Healthy Male Subjects
Conditions
Brief summary
to Compare the Pharmacokinetics and Safety of BAT3306 versus KEYTRUDA® Administered in Healthy Male Subjects
Detailed description
A Randomized, Double-blind, Single-dose, Three-arm Parallel Group, Phase I Study to Compare the Pharmacokinetics and Safety of BAT3306 versus KEYTRUDA® Administered in Healthy Male Subjects
Interventions
100mg/4ml;single dose;intravenous injection
DRUGPembrolizumab injection
100mg/4ml;single dose;intravenous injection
Sponsors
Bio-Thera Solutions
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
The subjects must sign the informed consent before they can start the screening procedure and entering the clinical study. They can only be included if they meet all the following criteria: 1. Adult males aged 18 to 55 years inclusive and with 18.0 to 28.0 kg/m2 body mass index (BMI) and body weight should between 50 to 85 kg（all contain boundary values）; 2. Subject is able to understand and to comply with protocol requirements, instructions, and restrictions, voluntarily agrees to participate in this study and has given a written informed consent prior to performing any of the screening procedures; 3. Physical examination, vital signs, 12-lead ECG, laboratory tests and other examination results of the subjects are normal or abnormal but with no clinical significance; 4. Non-smokers or smokers of less than 5 cigarettes per day for less than 10 years; 5. Agree to take effective contraception measures (including but not limited to: hormonal contraception, or physical contraception, or abstinence) and no sperm donation plan from the time of signing the informed consent form until 6 months after injection of study drug; 6. Must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other relevant procedures specified in this study.
Exclusion criteria
Subjects meeting any of the following shall not be included: 1. Have a history of and/or current clinically significant gastrointestinal (including but not limited to diverticulitis, stomach ulcers), renal, hepatic, cardiovascular, haematological， pulmonary, neurologic, metabolic (including but not limited to known diabetes mellitus), psychiatric or allergic disease excluding mild asymptomatic seasonal allergies, and other diseases that the investigator considers unsuitable for participation in this clinical study; 2. Subject with a psychiatric disorder or considered unsuitable for inclusion by the investigator (e.g., inability to understand and/or comply with study requirements or presence of any condition which, in the opinion of the investigator, would not allow safe participation in the study); 3. Previous or current clinically significant allergic disease(excluding mild asymptomatic seasonal allergy); or it is known or suspected that the subject may have allergic or hypersensitive reactions to any component of the study drug; or it is known or suspected that the subject may have allergic or hypersensitive reactions to hamster ovary cell products or other recombinant human or humanized antibodies; 4. Have a history of autoimmune disease and presence of thyroid function disorders or related history (e.g., hyperthyroidism, hypothyroidism, and other thyroid disorders); 5. Propensity for bleeding or thrombosis, or a history of non-traumatic bleeding with appropriate clinical treatment, or a history of thrombosis, or the presence of any disease that may put the subject at increased risk of bleeding or thrombosis(such as abnormal coagulation, thrombocytopenia, or INR \> 1.5); 6. History of any malignancy; 7. Abnormal ECG with clinical significance (as judged by the investigator) or QT interval \> 450 ms after Bazett correction (Bazett formula: Q-Tc = QT/(R-R)\^0.5, where R-R denotes the interval between two R waves in s); 8. History of hypertension or systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg at screening or baseline; 9. Have clinically significant chronic or acute infections at the time of screening/ enrollment; or Hepatitis B surface antigen (HBsAg) positive, or HCV, or HIV, or syphilis specific antibody test results show positive during the screening period; 10. Any prior exposure to Pembrolizumab or anti-PD-1 / L1 antibody (including monoclonal antibody, bispecific antibody and relevant target drugs); 11. Use of any biologic product within 3 months or any monoclonal antibody within 9 months prior to the study drug administration; 12. Use of prescription or over-the-counter medication within 14 days prior to study drug administration, or last dose is less than 5 half-lives from the date of administration of this study (whichever is longer); 13. Have used any herbal medicine or proprietary Chinese medicine within 14 days prior to study drug administration,; 14. Participated in another drug clinical trial within 3 months prior to study drug administration,, or intend to participate in another drug clinical trial during this study; 15. Live / attenuated or mRNA vaccine received within 4 weeks prior to study drug administration or planned to vaccination during the study; 16. Have had a major injury or previous surgical procedure or fracture within 4 weeks prior to study drug administration, or intend to have surgery during the study period; 17. Have donated blood or had a blood sample \> 400ml taken as a subject within 3 months prior to screening, or plan to donate blood during the study period; 18. History of alcohol dependence or a positive screening/baseline alcohol test result; 19. Consumption of alcoholic beverages within 48h prior to study drug administration; 20. History of substance abuse, or positive drug abuse test results during the screening period; 21. Inability to comply with the study's restrictions on smoking, alcohol consumption, and concomitant medications during the study. 22\. Can not stop high intensity physical exercise from the day of study drug administration till 30 days thereafter.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vd | Day1, Day2,Day3,Day4,Day8,Day22,Day29,Day36,Day43,Day51,Day71,Day85,Day99.Day113 | Number of participants to Single dose PK characteristics evaluation |
| CL | Day1, Day2,Day3,Day4,Day8,Day22,Day29,Day36,Day43,Day51,Day71,Day85,Day99.Day113 | Number of participants to single dose PK characteristics |
| Cmax | Day1, Day2,Day3,Day4,Day8,Day22,Day29,Day36,Day43,Day51,Day71,Day85,Day99.Day113 | Number of participants to Peak plasma concentration evaluation |
| AUC0-∞ | Day1, Day2,Day3,Day4,Day8,Day22,Day29,Day36,Day43,Day51,Day71,Day85,Day99.Day113 | Number of participants to area under the drug concentration-time curve evaluation |
| (AUC0-t) | Day1, Day2,Day3,Day4,Day8,Day22,Day29,Day36,Day43,Day51,Day71,Day85,Day99.Day113 | Number of participants to data point evaluation |
| Tmax | Day1, Day2,Day3,Day4,Day8,Day22,Day29,Day36,Day43,Day51,Day71,Day85,Day99.Day113 | Number of participants to single dose PK characteristics evaluation |
| t1/2 | Day1, Day2,Day3,Day4,Day8,Day22,Day29,Day36,Day43,Day51,Day71,Day85,Day99.Day113 | Number of participants to PK characteristics evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vital signs | Day1,Day2,Day3,Day4,Day5,Day8,Day15,Day22,Day29,Day36,Day43,Day57,Day71,Day85,Day99,Day113,End of study | Number of participants with abnormal vital signs |
| ECG parameters | Day1,Day2,Day5,Day15,Day43,Day113,End of study | Number of participants with abnormal ECG readings |
| Laboratory tests | Day1,Day2,Day5,Day15,Day22,Day29,Day43,Day71,Day85,Day113,End of study | Number of participants with abnormal laboratory test results |
| AEs, adverse events | Day1,Day2,Day3,Day4,Day5,Day8,Day15,Day22,Day29,Day36,Day43,Day57,Day71,Day85,Day99,Day113,End of study | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |
| Injection site reactions | Day1,Day2, Day3,Day 4, Day5, Day15; | Number of participants with injection site reactions |
| ADA antibody | Day1, Day 15, Day57, Day85, and Day113 | Number of participants to immunogenicity evaluation. |
| Nab positive | Day1, Day 15, Day57, Day85,Day113 | Number of participants to Immunogenicity evaluation when the ADA is positive. |
Countries
China
Outcome results
None listed