CClinicalTrials.gg
CompletedNCT03890302Updated Jul 21, 2020

Evaluate the Safety, Tolerability, Pharmacokinetics,and Clinical Activity of FB704A

A Phase 1 interventional study of FB704A and Placebo in Rheumatoid Arthritis, sponsored by Fountain Biopharma Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-21.

Sponsored by Fountain Biopharma Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was May 2020, 6 years 4 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Rheumatoid Arthritis
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 318 are open to participants now.

This study's enrollment of 31 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Fountain Biopharma Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    Cohort A

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

    Drug: FB704A · Drug: Placebo

  • Experimental
    Cohort B

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

    Drug: FB704A · Drug: Placebo

  • Experimental
    Cohort C

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

    Drug: FB704A · Drug: Placebo

  • Experimental
    Cohort D

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

    Drug: FB704A · Drug: Placebo

  • 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).

    Drug: FB704A · Drug: Placebo

Interventions

  • DrugFB704A

    Administered by IV infusion

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. Incidence of Adverse Events (AEs) (Part 1)

    Time frame: Up to Day 57

  2. Incidence of Adverse Events (AEs) (Part 2)

    Time frame: Up to Day 99

  3. Number of participants with clinical laboratory abnormalities (Part 1)

    Time frame: Up to Day 57

  4. Number of participants with clinical laboratory abnormalities (Part 1)

    Time frame: Up to Day 99

  5. Number of participants with physical examination abnormalities (Part 1)

    Time frame: Up to Day 57

  6. Number of participants with physical examination abnormalities (Part 2)

    Time frame: Up to Day 99

  7. Number of participants with dose limiting toxicities (DLT) (Part 1)

    Time frame: Up to Day 57

  8. Number of participants with dose limiting toxicities (DLT) (Part 2)

    Time frame: Up to Day 99

07

Study locations

1 site
  • Altasciences Clinical Kansas, Inc.
    Overland Park, Kansas 66212, United States
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03890302
Lead sponsor
Fountain Biopharma Inc.
Collaborators
Oneness Biotech Co., Ltd.
Responsible party
Sponsor
First posted
Mar 26, 2019
Start date
Mar 14, 2019
Primary completion
May 27, 2020
Completion
May 27, 2020
Last update
Jul 21, 2020

Study contacts

Martin Kankam, MD
principal investigator · Altasciences Clinical Kansas, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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