Healthy VolunteersPhase 1NCT06343714
A Study of FB1003 in Healthy and Osteoarthritis Pain Subjects
A Phase 1 study testing FB1003 in people with Healthy Volunteers, run by 4B Technologies Limited at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- FB1003
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 2 sitesAustralia
- Study dates
- 7 Apr 2024to 30 May 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Subject has abnormal screening or Check-in (D-1) laboratory values that suggest a clinically significant underlying disease or subject has the following lab abnormalities: alanine transferase (ALT) and/or aspartate transaminase (AST) >1.5 upper limit of normal (ULN).
- History of autonomic neuropathy, or diabetic neuropathy, or evidence of autonomic neuropathy, or presence of clinically relevant peripheral neuropathy.
- Resting heart rate of <50 or >100 beats per minute (not on ECG).
- History or evidence at screening of heart block.
- History of myocardial infarction, acute coronary syndromes, or cerebrovascular accident within 12 months prior to the screening visit.
- Human immunodeficiency virus (HIV), hepatitis B, or hepatitis C positive by serological testing at the screening visit.
- History or presence of malignancy within 5 years prior to screening, except subjects who have been treated successfully with no recurrence of basal or squamous cell carcinoma of the skin (<1 year), in situ cervical cancer, or in situ ductal breast cancer.
- Women of reproductive potential who have a positive serum pregnancy test result at the screening visit, or a positive urine pregnancy test result at the baseline visit (D-1), or who do not have their pregnancy test results on D-1.
- Subject has donated or lost 400 mL or more of his or her blood volume (including plasmapheresis) or had a transfusion of any blood product within 30 days prior to first dose of study intervention.
- Clinically significant illness within seven days before the first dose of the study intervention.
- History of multiple drug allergies or history of allergic reaction to the monoclonal antibody.
- History of severe intolerance to SC injection (minor reactions are permitted, e.g., localized swelling or redness).
- Significant concomitant illness or any medical or surgical condition, such as, but not limited to, cardiac, renal, neurological, endocrinological, gastrointestinal, hepatic, metabolic or lymphatic disease that would adversely affect the subject's participation in this study or interpretation of safety/PK data.
- Dosing with another investigational drug or therapy within 30 days or at least 5 half-lives of the investigational drug, whichever is longer.
- Systolic blood pressure (SBP) >140 mmHg and/or diastolic blood pressure (DBP) >90 mmHg after 5 minutes of resting in a seated position, unless determined by the Investigator to be not clinically relevant and well controlled with medications.
- Pregnant or breast-feeding women.
- Any conditions which would make the subject unsuitable for enrollment or could interfere with the subject's participation in or completion of the study in the opinion of the Investigator.
- Consume more than 14 (female) or 21 (male) units of alcohol per week (unit: 1 glass of wine (125 mL) = 1 measure of spirits = ½ pint of beer) within the 12 months before screening or positive screen for alcohol abuse.
- Smoking >4 cigarettes (or an equivalent amount of any other nicotine-containing product) per day within 30 days before screening.
- History or clinical evidence of drug abuse within the 12 months before screening or positive screen for drug abuse. Drug abuse is defined as compulsive, repetitive, and/or chronic use of drugs or other substances with or without problems related to their use and/or when stopping or a dose reduction will lead to withdrawal symptoms.
- Have received a live and/or non-live vaccine (including COVID) within 28 days prior to dosing or intend to receive a vaccine during the study period or at least 56 days after the last dose of IP.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites, 1 recruiting
- Recruiting
Veritus Research
Bayswater, Victoria, 3153
+61 3 8736 1750, info@veritusresearch.com
- Completed
Nucleus Network
Brisbane, Queensland, 4006
About this study
Official title: 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.
- Conditions
- Healthy Volunteers
- Being tested
- FB1003, Placebo
- Keywords
- Healthy participants, Osteoarthritis pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FB1003Drug
Subcutaneous (SC) injection
PlaceboDrug
Subcutaneous (SC) injection
| Study group | Role | What they receive |
|---|---|---|
| SAD Cohort 1 | Experimental | Participants in this cohort will receive SAD dose 1 of FB1003 or Placebo. Receives: Drug: FB1003; Drug: Placebo |
| SAD Cohort 2 | Experimental | Participants in this cohort will receive SAD dose 2 of FB1003 or Placebo. Receives: Drug: FB1003; Drug: Placebo |
| SAD Cohort 3 | Experimental | Participants in this cohort will receive SAD dose 3 of FB1003 or Placebo. Receives: Drug: FB1003; Drug: Placebo |
| SAD Cohort 4 | Experimental | Participants in this cohort will receive SAD dose 4 of FB1003 or Placebo. Receives: Drug: FB1003; Drug: Placebo |
| SAD Cohort 5 | Experimental | Participants in this cohort will receive SAD dose 5 of FB1003 or Placebo. Receives: Drug: FB1003; Drug: Placebo |
| OA pain Cohort1 | Experimental | Participants in this cohort will receive OA pain dose 1 of FB1003 or Placebo. Receives: Drug: FB1003; Drug: Placebo |
| OA pain Cohort 2 | Experimental | Participants in this cohort will receive OA pain dose 2 of FB1003 or Placebo. Receives: Drug: FB1003; Drug: Placebo |
| OA pain Cohort 3 | Experimental | Participants in this cohort will receive OA pain dose 3 of FB1003 or Placebo. Receives: Drug: FB1003; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to end of study, SAD up to 56 days and MAD up to 84 days.
Secondary outcomes (4)
FB1003 serum concentrations over time
The concentration of FB1003 will be evaluated.
Measured: 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
AUC0-∞ of FB1003 will be evaluated. The unit of measure is hour*microgram per milliliter (hr*mcg/mL).
Measured: Baseline to end of study, SAD up to 56 days and MAD up to 84 days.
Presence of anti-FB1003 antibodies over time
The percentage of subjects testing positive for ADA will be calculated.
Measured: 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).
Efficacy endpoints include:
- Changes from baseline in WOMAC pain, function and stiffness sub-scales during treatment
- Changes from baseline in NRS scale during treatment
Measured: 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start7 Apr 2024
- Primary completion28 Feb 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 4B Technologies Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343714
- Sponsor's protocol ID
- FB1003-04-101
- Status last verified
- Jun 2025
- First submitted
- 14 Mar 2024
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06343714
- Acronym / sponsor ID
- FB1003-04-101
- Conditions
- Healthy Volunteers
- Keywords
- Healthy participants, Osteoarthritis pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- 4B Technologies LimitedIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2024 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| SAD Cohort 1 | Experimental | Drug: FB1003, Drug: PlaceboParticipants in this cohort will receive SAD dose 1 of FB1003 or Placebo. |
| SAD Cohort 2 | Experimental | Drug: FB1003, Drug: PlaceboParticipants in this cohort will receive SAD dose 2 of FB1003 or Placebo. |
| SAD Cohort 3 | Experimental | Drug: FB1003, Drug: PlaceboParticipants in this cohort will receive SAD dose 3 of FB1003 or Placebo. |
| SAD Cohort 4 | Experimental | Drug: FB1003, Drug: PlaceboParticipants in this cohort will receive SAD dose 4 of FB1003 or Placebo. |
| SAD Cohort 5 | Experimental | Drug: FB1003, Drug: PlaceboParticipants in this cohort will receive SAD dose 5 of FB1003 or Placebo. |
| OA pain Cohort1 | Experimental | Drug: FB1003, Drug: PlaceboParticipants in this cohort will receive OA pain dose 1 of FB1003 or Placebo. |
| OA pain Cohort 2 | Experimental | Drug: FB1003, Drug: PlaceboParticipants in this cohort will receive OA pain dose 2 of FB1003 or Placebo. |
| OA pain Cohort 3 | Experimental | Drug: FB1003, Drug: PlaceboParticipants in this cohort will receive OA pain dose 3 of FB1003 or Placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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).
Key exclusion criteria (36 listed)
- Medical conditions for Part 1 only:
- Medical conditions for Part 2 only:
- 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.
- Subject has abnormal screening or Check-in (D-1) laboratory values that suggest a clinically significant underlying disease or subject has the following lab abnormalities: alanine transferase (ALT) and/or aspartate transaminase (AST) >1.5 upper limit of normal (ULN).
- History of autonomic neuropathy, or diabetic neuropathy, or evidence of autonomic neuropathy, or presence of clinically relevant peripheral neuropathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FB1003Subcutaneous (SC) injection | Drug | 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 |
| PlaceboSubcutaneous (SC) injection | Drug | 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 |
Primary outcome
The primary endpoint in the study is the incidence and severity of treatment emergent adverse events (TEAEs) in participants treated with FB1003 or placebo.
Time frame: Baseline to end of study, SAD up to 56 days and MAD up to 84 days.
The percentages of subjects experiencing AEs will be calculated.
4 secondary outcomes
FB1003 serum concentrations over time
Time frame: 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
Time frame: Baseline to end of study, SAD up to 56 days and MAD up to 84 days.
Presence of anti-FB1003 antibodies over time
Time frame: 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).
Time frame: 12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FB1003 in people with Healthy Volunteers, run by 4B Technologies Limited at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chief Medical Officer, M.D. (+86 10 53650709, ping.p.liu@4btechnologies.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint in the study is the incidence and severity of treatment emergent adverse events (TEAEs) in participants treated with FB1003 or placebo. (time frame: Baseline to end of study, SAD up to 56 days and MAD up to 84 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.