Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD4117 · 1 trial · 1 indication
A binary endpoint, defined as ≥ 1:40 HAI titer post-IMP administration.
Seroconversion status, defined as either a pre-IMP administration HAI titer \< 1:10 and a post-IMP administration HAI titer ≥ 1:40, or a pre-IMP administration titer ≥ 1:10 and 4-fold increase in post-IMP administration titer.
| Arm | Type | Description |
|---|---|---|
| Arm 1: Dosage Level 1 (DL1) of AZD4117 18 to 64 years of age | EXPERIMENTAL | Participants will receive DL1 AZD4117. |
| Arm 2: Dosage Level 2 (DL2) of AZD4117 18 to 64 years of age | EXPERIMENTAL | Participants will receive DL2 AZD4117. |
| Arm 3: DL1 of AZD4117 >= 65 years of age | EXPERIMENTAL | Participants will receive DL1 AZD4117. |
| Arm 4: DL2 of AZD4117 >= 65 years of age | EXPERIMENTAL | Participants will receive DL2 AZD4117. |
| Arm 5: DL1 of AZD5315 18 to 64 years of age | EXPERIMENTAL | Participants will receive DL1 AZD5315. |
| Arm 6: DL2 of AZD5315 18 to 64 years of age | EXPERIMENTAL | Participants will receive DL2 AZD5315. |
| Arm 7: DL1 of AZD5315 >= 65 years of age | EXPERIMENTAL | Participants will receive DL1 AZD5315. |
| Arm 8: DL2 of AZD5315 >= 65 years of age | EXPERIMENTAL | Participants will receive DL2 AZD5315. |
| Arm 9: placebo 18 to 64 years of age | PLACEBO_COMPARATOR | Participants will receive placebo. |
| Arm 10: placebo >= 65 years of age | PLACEBO_COMPARATOR | Participants will receive placebo. |
| Name | Type | Description |
|---|---|---|
| AZD4117 | BIOLOGICAL | Intramuscular (IM) injection |
| AZD5315 | BIOLOGICAL | IM injection |
| Placebo | OTHER | IM injection |
Key Inclusion Criteria: * Adults, ≥ 18 years of age at the time of signing the informed consent * Participants who are medically stable such that, according to the judgement of the Investigator, hospitalization within the study period is not anticipated and the participant appears likely to be able...
AZD4117 is an investigational monoclonal antibody being developed for Influenza A. It is currently in Phase 1 clinical development, with an active trial studying its safety and immunogenicity in healthy volunteers in the United States.
AZD4117 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The drug is currently in Phase 1 clinical trials for Influenza A.
AZD4117 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase I/II study is currently active but not recruiting participants.
AZD4117 is being studied in a Phase I/II clinical trial with the identifier NCT07128615, titled 'A Phase I/II Study on Safety AND Immunogenicity of AZD4117 and AZD5315 Vaccines (PANDA)'. The trial is active but not recruiting, with an enrollment of 405 participants.
AZD4117 is not the same as AZD5315. They are separate investigational drugs being studied together in a clinical trial (NCT07128615) for Influenza A. The trial evaluates the safety and immunogenicity of both AZD4117 and AZD5315 vaccines.