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This is a randomized, Phase I, open-label, single-dose study to evaluate the PK, safety, and tolerability of anifrolumab administered to male and female healthy Chinese participants aged 18 to 55 years. Approximately 24 participants, who fulfill the eligibility criteria, will be administered anifrolumab via SC route or IV route, and participants will be randomized to the two arms in a 1:1 ratio.
The purpose of this study is to evaluate the PK, safety, and tolerability of a single dose of anifrolumab subcutaneously or intravenously administered to healthy Chinese participants aged 18 to 55 years. The primary study endpoints are PK standard endpoints. The secondary study endpoints are standard endpoints for safety assessment, including adverse events, serious adverse events, and clinical safety laboratory measurements. The participants must abstain from taking prescription or non-prescription drugs (including vitamins and dietary or herbal supplements) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) before the start of study intervention until completion of the follow-up visit, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subcutaneous | Experimental |
| |
| Intravenous | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anifrolumab | Drug | Participants will receive a single SC or IV dose of anifrolumab at day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| SC and IV Arm: Area under the serum concentration-time curve from the pre-dose concentration extrapolated to infinity (AUCinf) | The concentration of anifrolumab in serum will be determined (AUCinf will be derived). | At predefined intervals throughout the study period (From Day 1 to Day 57) |
| SC and IV Arm: Maximum observed serum (peak) concentration (Cmax) | The concentration of anifrolumab in serum will be determined (Cmax will be derived). | At predefined intervals throughout the study period (From Day 1 to Day 57) |
| SC and IV Arm: Time to reach peak or maximum observed concentration (tmax) | The concentration of anifrolumab in serum will be determined (tmax will be derived). | At predefined intervals throughout the study period (From Day 1 to Day 57) |
| SC and IV Arm: Area under the serum concentration-time curve from pre-dose concentration to time of last quantifiable concentration (AUClast) | The concentration of anifrolumab in serum will be determined (AUClast will be derived). | At predefined intervals throughout the study period (From Day 1 to Day 57) |
| SC and IV Arm: half-life associated with the terminal slope of a semi-logarithmic concentration-time curve (t½λz) | The concentration of anifrolumab in serum will be determined (t½λz will be derived). | At predefined intervals throughout the study period (From Day 1 to Day 57) |
| Bioavailability (F) | The concentration of anifrolumab in serum will be determined (F will be derived). |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event | Assessments related to AEs cover
| From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Wuhan | 430022 | China |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.
Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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| ID | Term |
|---|---|
| C582345 | anifrolumab |
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| At predefined intervals throughout the study period (From Day 1 to Day 57) |
| SC Arm: Apparent total body clearance of drug after extravascular administration (CL/F) | The concentration of anifrolumab in serum will be determined (CL/F will be derived). | At predefined intervals throughout the study period (From Day 1 to Day 57) |
| SC Arm:Volume of distribution during the terminal phase after extravascular administration (Vz/F) | The concentration of anifrolumab in serum will be determined (Vz/F will be derived). | At predefined intervals throughout the study period (From Day 1 to Day 57) |
| IV Arm: volume of distribution during the terminal phase after intravenous administration (Vz) | The concentration of anifrolumab in serum will be determined (Vz will be derived). | At predefined intervals throughout the study period (From Day 1 to Day 57) |
| IV Arm: Apparent total body clearance of drug after intravenous administration (CL) | The concentration of anifrolumab in serum will be determined (CL will be derived). | At predefined intervals throughout the study period (From Day 1 to Day 57) |
| Vital Signs of blood pressure |
| From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks) |
| 12-lead ECG measurements include heart rate, RR interval, PR interval, QRS duration, and QT interval | Assessments related to ECG cover:
| From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks) |
| Safety haematology laboratory parameters: WBC, Neutrophils absolute count, RBC, Lymphocytes absolute count, Hb, Monocytes absolute count, HCT, Eosinophils absolute count, MCV, Basophils absolute count, MCH, Platelets, MCHC, Reticulocytes absolute count | Assessments related to clinical laboratory safety
| From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks) |
| Physical examination of height | Any new or aggravated clinically relevant abnormal medical finding at a physical examination as compared with the baseline assessment will be reported as an AE unless unequivocally related to the disease under study. | From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks) |
| Vital Signs of pulse rate |
| From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks) |
| Vital Signs of body temperature |
| From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks) |
| Vital Signs of respiratory rate |
| From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks) |
| Safety clinical chemistry laboratory parameters: Sodium, CRP, Potassium, ALP, Urea, ALT, Creatinine, AST, Albumin, GGT, Calcium, TBL, Phosphate, Conjugated bilirubin, Glucose, Creatine kinase | Assessments related to clinical laboratory safety
| From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks) |
| Safety urinalysis laboratory parameters: Glucose Protein, Blood, Microscopy (if positive for protein or blood) | Assessments related to clinical laboratory safety
| From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks) |
| Physical examination of weight | Any new or aggravated clinically relevant abnormal medical finding at a physical examination as compared with the baseline assessment will be reported as an AE unless unequivocally related to the disease under study. | From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks) |
| Physical examination of general appearance, the lungs, cardiovascular system, and the abdomen | Any new or aggravated clinically relevant abnormal medical finding at a physical examination as compared with the baseline assessment will be reported as an AE unless unequivocally related to the disease under study. | From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks) |