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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: COVID-19, SARS-CoV-2

Treatments: Biological: AZD3152 (Cohort 3); Biological: AZD3152 (Cohort 1); Biological: Placebo (Cohort 1); Biological: Placebo (Cohort 2); Biological: Placebo (Cohort 3); Biological: AZD3152 (Cohort 2)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05932641

D7000C00007

Details and patient eligibility

About

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.

Full description

This is a Phase I, randomised, double-blind, placebo controlled study evaluating the safety, tolerability, PK and PD of AZD3152 in healthy Japanese adult participants, 18 to 55 years of age. Approximately 24 healthy participants will be randomised at up to 2 study sites.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 6 patient groups, including a placebo group

Cohort 1 - AZD3152 300 mg IM direct anterolateral thigh injection

Experimental group

Treatment:

Biological: AZD3152 (Cohort 1)

Cohort 1 - Placebo IM direct anterolateral thigh injection

Placebo Comparator group

Treatment:

Biological: Placebo (Cohort 1)

Cohort 2 - AZD3152 600 mg IM direct anterolateral thigh injection

Experimental group

Treatment:

Biological: AZD3152 (Cohort 2)

Cohort 2 - Placebo direct anterolateral thigh injection

Placebo Comparator group

Treatment:

Biological: Placebo (Cohort 2)

Cohort 3 - AZD3152 1200 mg IV administration

Experimental group

Treatment:

Biological: AZD3152 (Cohort 3)

Cohort 3 - Placebo IV administration

Placebo Comparator group

Treatment:

Biological: Placebo (Cohort 3)