Actively Recruiting
A Study of FB1003 in Healthy and Osteoarthritis Pain Subjects
Led by 4B Technologies Limited · Updated on 2025-06-15
64
Participants Needed
2
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of Part 1 is to evaluate safety and tolerability of FB1003 when given subcutaneously to healthy participants. Blood tests will be done to examine blood exposure, concentration and half-life of FB1003 following administrations. For each participant, the study will last up to about 12 weeks for single ascending dose part, and 18 weeks for multiple ascending dose part, including screening. The purpose of Part 2 is to assess the safety, tolerability, PK and efficacy of SAD of SC administered FB1003 in adult subjects with osteoarthritis (OA) pain.
CONDITIONS
Official Title
A Study of FB1003 in Healthy and Osteoarthritis Pain Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects between 18 and 55 years of age at time of consent
- Able to understand and follow the study protocol
- In good health based on medical history, physical exam, vital signs, abdominal ultrasound, ECG, and lab tests
- Willing to avoid NSAIDs for 1 week before and 2 weeks after study treatment
- Weigh at least 45 kg with a body mass index between 18 and 32 kg/m2
- Capable of giving informed consent and complying with study requirements
- Women must be not of childbearing potential or agree to use effective contraception from screening through 90 days after last dose
- For Part 2 only: confirmed knee osteoarthritis by X-ray with Kellgren and Lawrence Grade 2 or higher
- For Part 2 only: willing to stop all pain medications except allowed rescue meds before Day 1 and during study
- For Part 2 only: moderate to severe knee pain with a WOMAC pain score of 4 or higher at screening and randomization
You will not qualify if you...
- History or presence of bone or joint disorders including osteoarthritis, rheumatoid arthritis, or other inflammatory joint diseases (Part 1 only)
- History of joint surgeries or dislocations
- Joint trauma within 30 days before screening
- Clinically significant blood abnormalities or kidney impairment (Part 2 only)
- History of seizures or inflammatory arthritis other than osteoarthritis
- History of osteonecrosis or osteoporotic fractures
- Recent significant trauma or surgery to knee, hip, or shoulder within the past year
- Fibromyalgia or other moderate/severe pain conditions affecting knee pain assessment
- Hospital admission or major surgery within 60 days prior to screening
- Planned surgery during the study period
- Serious mental illness requiring treatment
- Elevated liver enzymes or abnormal lab values indicating disease
- History of neuropathy
- Abnormal heart rates or heart block
- Recent myocardial infarction or stroke within 12 months
- Positive tests for HIV, hepatitis B or C
- History of cancer within 5 years except certain skin or in situ cancers
- Positive pregnancy test or lack of pregnancy test results for women of childbearing potential
- Recent blood donation or transfusion within 30 days
- Significant illness within 7 days before first dose
- History of multiple drug allergies or allergic reaction to monoclonal antibodies
- Severe intolerance to subcutaneous injections
- Significant medical conditions affecting participation or safety data
- Recent investigational drug use within 30 days or 5 half-lives
- High blood pressure above specified limits unless controlled
- Pregnant or breastfeeding women
- Excessive alcohol consumption or drug abuse history
- Recent vaccination within 28 days before dosing or planned vaccination during study or 56 days after last dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Nucleus Network
Brisbane, Queensland, Australia, 4006
Completed
2
Veritus Research
Bayswater, Victoria, Australia, 3153
Actively Recruiting
Research Team
C
Chief Medical Officer, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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