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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05932641
Recruitment Status : Active, not recruiting
First Posted : July 6, 2023
Last Update Posted : April 29, 2024
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19, SARS-CoV-2 Biological: AZD3152 (Cohort 1) Biological: Placebo (Cohort 1) Biological: AZD3152 (Cohort 2) Biological: Placebo (Cohort 2) Biological: AZD3152 (Cohort 3) Biological: Placebo (Cohort 3) Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model 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 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD3152 in Healthy Japanese Adults
Actual Study Start Date : July 31, 2023
Estimated Primary Completion Date : December 19, 2024
Estimated Study Completion Date : December 19, 2024
Arms and Interventions
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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
Experimental: Cohort 3 - AZD3152 1200 mg IV administration Biological: AZD3152 (Cohort 3)
Single dose of AZD3152 1200 mg IV 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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05932641


Locations
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Japan
Research Site
Fukuoka-shi, Japan, 812-0025
Sponsors and Collaborators
AstraZeneca
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT05932641    
Other Study ID Numbers: D7000C00007
First Posted: July 6, 2023    Key Record Dates
Last Update Posted: April 29, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: 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.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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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