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CompletedNCT06334211Updated Nov 13, 2024

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

A Phase 1 interventional study of FP-020 and placebo in Healthy, sponsored by Foresee Pharmaceuticals Co., Ltd.. Completed at 1 site in Australia. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-13.

Sponsored by Foresee Pharmaceuticals Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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 (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.

02

Conditions studied

  • Healthy

Keywords

  • Phase I
  • Safety and Tolerability
  • Pharmacokinetics
  • Randomized
  • Single & Multiple Ascending Oral Dose
  • Placebo-Controlled
  • Double Blinded
  • FP-020
03

In context

Lead sponsor

Foresee Pharmaceuticals Co., Ltd. is the lead sponsor of 15 studies on the registry; 2 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subject must be ≥ 18 years and ≤ 60 years of age at the time of signing .
  2. Subjects must be in good general health in the opinion of the Investigator, with no significant medical history, no abnormalities on physical examination, vital signs, , 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 (ULN) as specified by the testing laboratory unless deemed not clinically significant (NCS) by the Investigator, with the exception of 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. (BMI) within the range 18 to 32 kg/m2 (inclusive).
  7. Females of and not abstinent must be willing to use a double barrier 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 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.

Exclusion criteria

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 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 .
  6. The subject has a history of severe drug allergy or 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 (HIV) antibody or antigen.
  9. Positive virus (HCV) antibody or positive 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. 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 as deemed by the Investigator.
  15. Females with heavy menstruating cycles and borderline-low iron studies.
  16. (ALT) or aspartate aminotransferase (AST) >1.5 .
  17. outside of the normal range (total bilirubin between 0.1 and 1.2 mg/dL (1.71 to 20.5 µmol/L).
  18. \< 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 , 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. (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 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.
Terms in these criteria, in plain language(19)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    FP-020

    100 mg capsule

    Drug: FP-020

  • Placebo comparator
    placebo

    placebo capsule

    Other: placebo

Interventions

  • DrugFP-020

    MMP-12 inhibitor

  • Otherplacebo

    placebo

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Part 1 - up to 10 days and Part 2 - up to 17 days

  2. Clinically significant abnormalities.

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

    Time frame: Part 1 - up to 10 days and Part 2 - up to 17 days

Secondary outcomes

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

    Cmax (Maximum concentration)

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

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

    Tmax (Time to maximum concentration)

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

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

    AUC0-24 (Area under the curve time 0 to 24 hours)

    Time frame: Single ascending dose (Part 1) - up to 1 day

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

    AUC0-last (Area under the curve - to last time collected)

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

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

    AUC0-inf (Area under the curve - extrapolated to infinity)

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

  6. Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - λz

    λz (terminal elimination rate constant)

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

  7. Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - t1/2

    t1/2 (half-life)

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

  8. Evaluate the food effect on the PK profile of FP-020 - Cmax

    Cmax in fed vs fasted state

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

  9. Evaluate the food effect on the PK profile of FP-020 - Tmax

    Tmax in fed vs fasted state

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

  10. Evaluate the food effect on the PK profile of FP-020 - AUC

    AUC in fed vs fasted state

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

  11. Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - Cmax

    Cmax on Day 1 and Day 10

    Time frame: Multiple ascending dose (Part 2) - up to 10 days

  12. Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - Tmax

    Tmax on Day 1 and Day 10

    Time frame: Multiple ascending dose (Part 2) - up to 10 days

  13. Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - AUC0 - 24

    AUC0-24 on Day 1 and Day 10

    Time frame: Multiple ascending dose (Part 2) - up to 10 days

  14. Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - AUCo - last

    AUC0-last on Day 1 and Day 10

    Time frame: Multiple ascending dose (Part 2) - up to 10 days

  15. Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - AUC0 - inf

    AUC0-inf on Day 1 and Day 10

    Time frame: Multiple ascending dose (Part 2) - up to 10 days

  16. Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects λz

    λz on Day 10

    Time frame: Multiple ascending dose (Part 2) - up to 10 days

  17. Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - t1/2

    t1/2 on Day 10

    Time frame: Multiple ascending dose (Part 2) - up to 10 days

  18. Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - RCmax

    RCmax (ratio of Day 10 and Day 1 Cmax values)

    Time frame: Multiple ascending dose (Part 2) - up to 10 days

  19. Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - RAUC

    RAUC (ratio of Day 10 and Day 1 AUC0-24 values)

    Time frame: Multiple ascending dose (Part 2) - up to 10 days

07

Study locations

1 site
  • Scientia Clinical Research Ltd
    Randwick, New South Wales 2031, Australia
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2024 to primary completion in Sep 2024, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 1, 2024
First posted
Mar 27, 2024
StartActual
Apr 16, 2024
Primary completionActual
Sep 20, 2024
CompletionActual
Sep 20, 2024
Last update
Nov 13, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06334211
Lead sponsor
Foresee Pharmaceuticals Co., Ltd.
Collaborators
InClin, Inc.
Responsible party
Sponsor
First posted
Mar 27, 2024
Start date
Apr 16, 2024
Primary completion
Sep 20, 2024
Completion
Sep 20, 2024
Last update
Nov 13, 2024

Study contacts

Susan Whitaker, BSN
study director · Senior Director of Clinical Operations

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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Other studies from this sponsor

Foresee Pharmaceuticals Co., Ltd.

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