Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-27 @ 3:04 PM
Study NCT ID:
NCT06238466
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-09
First Post:
2024-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD1705 in Participants With Dyslipidemia
Sponsor:
AstraZeneca
Organization:
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD1705 in participants with dyslipidemia.
Detailed Description:
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 who may or may not be receiving moderate- or high-intensity statin therapy, B2 for Japanese participants not receiving statin therapy, and B3 for participants who may or may not be receiving moderate- or high-intensity statin therapy, with the additional diagnosis of type 2 diabetes (T2D), and with HbA1c \< 8%. 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.
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 who may or may not be receiving moderate- or high-intensity statin therapy, B2 for Japanese participants not receiving statin therapy, and B3 for participants who may or may not be receiving moderate- or high-intensity statin therapy, with the additional diagnosis of type 2 diabetes (T2D), and with HbA1c \< 8%. 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: