Rheumatoid ArthritisPhase 1NCT03890302
Evaluate the Safety, Tolerability, Pharmacokinetics,and Clinical Activity of FB704A
A Phase 1 study testing FB704A in people with Rheumatoid Arthritis, run by Fountain Biopharma Inc. at 1 site in United States.
Trial summary
The cause of Rheumatoid Arthritis (RA) is not fully understood. However, one of the substances secreted by certain cells in the body, interleukin-6 (IL-6), is believed to play a major role in chronic inflammation that is typical in RA. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- FB704A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2019to 27 May 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must provide written informed consent.
- No significant clinical, cardiac or physical abnormalities (Part 1 of study).
- Diagnosis of Rheumatoid Arthritis as defined by 2010 revised American College of Rheumatology (ACR) more than 3 months prior to start of study (Part 2 of study).
- If using oral corticosteroids (prednisone ≤ 10mg or equivalent) and/or NSAIDS, subjects must be on stable dose(s) for at least 14 days prior to start of Part 2 of study and dose must be expected to remain stable through end of Part 2 of study.
- Subjects must be being treated with 1 or a combination of disease modifying antirheumatic drugs (DMARDs) methotrexate, leflunomide, sulfasalazine, and/or hydroxychloroquine (but not simultaneous use of leflunomide and methotrexate), at any dose for at least 28 days prior to start of Part 2 of study and on a stable dose(s) for at least 14 days prior to start of Part 2 of study.
- Subjects with documented RA that meet all inclusion criteria but are not taking DMARDs may be permitted in Part 2 of the study at the discretion of an investigator.
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- Women of childbearing potential must agree to use one of the accepted contraceptive regimens from at least 30 days prior to first administration of the study medication, during the study, and for at least 60 days after last dose of the study medication.
- Women of non-childbearing potential should be surgically sterile or in a menopausal state (at least 1 year without menses).
- All males must agree to use highly effective contraception and to not donate sperm throughout the study and for 90 days following last dose of study medication.
- Subjects must have a body weight ≥ 50 kg at screening and a body mass index (BMI) of 19.0 to 30.0 kg/m2, inclusive (Part 2 of study).
- Subjects must have not smoked or used any nicotine products for at least 3 months before screening (Part 1 of study).
Who cannot join
- Women who are pregnant or lactating.
- Subject has a past history of, or a history of risk factors for, heart arrhythmias or long QT syndrome.
- Subject has recurrent chronic serious infection, or has had a serious infection within 60 days of start of study.
- Subject has latent or active tuberculosis.
- Subject has received any live attenuated vaccine (e.g. varicella-zoster, oral polio, rabies, flu vaccine) within 3 months of start of study.
- Subject has received any biological drug or blood product within 3 months or 5 half-lives of start of study; or has received any other study drug within 30 days or 5 half-lives of start of study.
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- Subject has previously been treated with any biologic, anti-interleukin-6 (anti-IL-6) or interleukin-6 receptor (IL-6) antagonist and/or has previous exposure to the study drug.
- Subjects with a documented history of an autoimmune disease other than rheumatoid arthritis or secondary Sjogren's syndrome.
- Other protocol-defined inclusion/exclusion criteria could apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Altasciences Clinical Kansas, Inc.
Overland Park, Kansas, 66212
About this study
Official title: A Phase 1, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Single and Multiple Ascending Doses of FB704A
The cause of Rheumatoid Arthritis (RA) is not fully understood. However, one of the substances secreted by certain cells in the body, interleukin-6 (IL-6), is believed to play a major role in chronic inflammation that is typical in RA. This study investigates the drug FB704A, which is believed to lower the inflammation caused by IL-6. This study will be in 2 sequential parts: a single increasing dose part (Part 1) and a multiple-increasing dose part (Part 2). Subjects will receive either active or placebo drug by IV infusion. Subjects in both parts will have a short stay in the clinic at the start of the study, then will return for outpatient visits.
- Conditions
- Rheumatoid Arthritis
- Being tested
- FB704A, Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FB704ADrug
Administered by IV infusion
PlaceboDrug
Identical in appearance and same excipients as FB704A, but without active compound. Administered by IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | 0.5 mg/kg study drug, or placebo, administered once Receives: Drug: FB704A; Drug: Placebo |
| Cohort B | Experimental | 2 mg/kg study drug, or placebo, administered once Receives: Drug: FB704A; Drug: Placebo |
| Cohort C | Experimental | 4 mg/kg study drug, or placebo, administered once Receives: Drug: FB704A; Drug: Placebo |
| Cohort D | Experimental | 8 mg/kg study drug, or placebo, administered once Receives: Drug: FB704A; Drug: Placebo |
| Cohort E | Experimental | Starting dose of 2 mg/kg or approximately half the maximum tolerated dose (MTD) in Part 1 (Cohorts A-D), whichever is lower, up to 4 mg/kg; or placebo. Administered 4 times (approximately once every 2 weeks). Receives: Drug: FB704A; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs) (Part 1)
Measured: Up to Day 57
Incidence of Adverse Events (AEs) (Part 2)
Measured: Up to Day 99
Number of participants with clinical laboratory abnormalities (Part 1)
Measured: Up to Day 57
Number of participants with clinical laboratory abnormalities (Part 1)
Measured: Up to Day 99
Number of participants with physical examination abnormalities (Part 1)
Measured: Up to Day 57
Number of participants with physical examination abnormalities (Part 2)
Measured: Up to Day 99
Number of participants with dose limiting toxicities (DLT) (Part 1)
Measured: Up to Day 57
Number of participants with dose limiting toxicities (DLT) (Part 2)
Measured: Up to Day 99
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start14 Mar 2019
- Primary completion27 May 2020
- Study completion27 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fountain Biopharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Oneness Biotech Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Martin Kankam, MD, Principal investigator, Altasciences Company Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890302
- Sponsor's protocol ID
- FB704ACLIS-01-RA
- Status last verified
- Jul 2020
- First submitted
- 25 Mar 2019
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Single and Multiple Ascending Doses of FB704A
- ClinicalTrials.gov ID
- NCT03890302
- Acronym / sponsor ID
- FB704ACLIS-01-RA
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Fountain Biopharma Inc.Industry (pharma, biotech, devices)
- Collaborators
- Oneness Biotech Co., Ltd.
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 27 May 2020 (actual)
- Study completion
- 27 May 2020 (actual)
- First posted
- 26 Mar 2019 (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 cause of Rheumatoid Arthritis (RA) is not fully understood. However, one of the substances secreted by certain cells in the body, interleukin-6 (IL-6), is believed to play a major role in chronic inflammation that is typical in RA. This study investigates the drug FB704A, which is believed to lower the inflammation caused by IL-6. This study will be in 2 sequential parts: a single increasing dose part (Part 1) and a multiple-increasing dose part (Part 2). Subjects will receive either active or placebo drug by IV infusion. Subjects in both parts will have a short stay in the clinic at the start of the study, then will return for outpatient visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: FB704A, Drug: Placebo0.5 mg/kg study drug, or placebo, administered once |
| Cohort B | Experimental | Drug: FB704A, Drug: Placebo2 mg/kg study drug, or placebo, administered once |
| Cohort C | Experimental | Drug: FB704A, Drug: Placebo4 mg/kg study drug, or placebo, administered once |
| Cohort D | Experimental | Drug: FB704A, Drug: Placebo8 mg/kg study drug, or placebo, administered once |
| Cohort E | Experimental | Drug: FB704A, Drug: PlaceboStarting dose of 2 mg/kg or approximately half the maximum tolerated dose (MTD) in Part 1 (Cohorts A-D), whichever is lower, up to 4 mg/kg; or placebo. Administered 4 times (approximately once every 2 weeks). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Subjects must provide written informed consent.
- No significant clinical, cardiac or physical abnormalities (Part 1 of study).
- Diagnosis of Rheumatoid Arthritis as defined by 2010 revised American College of Rheumatology (ACR) more than 3 months prior to start of study (Part 2 of study).
- If using oral corticosteroids (prednisone ≤ 10mg or equivalent) and/or NSAIDS, subjects must be on stable dose(s) for at least 14 days prior to start of Part 2 of study and dose must be expected to remain stable through end of Part 2 of study.
- Subjects must be being treated with 1 or a combination of disease modifying antirheumatic drugs (DMARDs) methotrexate, leflunomide, sulfasalazine, and/or hydroxychloroquine (but not simultaneous use of leflunomide and methotrexate), at any dose for at least 28 days prior to start of Part 2 of study and on a stable dose(s) for at least 14 days prior to start of Part 2 of study.
Key exclusion criteria (9 listed)
- Women who are pregnant or lactating.
- Subject has a past history of, or a history of risk factors for, heart arrhythmias or long QT syndrome.
- Subject has recurrent chronic serious infection, or has had a serious infection within 60 days of start of study.
- Subject has latent or active tuberculosis.
- Subject has received any live attenuated vaccine (e.g. varicella-zoster, oral polio, rabies, flu vaccine) within 3 months of start of study.
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 |
|---|---|---|
| FB704AAdministered by IV infusion | Drug | Cohort A, Cohort B, Cohort C, Cohort D, Cohort E |
| PlaceboIdentical in appearance and same excipients as FB704A, but without active compound. Administered by IV infusion | Drug | Cohort A, Cohort B, Cohort C, Cohort D, Cohort E |
Primary outcome
Incidence of Adverse Events (AEs) (Part 1)
Time frame: Up to Day 57
Incidence of Adverse Events (AEs) (Part 2)
Time frame: Up to Day 99
Number of participants with clinical laboratory abnormalities (Part 1)
Time frame: Up to Day 57
Number of participants with clinical laboratory abnormalities (Part 1)
Time frame: Up to Day 99
Number of participants with physical examination abnormalities (Part 1)
Time frame: Up to Day 57
Number of participants with physical examination abnormalities (Part 2)
Time frame: Up to Day 99
Number of participants with dose limiting toxicities (DLT) (Part 1)
Time frame: Up to Day 57
Number of participants with dose limiting toxicities (DLT) (Part 2)
Time frame: Up to Day 99
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Martin Kankam, MD principal investigator
Altasciences Company Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FB704A in people with Rheumatoid Arthritis, run by Fountain Biopharma Inc. at 1 site in United States.
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 11 inclusion and 9 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: finished, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) (Part 1) (time frame: Up to Day 57). The study lists 8 primary outcomes in all. 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 21 Jul 2020.