A Study of FB1003 in Healthy and Osteoarthritis Pain Subjects
Eligible age
18–75 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
Yes
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: 4B Technologies Limited
You may qualify if…
- ✓ Male or female subjects who, at the time of signing the informed consent form (ICF), are between 18 and 55 years of age (inclusive).
- ✓ The subject is capable of understanding and complying with protocol requirements
- ✓ Subjects in good health based on pre-study medical history, physical examinations, vital signs, abdominal ultrasound, 12-lead ECGs, clinical laboratory tests.
- ✓ Be willing to refrain from taking NSAID medications for 1 week prior to receiving study intervention and for 2 weeks after study intervention administration.
- ✓ The subject weighs at least 45 kg and has a body mass index between 18 and 32 kg/m2 (inclusive).
- ✓ Must be capable of giving signed informed consent as described which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- ✓ Women not of childbearing potential. OR must agree to use a double barrier highly effective method of contraception from the beginning of screening until at least 90 days after the last dose of study intervention.
- ✓ DISEASE CONDITIONS (PART 2 ONLY)
You may not qualify if…
- ✕ Medical conditions for Part 1 only:
- ✕ 1. History or presence at the screening visit of bone or joint disorders including but not limited to OA, avascular necrosis, destructive arthropathy, pathologic fractures, osteonecrosis, rheumatoid arthritis, neuropathic joint arthropathy, lupus erythematosus, or inflammatory joint diseases.
- ✕ 2. History of joint-related events such as, but not limited to, total joint replacement surgery, patella dislocation, hip dislocation, knee dislocation, or joint infections.
- ✕ 3. Trauma to any joint in the 30 days prior to the screening visit.
- ✕ Medical conditions for Part 2 only:
- ✕ 1. Clinically significant hematological findings at screening.
- ✕ 2. Abnormal findings indicating renal impairment, such as creatinine ≥1.5×ULN, estimated glomerular filtration rate (eGFR) of ≤60 mL/min/1.73 m2 in adults, as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula, at screening.
- ✕ 3. A history of non-febrile seizures.
Source: ClinicalTrials.gov · NCT06343714 · last updated 2025-06-15