Ignite Creation Date:
2025-12-24 @ 12:32 PM
Ignite Modification Date:
2026-01-03 @ 8:45 PM
Study NCT ID:
NCT06423261
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-09
First Post:
2024-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, Pharmacokinetics and Immunogenicity Study of GB002 Recombinant Peptide Inhalation Solution in Healthy Subjects
Sponsor:
Zhejiang Echon Biopharm Limited
Organization:
Study Overview
Official Title:
Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of GB002 Recombinant Polypeptide Inhalation Solution in a Randomized, Double-blind, Placebo-controlled, Dose-increasing Single and Multiple Administration in Chinese Healthy Adult Subjects.
Status:
ACTIVE_NOT_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:
This trial is conducted in China. The purpose of this clinical trial is to evaluate the safety and tolerability, pharmacokinetic (PK) characteristics, and immunogenicity of single/multiple inhalation of different doses of GB002 recombinant peptide in healthy subjects.
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?: