Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07285213 | Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody | PHASE2 | RECRUITING | 230 | — | — | Dec 10, 2025 | Jan 18, 2028 | Jun 3, 2026 | 114 | United States, Australia +12 |
| NCT06639997 | Safety and Tolerability of AZD5148 in Japanese Participants | PHASE1 | COMPLETED | 16 | — | — | Oct 31, 2024 | Dec 25, 2025 | Jan 30, 2026 | 1 | Japan |
rCDI is a recurrence of C difficile infection (CDI) occurring after initial clinical cure of the qualifying 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: * Positive local C. difficile toxin...