Healthy
Conditions
Brief 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).
Detailed description
* Part A is a randomized, double-blind, placebo-controlled, SAD study to assess safety, tolerability, and pharmacokinetics (PK) of FZ008-145 solution in healthy subjects. Up to 32 subjects will be enrolled in 4 cohorts. * Part B is a randomized, double-blind, placebo-controlled, SAD study to assess safety, tolerability, and PK of FZ008-145 tablet in healthy subjects. Up to 72 subjects will be enrolled in 9 cohorts. * Part D is a randomized, double-blind, placebo-controlled, 3-period, 3-treatment, 6-sequence crossover study to evaluate the cold pain tolerance effect of FZ008-145 tablet in healthy subjects. A total of 12 healthy subjects will be randomized to receive each of the three treatments (FZ008-145 at two dose levels and placebo) across three treatment periods, with appropriate washout between periods. * Part D2 is a randomized, double-blind, placebo-controlled, 3-period, 3-treatment, 6-sequence crossover study to evaluate the cold pain tolerance effect of FZ008-145 tablet in healthy subjects. A total of 12 healthy subjects will be randomized to evaluates higher single oral doses (FZ008-145 at two dose levels and placebo) across three treatment periods, with appropriate washout between periods. * Part E is an open-label, multiple ascending dose (MAD) study to assess the safety, tolerability, and pharmacokinetics of FZ008-145 tablet in healthy subjects. Approximately 48 healthy subjects will be enrolled into 6 sequential cohorts receiving once-daily or twice daily oral doses of FZ008-145 for 14 consecutive days under fasted conditions.
Interventions
DRUGFZ008-145 solution
Dose formulation- Oral solution
DRUGFZ008-145 Tablet
Dose formulation- Oral tablet
DRUGPlacebo
Dose formulation- Matching doses
Sponsors
Guangzhou Fermion Technology Co., LTD
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the safety of FZ008-145 solution by number of adverse events (AEs) and treatment-emergent adverse events (TEAEs) | 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. |
| To assess the safety of FZ008-145 tablet by number of adverse events (AEs) and treatment-emergent adverse events (TEAEs) | 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. |
| Number of participants with changes in laboratory parameters determined as adverse events following oral dose of FZ008-145 solution and FZ008-145 tablet | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the pharmacokinetics (PK) of FZ008-145 solution and FZ008-145 tablet | Up to 5 days post first dose administration | Cmax- Maximum plasma concentration |
Countries
Australia
Contacts
STUDY_DIRECTORShiqun Zhang
Guangzhou Fermion Technology Co., LTD
Outcome results
None listed