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

NCT ID: NCT05932641

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-31

Study Completion Date

2024-12-05

Brief Summary

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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.

Detailed Description

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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.

Conditions

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COVID-19, SARS-CoV-2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 in a ratio of 6:2 in each cohort to either AZD3152 or placebo administered IM or IV, across 3 fixed-dose cohorts. To participants who will receive the IMP via IM injection (Cohorts 1 and 2), the IMP will be given as a direct anterolateral thigh IM administration of AZD3152 or placebo. To participants who will receive the IMP via IV infusion (Cohort 3), the IMP will be administered as an IV infusion containing AZD3152 or placebo. The randomisation of Cohort 2 and 3 should be performed sequentially.
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cohort 1 - AZD3152 300 mg IM direct anterolateral thigh injection

Group Type EXPERIMENTAL

AZD3152 (Cohort 1)

Intervention Type BIOLOGICAL

Single dose of AZD3152 300 mg IM on Visit 2 Day 1

Cohort 1 - Placebo IM direct anterolateral thigh injection

Group Type PLACEBO_COMPARATOR

Placebo (Cohort 1)

Intervention Type BIOLOGICAL

Single dose of Placebo IM on Visit 2 Day 1

Cohort 2 - AZD3152 600 mg IM direct anterolateral thigh injection

Group Type EXPERIMENTAL

AZD3152 (Cohort 2)

Intervention Type BIOLOGICAL

Single dose of AZD3152 600 mg IM on Visit 2 Day 1

Cohort 2 - Placebo direct anterolateral thigh injection

Group Type PLACEBO_COMPARATOR

Placebo (Cohort 2)

Intervention Type BIOLOGICAL

Single dose of Placebo IM on Visit 2 Day 1

Cohort 3 - AZD3152 1200 mg IV administration

Group Type EXPERIMENTAL

AZD3152 (Cohort 3)

Intervention Type BIOLOGICAL

Single dose of AZD3152 1200 mg IV on Visit 2 Day 1

Cohort 3 - Placebo IV administration

Group Type PLACEBO_COMPARATOR

Placebo (Cohort 3)

Intervention Type BIOLOGICAL

Single dose of Placebo IM on Visit 2 Day 1

Interventions

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AZD3152 (Cohort 1)

Single dose of AZD3152 300 mg IM on Visit 2 Day 1

Intervention Type BIOLOGICAL

Placebo (Cohort 1)

Single dose of Placebo IM on Visit 2 Day 1

Intervention Type BIOLOGICAL

AZD3152 (Cohort 2)

Single dose of AZD3152 600 mg IM on Visit 2 Day 1

Intervention Type BIOLOGICAL

Placebo (Cohort 2)

Single dose of Placebo IM on Visit 2 Day 1

Intervention Type BIOLOGICAL

AZD3152 (Cohort 3)

Single dose of AZD3152 1200 mg IV on Visit 2 Day 1

Intervention Type BIOLOGICAL

Placebo (Cohort 3)

Single dose of Placebo IM on Visit 2 Day 1

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Fukuoka, , Japan

Site Status

Countries

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Japan

Other Identifiers

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D7000C00007

Identifier Type: -

Identifier Source: org_study_id