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Comparative Study to Evaluate the Pharmacokinetics of BAT2506 vs Simponi® in Healthy Subjects

Primary Purpose

Psoriatic Arthritis

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Drug: BAT2506 injection Other Names: Simponi(EU-licensed)

About this trial

This is an interventional treatment trial for Psoriatic Arthritis

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

The First Bethune Hospital of Jilin University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BAT2506 injection

Sinponi(EU-licensed)

Arm Description

50mg ；subcutaneous injection

Outcomes

Primary Outcome Measures

Pharmacokinetics Endpoint：AUC0-t

Pharmacokinetics Endpoint：Cmax

Secondary Outcome Measures

Pharmacokinetics Endpoint：AUC0-inf

Full Information

NCT ID

NCT04152759

First Posted

September 9, 2019

Last Updated

September 22, 2021

Sponsor

Bio-Thera Solutions

1. Study Identification

Unique Protocol Identification Number

NCT04152759

Brief Title

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

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

September 9, 2019 (Actual)

Primary Completion Date

December 31, 2020 (Actual)

Study Completion Date

December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bio-Thera Solutions

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriatic Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

182 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BAT2506 injection

Arm Type

Experimental

Arm Description

50mg ；subcutaneous injection

Arm Title

Sinponi(EU-licensed)

Arm Type

Active Comparator

Arm Description

50mg ；subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

Drug: BAT2506 injection Other Names: Simponi(EU-licensed)

Intervention Description

Drug: BAT2506 injection Each subject will receive single subcutaneous injection of 50 mg BAT2506 Injection or Simponi(EU-licensed). Other Names: Simponi(EU-licensed)

Primary Outcome Measure Information:

Title

Pharmacokinetics Endpoint：AUC0-t

Time Frame

0-71days

Title

Pharmacokinetics Endpoint：Cmax

Time Frame

0-71days

Secondary Outcome Measure Information:

Title

Pharmacokinetics Endpoint：AUC0-inf

Time Frame

0-71days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

The First Bethune Hospital of Jilin University

City

Changchun

State/Province

Jilin

Country

China

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Only one site study

Citations:

PubMed Identifier

33241960

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.

Results Reference

derived

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Comparative Study to Evaluate the Pharmacokinetics of BAT2506 vs Simponi® in Healthy Subjects

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