Actively Recruiting
A Phase 1 Study of FZ008-145 in Healthy Subjects.
Led by Guangzhou Fermion Technology Co., LTD · Updated on 2026-02-12
190
Participants Needed
1
Research Sites
79 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study will be conducted in 5 parts: Part A (single ascending dose \[SAD\] in solution formulation), Part C (food effect \[FE\]), Part D (cold pressor test \[CPT\] to evaluate pain tolerance following single dose), and Part E (multiple ascending dose \[MAD\] in tablet formulation).
CONDITIONS
Official Title
A Phase 1 Study of FZ008-145 in Healthy Subjects.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent before any study procedures
- Male or female aged 18 to 65 years (inclusive)
- Body mass index between 18 and 32 kg/m2 with minimum weight of 50 kg for males and 45 kg for females
- Generally healthy as determined by medical history, physical exam, vital signs, and ECG
- Normal clinical laboratory values at screening and Day -1 unless deemed not clinically significant
- Females must not be pregnant or lactating and must use effective contraception until 90 days after study completion
- Women of childbearing potential must have negative pregnancy tests and be willing to have additional tests
- Males must be surgically sterile or use effective contraception if sexually active with women of childbearing potential
- Willing and able to comply with all study procedures, including confinement and attending visits
You will not qualify if you...
- History of febrile illness or active infection within 14 days before first dose
- Substance abuse disorder or positive drug screen at screening or dosing days
- Consumed more than 14 units of alcohol per week in past 3 months or positive alcohol breath test
- History of alcohol allergy
- Excessive nicotine use (more than 5 cigarettes daily) or positive nicotine/cotinine test
- Participation in other investigational trials or use of investigational drugs within 28 days or 5 half-lives
- Positive tests for hepatitis B, hepatitis C, or HIV at screening
- Recent blood donation or significant blood loss within 1 month prior to dosing
- Plasma donation within 14 days prior to dosing
- Use of medications affecting study drug pharmacokinetics within 14 days prior to dosing
- History of QTc prolongation or abnormal ECG findings
- Liver disease or significant liver impairment
- Major surgery within 6 months prior to screening or planned during study
- Conditions interfering with drug absorption or metabolism
- Significant diseases including migraine, cardiovascular, liver, endocrine, gastrointestinal, neurological, pulmonary, psychiatric, or cancer
- History or suspected hypersensitivity to study drug or related substances
- Consumption of certain foods or juices (cranberries, grapefruit, caffeine etc.) before dosing as restricted
- Excessive sensitivity or tolerance to cold pain in Parts D and D2
- Other factors deemed ineligible by the Investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
CMAX Clinical Research Pty
Adelaide, South Australia, Australia, 5000
Actively Recruiting
Research Team
S
Shiqun Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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