Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06132360
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2023-11-06
Brief Title:
the Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamic Effects in Adult Subjects With Elevated LDL-C
Sponsor:
Ikaria Bioscience Pty Ltd
Organization:
Ikaria Bioscience Pty Ltd
Study Overview
Official Title:
A Phase 1 Randomized Single-blinded Placebo-controlled Single-ascending-dose Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamic Effects in Adult Subjects With Elevated LDL-C
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized placebo-controlled single ascending-dose SAD study of administered SC to adult subjects with elevated LDL-C Subjects who have signed an Ethics Committee EC-approved informed consent form ICF and have met all the protocol eligibility criteria during screening may be enrolled into the study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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?:
None