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AZD3366 · 1 trial · 1 indication
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...
AZD3366 is an investigational small molecule being developed for cardiovascular disease. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied for its potential role in treating conditions related to the cardiovascular system.
AZD3366 is being developed by AstraZeneca PLC, a multinational pharmaceutical company. AstraZeneca is listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for cardiovascular disease.
AZD3366 is currently in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical research for cardiovascular disease.
AZD3366 has one completed Phase 1 clinical trial registered under NCT04588727. The study, titled "Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AZD3366 in Healthy Subjects, Japanese and Chinese Subjects," enrolled 103 participants in the United States. The trial was randomized, double-blind, and placebo-controlled.
AZD3366 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for cardiovascular disease. The drug has completed a Phase 1 trial, but it remains in early-stage clinical research and has not received regulatory approval for any indication.