to receive a single subcutaneous SC dose as 1 or 2 injections of either FTX-101 or placebo in a 31 FTX-101 placebo ratio to have a total of 6 subjects receiving FTX-101 and 2 subjects receiving placebo An absolute bioavailability assessment will be integrated into one of the SAD cohorts Cohort A2 Cohort A3 or Cohort A4 The absolute bioavailability cohort will receive an IV dose of the assigned study treatment in Period 2 The selection of the SAD cohort and dose level for absolute bioavailability assessment will be determined based on interim safety tolerability and available PK data of previous cohorts
Part B - MAD
Part B consists of 3 planned cohorts B1 to B3 of 8 healthy adult male subjects each An additional MAD cohort B4 of 8 male subjects may be added at the discretion of the Sponsor depending on emerging safety and plasma PK data from the previous cohorts The proposed dosing regimen dose level and frequency for the first cohort B1 in Part B MAD will be based on available safety tolerability and PK data from Part A SAD The dosing regimens for each subsequent cohort in Part B will be determined based on the available blinded safety tolerability and PK data from Part A and any previous cohorts in Part B In each cohort subjects will be randomized to receive multiple SC doses of either FTX-101 or placebo in a 31 FTX-101 placebo ratio to have a total of 6 subjects receiving FTX-101 and 2 subjects receiving placebo
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