Clinical trial: Comparative Study to Evaluate the Pharmacokinetics of BAT2506 vs Simponi® in Healthy Subjects (NCT04152759)

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.
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years

Patient description (medical language): A 20-year-old man comes to the clinic for his routine checkup. The patient wears glasses for myopia and takes no medications.  Vital signs are normal.  On physical examination, the patient is tall with long upper extremities and fingers.  The face appears narrow with down-slanted palpebral fissures, flattened malar bones, and a small jaw.  The lungs are clear on auscultation.  The abdomen is soft with no organomegaly. The patient is diagnosed with Marfan syndrome, and he is cooperative with his medical appointments. He is working as driver.

Patient description (patient's own words): I'm a 20-year-old guy, working as a driver and I went to the clinic for my routine checkup. I have myopia, so I wear glasses and I don't take any other medications. My vitals were normal. I also did a physical exam, and I was told that I have long legs, arms, and fingers. They also told me that my face is quite narrow, with down-slanted eyes and a small jaw. My lungs were fine and my tummy too. I have been diagnosed with Marfan syndrome and I haven't been skipping any medical appointments since.

Does the patient match the trial criteria? Contradiction