A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD3152 in Healthy Japanese Adults
- Conditions
- COVID-19, SARS-CoV-2
- Registration Number
- jRCT2071230040
- Lead Sponsor
- Astrazeneca K.K
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 24
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Japanese men and women and 18 to 55 years of age inclusive, at the time of signing the informed consent.
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No positive results of SARS-CoV-2 NAT and/or rapid antigen tests.
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Healthy participants by medical history, physical examination, baseline safety laboratory studies, and screening parameters, according to the judgement of the investigators, with no concomitant disease or concomitant medication.
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ECG without clinically significant abnormalities.
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Able to complete the Follow-up Period through Day 361 as required by the protocol.
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Body weight 45 kg or more and 110 kg or less and BMI 18.0 or more to 30.0 kg/m2 or less.
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Known hypersensitivity to any component of the IMP.
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History of allergic disease or reactions likely to be exacerbated by any component of the IMP.
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Previous hypersensitivity, infusion related reaction or severe adverse reaction following administration of mAbs.
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Fever above 38.0 degrees celsius on day prior to or on day of randomisation/dosing.
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AST, ALT or serum creatinine above ULN; bilirubin and ALP >1.5 x ULN.
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Any vaccination except for COVID-19 vaccine (e.g., inactivated influenzae vaccine) planned.
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SARS CoV-2 or COVID-19:
Receipt of a COVID-19 vaccine within 3 months. COVID-19 infection within 3 months prior.
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method safety and tolerability To evaluate the safety and tolerability of AZD3152 administered IM or IV to healthy adult participants 18 to 55 years of age.
serum PK To characterise the serum PK of AZD3152 after single IM or IV administration of AZD3152.
- Secondary Outcome Measures
Name Time Method