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

Study Purpose

It is a randomized, double-blinded, single-dose, 2-arm parallel, comparative study to evaluate the pharmacokinetics and safety of BAT2506 Injection vs.#46;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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 50 Years
Gender Male
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04152759
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Bio-Thera Solutions
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Psoriatic Arthritis
Arms & Interventions

Arms

Experimental: BAT2506 injection

50mg ；subcutaneous injection

Active Comparator: Sinponi(EU-licensed)

50mg ；subcutaneous injection

Interventions

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

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

Contact a Trial Team

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International Sites

Changchun, Jilin, China

Status

Recruiting

Address

The First Bethune Hospital of Jilin University

Changchun, Jilin,

Site Contact

cailing Gu

clgu@bio-thera.com

86-020-22233606-201

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