Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD5148 · 3 trials · 2 indications
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.
To evaluate the safety and tolerability of AZD5148 administered as a single IV or IM dose to healthy adult participants.
To evaluate the safety and tolerability of AZD5148 administered as a single IV or IM dose to healthy 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 |
| Cohort 1: AZD5148 (dose 1) IM | EXPERIMENTAL | Participants will receive AZD5148 (dose 1) or matching placebo as an IM injection |
| Cohort 2a: AZD5148 (dose 2) IM | EXPERIMENTAL | Participants will receive AZD5148 (dose 2) or matching placebo as an IM injection |
| Cohort 2b: AZD5148 (dose 2) IM | EXPERIMENTAL | Participants of Chinese descent will receive AZD5148 (dose 2) or matching placebo as an IM injection |
| Cohort 3: AZD5148 (dose 2) IV | EXPERIMENTAL | Participants will receive AZD5148 (dose 2) or matching placebo as an IV bolus |
| Cohort 4a: AZD5148 (dose 3) IV | EXPERIMENTAL | Participants will receive AZD5148 (dose 3) or matching placebo as an IV bolus |
| Cohort 4b: AZD5148 (dose 3) IV | EXPERIMENTAL | Participants of Chinese descent will receive AZD5148 (dose 3) or matching placebo as an IV bolus |
| Cohort 5: AZD5148 (dose 4) IV | EXPERIMENTAL | Participants will receive AZD5148 (dose 4) or matching placebo as an IV bolus |
| 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 an investigational small molecule being studied for the prevention of recurrent Clostridioides difficile infection. It is also being evaluated in healthy participants to assess its safety, tolerability, and pharmacokinetics. The drug is in Phase 2 clinical development for the C. difficile infection indication.
AZD5148 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the NASDAQ under the ticker symbol AZN. AstraZeneca is conducting clinical trials of AZD5148 in multiple countries, including the United States, Japan, and several European nations.
AZD5148 is currently in Phase 2 clinical development for the prevention of recurrent Clostridioides difficile infection. The drug is investigational and has not been approved by regulatory authorities. Two Phase 1 studies in healthy participants have been completed, and a Phase 2 trial is actively recruiting participants.
AZD5148 has three clinical trials listed on ClinicalTrials.gov. NCT06469151 and NCT06639997 are completed Phase 1 studies in healthy adults. NCT07285213 is a recruiting Phase 2 trial studying prevention of recurrent C. difficile infection with an enrollment target of 230 participants across multiple countries.
AZD5148 is described as a small molecule in the development data. However, one of its clinical trials, NCT07285213, is titled 'Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody,' which suggests the drug may be evaluated as a monoclonal antibody in that specific study context.