Cardiovascular Clinical Trial
Official title:
A Phase I Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD1705 Following Single and Multiple Ascending Doses in Participants With Dyslipidemia
A study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD1705 in participants with dyslipidemia.
This is a first time in human study in male and female (of non-childbearing potential) participants with dyslipidemia. The study consists of two parts: 1. Part A (single ascending dose): Part A of the study will include three parts: A1 for non-Asian participants, A2 for Japanese participants, and A3 for Chinese participants. Parts A2 and A3 are optional. 2. Part B (multiple ascending dose): Part B of the study will include three parts: B1 for non-Asian participants receiving moderate- or high-intensity statin therapy, B2 for Japanese participants not receiving statin therapy, and B3 for participants who are receiving moderate- or high-intensity statin therapy, with the additional diagnosis of type 2 diabetes (T2D), and with HbA1c < 7.5%. Parts B2 and B3 are optional. The study will comprise of: - A Screening Period of maximum 60 days for both Part A and Part B. - Part A: A single dose of AZD1705 with an in-clinic period of 3 days. - An outpatient Follow-up Period of approximately 16 weeks. - Part B: 2 doses of AZD1705, given 28 days apart with an in-clinic period. - An outpatient Follow-up Period of approximately 20 weeks. ;
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