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

AstraZeneca24 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

COVID-19, SARS-CoV-2

Interventions

AZD3152 (Cohort 1)BIOLOGICAL

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

Placebo (Cohort 1)BIOLOGICAL

Single dose of Placebo IM on Visit 2 Day 1

AZD3152 (Cohort 2)BIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Research Site

Fukuoka, Japan

Outcomes

Primary Outcomes

To evaluate the safety and tolerability of AZD3152 - AEs

Occurrence of AEs collected up to Visit 9 (Day 91)

Time frame: 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)

Time frame: 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

Time frame: Up to Visit 7 (Day 29)

To evaluate the safety and tolerability of AZD3152 - Pulse rate

Pulse rate will be collected

Time frame: Up to Visit 7 (Day 29)

To evaluate the safety and tolerability of AZD3152 - Axillary temperature

Axillary temperature will be collected

Time frame: Up to Visit 7 (Day 29)

To evaluate the safety and tolerability of AZD3152 - Respiratory rate

Respiratory rate will be collected

Time frame: 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

Time frame: Up to Visit 7 (Day 29)

To evaluate the safety and tolerability of AZD3152 - Heart rate

Heart rate will be recorded

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Single dose of Placebo IM on Visit 2 Day 1

AZD3152 (Cohort 3)BIOLOGICAL

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

Placebo (Cohort 3)BIOLOGICAL

Single dose of Placebo IM on Visit 2 Day 1

Time frame: 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

Time frame: Up to Visit 12 (Day 361)

To characterise the Serum Pharmacokinetics of AZD3152 - Maximum concentration (Cmax)

AZD3152 concentration over time and Pharmacokinetics parameters

Time frame: 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

Time frame: Up to Visit 12 (Day 361)

To characterise the Serum Pharmacokinetics of AZD3152 - Terminal half-life (t½)

AZD3152 concentration over time and Pharmacokinetics parameters

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Up to Visit 7 (Day 29)

To evaluate the safety and tolerability of AZD3152 - Haematology - Haemoglobin

The following will be collected: \- Haemoglobin

Time frame: Up to Visit 7 (Day 29)

To evaluate the safety and tolerability of AZD3152 - Haematology - Haematocrit

The following will be collected: \- Haematocrit

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Up to Visit 7 (Day 29)

To evaluate the safety and tolerability of AZD3152 - Haematology - Platelets

The following will be collected: \- Platelets

Time frame: 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

Time frame: Up to Visit 7 (Day 29)

To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Sodium

The following will be collected: \- Sodium

Time frame: Up to Visit 7 (Day 29)

To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Potassium

The following will be collected: \- Potassium

Time frame: 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

Time frame: 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

Time frame: Up to Visit 7 (Day 29)

To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Albumin

The following will be collected: \- Albumin

Time frame: Up to Visit 7 (Day 29)

To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Calcium

The following will be collected: \- Calcium

Time frame: Up to Visit 7 (Day 29)

To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Phosphate

The following will be collected: \- Phosphate

Time frame: Up to Visit 7 (Day 29)

To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Glucose

The following will be collected: \- Glucose

Time frame: 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

Time frame: Up to Visit 7 (Day 29)

To evaluate the safety and tolerability of AZD3152 - Alkaline phosphatase

The following will be collected: \- Alkaline phosphatase

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Up to Visit 7 (Day 29)

To evaluate the safety and tolerability of AZD3152 - Urinalysis - Glucose

The following will be collected: \- Glucose

Time frame: Up to Visit 7 (Day 29)

To evaluate the safety and tolerability of AZD3152 - Urinalysis - Blood

The following will be collected: \- Blood

Time frame: Up to Visit 7 (Day 29)

To evaluate the safety and tolerability of AZD3152 - Urinalysis - Microscopy

The following will be collected: \- Microscopy

Time frame: Up to Visit 7 (Day 29)

To evaluate the safety and tolerability of AZD3152 - Urinalysis - Protein

The following will be collected: \- Protein

Time frame: 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

Time frame: 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

Time frame: Up to Visit 7 (Day 29)

To evaluate the safety and tolerability of AZD3152 - Coagulation - Prothrombin time

The following will be collected: \- Prothrombin time

Time frame: Up to Visit 7 (Day 29)

Secondary Outcomes

To evaluate the Anti-Drug Antibody responses to AZD3152 in serum

Incidence of Anti-Drug Antibody to AZD3152 in serum

Time frame: 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

Time frame: Up to Visit 12 (Day 361)