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

Phase 1

Completed

• Conditions: COVID-19, SARS-CoV-2
• Interventions: Biological: Placebo (Cohort 3); Biological: Placebo (Cohort 2); Biological: AZD3152 (Cohort 3); Biological: AZD3152 (Cohort 2); Biological: AZD3152 (Cohort 1); Biological: Placebo (Cohort 1)

• Registration Number: NCT05932641
• Lead Sponsor: AstraZeneca

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-05-15
• Study First Submitted QC: 2023-06-27
• Study First Posted: 2023-07-06
• Study Start: 2023-07-31
• Status Verified: 2024-12
• Primary Completion: 2024-12-05
• Study Completion: 2024-12-05
• Last Update Submitted: 2024-12-23
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 3 - Placebo IV administration	Placebo (Cohort 3)	-
Cohort 2 - Placebo direct anterolateral thigh injection	Placebo (Cohort 2)	-
Cohort 3 - AZD3152 1200 mg IV administration	AZD3152 (Cohort 3)	-
Cohort 2 - AZD3152 600 mg IM direct anterolateral thigh injection	AZD3152 (Cohort 2)	-
Cohort 1 - AZD3152 300 mg IM direct anterolateral thigh injection	AZD3152 (Cohort 1)	-
Cohort 1 - Placebo IM direct anterolateral thigh injection	Placebo (Cohort 1)	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research Site; 🇯🇵 Fukuoka-shi, Japan