Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2025-12-28 @ 7:10 PM
Study NCT ID:
NCT05518695
Status:
COMPLETED
Last Update Posted:
2022-11-15
First Post:
2022-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Pharmacokinetics of BAT2022 in Healthy Chinese Subjects
Sponsor:
Bio-Thera Solutions
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Phase I Clinical Study to Evaluate the Pharmacokinetics of BAT2022 in Healthy Chinese Subjects
Status:
COMPLETED
Status Verified Date:
2022-11
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:
To evaluate the safety and tolerability of BAT2022 in healthy subjects.
Detailed Description:
This is a single-center, randomized, double-blind, placebo-controlled, dose-escalation clinical study to evaluate the pharmacokinetics, safety, tolerability, immunogenicity and pharmacodynamics of BAT2022 for Injection in healthy subjects.
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?: