Study identifier:D7650C00001
ClinicalTrials.gov identifier:NCT06238466
EudraCT identifier:N/A
CTIS identifier:N/A
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
Cardiovascular
Phase 1
Yes
AZD1705
All
112
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
PAREXEL
No locations available
Arms | Assigned Interventions |
---|---|
Active Comparator: Part A1 (AZD1705) Non-Asian participants will receive AZD1705 subcutaneously on Day 1. | Drug: AZD1705 Participants will receive AZD1705 subcutaneously on Day 1 in Part A, and Days 1 and 29 in Part B. |
Active Comparator: Part A2 (AZD1705) Japanese participants will receive AZD1705 subcutaneously on Day 1. | Drug: AZD1705 Participants will receive AZD1705 subcutaneously on Day 1 in Part A, and Days 1 and 29 in Part B. |
Active Comparator: Part A3 (AZD1705) Chinese participants will receive AZD1705 subcutaneously on Day 1. | Drug: AZD1705 Participants will receive AZD1705 subcutaneously on Day 1 in Part A, and Days 1 and 29 in Part B. |
Active Comparator: Part B1 (AZD1705) Non-Asian participants who are receiving moderate- or high-intensity statin therapy will receive AZD1705 subcutaneously on Day 1 and Day 29. | Drug: AZD1705 Participants will receive AZD1705 subcutaneously on Day 1 in Part A, and Days 1 and 29 in Part B. |
Active Comparator: Part B2 (AZD1705) Japanese participants not receiving statin therapy will receive AZD1705 subcutaneously on Day 1 and Day 29. | Drug: AZD1705 Participants will receive AZD1705 subcutaneously on Day 1 in Part A, and Days 1 and 29 in Part B. |
Active Comparator: Part B3 (AZD1705) Participants who are receiving moderate- or high-intensity statin therapy and with the additional diagnosis of type 2 diabetes will receive AZD1705 subcutaneously on Day 1 and Day 29. | Drug: AZD1705 Participants will receive AZD1705 subcutaneously on Day 1 in Part A, and Days 1 and 29 in Part B. |
Placebo Comparator: Part A1 (Placebo) Non-Asian participants will receive placebo on Day 1. | Other: Placebo Participants will receive placebo on Day 1 in Part A, and Days 1 and 29 in Part B. |
Placebo Comparator: Part A2 (Placebo) Japanese participants will receive placebo on Day 1. | Other: Placebo Participants will receive placebo on Day 1 in Part A, and Days 1 and 29 in Part B. |
Placebo Comparator: Part A3 (Placebo) Chinese participants will receive placebo on Day 1. | Other: Placebo Participants will receive placebo on Day 1 in Part A, and Days 1 and 29 in Part B. |
Placebo Comparator: Part B1 (Placebo) Non-Asian participants who are receiving moderate- or high-intensity statin therapy will receive placebo on Day 1 and Day 29. | Other: Placebo Participants will receive placebo on Day 1 in Part A, and Days 1 and 29 in Part B. |
Placebo Comparator: Part B2 (Placebo) Japanese participants not receiving statin therapy will receive placebo on Day 1 and Day 29. | Other: Placebo Participants will receive placebo on Day 1 in Part A, and Days 1 and 29 in Part B. |
Placebo Comparator: Part B3 (Placebo) Participants who are receiving moderate- or high-intensity statin therapy and with the additional diagnosis of type 2 diabetes will receive placebo on Day 1 and Day 29. | Other: Placebo Participants will receive placebo on Day 1 in Part A, and Days 1 and 29 in Part B. |