Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-26 @ 3:44 PM
Study NCT ID:
NCT04973735
Status:
UNKNOWN
Last Update Posted:
2021-07-22
First Post:
2021-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Study of LY-CovMab Injection in Chinese Healthy Subjects
Sponsor:
Luye Pharma Group Ltd.
Organization:
Study Overview
Official Title:
A Phase I, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of LY-CovMab Injection in Chinese Healthy Subjects
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
A single center, randomized, doubled-blind, placebo-control and single ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of LY-CovMab Injection in Chinese healthy subjects.
Detailed Description:
A single center, randomized, doubled-blind, placebo-control and single ascending dose phase I study:
Primary objective: to evaluate the safety and tolerability of a single dose of LY-CovMab Injection in Chinese healthy subjects.
Secondary objective: to evaluate the pharmacokinetics (PK) and immunogenicity of a single dose of LY-CovMab injection in Chinese healthy subjects.
Primary objective: to evaluate the safety and tolerability of a single dose of LY-CovMab Injection in Chinese healthy subjects.
Secondary objective: to evaluate the pharmacokinetics (PK) and immunogenicity of a single dose of LY-CovMab injection in Chinese healthy subjects.
Study Oversight
Has Oversight DMC:
False
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?: