Pharmacokinetics, Immunogenicity, Safety and Tolerability of MEDI3506 in Health Chinese Participants

Exclusion Criteria

• 1.Any active medical or psychiatric condition or other reason which, in the opinion of the investigator, may compromise the safety of the participant in the study or interfere with evaluation of the investigational product or reduce the participant’s ability to participate in the study.
• 2.Any clinically relevant abnormal findings on physical examination of the cardiovascular system including ECG and vital signs at screening, and Day 1(pre-dose):
• a. Abnormal vital signs, after 10 minutes supine rest (confirmed by 1 controlled measurement), defined as any of the following:
• i. Fever greater than 37.5℃
• ii. SBP < 90 mmHg or ≥ 140 mmHg
• iii. DBP < 50 mmHg or ≥ 90 mmHg
• iv. Pulse < 45 or > 100 bpm
• b. Any clinically significant abnormalities in rhythm, conduction or morphology of the resting ECG, and any clinically significant abnormalities in the 12-lead ECG, as considered by the investigator that may interfere with the interpretation of QTc interval changes, including abnormal ST-T wave morphology, or left ventricular hypertrophy.
• 3. Any other clinically relevant abnormal findings on physical examination or laboratory testing including haematology, coagulation, clinical chemistry or urinalysis at screening or randomization, which in the opinion of the investigator may compromise the safety of the participant in the study or interfere with evaluation of the investigational product or reduce the participant’s ability to participate in the study. Abnormal findings include, but are not limited to:
• a. Serum alanine transaminase’ (ALT) or aspartate transaminase’ (AST) > 2.0 × upper limit of normal (ULN) or total bilirubin (TBL) > 2 × ULN (unless due to Gilbert’s disease) or evidence of chronic liver disease
• b. Total white blood cell count < 4,000 × 106/L
• c. Neutrophil count < 1,500/mm3
• d. Platelet count < 100,000/mm3
• e. Haemoglobin < 110 g/L
• 4. History or a reason to believe that a participant has a history of drug or alcohol abuse within the past 2 years prior to screening.
• 5. Positive drugs of abuse (DOA) including morphine, methamphetamine, ketamine, marijuana, methylenedioxymethamphetamin, and alcohol (unless can be explained by the participant’s medications).
• 6. Major surgery within 8 weeks prior to screening, or planned inpatient surgery or hospitalization during the study period.
• 7. Donation of blood or blood products in excess of 400 mL within 3 months prior to screening and until the end of the follow-up period [Day 113].
• 8. Participants who have a positive test for, or have been treated for hepatitis B, hepatitis C, Syphilis or HIV. Regarding the hepatitis B testing (hepatitis B surface antigen [HBsAg], hepatitis B surface antibody [anti-HBs], hepatitis B core antibody [anti-HBc]), any of the following would exclude the participant from the study:
• a. Participants positive for HBsAg.
• b. Participants positive for anti-HBc.
• Participants with a history of hepatitis B vaccination without a history of Hepatitis B are permitted.
• 9. Evidence of active or latent tuberculosis (TB):
• a. Positive diagnostic TB test during screening (defined as a positive interferon-gamma release assay [IGRA] test for TB at screening).
• b. Participants with an indeterminate IGRA should undergo repeat test and if still indeterminate may be enrolled only after treatment and subsequent negative IGRA.
• 10. Evidence of active COVID-19 infection:
• a. Positive diagnostic COVID-19 PCR result Or
• b. Subject has severe COVID-19 infection as defined by positive COVID-19 PCR result and hospitalization or radiological evidence of pneumonia in the previous 6 months.
• 11. Receiving any of the medications listed below:
• a. Any immunotherapy or immunosuppressive therapy (within 1 year prior to randomization).
• b. Chronic use of steroid medications.
• c. Investigational agents (within the last 3 months or at least 5 times the predicted half-life of the agent, whichever is greater).
• d. Marketed biologics, including omalizumab (within the last 3 months or at least 5 times the predicted half-life of the biologics, whichever is greater).
• e. Immunoglobulin or blood products (within 6 months prior or randomization).
• f. Live vaccines (until the end of the follow-up period [Day 113]).
• 12. Treatment with broad spectrum antibiotic within 4 weeks prior to randomization (Day 1).
• 13. Concurrent enrolment in another clinical study involving an investigational treatment.
• 14. Received administration of an investigational drug or participated in a device trial within 3 months and 5.5 half-lives, prior to screening (Visit 1).
• 15. History or current diagnosis of cancer, with the exception of cancer treated with apparent success with curative therapy (response duration of > 5 years).
• 16. History of an underlying condition that predisposes the participant to infections (e.g., history of splenectomy, known primary or secondary immune deficiency syndromes).
• 17. History of Inflammatory Bowel Disease or microscopic colitis.
• 18. A known history of severe reaction to any medication including biologic agents and human gamma globulin therapy.
• 19. History of allogeneic bone marrow transplant.
• 20. History of a viral, bacterial, or fungal significant infection (including unexplained diarrhea) within 4 weeks (28 days) prior to randomization (Day 1) or clinical suspicion of infection at the time of dosing.
• 21. History of herpes zoster within 3 months prior to randomization (Day 1).
• 22. Participants with recent (within 12 months) clinical history of infective hepatitis or unexplained jaundice.
• 23. Participant is a participating investigator, sub-investigator, study coordinator, or employee of the participating site, or is a first-degree relative of the aforementioned.
• 24. Inability of the patient, in the opinion of the investigator, to understand and/or comply with study medications, procedures and/or follow-up or any conditions that, in the opinion of the investigator, may render the patient unable to complete the study.