A Study on Pharmacokinetics and Safety of BAT2506 Injection Versus Simponi®

Study Overview
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Brief Summary
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This is a randomized, double-blind, parallel three-arm, and single-dose Phase I clinical study, designed to compare the similarity of pharmacokinetics, safety and immunogenicity between BAT2506 Injection and Simponi® (EU-licensed and US-licensed) after single subcutaneous administration in healthy Chinese male subjects.

Detailed Description
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This is a randomized, double-blind, parallel three-arm, and single-dose Phase I clinical study, designed to compare the similarity of pharmacokinetics, safety and immunogenicity between BAT2506 Injection and Simponi® (EU-licensed and US-licensed) after single subcutaneous administration in healthy Chinese male subjects. The study planes to enroll 375 healthy male subjects who will be randomly assigned to the BAT2506 Injection group, Simponi® (EU-licensed) or Simponi® (US-licensed) groups in a 1:1:1 ratio to receive a single subcutaneous injection of 50 mg BAT2506 Injection or Simponi® (EU-licensed or US-licensed).

Official Title
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A Randomized, Double-blind, Single-dose, Parallel Three-arm Comparative Study on Pharmacokinetics and Safety of BAT2506 Injection Versus the EU-licensed and US-licensed Simponi® in Healthy Chinese Male Subjects

Conditions
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Psoriatic Arthritis

Intervention / Treatment
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* Drug: BAT2506 injection
* Drug: Simponi® (EU commercially available product)
* Drug: Simponi® (US commercially available product)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1)Signed the ICF and fully understood the trial conduction, procedure and potential adverse reactions before included the trial; 2)Able to complete the study in accordance with the requirements of the protocol; 3)Subjects (including their partners) who are willing to refrain from pregnancy and will not donate sperm throughout the trial and within 6 months after the end of the study, and willing to take effective contraceptive method, see Appendix 4 for specific contraceptive methods; 4)Healthy male subjects at age of 18-55 years with a body mass index (BMI) between 18 and 28 kg/m2 (inclusive) and a body weight between 50 and 80 kg (inclusive); 5)Subjects with normal physical examination and vital signs or non-clinically significant abnormalities. Subjects with normal abdominal color Doppler ultrasound, laboratory tests and other examination results or non-clinically significant abnormalities. Exclusion Criteria: 1)Subjects who smoked more than 5 cigarettes every day within 3 months prior to the trial; 2)Subjects with a history of allergies to the study drug, or subjects with allergic constitution (allergic to a variety of drugs and foods); 3)Subjects with a history of alcohol abuse (consuming 14 or more units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine); 4)Subjects who donated blood within 3 months prior to screening or plan to donate blood during the study period; 5)Subjects who had major injuries or underwent surgery or had fractures within 4 weeks prior to enrollment, or who are scheduled to undergo surgery during the study period; 6)Subjects whose abnormalities in past medical history are clinically significant or other clinical findings suggest the following clinically significant diseases (including but not limited to gastrointestinal, renal, hepatic, neurological, blood, endocrine, neoplastic, pulmonary, immune, psychiatric or cardiovascular and cerebrovascular diseases); 7)Subjects who suffered from malignant tumors (excluding those with basal cell carcinoma which has been surgically resected); 8)Subjects with clinically significant chronic or acute infections at screening/enrollment, or with active infections, including acute and chronic infections and local infections (bacteria, viruses, parasites, fungi or other pathogens of opportunistic infectious diseases); 9)Patients having a history of tuberculosis, or having latent tuberculosis infection or clinically suspected tuberculosis (including but not limited to pulmonary tuberculosis); 10)Subjects who have contacted with tuberculosis patients or/and had symptoms and/or signs suspected of being tuberculosis within 3 months prior to screening ; 11)Subjects who have used Simponi®, any anti-tumor necrosis factor (TNF-α) biologic, or have used any biologics or monoclonal antibodies within 6 months prior to enrollment ; 12)Subjects who have used drugs (including but not limited to prescription drugs, traditional Chinese medicines, over-the-counter drugs, etc.) within 30 days prior to enrollment ; 13)Subjects who have participated in other drug clinical trials within 3 months prior to enrollment; 14)Have received live vaccine within 12 weeks prior to study administration or plan to receive live vaccine during study period; Have received inactivated vaccine (including COVID-2019 inactivated vaccine) within 2 weeks prior to administration or plan to receive inactivated vaccine during study period. 15)Subjects with a history of hypertension or systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg at screening/enrollment, which is judged to be a clinically significant abnormality; 16)Subjects with clinically significant abnormalities in ECG; 17)Positive hepatitis B surface antigen at screening [or negative hepatitis B surface antigen and meeting all three of the following: positive hepatitis B core antibody, negative hepatitis B surface antibody, and hepatitis B virus deoxyribonucleic acid (HBV DNA) levels exceed the normal quantification range]; or positive hepatitis C antibody, hepatitis C core antigen, HIV antigen/antibody, or positive syphilis spirochete antibody; 18)Subjects with clinically significant abnormalities in frontal chest radiography; 19)Those who have tested positive for enzyme-linked immunospot assay (T-SPOT. TB); 20)Subjects who have taken any alcoholic products within 24 hours prior to the use of the study drugs; 21)Those who have tested positive for drug abuse or have a history of drug abuse within past five years; 22)Ineligible subjects based on investigator's judgment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAT2506<br>BAT2506 injection, 50 mg, subcutaneous administration. Dose regimen: 50 mg/0.5 mL/syringe, subcutaneously injected at the lower abdomen, except for the 5 cm area around the navel. Do not inject into skin that is tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch mark. | Drug: BAT2506 injection<br>* 50 mg, subcutaneous administration<br>|
| Active Comparator: Simponi® (EU commercially available product)<br>50 mg, subcutaneous administration Dose regimen: 50 mg/0.5 mL/syringe, subcutaneously injected at the lower abdomen, except for the 5 cm area around the navel. Do not inject into skin that is tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch mark. | Drug: Simponi® (EU commercially available product)<br>* 50 mg, subcutaneous administration<br>|
| Active Comparator: Simponi® (US commercially available product)<br>50 mg, subcutaneous administration Dose regimen: 50 mg/0.5 mL/syringe, subcutaneously injected at the lower abdomen, except for the 5 cm area around the navel. Do not inject into skin that is tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch mark. | Drug: Simponi® (US commercially available product)<br>* 50 mg, subcutaneous administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Peak plasma concentration | on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78 | 
| AUC0-∞ | area under the drug concentration-time curve | on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (AUC0-t) | Area under the drug concentration-time curve from time 0 to the last quantifiable data point | on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78 | 
| temperature | number of participants with abnormal temperature findings | on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78 | 
| pulse | number of participants with abnormal pulse findings | on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78 | 
| blood pressure | number of participants with abnormal blood pressure findings | on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78 | 
| skin mucosa | number of participants with abnormal skin mucosa findings | on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78 | 
| lymph nodes | number of participants with abnormal lymph nodes findings | on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78 | 
| head and neck | number of participants with abnormal head and neck findings | on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78 | 
| chest | number of participants with abnormal chest findings | on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78 | 
| abdomen | number of participants with abnormal abdomen findings | on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78 | 
| spine/extremities | number of participants with abnormal spine/extremities findings | on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78 | 
| heart rate | number of participants with abnormal heart rate findings | on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78 | 
| PR Interval | number of participants with abnormal PR Interval findings | on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78 | 
| RR Interval | number of participants with abnormal RR Interval findings | on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78 | 
| QRS Interval | number of participants with abnormal QRS Interval findings | on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78 | 
| QT Interval | number of participants with abnormal QT Interval findings | on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78 | 
| QTc interval | number of participants with abnormal QTc Interval findings | on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78 | 
| hematology, | Number of participants with abnormal hematology findings | on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78 | 
| biochemistry | Number of participants with abnormal biochemistry findings | on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78 | 
| coagulation routine | Number of participants with abnormal coagulation routine findings | on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78 | 
| urinalysis | Number of participants with abnormal urinalysis findings | on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78 | 
| Injection-site reaction Injection-site reaction | Injection-site reaction Adverse events (AE), serious adverse events (SAE), etc. | on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78 | 
| Adverse events (AE) | Adverse events (AE), serious adverse events (SAE) | on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78 |