A Phase 1 Study of FZ008-145 in Healthy Subjects.

Phase
Recruitment status
Participants
Lead sponsor
Guangzhou Fermion Technology Co., LTD
Start date
Number of sites

Summary
The study will be conducted in 5 parts: Part A and Part B (single ascending dose \[SAD\] in solution formulation and tablet respectively), Part D and Part D2 (cold pressor test \[CPT\] to evaluate pain tolerance following single dose), and Part E (multiple ascending doses \[MAD\] in tablet formulation).
Short title
A Phase 1 Study of FZ008-145 in Healthy Subjects.
Official title
A Phase 1 Study Assessing Safety, Tolerability, Pharmacokinetics and Physiological Response (Pain Tolerance) to Single and Multiple Ascending Doses of FZ008-145 in Healthy Subjects.

Registry reports results
Listing at source
Recruitment status
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Actual participants
Participants
Participant count basis
Protocol amendments
Number of sites

Data monitoring committee
Registry sponsor category
Lead sponsor
Guangzhou Fermion Technology Co., LTD
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Randomised
Model
Sequential
Purpose
Treatment
Masking
Triple masking
Masked roles
Participants, Care providers, Investigators
Sources for study design

  1. To assess the safety of FZ008-145 solution by number of adverse events (AEs) and treatment-emergent adverse events (TEAEs)

    Timeframe: up to 14 days post first dose administration

    Safety of FZ008-145 solution is assessed by the incidence, nature, and severity of adverse events (AEs) and treatment-emergent adverse events (TEAEs) following administration of FZ008-145 solution. AEs and TEAEs are collected from the time of dosing through the end of the study and are summarized by number of participants experiencing at least one event.

  2. To assess the safety of FZ008-145 tablet by number of adverse events (AEs) and treatment-emergent adverse events (TEAEs)

    Timeframe: up to 14 days post first dose administration

    Safety of FZ008-145 solution is assessed by the incidence, nature, and severity of adverse events (AEs) and treatment-emergent adverse events (TEAEs) following administration of FZ008-145 solution. AEs and TEAEs are collected from the time of dosing through the end of the study and are summarized by number of participants experiencing at least one event.

  3. Number of participants with changes in laboratory parameters determined as adverse events following oral dose of FZ008-145 solution and FZ008-145 tablet

    Timeframe: up to 14 days post first dose administration

    The number of participants experiencing laboratory parameter abnormalities that are assessed as clinically significant and reported as adverse events (AEs) or treatment-emergent adverse events (TEAEs) following oral administration of FZ008-145 solution or FZ008-145 tablet.

  1. To evaluate the pharmacokinetics (PK) of FZ008-145 solution and FZ008-145 tablet

    Timeframe: Up to 5 days post first dose administration

    Cmax- Maximum plasma concentration

  2. To evaluate the pharmacokinetics (PK) of FZ008-145 solution and FZ008-145 tablet

    Timeframe: Up to 5 days post first dose administration

    Tmax- Time taken for maximum concentration

  3. To evaluate the pharmacokinetics (PK) of FZ008-145 solution and FZ008-145 tablet

    Timeframe: Up to 5 days post first dose administration

    AUC0-last- Area under curve from 0 to last

  4. To evaluate the pharmacokinetics (PK) of FZ008-145 solution and FZ008-145 tablet

    Timeframe: Up to 5 days post first dose administration

    AUC0-inf- Area under curve from 0 to infinity

  5. To evaluate the pharmacokinetics (PK) of FZ008-145 solution and FZ008-145 tablet

    Timeframe: Up to 5 days post first dose administration

    t1/2- terminal half-life

  6. To evaluate the pharmacokinetics (PK) of FZ008-145 solution and FZ008-145 tablet

    Timeframe: Up to 5 days post first dose administration

    CL/F- Apparent total body clearance

  7. To evaluate the pharmacokinetics (PK) of FZ008-145 solution and FZ008-145 tablet

    Timeframe: Up to 5 days post first dose administration

    Vz/F- Apparent total volume of distribution

  8. To evaluate the pharmacokinetics (PK) of FZ008-145 solution and FZ008-145 tablet

    Timeframe: Up to 4 days post first dose administration

    Ae- Amount of analyte that is eliminated in urine

  9. To evaluate the pharmacokinetics (PK) of FZ008-145 solution and FZ008-145 tablet

    Timeframe: Up to 4 days post first dose administration

    Fe- Fraction of analyte eliminated in Urine

  10. To evaluate the pharmacokinetics (PK) of FZ008-145 solution and FZ008-145 tablet

    Timeframe: Up to 4 days post first dose administration

    CLr- Clearance rate

Sources for outcomes

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
Yes

  1. Able and willing to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.
  2. Male or female aged 18 to 65 years (inclusive).
  3. Subject has body mass index of 18 to 32 kg/m2 with a minimum body weight of 50 kg for males, and 45 kg for females (inclusive).
  4. Subject is generally healthy, in the opinion of the Investigator, based on assessment 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 or designee. Tests could be repeated once if they are outside the relevant clinical reference range.
  5. Subject has clinical laboratory values (based on hematology, coagulation, biochemistry, and urinalysis parameters) within normal range, as specified by the testing laboratory, at Screening and Day -1 (for all parts except Part D/Part D2), unless deemed not clinically significant by the Investigator or delegate. Tests could be repeated once if they are outside the relevant clinical reference range.
  6. Females must not be pregnant or lactating, and must use acceptable, highly effective double contraception from Screening until 90 days after study completion, including the Follow-up period. Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening and Day -1 and be willing to have additional pregnancy tests as required throughout the study. Women not of childbearing potential must be postmenopausal for ≥ 12 months (postmenopausal status is to be confirmed through testing of follicle stimulating hormone (FSH) levels ≥ 40 IU/L at Screening for amenorrhoeic female subjects). Females must not donate eggs from the first dose of IP until at least 90 days after the last dose of IP. Males must be surgically sterile (> 90 days since vasectomy with no viable sperm), or if engaged in sexual relations with a WOCBP, either his partner must be surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or an acceptable, highly effective contraceptive method must be used from Screening until study completion, including the Follow-up period, and 90 days. Males with same-sex partners (abstinence from penile-vaginal intercourse) or are abstinent from heterosexual intercourse are not required to use contraception. Males must not donate sperm from the first dose of IP until at least 90 days after the last dose of IP.

8.Willing and able to comply with all study-related procedures and assessments, including confinement and attending necessary visits to the CRU.

  1. Has history of febrile illness or evidence of active infection within 14 days prior to the first dose of IP.

  2. Substance abuse-related disorder or a history of drug, and/or substance abuse deemed significant by the Investigator. Positive drug screen at Screening, Day 1 for Part D/Part D2 (Period1) and Day -1 for other parts. The test could be repeated once at the discretion of Investigator/designee.

  3. Has consumed more than 14 units of alcohol per week in the 3 months prior to signing the ICF (1 unit = 360 mL of beer with an alcohol content of 5%, or 45 mL of spirits with 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, or unable to abstain from alcohol during the trial period. The test could be repeated once at the discretion of the Investigator/designee.

  4. History of alcohol allergy.

  5. Has excessively used nicotine products (average daily smoking of more than 5 cigarettes) within the 3 months prior to Screening or refuse to abstain from smoking during the trial or has a positive nicotine/cotinine test at Day 1 for Part D/Part D2 (Period 1) and Day -1 for other parts.

  6. Participated in any other investigational trials or has been exposed to other investigational drugs within 28 days or 5 half-lives of the previously administered investigational drug (date derived from last study procedure [blood collection or dosing] of previous trial), whichever is longer, prior to admission to the CRU.

  7. Positive test for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody and human immunodeficiency virus (HIV) antibody at Screening.

  8. Donation of blood or significant blood loss ≥ 400 mL in 1 month prior to the first IP administration, has received a blood transfusion or used blood products within 1 month prior to first dosing, or plan to donate blood during this trial or within 1 month after the last IP administration.

  9. Plasma donation within 14 days prior to the first administration of IP.

  10. Has used any medication within 14 days prior to the first IP administration that the Investigator considers may affect the PK evaluation of the study drug (including prescription drugs, over-the-counter drugs, herbal medicines, functional vitamins, dietary supplements, etc.).

  11. History of previous QTc prolongation, or clinically significant abnormal ECG finding at Screening:

    1. Heart rate 45 to 100 beats per minute.
    2. PR 120 to 220 msec.
    3. QRS < 120 msec.
    4. Subjects with parameters outside the ranges of exclusion criteria 12a to 12c should be excluded from the study.
    5. QTcF ≥ 450 msec for males or QTcF ≥ 470 msec for females (confirmed by repeated examinations).
    6. Long QT syndrome.
    7. Use of concomitant medications that are known to prolong QT/QTc.
    8. Abnormal ECG findings as judged by the Investigator.
  12. 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]).

  13. Has had major surgery within 6 months prior to the Screening, or plan to have any surgeries during their participation in trial.

  14. Has any disease or condition that may interfere with the absorption/distribution/metabolism/excretion of the study drug, in the opinion of the Investigator (e.g., dysphagia, gastrointestinal diseases, cholecystectomy).

  15. Presence of diseases such as migraine, cardiovascular, liver, endocrine, gastrointestinal, metabolic, neurological, pulmonary, endocrine, psychiatric, or oncological history, or any other evidence deemed to be clinically significant by the Investigator and that may pose a risk to the safety of the subject or interfere with the conduct, progress, or completion of the study.

  16. Previous or suspected history of hypersensitivity or allergic reactions to the active ingredients of the study drug or other drugs and food.

  17. Consumption of foods or juices containing cranberries or pineapples, Seville oranges, grapefruit, pomegranate or caffeine (xanthine-containing products) for 48 hours prior to each dose and remain restricted until the end of PK collection on each dosing day for Part D and before the start of dosing until after collection of the final PK for other Parts, unless deemed acceptable by the Investigator.

  18. Subjects with other factors deemed ineligible to participate in the trial by the Investigator.

  19. Subjects who are excessively sensitive to cold pain (PTT < 10 seconds) or who tolerate it too long (PTT > 96 seconds) will be excluded from

  20. 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 > 96 seconds) will be excluded from the study

Sources for eligibility

  • CMAX Clinical Research PtyAdelaide, Australia
Sources for sites

Other registry identifiers

  • CTR20240574
Sources for references

Related records

Drugs (2)

Lead sponsors (1)