Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06334211
Status:
COMPLETED
Last Update Posted:
2024-06-10
First Post:
2024-03-01
Brief Title:
Safety Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of FP-020 in Healthy Adult Volunteers
Sponsor:
Foresee Pharmaceuticals Co Ltd
Organization:
Foresee Pharmaceuticals Co Ltd
Study Overview
Official Title:
A Phase 1 Randomized Double-blind Placebo-controlled Single-center Single and Multiple Ascending Oral Dose Study to Evaluate the Safety Tolerability and Pharmacokinetics of FP-020 in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2024-10
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:
This is a study to Investigate the Safety Tolerability and Pharmacokinetics of Single including Food Effect and Multiple Ascending Doses of FP-020 in Healthy Adult Volunteers
Detailed Description:
This is a Phase 1 first-in-human FIH 2-part Part 1 and Part 2 single-center randomized double-blind placebo-controlled single ascending dose SADmultiple ascending dose MAD study designed to evaluate the safety tolerability PK and food effect of FP-020 in healthy male and female subjects
Up to 72 healthy male and female adults including 40 subjects in Part 1 SAD and 32 in Part 2 MAD will be randomized Part 1 will include up to 5 SAD cohorts comprised of 8 subjects each inclusive of 1 food effect FE cohort Part 2 will include up to 4 MAD cohorts comprised of 8 subjects each
Part 1 - Single Ascending Dose
Following the Screening Period Day -28 to Day 2 eligible subjects will be admitted to the CRU on Day 1 to confirm eligibility and to begin an overnight fast before the start of study procedures on Day 1
Eligible subjects will be randomized to treatment within 1 of 5 sequentially ascending dose cohorts within 24 hours before the administration of study drug on Day 1
Dose Ascending Cohorts 1a to 1d
Within each cohort subjects will be assigned to receive a single dose of FP 020 or placebo on Day 1 in a 62 randomization ratio ie 6 to FP-020 and 2 to placebo
Sentinel dosing will occur within each cohort whereby on Day 1 the first 2 subjects will receive FP-020 or placebo as assigned per the 11 randomization schedule Following review by the Principal Investigator PI or suitably qualified sub-investigator of all available safety data obtained from these 2 sentinel subjects over the first 24 hours post dose the remaining 6 subjects in each ascending dose cohort will be randomly assigned to receive FP-020 or placebo in a 51 ratio on Day 3 in the morning
Subjects will receive their assigned dose on Day 1 under fasting conditions 10 hours and complete postdosing procedures as detailed in the Schedule of Assessments Subjects will remain in the unit for 72 hours ie until Day 4 and will return to the clinic on Day 8 2 daysEnd of Study EOS or Early Termination ET visit for follow-up safety assessments
Food Effect Cohort 1e
The FE Cohort will be initiated when SAD Cohorts 1a to 1d have been completed and will be dosed at one of the doses used in one of these cohorts Sentinel dosing will therefore not be required as safety and tolerability at this dose will have already been established
For the FE Cohort 1e subjects will remain in the CRU from Day -1 through Day 11 Subjects will be randomized on Day 1 or Day 1 to receive their assigned study drug FP-020 or placebo at the same dose in a cross-over fashion once fasted Treatment Period 1 and once fed Treatment Period 2 on Day 1 and Day 8 respectively The 2 periods will be separated by at least 6 days
Administration of study drug under fed conditions will entail dosing 30 minutes after commencing a standard high-calorie breakfast subjects are to consume the high-calorie meal within 30 minutes entirely
Subjects will remain in the unit until Day 11 and will return to the clinic on Day 15 2 daysEOS visit for follow-up safety assessments
Part 2 - Multiple Ascending Dose
Part 2 may be initiated after at least 2 Part 1 SAD cohorts have completed dosing at a dose determined by the SMC based on safety and PK data from these SAD cohorts
Following the Screening Period Day -28 to Day 2 eligible subjects will be admitted to the CRU on Day -1 to confirm eligibility
On Day 1 or Day 1 eligible subjects will be randomized to treatment into 1 of the sequential cohorts in Part 2
Within each cohort subjects will be randomized to receive once daily dose of FP-020 or placebo in a 62 ratio in the CRU for 10 days Subjects will receive their assigned treatment in the morning under fasting conditions
Sentinel dosing will occur within each cohort whereby on Day 1 the first 2 subjects will be assigned to receive FP-020 or placebo in a 11 randomization ratio Following PI review of the safety data obtained in these 2 sentinel subjects over the first 48 hours the remaining 6 subjects in each cohort will be randomly assigned to receive FP-020 or placebo for 10 days in a 51 ratio starting on Day 4 in the morning
Subjects in Part 2 will be confined in the CRU from Days -1 to 13 Subjects will return to the CRU on Day 17 2 daysEOS visit for follow-up safety assessments
The recommended dose for each MAD cohort and the final number of Part 2 MAD cohorts will be determined by the Safety Monitoring Committee SMC following the blinded review of the available PK and safety data from Part 1 and preceding cohorts in Part 2 The decision to proceed to each successive dose level will be based on blinded assessment of all available safety and PK data by the SMC Each follow-on cohort will not commence dosing until a minimum of 7 subjects from the prior cohort have completed their in-houseconfinement period Also dosing of the next cohort will not occur until at least 7 days have elapsed since dosing of the previous cohort
Up to 72 healthy male and female adults including 40 subjects in Part 1 SAD and 32 in Part 2 MAD will be randomized Part 1 will include up to 5 SAD cohorts comprised of 8 subjects each inclusive of 1 food effect FE cohort Part 2 will include up to 4 MAD cohorts comprised of 8 subjects each
Part 1 - Single Ascending Dose
Following the Screening Period Day -28 to Day 2 eligible subjects will be admitted to the CRU on Day 1 to confirm eligibility and to begin an overnight fast before the start of study procedures on Day 1
Eligible subjects will be randomized to treatment within 1 of 5 sequentially ascending dose cohorts within 24 hours before the administration of study drug on Day 1
Dose Ascending Cohorts 1a to 1d
Within each cohort subjects will be assigned to receive a single dose of FP 020 or placebo on Day 1 in a 62 randomization ratio ie 6 to FP-020 and 2 to placebo
Sentinel dosing will occur within each cohort whereby on Day 1 the first 2 subjects will receive FP-020 or placebo as assigned per the 11 randomization schedule Following review by the Principal Investigator PI or suitably qualified sub-investigator of all available safety data obtained from these 2 sentinel subjects over the first 24 hours post dose the remaining 6 subjects in each ascending dose cohort will be randomly assigned to receive FP-020 or placebo in a 51 ratio on Day 3 in the morning
Subjects will receive their assigned dose on Day 1 under fasting conditions 10 hours and complete postdosing procedures as detailed in the Schedule of Assessments Subjects will remain in the unit for 72 hours ie until Day 4 and will return to the clinic on Day 8 2 daysEnd of Study EOS or Early Termination ET visit for follow-up safety assessments
Food Effect Cohort 1e
The FE Cohort will be initiated when SAD Cohorts 1a to 1d have been completed and will be dosed at one of the doses used in one of these cohorts Sentinel dosing will therefore not be required as safety and tolerability at this dose will have already been established
For the FE Cohort 1e subjects will remain in the CRU from Day -1 through Day 11 Subjects will be randomized on Day 1 or Day 1 to receive their assigned study drug FP-020 or placebo at the same dose in a cross-over fashion once fasted Treatment Period 1 and once fed Treatment Period 2 on Day 1 and Day 8 respectively The 2 periods will be separated by at least 6 days
Administration of study drug under fed conditions will entail dosing 30 minutes after commencing a standard high-calorie breakfast subjects are to consume the high-calorie meal within 30 minutes entirely
Subjects will remain in the unit until Day 11 and will return to the clinic on Day 15 2 daysEOS visit for follow-up safety assessments
Part 2 - Multiple Ascending Dose
Part 2 may be initiated after at least 2 Part 1 SAD cohorts have completed dosing at a dose determined by the SMC based on safety and PK data from these SAD cohorts
Following the Screening Period Day -28 to Day 2 eligible subjects will be admitted to the CRU on Day -1 to confirm eligibility
On Day 1 or Day 1 eligible subjects will be randomized to treatment into 1 of the sequential cohorts in Part 2
Within each cohort subjects will be randomized to receive once daily dose of FP-020 or placebo in a 62 ratio in the CRU for 10 days Subjects will receive their assigned treatment in the morning under fasting conditions
Sentinel dosing will occur within each cohort whereby on Day 1 the first 2 subjects will be assigned to receive FP-020 or placebo in a 11 randomization ratio Following PI review of the safety data obtained in these 2 sentinel subjects over the first 48 hours the remaining 6 subjects in each cohort will be randomly assigned to receive FP-020 or placebo for 10 days in a 51 ratio starting on Day 4 in the morning
Subjects in Part 2 will be confined in the CRU from Days -1 to 13 Subjects will return to the CRU on Day 17 2 daysEOS visit for follow-up safety assessments
The recommended dose for each MAD cohort and the final number of Part 2 MAD cohorts will be determined by the Safety Monitoring Committee SMC following the blinded review of the available PK and safety data from Part 1 and preceding cohorts in Part 2 The decision to proceed to each successive dose level will be based on blinded assessment of all available safety and PK data by the SMC Each follow-on cohort will not commence dosing until a minimum of 7 subjects from the prior cohort have completed their in-houseconfinement period Also dosing of the next cohort will not occur until at least 7 days have elapsed since dosing of the previous cohort
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?:
False
Is an FDA AA801 Violation?:
None