Clinical trial NCT05932641: Study of AZD3152 Intramuscular Injection or Intravenous Infusion in Healthy Japanese Adult Participants
Official title: A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD3152 in Healthy Japanese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COVID-19, SARS-CoV-2
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-07-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: To evaluate the safety and tolerability of AZD3152 - AEs
timeFrame: Up to Visit 9 (Day 91)
measure: To evaluate the safety and tolerability of AZD3152 - SAEs, MAAEs, and AESIs
timeFrame: Up to Visit 12 (Day 361)
measure: To evaluate the safety and tolerability of AZD3152 - Blood pressure
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Pulse rate
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Axillary temperature
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Respiratory rate
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Heart rate
timeFrame: Up to Visit 7 (Day 29)
measure: To characterise the Serum Pharmacokinetics of AZD3152 - Concentration at the end of infusion (Ceoi) (after intravenous only)
timeFrame: Up to Visit 12 (Day 361)
measure: To characterise the Serum Pharmacokinetics of AZD3152 - Maximum concentration (Cmax)
timeFrame: Up to Visit 12 (Day 361)
measure: To characterise the Serum Pharmacokinetics of AZD3152 - Time to maximum concentration (tmax)
timeFrame: Up to Visit 12 (Day 361)
measure: To characterise the Serum Pharmacokinetics of AZD3152 - Terminal half-life (t½)
timeFrame: Up to Visit 12 (Day 361)
measure: To characterise the Serum Pharmacokinetics of AZD3152 - Area under the concentration-time curve at the last measured time point (AUClast)
timeFrame: Up to Visit 12 (Day 361)
measure: To characterise the Serum Pharmacokinetics of AZD3152 - Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
timeFrame: Up to Visit 12 (Day 361)
measure: To evaluate the safety and tolerability of AZD3152 - Haematology - White blood cell count
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Haematology - Red blood cell count
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Haematology - Haemoglobin
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Haematology - Haematocrit
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Haematology - Mean corpuscular volume
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Haematology - Mean corpuscular haemoglobin
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Haematology - Mean corpuscular haemoglobin concentration
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Haematology - Neutrophils absolute count
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Haematology - Lymphocytes absolute count
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Haematology - Monocytes absolute count
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Haematology - Eosinophils absolute count
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Haematology - Basophils absolute count
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Haematology - Platelets
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Haematology - Reticulocytes absolute count
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Sodium
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Potassium
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Blood urea nitrogen
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Creatinine and estimated glomerular filtration rate
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Albumin
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Calcium
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Phosphate
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Glucose
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - C reactive protein
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Alkaline phosphatase
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Alanine aminotransferase
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Aspartate aminotransferase
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Gamma glutamyl transpeptidase
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Total bilirubin
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Unconjugated bilirubin
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Conjugated bilirubin
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Creatine kinase
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Troponin T and I
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Urinalysis - Glucose
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Urinalysis - Blood
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Urinalysis - Microscopy
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Urinalysis - Protein
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Coagulation - International normalised ratio
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Coagulation - Activated partial thrombin time
timeFrame: Up to Visit 7 (Day 29)
measure: To evaluate the safety and tolerability of AZD3152 - Coagulation - Prothrombin time
timeFrame: Up to Visit 7 (Day 29)
Secondary outcomes:
measure: To evaluate the Anti-Drug Antibody responses to AZD3152 in serum
timeFrame: Up to Visit 12 (Day 361)
measure: The serum neutralising responses against SARS-CoV-2 using geometric mean titer (GMT) and geometric mean fold rise (GMFR) from baseline
timeFrame: Up to Visit 12 (Day 361)
Other outcomes:
Locations:
city: Fukuoka-shi
country: Japan
facility: Research Site
Study officials:
References: