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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03890302
• Date of registration: 25/03/2019
• Prospective Registration: No
• Primary sponsor: Fountain Biopharma Inc.
• Public title: Evaluate the Safety, Tolerability, Pharmacokinetics,and Clinical Activity of FB704A
• Scientific 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
• Date of first enrolment: March 14, 2019
• Target sample size: 31
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03890302
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Martin Kankam, MD
• Affiliation: Altasciences Clinical Kansas, Inc.

Key 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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: FB704A

Drug: Placebo

Primary Outcome(s)

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 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]

Number of participants with clinical laboratory abnormalities (Part 1) [Time Frame: Up to Day 99]

Number of participants with physical examination abnormalities (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 physical examination abnormalities (Part 1) [Time Frame: Up to Day 57]

Secondary ID(s)

FB704ACLIS-01-RA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Oneness Biotech Co., Ltd.