COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05932641

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com

2023-07-06

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

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.

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.

6

AstraZeneca

18

55

Japan

Healthy volunteers

N/A

24

To characterise the Serum Pharmacokinetics of AZD3152 - Area under the concentration-time curve at the last measured time point (AUClast);To characterise the Serum Pharmacokinetics of AZD3152 - Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf);To characterise the Serum Pharmacokinetics of AZD3152 - Concentration at the end of infusion (Ceoi) (after intravenous only);To characterise the Serum Pharmacokinetics of AZD3152 - Maximum concentration (Cmax);To characterise the Serum Pharmacokinetics of AZD3152 - Terminal half-life (t½);To characterise the Serum Pharmacokinetics of AZD3152 - Time to maximum concentration (tmax);To evaluate the safety and tolerability of AZD3152 - AEs;To evaluate the safety and tolerability of AZD3152 - Alkaline phosphatase;To evaluate the safety and tolerability of AZD3152 - Axillary temperature;To evaluate the safety and tolerability of AZD3152 - Blood pressure;To evaluate the safety and tolerability of AZD3152 - Coagulation - Activated partial thrombin time;To evaluate the safety and tolerability of AZD3152 - Coagulation - International normalised ratio;To evaluate the safety and tolerability of AZD3152 - Coagulation - Prothrombin time;To evaluate the safety and tolerability of AZD3152 - Haematology - Basophils absolute count;To evaluate the safety and tolerability of AZD3152 - Haematology - Eosinophils absolute count;To evaluate the safety and tolerability of AZD3152 - Haematology - Haematocrit;To evaluate the safety and tolerability of AZD3152 - Haematology - Haemoglobin;To evaluate the safety and tolerability of AZD3152 - Haematology - Lymphocytes absolute count;To evaluate the safety and tolerability of AZD3152 - Haematology - Mean corpuscular haemoglobin;To evaluate the safety and tolerability of AZD3152 - Haematology - Mean corpuscular haemoglobin concentration;To evaluate the safety and tolerability of AZD3152 - Haematology - Mean corpuscular volume;To evaluate the safety and tolerability of AZD3152 - Haematology - Monocytes absolute count;To evaluate the safety and tolerability of AZD3152 - Haematology - Neutrophils absolute count;To evaluate the safety and tolerability of AZD3152 - Haematology - Platelets;To evaluate the safety and tolerability of AZD3152 - Haematology - Red blood cell count;To evaluate the safety and tolerability of AZD3152 - Haematology - Reticulocytes absolute count;To evaluate the safety and tolerability of AZD3152 - Haematology - White blood cell count;To evaluate the safety and tolerability of AZD3152 - Heart rate;To evaluate the safety and tolerability of AZD3152 - PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval;To evaluate the safety and tolerability of AZD3152 - Pulse rate;To evaluate the safety and tolerability of AZD3152 - Respiratory rate;To evaluate the safety and tolerability of AZD3152 - SAEs, MAAEs, and AESIs;To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Alanine aminotransferase;To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Albumin;To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Aspartate aminotransferase;To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Blood urea nitrogen;To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Calcium;To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Conjugated bilirubin;To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - C reactive protein;To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Creatine kinase;To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Creatinine and estimated glomerular filtration rate;To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Gamma glutamyl transpeptidase;To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Glucose;To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Phosphate;To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Potassium;To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Sodium;To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Total bilirubin;To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Troponin T and I;To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Unconjugated bilirubin;To evaluate the safety and tolerability of AZD3152 - Urinalysis - Blood;To evaluate the safety and tolerability of AZD3152 - Urinalysis - Glucose;To evaluate the safety and tolerability of AZD3152 - Urinalysis - Microscopy;To evaluate the safety and tolerability of AZD3152 - Urinalysis - Protein

None

Phase 1

[{"arm_notes": "Cohort 1\n300 mg IM", "treatment_id": 2664, "treatment_name": "Azd3152", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Cohort 1", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "Cohort 2\n600 mg IM", "treatment_id": 2664, "treatment_name": "Azd3152", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Cohort 2", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "Cohort 3\n600 mg IV", "treatment_id": 2664, "treatment_name": "Azd3152", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Cohort 3", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]