Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-01-04 @ 3:45 AM
Study NCT ID:
NCT06549959
Status:
RECRUITING
Last Update Posted:
2024-08-12
First Post:
2024-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single Dose Study to Investigate the Pharmacokinetics (PK) of Telitacicept Pre-filled Injection and Freeze-dried Powder Injection in Chinese Healthy Subjects
Sponsor:
RemeGen Co., Ltd.
Organization:
Study Overview
Official Title:
An Open-label, Randomized, Parallel Group, Single Dose Study to Investigate the Pharmacokinetics of Telitacicept Pre-filled Injection and Freeze-dried Powder Injection in Chinese Healthy Subjects
Status:
RECRUITING
Status Verified Date:
2024-08
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 an open-label, randomized, parallel group, single dose study in healthy Chinese subjects. The purpose of this study is to evaluate the Pharmacokinetics and safety of Telitacicept Pre-filled Injection and Freeze-dried powder Injection.
Detailed Description:
None
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?: