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Study of AZD3152 Intramuscular Injection or Intravenous Infusion in Healthy Japanese Adult Participants

CompletedPhase 1

Sponsor: AstraZeneca

Conditions: COVID-19, SARS-CoV-2

Interventions: AZD3152 (Cohort 1), Placebo (Cohort 1), AZD3152 (Cohort 2), Placebo (Cohort 2), AZD3152 (Cohort 3)

Countries: Japan

AZD3152 is being evaluated for administration to prevent COVID-19. This Phase I study will gather important information on the safety and tolerability of AZD3152 as well as relevant data on the PK, PD (as the neutralising responses against SARS-CoV-2) profile and the generation of ADA to AZD3152.

Eligibility overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Japanese men and women and 18 to 55 years of age inclusive, at the time of signing the informed consent.
* No positive results of SARS-CoV-2 NAT and/or rapid antigen tests.
* 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.
* ECG without clinically significant abnormalities.
* Able to complete the Follow-up Period through Day 361 as required by the protocol.
* Body weight ≥ 45 kg and ≤ 110 kg and BMI ≥ 18.0 to ≤ 30.0 kg/m2.

Exclusion Criteria:

* Known hypersensitivity to any component of the IMP.
* History of allergic disease or reactions likely to be exacerbated by any component of the IMP.
* Previous hypersensitivity, infusion related reaction or severe adverse reaction following administration of mAbs.
* Fever above 38.0°C on day prior to or on day of randomisation/dosing.
* AST, ALT or serum creatinine above ULN; bilirubin and ALP \>1.5 × ULN.
* Any vaccination except for COVID-19 vaccine (e.g., inactivated influenzae vaccine) planned.
* SARS CoV-2 or COVID-19:

Receipt of a COVID-19 vaccine within 3 months. COVID-19 infection within 3 months prior.

Locations (1)

Fukuoka, Japan