Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06504043
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-02
Brief Title:
A Study on Evaluating the Safety of HST101 in Healthy Chinese Participants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Single-Center Phase I Clinical Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of a Single Dose of HST101 in Healthy Chinese Study Participants With Elevated LDL-C Levels
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
This is a single-center randomized double-blind placebo-controlled single SC dose cohort study to evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of a Single Dose of HST101 in Healthy Chinese Participants with Elevated LDL-C Levels
Detailed Description:
The planned 30 study participants will be assigned to low- or high-dose 2 cohorts and 15 participants in each cohort will be randomized to either the HST101 group or the corresponding dose placebo group and will be administered in parallel according to the following two cohortsCohort 1 15 study participants will receive the low dose of HST101 or placebo at a corresponding dose Cohort 2 15 study participants will receive the high dose of HST101 or placebo at a corresponding dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None