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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04588727 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AZD3366 in Healthy Subjects, Japanese and Chinese Subjects | PHASE1 | COMPLETED | 103 | — | — | Oct 15, 2020 | Jan 19, 2022 | Dec 18, 2023 | 1 | United States |
Adverse events will be assessed to investigate the safety and tolerability of intravenous administration of AZD3366 in healthy subjects, healthy Japanese subjects and healthy Chinese subjects.
| Arm | Type | Description |
|---|---|---|
| AZD3366 Dose 1 Part A | EXPERIMENTAL | Randomized healthy subjects will receive Dose 1 of AZD3366. |
| AZD3366 Dose 2 Part A | EXPERIMENTAL | Randomized healthy subjects will receive Dose 2 of AZD3366. |
| AZD3366 Dose 3 Part A | EXPERIMENTAL | Randomized healthy subjects will receive Dose 3 of AZD3366. |
| AZD3366 Dose 4 Part A | EXPERIMENTAL | Randomized healthy subjects will receive Dose 4 of AZD3366. |
| AZD3366 Dose 5 Part A | EXPERIMENTAL | Randomized healthy subjects and healthy Japanese subjects will receive Dose 5 of AZD3366. |
| AZD3366 Dose 6 Part A | EXPERIMENTAL | Randomized healthy subjects and healthy Japanese subjects will receive Dose 6 of AZD3366. |
| AZD3366 Dose 7 Part A | EXPERIMENTAL | Randomized healthy subjects, healthy Japanese subjects, and healthy Chinese subjects will receive Dose 7 of AZD3366. |
| Placebo Part A | PLACEBO_COMPARATOR | Randomized healthy subjects, healthy Japanese subjects, and healthy Chinese subjects will receive Placebo matched to AZD3366. |
| AZD3366 Dose X Part B | EXPERIMENTAL | Randomized healthy subjects will receive Dose X of AZD3366 in conjunction with concomitant administration of ticagrelor and ASA. |
| Placebo Dose X Part B | PLACEBO_COMPARATOR | Randomized healthy subjects will receive Dose X of placebo in conjunction with concomitant administration of ticagrelor and ASA. |
| Name | Type | Description |
|---|---|---|
| AZD3366 | DRUG | In Part A, subjects will be randomized to receive intravenous infusion AZD3366 dose 1-7, single ascending dose (SAD). In Part A, Dose 2-7 may be adjusted based on PK data from previous cohort\[s\]. In Part B, subjects will be randomized to receive intravenous infusion AZD3366 dose X (a dose resulting in predicted therapeutic exposure). |
| Placebo | DRUG | In Part A and Part B, subjects will be randomized to receive intravenous infusion of placebo (0.9% sodium chloride solution). |
| Ticagrelor | DRUG | In Part B, subjects will receive oral ticagrelor tablets. |
| acetylsalicylic acid (ASA) | DRUG | In Part B, subjects will receive oral ASA chewable tablets. |
Inclusion Criteria: 1. Healthy men and women of non-childbearing potential 2. Females must have a negative pregnancy test at Screening and on admission to the study center, must not be lactating, and must be of non-childbearing potential, confirmed at Screening, by fulfilling one of the below crite...