Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-25 @ 5:19 PM
Study NCT ID:
NCT06657703
Status:
RECRUITING
Last Update Posted:
2025-04-17
First Post:
2024-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, and Pharmacokinetics of Single Doses of HC022 in Healthy Subjects.
Sponsor:
HC Biopharma Inc.
Organization:
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:
RECRUITING
Status Verified Date:
2025-04
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:
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 subjects；To 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:
True
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?:
False
Is an FDA AA801 Violation?: