Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD5148 · 2 trials · 1 indication
Recurrence of C difficile infection (rCDI) occurring after initial clinical cure (ICC) of the qualifying C difficile infection (CDI). CDI is defined as a history of diarrhea (\>=3 unformed stools, ie, type 6 or 7 stool on Bristol Stool Scale in \<=24 hours for 2 consecutive calendar days) accompanied by a positive stool test for C difficile toxin.
To evaluate the safety and tolerability of AZD5148 administered as a single IV or IM dose to healthy Japanese adult participants.
To evaluate the safety and tolerability of AZD5148 administered as a single IV or IM dose to healthy Japanese adult participants.
To evaluate the safety and tolerability of AZD5148 administered as a single IV or IM dose to healthy Japanese adult participants.
| Arm | Type | Description |
|---|---|---|
| AZD5148: dose A | EXPERIMENTAL | Participants will receive a single dose A of AZD5148 administered via either intramuscular injection or intravenous push. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a single dose of placebo via intramuscular or intravenous push. |
| Cohort 1 - AZD5148 IM | EXPERIMENTAL | Biological: AZD5148 (Cohort 1) ・Single dose of AZD5148 IM |
| Cohort 1 - Placebo IM | PLACEBO_COMPARATOR | Biological: Placebo (Cohort 1) Single dose of Placebo IM |
| Cohort 2 - AZD5148 IV | EXPERIMENTAL | Biological: AZD5148 (Cohort 2) ・Single dose of AZD5148 IV |
| Cohort 2 - Placebo IV | PLACEBO_COMPARATOR | Biological: Placebo (Cohort 2) Single dose of Placebo IV |
| Name | Type | Description |
|---|---|---|
| AZD5148 | DRUG | Participants will receive a single dose A of AZD5148 administered via either intramuscular injection or intravenous push. |
| Placebo | OTHER | Participants will receive a single dose of placebo (0.9% (w/v) sodium chloride for injection) administered via either intramuscular injection or intravenous push. |
Inclusion Criteria: Participant must be ≥ 18 years of age at the time of signing the informed consent, capable of giving signed informed consent. Participants with a qualifying C. difficile infection episode at the time of providing informed consent defined by: * History of 3 or more unformed sto...
AZD5148 is being developed for the prevention of recurrent Clostridioides difficile infection, a serious bacterial infection of the gut. It is an investigational small molecule from AstraZeneca PLC, currently in Phase 2 clinical development, and is not yet approved for any use.
AZD5148 is developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. The company is running the clinical program for the drug in Clostridioides difficile infection, including a Phase 2 prevention study and a completed Phase 1 study in Japanese participants.
AZD5148 is in Phase 2 clinical development. The lead trial, NCT07285213, is a recruiting Phase 2 study evaluating the drug for prevention of recurrent Clostridioides difficile infection. A separate Phase 1 safety and tolerability study in Japanese participants, NCT06639997, has been completed.
AZD5148 has two registered trials. NCT07285213 is a recruiting Phase 2 study in Clostridioides difficile infection with 230 planned participants across the United States, Australia, Canada, Europe and Japan. NCT06639997 was a completed Phase 1 safety and tolerability study in 16 Japanese participants, including healthy volunteers.
The Phase 2 trial NCT07285213 is a randomized, double-blind, placebo-controlled study of AZD5148 for prevention of recurrent Clostridioides difficile infection. It plans to enroll 230 participants aged 18 years and older of all sexes, and is currently recruiting across multiple countries in North America, Europe and Asia-Pacific.
No. AZD5148 is an investigational drug and has not been approved by the FDA. It remains in clinical development, with a Phase 2 trial currently recruiting and a Phase 1 trial completed, so it is not available as a marketed treatment for Clostridioides difficile infection.