Bioequivalence study of FKB327 and adalimumab in healthy adult male subjects

Phase 1

• Conditions: Rheumatoid arthritis; D001172

• Registration Number: JPRN-jRCT2071200058
• Lead Sponsor: Yonemura Takuma

Brief Summary

In the primary PK similarity analysis, the 90% CIs of the geometric LS mean ratios for Cmax and AUC0-360h were fully contained within the predefined PK similarity range of 0.80 to 1.25, although the upper limit of 90% CI of the geometric LS mean ratio for AUC0-t was slightly outside the pre-defined range. In the planned supplementary analysis including the ADA categorical titers as a covariate, all primary PK endopoint met equivalent range.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-06-01
• Study Start: 2020-11-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 130

Inclusion Criteria

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

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics parameters for bioequivalence: Cmax, AUC0-360, AUC0-t

Secondary Outcome Measures

Name	Time	Method
Secondary pharmacokinetics parameters: AUC0-infinity, Tmax, T1/2<br>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)