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Completed

NCT Number: NCT05932641

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

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.

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Key information

Conditions

COVID-19, SARS-CoV-2 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Fukuoka, 812-0025, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Placebo (Cohort 2)

Biological

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

Primary outcomes

  1. To evaluate the safety and tolerability of AZD3152 - AEs

    Time frame: Up to Visit 9 (Day 91)

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

  2. To evaluate the safety and tolerability of AZD3152 - SAEs, MAAEs, and AESIs

    Time frame: Up to Visit 12 (Day 361)

    Occurrence of SAEs, MAAEs, and AESIs collected up to Visit 12 (Day 361)

  3. To evaluate the safety and tolerability of AZD3152 - Blood pressure

    Time frame: Up to Visit 7 (Day 29)

    The following variables will be collected:

    • Systolic Blood pressure
    • Diastolic Blood pressure

  4. To evaluate the safety and tolerability of AZD3152 - Pulse rate

    Time frame: Up to Visit 7 (Day 29)

    Pulse rate will be collected

  5. To evaluate the safety and tolerability of AZD3152 - Axillary temperature

    Time frame: Up to Visit 7 (Day 29)

    Axillary temperature will be collected

  6. To evaluate the safety and tolerability of AZD3152 - Respiratory rate

    Time frame: Up to Visit 7 (Day 29)

    Respiratory rate will be collected

  7. To evaluate the safety and tolerability of AZD3152 - PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval

    Time frame: Up to Visit 7 (Day 29)

    PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval will be recorded

  8. To evaluate the safety and tolerability of AZD3152 - Heart rate

    Time frame: Up to Visit 7 (Day 29)

    Heart rate will be recorded

  9. To characterise the Serum Pharmacokinetics of AZD3152 - Concentration at the end of infusion (Ceoi) (after intravenous only)

    Time frame: Up to Visit 12 (Day 361)

    AZD3152 concentration over time and Pharmacokinetics parameters

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

    Time frame: Up to Visit 12 (Day 361)

    AZD3152 concentration over time and Pharmacokinetics parameters

  11. To characterise the Serum Pharmacokinetics of AZD3152 - Time to maximum concentration (tmax)

    Time frame: Up to Visit 12 (Day 361)

    AZD3152 concentration over time and Pharmacokinetics parameters

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

    Time frame: Up to Visit 12 (Day 361)

    AZD3152 concentration over time and Pharmacokinetics parameters

  13. To characterise the Serum Pharmacokinetics of AZD3152 - Area under the concentration-time curve at the last measured time point (AUClast)

    Time frame: Up to Visit 12 (Day 361)

    AZD3152 concentration over time and Pharmacokinetics parameters

  14. To characterise the Serum Pharmacokinetics of AZD3152 - Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)

    Time frame: Up to Visit 12 (Day 361)

    AZD3152 concentration over time and Pharmacokinetics parameters

  15. To evaluate the safety and tolerability of AZD3152 - Haematology - White blood cell count

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • White blood cell count

  16. To evaluate the safety and tolerability of AZD3152 - Haematology - Red blood cell count

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Red blood cell count

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

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Haemoglobin

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

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Haematocrit

  19. To evaluate the safety and tolerability of AZD3152 - Haematology - Mean corpuscular volume

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Mean corpuscular volume

  20. To evaluate the safety and tolerability of AZD3152 - Haematology - Mean corpuscular haemoglobin

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Mean corpuscular haemoglobin

  21. To evaluate the safety and tolerability of AZD3152 - Haematology - Mean corpuscular haemoglobin concentration

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Mean corpuscular haemoglobin concentration

  22. To evaluate the safety and tolerability of AZD3152 - Haematology - Neutrophils absolute count

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Neutrophils absolute count

  23. To evaluate the safety and tolerability of AZD3152 - Haematology - Lymphocytes absolute count

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Lymphocytes absolute count

  24. To evaluate the safety and tolerability of AZD3152 - Haematology - Monocytes absolute count

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Monocytes absolute count

  25. To evaluate the safety and tolerability of AZD3152 - Haematology - Eosinophils absolute count

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Eosinophils absolute count

  26. To evaluate the safety and tolerability of AZD3152 - Haematology - Basophils absolute count

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Basophils absolute count

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

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Platelets

  28. To evaluate the safety and tolerability of AZD3152 - Haematology - Reticulocytes absolute count

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Reticulocytes absolute count

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

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Sodium

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

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Potassium

  31. To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Blood urea nitrogen

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Blood urea nitrogen

  32. To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Creatinine and estimated glomerular filtration rate

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Creatinine and estimated glomerular filtration rate

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

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Albumin

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

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Calcium

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

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Phosphate

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

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Glucose

  37. To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - C reactive protein

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • C reactive protein

  38. To evaluate the safety and tolerability of AZD3152 - Alkaline phosphatase

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Alkaline phosphatase

  39. To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Alanine aminotransferase

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Alanine aminotransferase

  40. To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Aspartate aminotransferase

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Aspartate aminotransferase

  41. To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Gamma glutamyl transpeptidase

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Gamma glutamyl transpeptidase

  42. To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Total bilirubin

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Total bilirubin

  43. To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Unconjugated bilirubin

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Unconjugated bilirubin

  44. To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Conjugated bilirubin

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Conjugated bilirubin

  45. To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Creatine kinase

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Creatine kinase

  46. To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Troponin T and I

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Troponin T and I

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

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Glucose

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

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Blood

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

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Microscopy

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

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Protein

  51. To evaluate the safety and tolerability of AZD3152 - Coagulation - International normalised ratio

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • International normalised ratio

  52. To evaluate the safety and tolerability of AZD3152 - Coagulation - Activated partial thrombin time

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Activated partial thrombin time

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

    Time frame: Up to Visit 7 (Day 29)

    The following will be collected:

    • Prothrombin time

Secondary outcomes

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

    Time frame: Up to Visit 12 (Day 361)

    Incidence of Anti-Drug Antibody to AZD3152 in serum

  2. The serum neutralising responses against SARS-CoV-2 using geometric mean titer (GMT) and geometric mean fold rise (GMFR) from baseline

    Time frame: Up to Visit 12 (Day 361)

    Blood samples as neutralising responses against SARS-CoV-2 in serum will be collected

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 6, 2023
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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