Bioequivalence study of FKB327 and adalimumab in healthy adult male subjects

JRCT ID: jRCT2071200058

Registered date:25/11/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Rheumatoid arthritis
• Date of first enrollment: 21/12/2015
• Target sample size: 130
• Study type: Interventional

Intervention(s)

Experimental: FKB327 (Adalimumab biosimilar)
Intervention Description: Single-dose 40 mg of FKB327 administered subcutaneously injection on day 1.
Drug: FKB327 provided as a prefilled syringe contain 40 mg / 0.8 mL of drug

Active Comparator: US licenced Adalimumab
Single-dose 40 mg administered of US licenced Adalimumab subcutaneously injection on day 1.
Drug: US licenced Adalimumab provided as a prefilled syringe contain 40 mg / 0.8 mL of drug

Outcome(s)

• Primary Outcome: Pharmacokinetics parameters for bioequivalence: Cmax, AUC0-360, AUC0-t

Secondary Outcome

Secondary pharmacokinetics parameters: AUC0-infinity, Tmax, T1/2
Safety evaluation: Adverse event, Laboratory tests, 12-lead electrocardiogram (ECG), anti-drug antibody (ADA), Local tolerability (injection site reaction, Visual Analogue Scale (VAS) for pain at the injection site)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 45age old
• Gender: Male

Include criteria

Japanese healthy male subjects
aged 20 to 44 years, with body mass index (BMI) of >= 18.5 and < 25.0 kg/m2.

Exclude criteria

1. History or presence of illness (including drug or alcohol dependence, drug allergy, allergic disease (including severe natural rubber-latex allergy), respiratory disease, endocrine, renal, or hepatic disease, diabetes mellitus, or cardiac disease)
2. A history of cancer.
3. History or presence of psychiatric disease.
4. Evidence of any significant bacterial, viral, fungal, or parasitic infection within 28 days before dosing.
5. Positive for any one of infectious disease testing (Hepatitis B surface (HBs), anti-HBc antibody, Hepatitis C virus (HCV), Human immunodeficiency virus (HIV) antigen-antibody), and tuberculosis.
6. Positive for any one of drugs of abuse test.
7. History of hepatitis B.
8. Participated in another clinical study or any other type of medical research within 4 months before dosing.
9. Previous treatment with adalimumab.
10. Receipt of a live vaccine (e.g., BCG, polio, measles, rubella) within the 3 months before dosing.
11. History of ADAs to any drug.

Related Information

• Primary Sponsor: Yonemura Takuma