Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD0543 · 1 trial · 1 indication
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Low Dose AZD0543 | EXPERIMENTAL | Participants will receive a single AZD0543 dose. |
| Cohort 1: Placebo | PLACEBO_COMPARATOR | Participants will receive a single dose of placebo. |
| Cohort 2: Medium Dose AZD0543 | EXPERIMENTAL | Participants will receive a single AZD0543 dose. |
| Cohort 2: Placebo | PLACEBO_COMPARATOR | Participants will receive a single dose of placebo. |
| Cohort 3: High Dose AZD0543 | EXPERIMENTAL | Participants will receive a single AZD0543 dose. |
| Cohort 3: Placebo | PLACEBO_COMPARATOR | Participants will receive a single dose of placebo. |
| Name | Type | Description |
|---|---|---|
| AZD0543 | BIOLOGICAL | Sterile solution for injection or infusion administered as a single IM or IV dose on Day 1. |
| Placebo | OTHER | Volume-matched 0.9% (w/v) sterile saline solution for injection or infusion administered as a single IM or IV dose on Day 1. |
Key Inclusion Criteria: * Age 18 to 55 years * Body weight ≥ 45 kg and ≤ 110 kg and BMI within the range ≥ 18.0 kg/m2 to ≤ 30 kg/m2 Key Exclusion Criteria: * Hypersensitivity to IMP/components * Severe adverse reaction/hypersensitivity to other mAbs * Acute fever/illness/infection within 3 days o...
AZD0543 is an investigational monoclonal antibody being developed by AstraZeneca PLC for human metapneumovirus infection. It is currently in Phase 1 clinical development and has not been approved by the FDA. The program is evaluating the drug in healthy adult volunteers.
AZD0543 is being studied for human metapneumovirus infection, a respiratory viral illness. It is an investigational monoclonal antibody and is not yet approved for any use. The ongoing Phase 1 trial is designed to assess safety and pharmacokinetics in healthy adults rather than to treat patients.
AZD0543 is developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the Phase 1 study evaluating the monoclonal antibody in healthy adult volunteers.
AZD0543 is in Phase 1 clinical development. The only registered trial is a Phase 1 study, and it is currently recruiting. AZD0543 is investigational and has not received FDA approval for human metapneumovirus infection or any other indication.
AZD0543 is being evaluated in one clinical trial, NCT07824622, titled Study of Safety and PK of AZD0543 in Healthy Adults. The Phase 1 trial is recruiting 144 healthy volunteers aged 18 years and older in the United States. It is randomized, double blind, and placebo controlled.