HealthyPhase 1NCT06685809
A Phase 1 Study of FZ008-145 in Healthy Subjects.
A Phase 1 study testing FZ008-145 solution and FZ008-145 Tablet in people with Healthy, run by Guangzhou Fermion Technology Co., LTD at 1 site in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- FZ008-145 solution and FZ008-145 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 1 siteAustralia
- Study dates
- 25 Nov 2024to 14 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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 kg for males, and 45 kg for females (inclusive).
- 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.
- 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.
- 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.
Who cannot join
- Has history of febrile illness or evidence of active infection within 14 days prior to the first dose of IP.
- 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.
- 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.
- History of alcohol allergy.
- 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.
- 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.
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- 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 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.
- 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 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.).
- History of previous QTc prolongation, or clinically significant abnormal ECG finding at 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 12c should be excluded from the study.
- QTcF ≥ 450 msec for males or QTcF ≥ 470 msec for females (confirmed by repeated examinations).
- 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 any surgeries during their participation in trial.
- 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).
- 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.
- Previous or suspected history of hypersensitivity or allergic reactions to the active ingredients of the study drug or other drugs and food.
- 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.
- Subjects with other factors deemed ineligible to participate in the trial by the Investigator.
- Subjects who are excessively sensitive to cold pain (PTT < 10 seconds) or who tolerate 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 > 96 seconds) will be excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
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.
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).
Read the 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.
- Conditions
- Healthy
- Being tested
- FZ008-145 solution, FZ008-145 Tablet, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FZ008-145 solutionDrug
Also called FZ008-145 Oral solution
Dose formulation- Oral solution
FZ008-145 TabletDrug
Also called FZ008-145 Oral tablet
Dose formulation- Oral tablet
PlaceboDrug
Also called Matching doses/form placebo
Dose formulation- Matching doses
| Study group | Role | What they receive |
|---|---|---|
| FZ008-145 solution- Part A | Experimental | All participants will receive single dose of oral FZ008-145 solution or placebo. Receives: Drug: FZ008-145 solution; Drug: Placebo |
| FZ008-145 tablet- Part B | Experimental | All participants will receive single dose of oral FZ008-145 tablet or placebo. Receives: Drug: FZ008-145 Tablet; Drug: Placebo |
| FZ008-145 tablet - Part D | Experimental | Subjects will participate in a 3-period, 3-treatment, 6-sequence crossover study. Each subject will receive a single oral dose of FZ008-145 tablet at two different dose levels and placebo, with each treatment administered in a randomized sequence.
Each treatment period will be separated by a washout period of at least 10 days. Cold pressor testing will be conducted following each dosing to assess pain tolerance. Receives: Drug: FZ008-145 Tablet; Drug: Placebo |
| FZ008-145 tablet - Part D2 | Experimental | Subjects will participate in a 3-period, 3-treatment, 6-sequence crossover study. Each subject will receive a single oral dose of FZ008-145 tablet at two different dose levels and placebo, with each treatment administered in a randomized sequence.
Each treatment period will be separated by a washout period of at least 10 days. Cold pressor testing will be conducted following each dosing to assess pain tolerance. Receives: Drug: FZ008-145 Tablet; Drug: Placebo |
| FZ008-145 tablet - Part E | Experimental | Part E includes up to 6 cohorts (E1-E6). Subjects will be enrolled into 6 sequential cohorts. Each cohort will receive once-daily or twice daily oral doses of FZ008-145 or placebo tablet for 14 consecutive days under fasted conditions. Receives: Drug: FZ008-145 Tablet; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of FZ008-145 solution by number of adverse events (AEs) and treatment-emergent adverse events (TEAEs)
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.
Measured: up to 14 days post first dose administration
To assess the safety of FZ008-145 tablet by number of adverse events (AEs) and treatment-emergent adverse events (TEAEs)
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.
Measured: up to 14 days post first dose administration
Number of participants with changes in laboratory parameters determined as adverse events following oral dose of FZ008-145 solution and FZ008-145 tablet
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.
Measured: up to 14 days post first dose administration
Secondary outcomes (10)
To evaluate the pharmacokinetics (PK) of FZ008-145 solution and FZ008-145 tablet
Cmax- Maximum plasma concentration
Measured: Up to 5 days post first dose administration
To evaluate the pharmacokinetics (PK) of FZ008-145 solution and FZ008-145 tablet
Tmax- Time taken for maximum concentration
Measured: Up to 5 days post first dose administration
To evaluate the pharmacokinetics (PK) of FZ008-145 solution and FZ008-145 tablet
AUC0-last- Area under curve from 0 to last
Measured: Up to 5 days post first dose administration
To evaluate the pharmacokinetics (PK) of FZ008-145 solution and FZ008-145 tablet
AUC0-inf- Area under curve from 0 to infinity
Measured: Up to 5 days post first dose administration
To evaluate the pharmacokinetics (PK) of FZ008-145 solution and FZ008-145 tablet
t1/2- terminal half-life
Measured: Up to 5 days post first dose administration
To evaluate the pharmacokinetics (PK) of FZ008-145 solution and FZ008-145 tablet
CL/F- Apparent total body clearance
Measured: Up to 5 days post first dose administration
To evaluate the pharmacokinetics (PK) of FZ008-145 solution and FZ008-145 tablet
Vz/F- Apparent total volume of distribution
Measured: Up to 5 days post first dose administration
To evaluate the pharmacokinetics (PK) of FZ008-145 solution and FZ008-145 tablet
Ae- Amount of analyte that is eliminated in urine
Measured: Up to 4 days post first dose administration
To evaluate the pharmacokinetics (PK) of FZ008-145 solution and FZ008-145 tablet
Fe- Fraction of analyte eliminated in Urine
Measured: Up to 4 days post first dose administration
To evaluate the pharmacokinetics (PK) of FZ008-145 solution and FZ008-145 tablet
CLr- Clearance rate
Measured: Up to 4 days post first dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start25 Nov 2024
- Primary completion14 Apr 2026
- Study completion14 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Fermion Technology Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shiqun Zhang, Study director, Guangzhou Fermion Technology Co., LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685809
- Sponsor's protocol ID
- FZ008-P101
- Other IDs
- CTR20240574
- Status last verified
- May 2026
- First submitted
- 11 Nov 2024
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06685809
- Acronym / sponsor ID
- FZ008-P101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Guangzhou Fermion Technology Co., LTDIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 14 Apr 2026 (actual)
- Study completion
- 14 Apr 2026 (actual)
- First posted
- 13 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| FZ008-145 solution- Part A | Experimental | Drug: FZ008-145 solution, Drug: PlaceboAll participants will receive single dose of oral FZ008-145 solution or placebo. |
| FZ008-145 tablet- Part B | Experimental | Drug: FZ008-145 Tablet, Drug: PlaceboAll participants will receive single dose of oral FZ008-145 tablet or placebo. |
| FZ008-145 tablet - Part D | Experimental | Drug: FZ008-145 Tablet, Drug: PlaceboSubjects will participate in a 3-period, 3-treatment, 6-sequence crossover study. Each subject will receive a single oral dose of FZ008-145 tablet at two different dose levels and placebo, with each treatment administered in a randomized sequence. Each treatment period will be separated by a washout period of at least 10 days. Cold pressor testing will be conducted following each dosing to assess pain tolerance. |
| FZ008-145 tablet - Part D2 | Experimental | Drug: FZ008-145 Tablet, Drug: PlaceboSubjects will participate in a 3-period, 3-treatment, 6-sequence crossover study. Each subject will receive a single oral dose of FZ008-145 tablet at two different dose levels and placebo, with each treatment administered in a randomized sequence. Each treatment period will be separated by a washout period of at least 10 days. Cold pressor testing will be conducted following each dosing to assess pain tolerance. |
| FZ008-145 tablet - Part E | Experimental | Drug: FZ008-145 Tablet, Drug: PlaceboPart E includes up to 6 cohorts (E1-E6). Subjects will be enrolled into 6 sequential cohorts. Each cohort will receive once-daily or twice daily oral doses of FZ008-145 or placebo tablet for 14 consecutive days under fasted conditions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- 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 kg for males, and 45 kg for females (inclusive).
- 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.
- 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.
Key exclusion criteria (28 listed)
- Has history of febrile illness or evidence of active infection within 14 days prior to the first dose of IP.
- 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.
- 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.
- History of alcohol allergy.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FZ008-145 solutionAlso: FZ008-145 Oral solutionDose formulation- Oral solution | Drug | FZ008-145 solution- Part A |
| FZ008-145 TabletAlso: FZ008-145 Oral tabletDose formulation- Oral tablet | Drug | FZ008-145 tablet - Part D, FZ008-145 tablet - Part D2, FZ008-145 tablet - Part E, FZ008-145 tablet- Part B |
| PlaceboAlso: Matching doses/form placeboDose formulation- Matching doses | Drug | FZ008-145 solution- Part A, FZ008-145 tablet - Part D, FZ008-145 tablet - Part D2, FZ008-145 tablet - Part E, FZ008-145 tablet- Part B |
Primary outcome
To assess the safety of FZ008-145 solution by number of adverse events (AEs) and treatment-emergent adverse events (TEAEs)
Time frame: 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)
Time frame: 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
Time frame: 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.
10 secondary outcomes
To evaluate the pharmacokinetics (PK) of FZ008-145 solution and FZ008-145 tablet
Time frame: Up to 5 days post first dose administration
To evaluate the pharmacokinetics (PK) of FZ008-145 solution and FZ008-145 tablet
Time frame: Up to 5 days post first dose administration
To evaluate the pharmacokinetics (PK) of FZ008-145 solution and FZ008-145 tablet
Time frame: Up to 5 days post first dose administration
To evaluate the pharmacokinetics (PK) of FZ008-145 solution and FZ008-145 tablet
Time frame: Up to 5 days post first dose administration
To evaluate the pharmacokinetics (PK) of FZ008-145 solution and FZ008-145 tablet
Time frame: Up to 5 days post first dose administration
To evaluate the pharmacokinetics (PK) of FZ008-145 solution and FZ008-145 tablet
Time frame: Up to 5 days post first dose administration
To evaluate the pharmacokinetics (PK) of FZ008-145 solution and FZ008-145 tablet
Time frame: Up to 5 days post first dose administration
To evaluate the pharmacokinetics (PK) of FZ008-145 solution and FZ008-145 tablet
Time frame: Up to 4 days post first dose administration
To evaluate the pharmacokinetics (PK) of FZ008-145 solution and FZ008-145 tablet
Time frame: Up to 4 days post first dose administration
To evaluate the pharmacokinetics (PK) of FZ008-145 solution and FZ008-145 tablet
Time frame: Up to 4 days post first dose administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiqun Zhang study director
Guangzhou Fermion Technology Co., LTD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FZ008-145 solution and FZ008-145 Tablet in people with Healthy, run by Guangzhou Fermion Technology Co., LTD at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety of FZ008-145 solution by number of adverse events (AEs) and treatment-emergent adverse events (TEAEs) (time frame: up to 14 days post first dose administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.