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

NCT06334211 | Completed Phase 1

• 1 other identifier: FP-020C-23-001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Phase I; Safety and Tolerability; Pharmacokinetics; Randomized; Single & Multiple Ascending Oral Dose; Placebo-Controlled; Double Blinded; FP-020

Outcome Measures

Primary Outcomes (2)

• The incidence, severity, and type of Adverse Events (AEs) and Serious Adverse Events (SAEs).

  * Treatment-emergent AEs up to End of Study (EOS) * Treatment-emergent AEs leading to premature discontinuation of study drug * Treatment-emergent SAEs up to EOS * Incidence of DLTs per dose level

  Part 1 - up to 10 days and Part 2 - up to 17 days

• Clinically significant abnormalities.

  Clinically significant abnormalities in physical examination, vital signs, 12-lead Electrocardiograms (ECGs), and safety laboratory results.

  Part 1 - up to 10 days and Part 2 - up to 17 days

Secondary Outcomes (19)

• Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - Cmax

  Single ascending dose (Part 1) - up to 10 days

• Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - Tmax

  Single ascending dose (Part 1) - up to 10 days

• Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - AUC0-24 hours

  Single ascending dose (Part 1) - up to 1 day

• Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - AUC0 - last

  Single ascending dose (Part 1) - up to 10 days

• Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - AUC0-inf

  Single ascending dose (Part 1) - up to 10 days

Study Arms (2)

FP-020

EXPERIMENTAL

100 mg capsule

Drug: FP-020

placebo

PLACEBO COMPARATOR

placebo capsule

Other: placebo

Interventions

FP-020 DRUG

MMP-12 inhibitor

FP-020

placebo OTHER

placebo

placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject must be ≥ 18 years and ≤ 60 years of age at the time of signing informed consent.
• Subjects must be in good general health in the opinion of the Investigator, with no significant medical history, no clinically significant abnormalities on physical examination, vital signs, ECG, and laboratory safety tests performed at Screening and/or before administration of the first dose of study drug.
• Clinical laboratory test values within normal ranges or \< 1.5 times the upper limit of normal (ULN) as specified by the testing laboratory unless deemed not clinically significant (NCS) by the Investigator, with the exception of bilirubin as described below.
• Nonsmoker or ex-smoker who has discontinued smoking and/or use of nicotine containing products for at least 6 months prior to the first dose of study drug, confirmed by a negative cotinine test at Screening and Day -1. Note however that casual smoking (e.g., 5 cigarettes \[or equivalent\] per week) is permitted during that period (i.e., within 3 months prior to dosing) as long as the cotinine test on Day 1 is negative.
• Ability to communicate well with the Investigator, in the local language, and to understand and comply with the requirements of the study.
• Body mass index (BMI) within the range 18 to 32 kg/m2 (inclusive).
• Females of childbearing potential and not abstinent must be willing to use a double barrier contraceptive method (progesterone-only hormone contraceptive \[oral, injectable, implantable\], intrauterine device \[IUD\], diaphragm, cervical cap, contraceptive sponge, condom) and refrain from oocyte donation from screening to 30 days after the last dose of study intervention. Estrogen-containing products are not allowed. Females who are abstinent are not required to use a contraceptive method unless they become sexually active. Alternatively, females must be postmenopausal for ≥1 year or surgically sterile (with tubal ligation, hysterectomy, or bilateral oophorectomy) for ≥6 months, confirmed by FSH level \>40mIU at Screening. Note that females on HRT are not eligible.
• Males with female partners of childbearing potential will agree to use barrier contraceptive (i.e., condom) and their female partners must use a highly effective method of contraception from screening to 90 days after the last dose of study drug. Males must also refrain from sperm donations during this time period. Males who are abstinent will not be required to use a contraceptive method unless they become sexually active.
• Subjects capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

You may not qualify if:

• Recent (less than 6 weeks) wound, or presence of an ongoing non-healing skin wound.
• Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would significantly alter the absorption, metabolism, or elimination of drugs; constitute a risk when taking the study intervention; interfere with the interpretation of data; or would make it unlikely that the subject will complete the study per protocol.
• Active malignancy and/or history of malignancy in the past 5 years, with the exception of completely excised non-melanoma skin cancer or low grade cervical intraepithelial neoplasia.
• Serious local or systemic infection within 1 month of Screening requiring antibiotic treatment or history of recurrent infections.
• Surgery within the past 3 months prior to the first dose of study drug administration determined by the Investigator to be clinically relevant.
• The subject has a history of severe drug allergy or hypersensitivity or food allergy, including anaphylaxis.
• The subject has donated more than 1 unit (500 mL) of blood within 4 weeks prior to the first dose of study drug.
• Positive for human immunodeficiency virus (HIV) antibody or antigen.
• Positive hepatitis C virus (HCV) antibody or positive hepatitis B surface antigen (HBsAg).
• Positive urine drug screen/alcohol breath test on Day -1 (admission). Repeat urine drug screens will be permitted for suspected false positive results.
• Positive COVID-19 test (conducted as per institutional guidelines).
• Abnormal vital signs (resting heart rate \< 40 or \> 100 bpm; resting systolic blood pressure \>150 or \< 90 mmHg or diastolic blood pressure \> 90 or \< 50 mmHg) at Screening or before administration of the first dose of study drug.
• Any other abnormal vital signs that are considered to be clinically significant by the Investigator.
• QTcF interval (QT with Fridericia's correction) \> 450 msec in males and \> 470 msec in females (based on the mean of triplicate measurements taken at screening), cardiac arrhythmia, or any clinically significant abnormality in the resting ECG as deemed by the Investigator.
• Females with heavy menstruating cycles and borderline-low iron studies.

Sponsors & Collaborators

• Foresee Pharmaceuticals Co., Ltd.: lead
• InClin, Inc.: collaborator

Study Sites (1)

Scientia Clinical Research Ltd

Randwick, New South Wales, 2031, Australia

Location

Study Officials

• Susan Whitaker, BSN

  Senior Director of Clinical Operations

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blind (placebo appears the same as active FP-020)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 27, 2024
• Study Start: April 16, 2024
• Primary Completion: September 20, 2024
• Study Completion: September 20, 2024
• Last Updated: November 13, 2024

Record last verified: 2024-10

Locations

AU (1)