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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06334211




Registration number
NCT06334211
Ethics application status
Date submitted
1/03/2024
Date registered
27/03/2024
Date last updated
10/06/2024

Titles & IDs
Public title
Safety, Tolerability, and Pharmacokinetics, of Single and Multiple Ascending Doses of FP-020 in Healthy Adult Volunteers
Scientific 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
Secondary ID [1] 0 0
FP-020C-23-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - FP-020
Other interventions - placebo

Experimental: FP-020 - 100 mg capsule

Placebo Comparator: placebo - placebo capsule


Treatment: Drugs: FP-020
MMP-12 inhibitor

Other interventions: placebo
placebo
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The incidence, severity, and type of Adverse Events (AEs) and Serious Adverse Events (SAEs).
Timepoint [1] 0 0
Part 1 - up to 10 days and Part 2 - up to 17 days
Primary outcome [2] 0 0
Clinically significant abnormalities.
Timepoint [2] 0 0
Part 1 - up to 10 days and Part 2 - up to 17 days
Secondary outcome [1] 0 0
Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - Cmax
Timepoint [1] 0 0
Single ascending dose (Part 1) - up to 10 days
Secondary outcome [2] 0 0
Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - Tmax
Timepoint [2] 0 0
Single ascending dose (Part 1) - up to 10 days
Secondary outcome [3] 0 0
Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - AUC0-24 hours
Timepoint [3] 0 0
Single ascending dose (Part 1) - up to 1 day
Secondary outcome [4] 0 0
Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - AUC0 - last
Timepoint [4] 0 0
Single ascending dose (Part 1) - up to 10 days
Secondary outcome [5] 0 0
Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - AUC0-inf
Timepoint [5] 0 0
Single ascending dose (Part 1) - up to 10 days
Secondary outcome [6] 0 0
Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - ?z
Timepoint [6] 0 0
Single ascending dose (Part 1) - up to 10 days
Secondary outcome [7] 0 0
Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - t1/2
Timepoint [7] 0 0
Single ascending dose (Part 1) - up to 10 days
Secondary outcome [8] 0 0
Evaluate the food effect on the PK profile of FP-020 - Cmax
Timepoint [8] 0 0
Single ascending dose (Part 1) - up to 10 days
Secondary outcome [9] 0 0
Evaluate the food effect on the PK profile of FP-020 - Tmax
Timepoint [9] 0 0
Single ascending dose (Part 1) - up to 10 days
Secondary outcome [10] 0 0
Evaluate the food effect on the PK profile of FP-020 - AUC
Timepoint [10] 0 0
Single ascending dose (Part 1) - up to 10 days
Secondary outcome [11] 0 0
Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - Cmax
Timepoint [11] 0 0
Multiple ascending dose (Part 2) - up to 10 days
Secondary outcome [12] 0 0
Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - Tmax
Timepoint [12] 0 0
Multiple ascending dose (Part 2) - up to 10 days
Secondary outcome [13] 0 0
Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - AUC0 - 24
Timepoint [13] 0 0
Multiple ascending dose (Part 2) - up to 10 days
Secondary outcome [14] 0 0
Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - AUCo - last
Timepoint [14] 0 0
Multiple ascending dose (Part 2) - up to 10 days
Secondary outcome [15] 0 0
Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - AUC0 - inf
Timepoint [15] 0 0
Multiple ascending dose (Part 2) - up to 10 days
Secondary outcome [16] 0 0
Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects ?z
Timepoint [16] 0 0
Multiple ascending dose (Part 2) - up to 10 days
Secondary outcome [17] 0 0
Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - t1/2
Timepoint [17] 0 0
Multiple ascending dose (Part 2) - up to 10 days
Secondary outcome [18] 0 0
Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - RCmax
Timepoint [18] 0 0
Multiple ascending dose (Part 2) - up to 10 days
Secondary outcome [19] 0 0
Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - RAUC
Timepoint [19] 0 0
Multiple ascending dose (Part 2) - up to 10 days

Eligibility
Key inclusion criteria
1. Subject must be = 18 years and = 60 years of age at the time of signing informed
consent.

2. 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.

3. 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.

4. 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.

5. Ability to communicate well with the Investigator, in the local language, and to
understand and comply with the requirements of the study.

6. Body mass index (BMI) within the range 18 to 32 kg/m2 (inclusive).

7. 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.

8. 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.

9. Subjects capable of giving signed informed consent which includes compliance with the
requirements and restrictions listed in the ICF and in this protocol.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Recent (less than 6 weeks) wound, or presence of an ongoing non-healing skin wound.

2. 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.

3. 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.

4. Serious local or systemic infection within 1 month of Screening requiring antibiotic
treatment or history of recurrent infections.

5. Surgery within the past 3 months prior to the first dose of study drug administration
determined by the Investigator to be clinically relevant.

6. The subject has a history of severe drug allergy or hypersensitivity or food allergy,
including anaphylaxis.

7. The subject has donated more than 1 unit (500 mL) of blood within 4 weeks prior to the
first dose of study drug.

8. Positive for human immunodeficiency virus (HIV) antibody or antigen.

9. Positive hepatitis C virus (HCV) antibody or positive hepatitis B surface antigen
(HBsAg).

10. Positive urine drug screen/alcohol breath test on Day -1 (admission). Repeat urine
drug screens will be permitted for suspected false positive results.

11. Positive COVID-19 test (conducted as per institutional guidelines).

12. 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.

13. Any other abnormal vital signs that are considered to be clinically significant by the
Investigator.

14. 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.

15. Females with heavy menstruating cycles and borderline-low iron studies.

16. Alanine transaminase (ALT) or aspartate aminotransferase (AST) >1.5 upper limit of
normal.

17. Bilirubin outside of the normal range (total bilirubin between 0.1 and 1.2 mg/dL (1.71
to 20.5 µmol/L).

18. Creatinine clearance < 90 mL/min (estimated from Cockcroft Gault equation).

19. Subject is pregnant, lactating, or is planning to become pregnant during the study.

20. Inability to tolerate oral medications.

21. All prescription and over-the-counter medications (including herbal medications)
except for non-estrogen contraceptives, are prohibited within 7 days before dosing
through EOS.

22. Any estrogen-containing products, e.g., contraceptives, patches, creams, implants,
within 14 days prior to administration of the first dose of study drug through EOS.

23. Live vaccine(s) within 1 month before Screening or plans to receive such vaccines
during the study.

24. Treatment with biologic agents (such as monoclonal antibodies including marketed
drugs) within 3 months or 5 half-lives (whichever is longer) before dosing.

25. Current participation in any other investigational drug study or receipt of an
investigational drug within 30 days or 5 half-lives (whichever is longer) before
dosing.

26. Significant weight loss or gain between Screening and administration of first dose of
study drug.

27. Blood donation or significant blood loss within 60 days prior to administration of
first dose of study drug.

28. Plasma donation within 7 days prior to administration of first dose of study drug.

29. Diets that could alter metabolism (i.e., high protein, Slim Fast®, Nutrisystem®, etc.)
within 7 days prior to administration of first dose of study drug.

30. History or presence of alcohol or drug abuse (including recreational marijuana use)
within 1 year prior to administration of first dose of study drug and unwillingness to
abstain during the dosing period.

31. Intake of alcohol or caffeine-containing products 48 hours before administration of
first dose of study drug.

32. Use of tobacco products (e.g., cigarettes, e-cigarettes, cigars, smokeless tobacco)
confirmed by a positive cotinine test on Day -1.

33. Failure to satisfy the Investigator of fitness to participate for any other reason.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
11/10/2024
Actual
Sample size
Target
74
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Scientia Clinical Research Ltd - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Foresee Pharmaceuticals Co., Ltd.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
InClin, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06334211
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Susan Whitaker, BSN
Address 0 0
Senior Director of Clinical Operations
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Susan Whitaker, BSN
Address 0 0
Country 0 0
Phone 0 0
(856) 217-3644
Fax 0 0
Email 0 0
susan.whitaker@foreseepharma.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06334211