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To evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AZD7442 in Healthy Chinese Adults. vs. placebo
A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD7442 in healthy Chinese participants 18 to 55 years of age, approximately 60 participants will be randomised in a 4:1 ratio to either AZD7442 or placebo, administered by intramuscular (IM) injection or intravenous (IV) infusion, and approximately 479 days in duration for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 300 mg AZD7442 IM | Experimental | Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection. |
|
| 300mg placebo IM | Placebo Comparator | Administration of placebo with dose match to AZD7442 in the same cohort sequentially by intramuscular (IM) injection. |
|
| 600 mg AZD7442 IM | Experimental | Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection. |
|
| 600mg placebo IM | Placebo Comparator | Administration of placebo with dose match to AZD7442 in the same cohort sequentially by intramuscular (IM) injection. |
|
| 300 mg AZD7442 IV | Experimental | co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion. |
|
| 300mg placebo IV |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD7442 IM | Drug | In cohort 1, participants will be randomized to receive 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) administered sequentially as direct gluteal IM injections. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | To evaluate the safety and tolerability of AZD7442 administered IM or IV to healthy Chinese participants 18 to 55 years of age. | From day 1 to approximately 15 months after administration (through Day 451). |
| Incidence of serious adverse events (SAEs) | To evaluate the safety and tolerability of AZD7442 administered IM or IV to healthy Chinese participants 18 to 55 years of age. | From day 1 to approximately 15 months after administration (through Day 451). |
| Incidence of adverse event of special interests (AESIs) | To evaluate the safety and tolerability of AZD7442 administered IM or IV to healthy Chinese participants 18 to 55 years of age. | From day 1 to approximately 15 months after administration (through Day 451). |
| Number of participants with abnormal laboratory test results | Measurement of white blood cell (WBC) count, red blood cell (RBC) count. | From day 1 to approximately 15 months after administration (through Day 451). |
| Number of participants with abnormal laboratory test results | Measurement of sodium, potassium, urea/blood urea nitrogen (BUN), calcium, phosphate, glucose, c-reactive protein (CRP). | From day 1 to approximately 15 months after administration (through Day 451). |
| Number of participants with abnormal Coagulation test results | Measurement of prothrombin time, activated partial thrombin time (aPTT). | From day 1 to approximately 15 months after administration (through Day 451). |
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Inclusion Criteria:
Exclusion Criteria:
Medical condition:
Laboratory related:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Guangzhou | 510515 | China | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40799036 | Derived | Li N, Zhang J, Zhang W, Xu Z, Yao X, He A, Liu S, Ge X, Liu J, Li Y, Chen CC, Zhang H. Safety, Tolerability, and Pharmacokinetics of the Long-Acting SARS-CoV-2-Neutralizing Monoclonal Antibody Combination AZD7442 (Tixagevimab/Cilgavimab) in Healthy Chinese Adults. Clin Pharmacol Drug Dev. 2025 Nov;14(11):836-845. doi: 10.1002/cpdd.1583. Epub 2025 Aug 13. |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma 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 de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000714168 | cilgavimab and tixagevimab drug combination |
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| Placebo Comparator |
co-administration of a single dose of placebo in equivalent volume by intravenous (IV) infusion. |
|
| 600 mg AZD7442 IV | Experimental | co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion. |
|
| 600mg placebo IV | Placebo Comparator | co-administration of a single dose of placebo in equivalent volume by intravenous (IV) infusion. |
|
|
| Placebo IM | Drug | In cohort 1, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort administered sequentially as direct gluteal IM injections. |
|
|
| AZD7442 IM | Drug | In cohort 2, participants will be randomized to receive 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) administered sequentially as direct gluteal IM injections. |
|
|
| Placebo IM | Drug | In cohort 2, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort administered sequentially as direct gluteal IM injections. |
|
|
| AZD7442 IV | Drug | In cohort 3, participants will be randomized to receive 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) mixed in IV bag co-administered as a single IV infusion. |
|
|
| Placebo IV | Drug | In cohort 3, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort as a single IV infusion. |
|
|
| AZD7442 IV | Drug | In cohort 4, participants will be randomized to receive 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) mixed in IV bag co-administered as a single IV infusion. |
|
|
| Placebo IV | Drug | In cohort 4, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort as a single IV infusion. |
|
|
| Number of participants with abnormal urinalysis | Measurement of glucose, protein, and blood. | From day 1 to approximately 15 months after administration (through Day 451). |
| Number of participants with abnormal ECG readings | Results for PR interval, QRS duration, QT interval, QTcF interval, and RR interval will be analyzed. | From day 1 to approximately 15 months after administration (through Day 451). |
| Number of participants with abnormal vital signs | Measurement of systolic blood pressure (mm Hg), diastolic blood pressure (mm Hg). | From day 1 to approximately 15 months after administration (through Day 451). |
| Number of participants with abnormal laboratory test results | Measurement of neutrophils absolute count, lymphocytes absolute count, monocytes absolute count, eosinophils absolute count, Platelets, Reticulocytes absolute count. | From day 1 to approximately 15 months after administration (through Day 451). |
| Number of participants with abnormal laboratory test results | Measurement of haemoglobin (Hb). | From day 1 to approximately 15 months after administration (through Day 451). |
| Number of participants with abnormal laboratory test results | Measurement of haematocrit (HCT). | From day 1 to approximately 15 months after administration (through Day 451). |
| Number of participants with abnormal laboratory test results | Measurement of mean corpuscular volume (MCV). | From day 1 to approximately 15 months after administration (through Day 451). |
| Number of participants with abnormal laboratory test results | Measurement of mean corpuscular haemoglobin (MCH). | From day 1 to approximately 15 months after administration (through Day 451). |
| Number of participants with abnormal laboratory test results | Measurement of alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transpeptidase (GGT), creatine kinase. | From day 1 to approximately 15 months after administration (through Day 451). |
| Number of participants with abnormal laboratory test results | Measurement of creatinine, total bilirubin, conjugated bilirubin. | From day 1 to approximately 15 months after administration (through Day 451). |
| Number of participants with abnormal laboratory test results | Measurement of albumin. | From day 1 to approximately 15 months after administration (through Day 451). |
| Number of participants with abnormal Coagulation test results | Measurement of international normalised ratio (INR). | From day 1 to approximately 15 months after administration (through Day 451). |
| Number of participants with abnormal ECG readings | Results for heart rate will be analyzed. | From day 1 to approximately 15 months after administration (through Day 451). |
| Number of participants with abnormal vital signs | Measurement of pulse rate (beats per minute), respiratory rate (breaths per minute). | From day 1 to approximately 15 months after administration (through Day 451). |
| Number of participants with abnormal vital signs | Measurement of body temperature (in degree Celsius). | From day 1 to approximately 15 months after administration (through Day 451). |
| Shanghai |
| 201107 |
| China |
| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |