COVID-19 MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: AZD3152
Product Code: AZD3152
Pharmaceutical Form: Solution for injection
INN or Proposed INN: AZD3152
CAS Number: 2768288-97-5
Current Sponsor code: AZD3152
Other descriptive name: mono
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Sentinel Safety Cohort Participants (Phase I) Participants are eligible to be included in the Sentinel Safety Cohort only if all of the following criteria apply: 1.Healthy participants according to medical history, physical examination, baseline safety laboratory tests, and screening parameters, according to the judgment of the investigator, with no concomitant disease or concomitant medication (except for medication specifically permitted by the protocol) 2.Age 18 to 55 years at the time of signing the informed consent 3. Written informed consent and any locally required authorization (eg, HIPAA in the US) obtained from the participant prior to performing any protocol-related procedures, including screening evaluations. 4.Negative rapid antigen test at Visit 1 5.Weight = 45 kg and = 110 kg at screening Main Cohort Participants (Phase III) Participants are eligible to be included in the Main Cohort only if all of the following criteria apply: 1.Participant must be 12 years of age or older at the time of signing the informed consent. 2. Written informed consent and any locally required authorization (eg, HIPAA in the US) obtained from the participant prior to performing any protocol-related procedures, including screening evaluations. For participants from 12 to < 18 years of age, their parents or legal guardians must give their signed written informed consent, as appropriate, and participants will sign an assent form. 3.Negative rapid antigen test prior to dosing at Visit 1. 4.Weight = 40 kg at screening 5.Participants must satisfy at least 1 of the following risk factors at enrollment: •Have solid tumor cancer and be on active immunosuppressive treatment •Have hematologic malignancy •Transplant participants must satisfy at least one of the following: o Have had a solid organ transplant within 2 years and / or o Had a hematopoietic stem cell transplant within 2 years and / or o Who have chronic graft-versus-host disease o Participants who previously had a solid organ transplant or hematopoietic stem cell transplant more than 2 years prior to Visit 1 may also be eligible based on the inclusion criterion for immunosuppressive treatment •Are actively taking immunosuppressive medicines (eg, are using corticosteroids [ie,= 20 mg prednisone or equivalent per day when administered for = 2 weeks], alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive [eg,Bruton’s tyrosine kinase inhibitors], tumor-necrosis blockers, or other immunosuppressive biologic agents (eg, for rheumatic diseases) •Received chimeric antigen receptor T cell therapy •Within 1 year of receiving B-cell depleting therapies (eg, rituximab, ocrelizumab, ofatumumab, alemtuzumab) •Have a moderate or severe primary (eg, DiGeorge syndrome) or secondary (eg, hemodialysis) immunodeficiency • Advanced or untreated HIV infection (people with HIV and CD4 cell counts < 200/mm3 within 6 months of Visit 1, history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV) 6.Medically stable defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 1 month prior to enrollment, with no acute change in condition at the time of study enrollment as judged by the Investigator and no expected changes at the time of the enrollment 7 Able to understand and comply with all study requirements/procedu
Exclusion criteria
Exclusion criteria: Sentinel Safety Cohort Participants (Phase I) Participants are excluded from the Sentinel Safety Cohort if any of the following criteria apply: 1.Women who are pregnant, lactating, or of childbearing potential and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention adm and until at least 6 months after study intervention adm (see details in CSP) 2.Known hypersensitivity to any component of the study intervention. 3.Previous hypersensitivity or severe adverse reaction following admof a mAb. 4.Acute (time-limited) or febrile (temperature = 38.0°C illness/infection on day prior to or day of planned dosing; participants excluded for transient acute illness may be dosed if illness resolves within the screening period or may be rescreened once. 5.Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to Visit 1. 6.Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM inj or venipuncture. 7.Receipt of immunoglobulin (non-COVID related) or blood products within 6 months prior to Visit 1 8.Previous receipt of a mAb against SARS-CoV-2 9.Receipt of a COVID-19 vaccine within 3 months prior to Visit 1 10.Receipt of a COVID-19 antiviral for prophylaxis within at least 2 weeks prior to Visit 1 11.COVID-19 within 3 months prior to Visit 1 (confirmed either by laboratory testing or a rapid test [including at home testing]) 12. Receipt of any IMP in the preceding 90 days or expected receipt of IMP during the period of study follow-up, or concurrent participation in another interventional study. Main Cohort Participants (Phase III) Participants are excluded from the Main Cohort if any of the following criteria apply: 1.Women who are pregnant, lactating, or of childbearing potential and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration. Note: female participants aged > 12 years will be considered to be a woman of childbearing potential(see details in CSP) 2.Known hypersensitivity to any component of the study intervention. 3.Previous hypersensitivity or severe adverse reaction following administration of a mAb. 4.Acute (time-limited) or febrile (temperature = 38.0°C [100.4ºF]) illness/infection on day prior to or day of planned dosing; participants excluded for transient acute illness may be dosed if illness resolves and may be rescreened for enrollment once. 5.Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to Visit 1. 6.Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture. 7.Receipt of IV or SC immunoglobulin within 6 months prior to Visit 1 or expected to receive IV and SC immunoglobulin 6 months after dosing. 8 Receipt of convalescent COVID-19 plasma treatment within 6 months prior to Visit 1. 9 Previous receipt of a mAb against SARS-CoV-2 within 6 months prior to Visit 1. 10 Receipt of a COVID-19 vaccine within 3 months prior to Visit 1. 11 Receipt of a COVID-19 antiviral for prophylaxis within at least 2 weeks prior to Visit 1. 12 COVID-19 within 3 months prior to Visit 1 (confirmed either by laboratory testing o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main Cohort 1.To evaluate the safety of AZD3152 and EVUSHELD and/or placebo 2. To compare the efficacy of AZD3152 to EVUSHELD and/or placebo in the prevention of symptomatic COVID-19 caused by any SARS CoV 2 variant 3. To compare the efficacy of AZD3152 to EVUSHELD and/or placebo in the prevention of symptomatic COVID 19 attributable to matched variants (variants that do not contain the F456L mutation) Sentinel Safety Cohort 1.To evaluate the safety of AZD5156;Secondary Objective: Main Cohort 1. To compare the nAb responses to the SARS-CoV-2 variants Alpha, Omicron BA.2, Omicron BA.4/5 and/or Omicron XBB.1.5 in serum following AZD3152 and EVUSHELD and/or placebo administration 2.To describe the incidence of symptomatic COVID-19, severe COVID-19, COVID-19 related hospitalization, and COVID-19 related death in participants receiving study intervention 3.To characterize the PK of AZD3152 and AZD7442 in serum 4.To evaluate the ADA responses to AZD3152 and AZD7442 in serum Sentinel Safety Cohort 1.To characterize the PK of AZ5156 and AZD3152 in serum 2.To evaluate the ADA responses to AZD5156, AZD3152 and AZD1061 in serum;Timepoint(s) of evaluation of this end point: Primary (Main Cohort) For safety: Occurrence of AEs collected through approximately 90 days after IMP administration. SAEs, MAAEs, and AESIs collected throughout the study For Efficacy: Negative RT-PCR at baseline to positive at any time up to Visit 9 (12 months) AND Satisfying modified WHO definition of symptomatic COVID-19 Primary (Sentinel Safety Cohort) For safety: Occurrence of AEs collected through approximately 90 days after IMP administration. SAEs, MAAEs, and AESIs collected throughout the study;Primary end point(s): Main Cohort 1.Occurrence of AEs collected through approximately 90 days after each IMP administration SAEs, MAAEs and AESIs collected through the study 2. Population: SARS-CoV-2-Negative Set Endpoint: Confirmed symptomatic COVID-19 case, classified as a binary outc | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Geometric mean titer (GMT) and geometric mean fold rise (GMFR) ratio of SARS-CoV-2 nAbs between the treatment arms at Visit 3 (Day 29). 2.Incidence of a post treatment: • Symptomatic COVID-19 case (negative RT PCR at baseline to positive at any time up to 6 and 12 months) caused by any SARS-CoV-2 variant • Symptomatic COVID-19 case (negative RT PCR at baseline to positive at any time up to 6 and 12 months) caused by any SARS-CoV-2 matched variants •Severe COVID-19 caused by any SARS-CoV-2 variant • Severe COVID-19 caused by any SARS-CoV-2 matched variants •Composite of COVID-19 related hospitalization and/or COVID-19 related death •COVID-19 related hospitalization (separately) •COVID 19 related death (separately) 3. AZD3152, AZD7442, AZD1061 and AZD8895 concentrations over time and PK parameters In the Main Cohort: AZD5156, and AZD7442, AZD1061, AZD3152, and AZD8895 concentrations over time 4.Incidence of ADA Sentinel Safety Cohort 1.AZD5156, AZD1061, and AZD3152 concentrations over time and PK parameters 2.Incidence of ADA;Timepoint(s) of evaluation of this end point: GMT and GMFR ratio of SARS-CoV-2 nAbs between the treatment arms at Visit 3 (Day 29). Descriptive statistics for GMTs and GMFRs will include the number of participants, geometric mean, gSD, 95% CI, minimum, and maximum and summarized by treatment arm and visit | — |
Countries
Argentina, Belgium, Canada, Denmark, France, Germany, Israel, Korea, Democratic People's Republic of, Malaysia, Mexico, Poland, Spain, Sweden, Taiwan, Thailand, Türkiye, United Kingdom, United States, Viet Nam
Contacts
Public ContactInformation Center
AstraZeneca AB
Outcome results
None listed