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

NCT05932641 | Completed Phase 1 FDA Drug

• 1 other identifier: D7000C00007
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19, SARS-CoV-2

Outcome Measures

Primary Outcomes (53)

• 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 Outcomes (2)

• To evaluate the Anti-Drug Antibody responses 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

  Up to Visit 12 (Day 361)

Study Arms (6)

Cohort 1 - AZD3152 300 mg IM direct anterolateral thigh injection

EXPERIMENTAL

Biological: AZD3152 (Cohort 1)

Cohort 1 - Placebo IM direct anterolateral thigh injection

PLACEBO COMPARATOR

Biological: Placebo (Cohort 1)

Cohort 2 - AZD3152 600 mg IM direct anterolateral thigh injection

EXPERIMENTAL

Biological: AZD3152 (Cohort 2)

Cohort 2 - Placebo direct anterolateral thigh injection

PLACEBO COMPARATOR

Biological: Placebo (Cohort 2)

Cohort 3 - AZD3152 1200 mg IV administration

EXPERIMENTAL

Biological: AZD3152 (Cohort 3)

Cohort 3 - Placebo IV administration

PLACEBO COMPARATOR

Biological: Placebo (Cohort 3)

Interventions

AZD3152 (Cohort 1) BIOLOGICAL

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

Cohort 1 - AZD3152 300 mg IM direct anterolateral thigh injection

Placebo (Cohort 1) BIOLOGICAL

Single dose of Placebo IM on Visit 2 Day 1

Cohort 1 - Placebo IM direct anterolateral thigh injection

AZD3152 (Cohort 2) BIOLOGICAL

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

Cohort 2 - AZD3152 600 mg IM direct anterolateral thigh injection

Placebo (Cohort 2) BIOLOGICAL

Single dose of Placebo IM on Visit 2 Day 1

Cohort 2 - Placebo direct anterolateral thigh injection

AZD3152 (Cohort 3) BIOLOGICAL

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

Cohort 3 - AZD3152 1200 mg IV administration

Placebo (Cohort 3) BIOLOGICAL

Single dose of Placebo IM on Visit 2 Day 1

Cohort 3 - Placebo IV administration

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Fukuoka, 812-0025, Japan

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: July 6, 2023
• Study Start: July 31, 2023
• Primary Completion: December 5, 2024
• Study Completion: December 5, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• 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.

Locations

JP (1)