NCT06334211已完成1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Clinically significant abnormalities.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double-blind (placebo appears the same as active FP-020)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 -
- •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.
排除标准
- •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.
- •Alanine transaminase (ALT) or aspartate aminotransferase (AST) >1.5 upper limit of normal.
- •Bilirubin outside of the normal range (total bilirubin between 0.1 and 1.2 mg/dL (1.71 to 20.5 µmol/L).
- •Creatinine clearance < 90 mL/min (estimated from Cockcroft Gault equation).
- •Subject is pregnant, lactating, or is planning to become pregnant during the study.
- •Inability to tolerate oral medications.
- •All prescription and over-the-counter medications (including herbal medications) except for non-estrogen contraceptives, are prohibited within 7 days before dosing through EOS.
- •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.
- •Live vaccine(s) within 1 month before Screening or plans to receive such vaccines during the study.
- •Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) before dosing.
- •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.
- •Significant weight loss or gain between Screening and administration of first dose of study drug.
- •Blood donation or significant blood loss within 60 days prior to administration of first dose of study drug.
- •Plasma donation within 7 days prior to administration of first dose of study drug.
- •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.
- •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.
- •Intake of alcohol or caffeine-containing products 48 hours before administration of first dose of study drug.
- •Use of tobacco products (e.g., cigarettes, e-cigarettes, cigars, smokeless tobacco) confirmed by a positive cotinine test on Day -
- •Failure to satisfy the Investigator of fitness to participate for any other reason.
研究组 & 干预措施
FP-020
Experimental
100 mg capsule
干预措施: FP-020 (Drug)
placebo
Placebo Comparator
placebo capsule
干预措施: placebo (Other)
结局指标
主要结局
Clinically significant abnormalities.
时间窗: Part 1 - up to 10 days and Part 2 - up to 17 days
Clinically significant abnormalities in physical examination, vital signs, 12-lead Electrocardiograms (ECGs), and safety laboratory results.
The incidence, severity, and type of Adverse Events (AEs) and Serious Adverse Events (SAEs).
时间窗: Part 1 - up to 10 days and Part 2 - up to 17 days
* 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
次要结局
- Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - Tmax(Single ascending dose (Part 1) - up to 10 days)
- Evaluate the food effect on the PK profile of FP-020 - Tmax(Single ascending dose (Part 1) - up to 10 days)
- 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 - AUC0 - last(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-inf(Single ascending dose (Part 1) - up to 10 days)
- Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - λz(Single ascending dose (Part 1) - up to 10 days)
- Evaluate the food effect on the PK profile of FP-020 - Cmax(Single ascending dose (Part 1) - up to 10 days)
- Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - Tmax(Multiple ascending dose (Part 2) - up to 10 days)
- Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - AUC0 - 24(Multiple ascending dose (Part 2) - up to 10 days)
- Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects λz(Multiple ascending dose (Part 2) - up to 10 days)
- Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - t1/2(Multiple ascending dose (Part 2) - up to 10 days)
- Pharmacokinetic (PK) profile of FP-020 after single, ascending oral doses - t1/2(Single ascending dose (Part 1) - up to 10 days)
- Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - AUCo - last(Multiple ascending dose (Part 2) - up to 10 days)
- Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - RAUC(Multiple ascending dose (Part 2) - up to 10 days)
- Evaluate the food effect on the PK profile of FP-020 - AUC(Single ascending dose (Part 1) - up to 10 days)
- Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - Cmax(Multiple ascending dose (Part 2) - up to 10 days)
- Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - AUC0 - inf(Multiple ascending dose (Part 2) - up to 10 days)
- Evaluate the PK profile of FP-020 after multiple ascending oral doses in healthy subjects - RCmax(Multiple ascending dose (Part 2) - up to 10 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Safety, Tolerability & PK of AZD0328 in Caucasian & JapaneseHealthy VolunteersNCT00738959AstraZeneca64
已完成
1 期
A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of BIIB091, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Healthy Adult ParticipantsHealthy VolunteerNCT03943056Biogen64
已完成
1 期
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GDC-0853 in Healthy Japanese and Caucasian ParticipantsHealthy VolunteerNCT03188783Hoffmann-La Roche32
已完成
1 期
A Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP4058 Following Single Oral DosesPharmacokinetics of ASP4058Healthy SubjectsFood Effect of ASP4058NCT01998646Astellas Pharma Global Development, Inc.130
已完成
1 期
A Dose Escalation Study to Assess Safety, Tolerability and Pharmacokinetics of ASP2409 Following a Single Intravenous Dose in Patients With Rheumatoid Arthritis on MethotrexatePharmacokinetics of ASP2409Rheumatoid ArthritisNCT02171143Astellas Pharma Global Development, Inc.58