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

A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD3152 in Healthy Japanese Adults

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19, SARS-CoV-2
• Intervention / Treatment: Biological: AZD3152 (Cohort 1); Biological: Placebo (Cohort 1); Biological: AZD3152 (Cohort 2); Biological: Placebo (Cohort 2); Biological: Placebo (Cohort 3); Biological: AZD3152 (Cohort 3)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka-shi, Japan, 812-0025
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 - AZD3152 300 mg IM direct anterolateral thigh injection	Biological: AZD3152 (Cohort 1); Single dose of AZD3152 300 mg IM on Visit 2 Day 1
Placebo Comparator: Cohort 1 - Placebo IM direct anterolateral thigh injection	Biological: Placebo (Cohort 1); Single dose of Placebo IM on Visit 2 Day 1
Experimental: Cohort 2 - AZD3152 600 mg IM direct anterolateral thigh injection	Biological: AZD3152 (Cohort 2); Single dose of AZD3152 600 mg IM on Visit 2 Day 1
Placebo Comparator: Cohort 2 - Placebo direct anterolateral thigh injection	Biological: Placebo (Cohort 2); Single dose of Placebo IM on Visit 2 Day 1
Placebo Comparator: Cohort 3 - Placebo IV administration	Biological: Placebo (Cohort 3); Single dose of Placebo IM on Visit 2 Day 1
Experimental: Cohort 3 - AZD3152 1200 mg IV administration	Biological: AZD3152 (Cohort 3); Single dose of AZD3152 1200 mg IV on Visit 2 Day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the safety and tolerability of AZD3152 - AEs	Occurrence of AEs collected up to Visit 9 (Day 91)	Up to Visit 9 (Day 91)
To evaluate the safety and tolerability of AZD3152 - SAEs, MAAEs, and AESIs	Occurrence of SAEs, MAAEs, and AESIs collected up to Visit 12 (Day 361)	Up to Visit 12 (Day 361)
To evaluate the safety and tolerability of AZD3152 - Blood pressure	The following variables will be collected: Systolic Blood pressure; Diastolic Blood pressure	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Pulse rate	Pulse rate will be collected	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Axillary temperature	Axillary temperature will be collected	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Respiratory rate	Respiratory rate will be collected	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval	PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval will be recorded	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Heart rate	Heart rate will be recorded	Up to Visit 7 (Day 29)
To characterise the Serum Pharmacokinetics of AZD3152 - Concentration at the end of infusion (Ceoi) (after intravenous only)	AZD3152 concentration over time and Pharmacokinetics parameters	Up to Visit 12 (Day 361)
To characterise the Serum Pharmacokinetics of AZD3152 - Maximum concentration (Cmax)	AZD3152 concentration over time and Pharmacokinetics parameters	Up to Visit 12 (Day 361)
To characterise the Serum Pharmacokinetics of AZD3152 - Time to maximum concentration (tmax)	AZD3152 concentration over time and Pharmacokinetics parameters	Up to Visit 12 (Day 361)
To characterise the Serum Pharmacokinetics of AZD3152 - Terminal half-life (t½)	AZD3152 concentration over time and Pharmacokinetics parameters	Up to Visit 12 (Day 361)
To characterise the Serum Pharmacokinetics of AZD3152 - Area under the concentration-time curve at the last measured time point (AUClast)	AZD3152 concentration over time and Pharmacokinetics parameters	Up to Visit 12 (Day 361)
To characterise the Serum Pharmacokinetics of AZD3152 - Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)	AZD3152 concentration over time and Pharmacokinetics parameters	Up to Visit 12 (Day 361)
To evaluate the safety and tolerability of AZD3152 - Haematology - White blood cell count	The following will be collected: - White blood cell count	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Haematology - Red blood cell count	The following will be collected: - Red blood cell count	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Haematology - Haemoglobin	The following will be collected: - Haemoglobin	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Haematology - Haematocrit	The following will be collected: - Haematocrit	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Haematology - Mean corpuscular volume	The following will be collected: - Mean corpuscular volume	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Haematology - Mean corpuscular haemoglobin	The following will be collected: - Mean corpuscular haemoglobin	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Haematology - Mean corpuscular haemoglobin concentration	The following will be collected: - Mean corpuscular haemoglobin concentration	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Haematology - Neutrophils absolute count	The following will be collected: - Neutrophils absolute count	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Haematology - Lymphocytes absolute count	The following will be collected: - Lymphocytes absolute count	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Haematology - Monocytes absolute count	The following will be collected: - Monocytes absolute count	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Haematology - Eosinophils absolute count	The following will be collected: - Eosinophils absolute count	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Haematology - Basophils absolute count	The following will be collected: - Basophils absolute count	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Haematology - Platelets	The following will be collected: - Platelets	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Haematology - Reticulocytes absolute count	The following will be collected: - Reticulocytes absolute count	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Sodium	The following will be collected: - Sodium	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Potassium	The following will be collected: - Potassium	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Blood urea nitrogen	The following will be collected: - Blood urea nitrogen	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Creatinine and estimated glomerular filtration rate	The following will be collected: - Creatinine and estimated glomerular filtration rate	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Albumin	The following will be collected: - Albumin	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Calcium	The following will be collected: - Calcium	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Phosphate	The following will be collected: - Phosphate	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Glucose	The following will be collected: - Glucose	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - C reactive protein	The following will be collected: - C reactive protein	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Alkaline phosphatase	The following will be collected: - Alkaline phosphatase	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Alanine aminotransferase	The following will be collected: - Alanine aminotransferase	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Aspartate aminotransferase	The following will be collected: - Aspartate aminotransferase	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Gamma glutamyl transpeptidase	The following will be collected: - Gamma glutamyl transpeptidase	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Total bilirubin	The following will be collected: - Total bilirubin	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Unconjugated bilirubin	The following will be collected: - Unconjugated bilirubin	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Conjugated bilirubin	The following will be collected: - Conjugated bilirubin	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Creatine kinase	The following will be collected: - Creatine kinase	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Troponin T and I	The following will be collected: - Troponin T and I	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Urinalysis - Glucose	The following will be collected: - Glucose	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Urinalysis - Blood	The following will be collected: - Blood	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Urinalysis - Microscopy	The following will be collected: - Microscopy	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Urinalysis - Protein	The following will be collected: - Protein	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Coagulation - International normalised ratio	The following will be collected: - International normalised ratio	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Coagulation - Activated partial thrombin time	The following will be collected: - Activated partial thrombin time	Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Coagulation - Prothrombin time	The following will be collected: - Prothrombin time	Up to Visit 7 (Day 29)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the Anti-Drug Antibody responses to AZD3152 in serum	Incidence of Anti-Drug Antibody to AZD3152 in serum	Up to Visit 12 (Day 361)
The serum neutralising responses against SARS-CoV-2 using geometric mean titer (GMT) and geometric mean fold rise (GMFR) from baseline	Blood samples as neutralising responses against SARS-CoV-2 in serum will be collected	Up to Visit 12 (Day 361)

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2023
• Primary Completion (Estimated): December 19, 2024
• Study Completion (Estimated): December 19, 2024

Study Registration Dates

• First Submitted: May 15, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: D7000C00007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes