Bioequivalence study of FKB327 and adalimumab in healthy adult male subjects; Multicenter study

Phase 1

• Conditions: Rheumatoid arthritis; D001172

• Registration Number: JPRN-jRCT2071200057
• Lead Sponsor: Yazawa Rie

Brief Summary

The primary PK similarity analysis showed that, in the primary PK parameters (Cmax and AUC0-t) and secondary PK parameters (AUC0-infinity, AUC0-360h, and t1/2), the 90% CIs of the geometric LS mean ratios were fully contained within the pre-defined PK similarity range of 0.80 to 1.25. There was no difference in safety profile and immunogenicity between the treatment groups. The study demonstrated PK similarity and confirmed comparable safety profiles between FKB327 and Humira.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-11-06
• 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-t

Secondary Outcome Measures

Name	Time	Method
Secondary pharmacokinetics parameters: AUC0-infinity, Tmax, T1/2<br>Safety: Adverse events, Laboratory tests, Vital signs, 12-lead ECG, Anti-drug antibody, Local tolerability, Injection site reaction