Clinical trial NCT04152759: Comparative Study to Evaluate the Pharmacokinetics of BAT2506 vs Simponi® in Healthy Subjects
Official title: A Randomized, Double-blinded, Single-dose, 2-arm Parallel, Comparative Study to Evaluate the Pharmacokinetics and Safety of BAT2506 Injection vs Simponi in Healthy Chinese Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriatic Arthritis
Lead sponsor: Bio-Thera Solutions
Sponsor class: INDUSTRY
First posted: 2019-11-05
Enrollment: 182
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is a randomized, double-blinded, single-dose, 2-arm parallel, comparative study to evaluate the pharmacokinetics and safety of BAT2506 Injection vs Simponi in healthy chinese male subjects A total of 182 subjects are planned to be included and randomized at a ratio of 1:1 to receive single subcutaneous administration of 50mg BAT2506 Injection or Simponi® (EU-licensed ).

The study has a screening period of 14 days. PK blood samples will be collected from subjects to determine the serum concentration of Golimumab, thus to evaluate the change and similarity of the pharmacokinetics of the two study drugs.

The investigator will perform safety evaluation for vital signs, physical examinations, injection site reaction, ECG, clinical laboratory tests and adverse events throughout the study. Immunogenicity evaluation (ADA, ADA titration and nAb) will also be evaluated.

Detailed description: It is a randomized, double-blinded, single-dose, 2-arm parallel, comparative study to evaluate the pharmacokinetics and safety of BAT2506 Injection vs Simponi in healthy chinese male subjects A total of 182 subjects are planned to be included and randomized at a ratio of 1:1 to receive single subcutaneous administration of 50mg BAT2506 Injection or Simponi® (EU-licensed ).

The study has a screening period of 14 days. PK blood samples will be collected from subjects to determine the serum concentration of Golimumab, thus to evaluate the change and similarity of the pharmacokinetics of the two study drugs.

The investigator will perform safety evaluation for vital signs, physical examinations, injection site reaction, ECG, clinical laboratory tests and adverse events throughout the study. Immunogenicity evaluation (ADA, ADA titration and nAb) will also be evaluated.

Eligibility criteria: Inclusion Criteria:

* Healthy male subjects aged18 and 50 years inclusive; BMI between 18 and 28 kg/m2 and body weight between 50 and 80 kg.
* Physical examinations and vital signs are normal or abnormal without clinical significance.
* Abdominal color Doppler ultrasound, laboratory tests, etc. are normal or abnormal without clinical significance.

Exclusion Criteria:

* Any current or history of severe allergic reaction to foods or drugs and History of allergy to study products.
* Having severe injuries or surgery or fractures within 4 weeks before enrollment,or to receive surgery during the study.
* Having clinically significantclinical history abnormalities or other clinically indicated diseases (including but not limited to gastrointestinal, renal, liver, neurological, hematological, endocrine, tumor, lung, immune, mental or cardiovascular diseases).
* Having malignant tumor (excluding basal cell carcinoma who has undergone resection).
* Having clinically significant chronic or acute infections at screening/incorporation; or active infections,Includes acute and chronic infections as well as local infections (bacteria, viruses, parasites, fungi or other opportunities) Sexually infected pathogen).
* Having a history of tuberculosis or latent tuberculosis or clinical manifestations suspected of being tuberculosis(including But not limited to tuberculosis).
* Having been exposed to tuberculosis or/and suspected tuberculosis symptoms and/or signs within 3 months before screening.
* Having used simponi,or any anti-tumor necrosis factor (TNF-α) biologic preparation or any biological products within 6 months before enrollment or monoclonal antibodies within a month.
* Having used drugs within 30 days before enrollment (including but not limited to prescription drugs, Chinese medicine, non-prescription drugs).
* Having vaccinated active / attenuated vaccine within 12 weeks before screening or planned to vaccinate active /attenuated vaccine the during the study.
* Having a history of hypertension or systolic blood pressure ≥ 140 mmHg, or diastolic blood pressure ≥ at screening/inclusion90 mmHg, and it is judged abnormalities with clinical significance.
* Electrocardiogram (ECG) examination abnormalities with clinical significance;
* Having positive detection of golimumab anti-drug antibody (ADA) during screening.
* Chest orthotopic examination abnormalities with clinical significance.
* Tuberculosis enzyme-linked immunospot assay (T-SPOT. TB) positive test,
* Having any alcoholic products within 24 hours prior to the use of the study drug.
* A drug abuse test positive or a history of drug abuse over the past five years.

Primary outcomes:
measure: Pharmacokinetics Endpoint：AUC0-t
timeFrame: 0-71days
measure: Pharmacokinetics Endpoint：Cmax
timeFrame: 0-71days
Secondary outcomes:
measure: Pharmacokinetics Endpoint：AUC0-inf
timeFrame: 0-71days
Other outcomes:
Locations:
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
state: Jilin
Study officials:
References:
citation: Wu M, Sun J, Wu D, Xu J, Wei J, Wang Z, Yu J, Li S, Zhang H, Ding Y. A Phase I, Randomized, Double-Blind, Single-Dose, Parallel-Group Study to compare Pharmacokinetic Similarity, Safety, and Immunogenicity Between BAT2506 and Golimumab in Healthy Chinese Male Subjects. Expert Opin Investig Drugs. 2021 Jan;30(1):77-83. doi: 10.1080/13543784.2021.1851364. Epub 2020 Nov 26.