Phase
Condition
N/ATreatment
FZ008-145 Tablet
Placebo
FZ008-145 solution
Clinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Able and willing to provide written informed consent after the nature of the studyhas been explained and prior to the commencement of any study procedures.
Male or female aged 18 to 65 years (inclusive).
Subject has body mass index of 18 to 32 kg/m2 with a minimum body weight of 50 kgfor males, and 45 kg for females (inclusive).
Subject is generally healthy, in the opinion of the Investigator, based onassessment of medical history, physical examination, vital signs, electrocardiogram (ECG), and other relevant tests conducted at Screening, Day 1 for Part D/Part D2 (period 1) and Day -1 for other parts at the discretion of the Investigator ordesignee. Tests could be repeated once if they are outside the relevant clinicalreference range.
Subject has clinical laboratory values (based on hematology, coagulation,biochemistry, and urinalysis parameters) within normal range, as specified by thetesting laboratory, at Screening and Day -1 (for all parts except Part D/Part D2),unless deemed not clinically significant by the Investigator or delegate. Testscould be repeated once if they are outside the relevant clinical reference range.
Females must not be pregnant or lactating, and must use acceptable, highly effectivedouble contraception from Screening until 90 days after study completion, includingthe Follow-up period. Women of childbearing potential (WOCBP) must have a negativepregnancy test at Screening and Day -1 and be willing to have additional pregnancytests as required throughout the study. Women not of childbearing potential must bepostmenopausal for ≥ 12 months (postmenopausal status is to be confirmed throughtesting of follicle stimulating hormone (FSH) levels ≥ 40 IU/L at Screening foramenorrhoeic female subjects). Females must not donate eggs from the first dose ofIP until at least 90 days after the last dose of IP. Males must be surgicallysterile (> 90 days since vasectomy with no viable sperm), or if engaged in sexualrelations with a WOCBP, either his partner must be surgically sterile (e.g., tubalocclusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or anacceptable, highly effective contraceptive method must be used from Screening untilstudy completion, including the Follow-up period, and 90 days. Males with same-sexpartners (abstinence from penile-vaginal intercourse) or are abstinent fromheterosexual intercourse are not required to use contraception. Males must notdonate sperm from the first dose of IP until at least 90 days after the last dose ofIP.
8.Willing and able to comply with all study-related procedures and assessments, including confinement and attending necessary visits to the CRU.
Exclusion
Exclusion Criteria:
Has history of febrile illness or evidence of active infection within 14 days priorto the first dose of IP.
Substance abuse-related disorder or a history of drug, and/or substance abuse deemedsignificant by the Investigator. Positive drug screen at Screening, Day 1 for PartD/Part D2 (Period1) and Day -1 for other parts. The test could be repeated once atthe discretion of Investigator/designee.
Has consumed more than 14 units of alcohol per week in the 3 months prior to signingthe ICF (1 unit = 360 mL of beer with an alcohol content of 5%, or 45 mL of spiritswith an alcohol content of 40%, or 150 mL of wine with an alcohol content of 12%),or has a positive alcohol breath test (breath alcohol concentration > 0.0 mg/100 mL)at Screening, Day 1 for Part D/Part D2 (Period1) and Day -1 for other parts, orunable to abstain from alcohol during the trial period. The test could be repeatedonce at the discretion of the Investigator/designee.
History of alcohol allergy.
Has excessively used nicotine products (average daily smoking of more than 5cigarettes) within the 3 months prior to Screening or refuse to abstain from smokingduring the trial or has a positive nicotine/cotinine test at Day 1 for Part D/PartD2 (Period 1) and Day -1 for other parts.
Participated in any other investigational trials or has been exposed to otherinvestigational drugs within 28 days or 5 half-lives of the previously administeredinvestigational drug (date derived from last study procedure [blood collection ordosing] of previous trial), whichever is longer, prior to admission to the CRU.
Positive test for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV)antibody and human immunodeficiency virus (HIV) antibody at Screening.
Donation of blood or significant blood loss ≥ 400 mL in 1 month prior to the firstIP administration, has received a blood transfusion or used blood products within 1month prior to first dosing, or plan to donate blood during this trial or within 1month after the last IP administration.
Plasma donation within 14 days prior to the first administration of IP.
Has used any medication within 14 days prior to the first IP administration that theInvestigator considers may affect the PK evaluation of the study drug (includingprescription drugs, over-the-counter drugs, herbal medicines, functional vitamins,dietary supplements, etc.).
History of previous QTc prolongation, or clinically significant abnormal ECG findingat Screening:
Heart rate 45 to 100 beats per minute.
PR 120 to 220 msec.
QRS < 120 msec.
Subjects with parameters outside the ranges of exclusion criteria 12a to 12cshould be excluded from the study.
QTcF ≥ 450 msec for males or QTcF ≥ 470 msec for females (confirmed by repeatedexaminations).
Long QT syndrome.
Use of concomitant medications that are known to prolong QT/QTc.
Abnormal ECG findings as judged by the Investigator.
Has liver disease or clinically significant liver impairment at Screening (e.g.,aspartate aminotransferase [AST], alanine aminotransferase [ALT], or total bilirubin > 1.5 times the upper limit of normal [ULN]).
Has had major surgery within 6 months prior to the Screening, or plan to have anysurgeries during their participation in trial.
Has any disease or condition that may interfere with theabsorption/distribution/metabolism/excretion of the study drug, in the opinion ofthe Investigator (e.g., dysphagia, gastrointestinal diseases, cholecystectomy).
Presence of diseases such as migraine, cardiovascular, liver, endocrine,gastrointestinal, metabolic, neurological, pulmonary, endocrine, psychiatric, oroncological history, or any other evidence deemed to be clinically significant bythe Investigator and that may pose a risk to the safety of the subject or interferewith the conduct, progress, or completion of the study.
Previous or suspected history of hypersensitivity or allergic reactions to theactive ingredients of the study drug or other drugs and food.
Consumption of foods or juices containing cranberries or pineapples, Sevilleoranges, grapefruit, pomegranate or caffeine (xanthine-containing products) for 48hours prior to each dose and remain restricted until the end of PK collection oneach dosing day for Part D and before the start of dosing until after collection ofthe final PK for other Parts, unless deemed acceptable by the Investigator.
Subjects with other factors deemed ineligible to participate in the trial by theInvestigator.
Subjects who are excessively sensitive to cold pain (PTT < 10 seconds) or whotolerate it too long (PTT > 96 seconds) will be excluded from
Part D.Part D/Part D2 ONLY; Subjects who are excessively sensitive to cold pain (defined as a PTT < 10 seconds) or who tolerate cold pain (defined as a PTT > 96seconds) will be excluded from the study
Study Design
Study Description
Connect with a study center
CMAX Clinical Research Pty
Adelaide, South Australia 5000
AustraliaSite Not Available
CMAX Clinical Research Pty
Adelaide 2078025, South Australia 2061327 5000
AustraliaActive - Recruiting

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