Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD6489 · 1 trial · 1 indication
To assess the safety of a single IM vaccination with AZD6489 or licensed RSV vaccines
To assess the safety of a single IM vaccination with AZD6489 or licensed RSV vaccines
To assess the safety of a single IM vaccination with AZD6489 or licensed RSV vaccines
To assess the safety of a single IM vaccination with AZD6489 or licensed RSV vaccines
To assess the safety of a single IM vaccination with AZD6489 or licensed RSV vaccines
To assess the safety of a single IM vaccination with AZD6489 or licensed RSV vaccines
To characterize the nAb responses to RSV A in serum following a single IM vaccination with AZD6489
| Arm | Type | Description |
|---|---|---|
| AZD6489 Dose A | EXPERIMENTAL | Participants will receive AZD6489 Dose A as a single dose intramuscular injection on Day 1. |
| AZD6489 Dose B | EXPERIMENTAL | Participants will receive AZD6489 Dose B as a single dose intramuscular injection on Day 1. |
| Licensed RSV vaccine #1 | ACTIVE_COMPARATOR | Participants will receive licensed RSV vaccine #1 as a single dose intramuscular injection on Day 1. |
| Licensed RSV vaccine #2 | ACTIVE_COMPARATOR | Participants will receive licensed RSV vaccine #2 as a single dose intramuscular injection on Day 1. |
| Name | Type | Description |
|---|---|---|
| AZD6489 | BIOLOGICAL | Participants will receive AZD6489 as a single intramuscular injection. |
| Licensed RSV vaccine #1 | BIOLOGICAL | Participants will receive licensed RSV vaccine #1 as a single intramuscular injection. |
| Licensed RSV vaccine #2 | BIOLOGICAL | Participants will receive licensed RSV vaccine #2 as a single intramuscular injection. |
Inclusion Criteria: * Participant must be ≥ 60 years of age at the time of signing the informed consent. * Participants who are medically stable in the opinion of the Investigator at the time of study intervention. Participants with chronic stable medical conditions with or without specific treatme...
AZD6489 is an investigational monoclonal antibody being developed for RSV, or Respiratory Syncytial Virus. It is currently in Phase 1 clinical development for this infectious disease indication.
AZD6489 is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting clinical trials to evaluate the safety and immunogenicity of this investigational monoclonal antibody.
AZD6489 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is active but not recruiting participants.
AZD6489 is being studied in the ARIES trial, registered as NCT07717840. This Phase 1 study is evaluating the safety and immunogenicity of AZD6489 in participants 60 years of age and older, with an enrollment of 164 participants in the United States.
Yes, AZD6489 is a monoclonal antibody. It is being developed as a potential treatment or preventive option for RSV, Respiratory Syncytial Virus, and is currently in Phase 1 clinical trials.