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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03890302
Recruitment Status : Completed
First Posted : March 26, 2019
Last Update Posted : July 21, 2020
Sponsor:
Collaborator:
Oneness Biotech Co., Ltd.
Information provided by (Responsible Party):
Fountain Biopharma Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: FB704A Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 14, 2019
Actual Primary Completion Date : May 27, 2020
Actual Study Completion Date : May 27, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis

Arm Intervention/treatment
Experimental: Cohort A
0.5 mg/kg study drug, or placebo, administered once
Drug: FB704A
Administered by IV infusion

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

Experimental: Cohort B
2 mg/kg study drug, or placebo, administered once
Drug: FB704A
Administered by IV infusion

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

Experimental: Cohort C
4 mg/kg study drug, or placebo, administered once
Drug: FB704A
Administered by IV infusion

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

Experimental: Cohort D
8 mg/kg study drug, or placebo, administered once
Drug: FB704A
Administered by IV infusion

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

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
Administered by IV infusion

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




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890302


Locations
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United States, Kansas
Altasciences Clinical Kansas, Inc.
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
Fountain Biopharma Inc.
Oneness Biotech Co., Ltd.
Investigators
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Principal Investigator: Martin Kankam, MD Altasciences Clinical Kansas, Inc.
Additional Information:
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Responsible Party: Fountain Biopharma Inc.
ClinicalTrials.gov Identifier: NCT03890302    
Other Study ID Numbers: FB704ACLIS-01-RA
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases