Safety, Tolerability, and Pharmacokinetics, of Single and Multiple Ascending Doses of FP-020 in Healthy Adult Volunteers

Healthy Clinical Trial

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 Recruiting

Clinical Trial 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.

Clinical Trial 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 (SAD)/multiple 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 6:2 randomization ratio (i.e., 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 1:1 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 5:1 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 (i.e., until Day 4) and will return to the clinic on Day 8 (± 2 days)/End 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 days)/EOS 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 6:2 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 1:1 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 5:1 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 days)/EOS 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 cohort(s) 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-house/confinement period. Also, dosing of the next cohort will not occur until at least 7 days have elapsed since dosing of the previous cohort. ;

Related Conditions & MeSH terms

• Healthy

• NCT number: NCT06334211
• Study type: Interventional
• Source: Foresee Pharmaceuticals Co., Ltd.
• Contact: Susan Whitaker, BSN
• Phone: (856) 217-3644
• Email: susan.whitaker@foreseepharma.com
• Status: Recruiting
• Phase: Phase 1
• Start date: April 16, 2024
• Completion date: October 11, 2024