A Study of FB1003 in Healthy and Osteoarthritis Pain Subjects

NCT06343714 | Recruiting Phase 1

• 1 other identifier: FB1003-04-101
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

Brief Summary

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

Healthy Volunteers

Keywords

Healthy participants, Osteoarthritis pain

Outcome Measures

Primary Outcomes (1)

• The primary endpoint in the study is the incidence and severity of treatment emergent adverse events (TEAEs) in participants treated with FB1003 or placebo.

  The percentages of subjects experiencing AEs will be calculated.

  Baseline to end of study, SAD up to 56 days and MAD up to 84 days.

Secondary Outcomes (4)

• FB1003 serum concentrations over time

  Baseline to end of study, SAD up to 56 days and MAD up to 84 days.

• PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC0-∞) of FB1003

  Baseline to end of study, SAD up to 56 days and MAD up to 84 days.

• Presence of anti-FB1003 antibodies over time

  Baseline to end of study, SAD up to 56 days and MAD up to 84 days)

• To assess the effect of FB1003 on overall changes of disease activity following SC administration in subjects with OA pain (Part 2).

  12 weeks.

Study Arms (8)

SAD Cohort 1

EXPERIMENTAL

Participants in this cohort will receive SAD dose 1 of FB1003 or Placebo.

Drug: FB1003; Drug: Placebo

SAD Cohort 2

EXPERIMENTAL

Participants in this cohort will receive SAD dose 2 of FB1003 or Placebo.

Drug: FB1003; Drug: Placebo

SAD Cohort 3

EXPERIMENTAL

Participants in this cohort will receive SAD dose 3 of FB1003 or Placebo.

Drug: FB1003; Drug: Placebo

SAD Cohort 4

EXPERIMENTAL

Participants in this cohort will receive SAD dose 4 of FB1003 or Placebo.

Drug: FB1003; Drug: Placebo

SAD Cohort 5

EXPERIMENTAL

Participants in this cohort will receive SAD dose 5 of FB1003 or Placebo.

Drug: FB1003; Drug: Placebo

OA pain Cohort1

EXPERIMENTAL

Participants in this cohort will receive OA pain dose 1 of FB1003 or Placebo.

Drug: FB1003; Drug: Placebo

OA pain Cohort 2

EXPERIMENTAL

Participants in this cohort will receive OA pain dose 2 of FB1003 or Placebo.

Drug: FB1003; Drug: Placebo

OA pain Cohort 3

EXPERIMENTAL

Participants in this cohort will receive OA pain dose 3 of FB1003 or Placebo.

Drug: FB1003; Drug: Placebo

Interventions

FB1003 DRUG

Subcutaneous (SC) injection

OA pain Cohort 2; OA pain Cohort 3; OA pain Cohort1; SAD Cohort 1; SAD Cohort 2; SAD Cohort 3; SAD Cohort 4; SAD Cohort 5

Placebo DRUG

Subcutaneous (SC) injection

OA pain Cohort 2; OA pain Cohort 3; OA pain Cohort1; SAD Cohort 1; SAD Cohort 2; SAD Cohort 3; SAD Cohort 4; SAD Cohort 5

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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)
• 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.

You may not qualify if:

• Medical conditions for Part 1 only:
• 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.
• History of joint-related events such as, but not limited to, total joint replacement surgery, patella dislocation, hip dislocation, knee dislocation, or joint infections.
• Trauma to any joint in the 30 days prior to the screening visit.
• Medical conditions for Part 2 only:
• Clinically significant hematological findings at screening.
• 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.
• A history of non-febrile seizures.
• History of inflammatory arthritis other than OA, in the judgment of the investigator would make the subject inappropriate for entry into this study.
• History of osteonecrosis / osteoporotic fracture (including minimally traumatic or atraumatic fracture).
• History of significant trauma (including sports injury) or surgery to a knee, hip or shoulder within last year.
• Fibromyalgia, regional pain caused by lumbar / cervical compression with radiculopathy, or other moderate/severe pain that may confound assessment of knee pain.
• A hospital admission or major surgery within 60 days prior to screening.
• Planned surgery to a knee, hip, or shoulder during the study.
• Active or history of serious mental illness or psychiatric disorder, including but not limited to schizophrenia, bipolar disorder, or major depressive disorder, which require current medical intervention.

Sponsors & Collaborators

• 4B Technologies Limited: lead

Study Sites (2)

Nucleus Network

Brisbane, Queensland, 4006, Australia

COMPLETED

Veritus Research

Bayswater, Victoria, 3153, Australia

RECRUITING

Central Study Contacts

Chief Medical Officer, M.D.

CONTACT

+86 10 53650709; ping.p.liu@4btechnologies.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: April 3, 2024
• Study Start: April 7, 2024
• Primary Completion: February 28, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)