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A Phase 1 Study of FZ008-145 in Healthy Subjects.
The study will be conducted in 3 parts: Part A (single ascending dose \[SAD\] in solution formulation), Part B (SAD in tablet formulation), and Part C (food effect \[FE\]).
Study details:
* 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 40 subjects will be enrolled in 5 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 24 subjects will be enrolled in 3 cohorts. * Part C is a randomized, open-label, 2-period, 2-treatment (2×2) crossover study to assess the effect of food on bioavailability of FZ008-145 tablet in healthy subjects. A total of 20 healthy subjects will be allocated to 2 cohorts.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : Yes
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-12-09
Primary completion: 2025-07-31
Study completion finish: 2025-08-15
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT06685809
Intervention or treatment
DRUG: FZ008-145 solution
DRUG: FZ008-145 Tablet
DRUG: Placebo
Conditions
- • Healthy
Find a site
Closest Location:
CMAX Clinical Research Pty
Research sites nearby
Select from list below to view details:
CMAX Clinical Research Pty
Adelaide, South Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: FZ008-145 solution- Part A
| DRUG: FZ008-145 solution
|
EXPERIMENTAL: FZ008-145 tablet- Part B
| DRUG: FZ008-145 Tablet
|
EXPERIMENTAL: FZ008-145 tablet- Part C
| DRUG: FZ008-145 Tablet
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
To assess the safety of FZ008-145 solution by number of adverse events (AEs) and treatment-emergent adverse events (TEAEs) | Not Specified | 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) | Not Specified | 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 | Not Specified | up to 14 days post first dose administration |
To assess effect of high-fat meal on pharmacokinetics (PK) of FZ008-145 tablet -Cmax (maximum plasma concentration) | Not Specified | Up to 5 days post first dose administration |
To assess effect of high-fat meal on pharmacokinetics (PK) of FZ008-145 tablet -AUC0-last (Area under curve from 0 to last) | Not Specified | Up to 5 days post first dose administration |
To assess effect of high-fat meal on pharmacokinetics (PK) of FZ008-145 tablet -AUC0-inf (Area under curve from 0 to infinity) | Not Specified | Up to 5 days post first dose administration |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
To evaluate the pharmacokinetics (PK) of FZ008-145 solution and FZ008-145 tablet | Cmax- Maximum plasma concentration | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Up to 4 days post first dose administration |
To evaluate the pharmacokinetics (PK) of FZ008-145 solution and FZ008-145 tablet | CLr- Clearance rate | Up to 4 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) in Part C | Not Specified | up to 14 days post first dose administration |
Frequently Asked Questions
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