A Placebo-controlled Study to Evaluate the Safety, Movement Through, and Reaction of the Body to Single and Multiple Increasing Doses of FB704A

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years - 55 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.
  • - 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).

Exclusion Criteria:

  • - 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.
  • - 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Fountain Biopharma Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Martin Kankam, MD
Principal Investigator Affiliation Altasciences Clinical Kansas, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis
Study Website: View Trial Website
Arms & Interventions


Experimental: Cohort A

0.5 mg/kg study drug, or placebo, administered once

Experimental: Cohort B

2 mg/kg study drug, or placebo, administered once

Experimental: Cohort C

4 mg/kg study drug, or placebo, administered once

Experimental: Cohort D

8 mg/kg study drug, or placebo, administered once

Experimental: Cohort E

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).

Experimental: Cohort F

Starting dose of 4 mg/kg or the MTD reached in Part 1 (Cohorts A-D), whichever is lower; or placebo. Administered 4 times (approximately once every 2 weeks).


Drug: - FB704A

Administered by IV infusion

Drug: - Placebo

Identical in appearance and same excipients as FB704A, but without active compound. Administered by IV infusion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Altasciences Clinical Kansas, Inc., Overland Park, Kansas




Altasciences Clinical Kansas, Inc.

Overland Park, Kansas, 66212

Site Contact

Recruitment Manager

[email protected]