Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06657703
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-18
Brief Title:
Safety Tolerability and Pharmacokinetics of Single Doses of HC022 in Healthy Subjects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase Ia Single Center Randomized Double-blind Placebo-controlled Study Evaluating the Safety Tolerability Pharmacokinetics and Immunogenicity of Single Doses of HC022 in Healthy Subjects
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
The primary objective of this phase Ia study is to evaluate the safety and tolerability of single-ascending subcutaneous SC doses of HC022 in healthy subjects Secondary objectives of study are as follows To estimate the PK parameters of single-ascending SC doses of HC022 in healthy subjectsTo evaluate the immunogenicity of HC022 administered to healthy subjects
Detailed Description:
This is a first-in-human study of HC022 to assess safety tolerability and pharmacokinetic PK and pharmacodynamic PD effects of single HC022 doses in healthy subjects
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