Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AZD3152 (Cohort 1), AZD3152 (Parent study Main Cohort)
AZD3152 · 3 trials · 2 indications
The safety profile will be evaluated using vital signs, laboratory data, electrocardiograms (ECGs), and adverse event data
Occurrence of AEs collected up to Visit 9 (Day 91)
Occurrence of SAEs, MAAEs, and AESIs collected up to Visit 12 (Day 361)
The following variables will be collected: * Systolic Blood pressure * Diastolic Blood pressure
Pulse rate will be collected
Axillary temperature will be collected
Respiratory rate will be collected
PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval will be recorded
Heart rate will be recorded
AZD3152 concentration over time and Pharmacokinetics parameters
AZD3152 concentration over time and Pharmacokinetics parameters
AZD3152 concentration over time and Pharmacokinetics parameters
AZD3152 concentration over time and Pharmacokinetics parameters
AZD3152 concentration over time and Pharmacokinetics parameters
AZD3152 concentration over time and Pharmacokinetics parameters
The following will be collected: \- White blood cell count
The following will be collected: \- Red blood cell count
The following will be collected: \- Haemoglobin
The following will be collected: \- Haematocrit
The following will be collected: \- Mean corpuscular volume
The following will be collected: \- Mean corpuscular haemoglobin
The following will be collected: \- Mean corpuscular haemoglobin concentration
The following will be collected: \- Neutrophils absolute count
The following will be collected: \- Lymphocytes absolute count
The following will be collected: \- Monocytes absolute count
The following will be collected: \- Eosinophils absolute count
The following will be collected: \- Basophils absolute count
The following will be collected: \- Platelets
The following will be collected: \- Reticulocytes absolute count
The following will be collected: \- Sodium
The following will be collected: \- Potassium
The following will be collected: \- Blood urea nitrogen
The following will be collected: \- Creatinine and estimated glomerular filtration rate
The following will be collected: \- Albumin
The following will be collected: \- Calcium
The following will be collected: \- Phosphate
The following will be collected: \- Glucose
The following will be collected: \- C reactive protein
The following will be collected: \- Alkaline phosphatase
The following will be collected: \- Alanine aminotransferase
The following will be collected: \- Aspartate aminotransferase
The following will be collected: \- Gamma glutamyl transpeptidase
The following will be collected: \- Total bilirubin
The following will be collected: \- Unconjugated bilirubin
The following will be collected: \- Conjugated bilirubin
The following will be collected: \- Creatine kinase
The following will be collected: \- Troponin T and I
The following will be collected: \- Glucose
The following will be collected: \- Blood
The following will be collected: \- Microscopy
The following will be collected: \- Protein
The following will be collected: \- International normalised ratio
The following will be collected: \- Activated partial thrombin time
The following will be collected: \- Prothrombin time
Evaluation of the safety of IM or IV administration of AZD3152 will be done.
Evaluation of the safety of IM or IV administration of AZD3152 will be done.
Evaluation of the safety of IM or IV administration of AZD3152 will be done.
Pharmacokinetics (PK) characterization of AZD3152 in serum after a single IM or IV dose.
PK (Cmax) characterization of AZD3152 in serum after a single IM or IV dose.
PK (tmax) characterization of AZD3152 in serum after a single IM or IV dose.
PK (t1/2) characterization of AZD3152 in serum after a single IM or IV dose.
PK (AUClast) characterization of AZD3152 in serum after a single IM or IV dose.
PK (AUCinf) characterization of AZD3152 in serum after a single IM or IV dose.
PK (CL/F) characterization of AZD3152 in serum after a single IM.
PK (Vz/F) characterization of AZD3152 in serum after a single IM.
PK (CL) characterization of AZD3152 in serum after a single IV.
PK (Vz) characterization of AZD3152 in serum after a single IV.
PK (Vss) characterization of AZD3152 in serum after a single IV.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Single dose of Placebo IM (0.9% sodium chloride) |
| AZD3152 | EXPERIMENTAL | Single dose of 300 mg IM |
| Cohort 1 - AZD3152 300 mg IM direct anterolateral thigh injection | EXPERIMENTAL | - |
| Cohort 1 - Placebo IM direct anterolateral thigh injection | PLACEBO_COMPARATOR | - |
| Cohort 2 - AZD3152 600 mg IM direct anterolateral thigh injection | EXPERIMENTAL | - |
| Cohort 2 - Placebo direct anterolateral thigh injection | PLACEBO_COMPARATOR | - |
| Cohort 3 - AZD3152 1200 mg IV administration | EXPERIMENTAL | - |
| Cohort 3 - Placebo IV administration | PLACEBO_COMPARATOR | - |
| AZD3152 Dose X (IM) | EXPERIMENTAL | Participants will receive dose X of AZD3152 on Day 1 as a single IM injection. |
| AZD3152 Dose X (IV) | EXPERIMENTAL | Participants will receive dose X of AZD3152 on Day 1 as an IV infusion. |
| AZD3152 Dose Y (IM) | EXPERIMENTAL | Participants will receive dose Y of AZD3152 on Day 1 as 2 sequential IM injections. |
| AZD3152 Dose Y (IV) | EXPERIMENTAL | Participants will receive dose Y of AZD3152 on Day 1 as an IV infusion. |
| AZD3152 Dose Z (IV) | EXPERIMENTAL | Participants will receive dose Z of AZD3152 on Day 1 as an IV infusion. |
| Pooled placebo | PLACEBO_COMPARATOR | Participant will receive placebo on Day 1 either via IM injection or IV infusion. |
| Name | Type | Description |
|---|---|---|
| Biological: AZD3152 | BIOLOGICAL | 300 mg single dose of AZD3152 IM |
| Biological: Placebo | BIOLOGICAL | Single dose of Placebo IM (0.9% sodium chloride) |
| 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 |
| AZD3152 | DRUG | AZD3152 will be administered via IM injection or IV infusion, as per the assigned arms. |
| Placebo | OTHER | Placebo is a matching volume of 0.9% sodium chloride, will be administered via IM injection or IV infusion, as per the assigned arms. |
Inclusion Criteria: * Participant must be 18 years of age or older at the time of signing the informed consent. * Weight ≥ 45 kg at Visit 1. * Participants must satisfy at least 1 of the following risk factors at enrollment: 1. Obese, ie, BMI ≥ 30 2. Congestive heart failure 3. Chronic obstr...
Top 9 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | ibuzatrelvir, Nirmatrelvir/ ritonavir, BNT162b2/RIV |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Molnupiravir |
| Invivyd, Inc. | IVVD | 2 | PHASE3 | VYD2311 |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | Tradipitant |
| Moderna, Inc. | MRNA | 2 | PHASE2 | mRNA-1283, mRNA-1273 |
| ImmunityBio Inc | IBRX | 2 | PHASE2 | Nogapendekin alfa inbakicept |
| Traws Pharma, Inc. | TRAW | 1 | PHASE2 | Ratutrelvir |
| GeoVax Labs, Inc. | GOVX | 1 | PHASE2 | GEO-CM04S1 |
| Gilead Sciences, Inc. | GILD | 1 | PHASE2 | Remdesivir |
AZD3152 is an investigational small molecule developed by AstraZeneca PLC for COVID-19 and SARS-CoV-2. It is being studied for prevention or treatment in adults at high risk of severe COVID-19, including those with conditions that may reduce vaccine response. It has been tested in Phase 1 and Phase 2 clinical trials.
AZD3152 is being developed for COVID-19 and SARS-CoV-2, specifically for adults with conditions that increase the risk of inadequate protective immune response after vaccination and thus are at high risk of developing severe COVID-19. It is not yet approved and remains investigational.
AZD3152 is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical trials evaluating AZD3152 for COVID-19 and SARS-CoV-2.
AZD3152 has been studied in Phase 1 and Phase 2 clinical trials. The Phase 1 trials are completed, and a Phase 2 trial in adults at high risk of severe COVID-19 is also completed. It is an investigational drug and has not been approved by the FDA.
AZD3152 has been evaluated in three completed trials: NCT06057064, a Phase 2 study in adults at high risk of severe COVID-19; NCT05932641, a Phase 1 study in healthy Japanese adults; and NCT05872958, a Phase 1 dose exploration study in healthy volunteers. All trials are completed.
Yes, AZD3152 is also referred to as AZD3152 (Cohort 1), AZD3152 (Parent study Main Cohort), and Biological: AZD3152. These alternative names refer to the same investigational drug developed by AstraZeneca for COVID-19 and SARS-CoV-2.