Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-28 @ 9:10 AM
Study NCT ID:
NCT05017168
Status:
COMPLETED
Last Update Posted:
2022-08-11
First Post:
2021-07-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P63 in Healthy Subjects
Sponsor:
Celltrion
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P63 in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2022-08
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 is a Phase I study that randomized, double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to evaluate Safety, Tolerability and Pharmacokinetics of CT-P63 in Healthy Subjects.
Detailed Description:
CT-P63 is a monoclonal antibody targeted against SARS-CoV-2 spike RBD as a treatment for SARS CoV 2 infection. CT-P63 is currently being developed by the Sponsor as a potential treatment for SARS-CoV-2 infection. In this study, safety, tolerability, and pharmacokinetics of CT-P63 will be evaluated 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?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2021-003530-37 | EUDRACT_NUMBER | None | View |