A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Escalating Single and Multiple Doses of FB1003 in the Healthy and Osteoarthritis Pain Subjects
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.
• 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)
• Subject has confirmation of OA of the knee through the radiographs of both knees with a Posterior-Anterior, Fixed-flexion view taken during the Screening Period using American College of Rheumatology (ACR) clinical and radiographic diagnostic criteria.
• Evidence of knee OA with a Kellgren and Lawrence (KL) Grade ≥2.
• Subject is willing to discontinue all pain medication at least 5 half-lives from Day 1 visit and agree to take only the allowed Rescue Medications through study completion (maximum 4000 mg paracetamol per day).
• Subject has moderate to severe pain in the index joint defined as a Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) average pain subscale score of ≥4 at both the screening and randomization visits.