Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AZD3366 in Healthy Subjects, Japanese and Chinese Subjects

Summary

Part A of this study is a Phase 1, First-in-human (FiH), randomized, single-blind, placebo controlled study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD3366 following single intravenous (IV) ascending doses. Part B of this study is a randomized, single-blind, parallel group placebo-controlled study to assess the safety, tolerability and PD of a single IV administration of AZD3366 with concomitant loading doses followed by repeated maintenance dosing of ticagrelor and acetylsalicylic acid (ASA).

Timeline

Start

2020-10-15

Primary completion

2022-01-19

Completion

2022-01-19

Publications

• Kardassis D, Egnell AC, Astrand M, Daniels SJ, Whatling C, Fjellstrom O, Gabrielsen A. Safety, Tolerability, and Pharmacodynamics of AZD3366 (Optimized Human CD39L3 Apyrase) Alone and in Combination With Ticagrelor and Acetylsalicylic Acid: A Phase 1, Randomized, Placebo-Controlled Study. J Am Heart Assoc. 2024 Jun 4;13(11):e033985. doi: 10.1161/JAHA.123.033985. Epub 2024 May 28.

Drugs

Indications