Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-25 @ 4:43 PM
Study NCT ID:
NCT05542303
Status:
COMPLETED
Last Update Posted:
2025-04-06
First Post:
2022-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Safety, Tolerability and Pharmacokinetics Study of ZB001 in Healthy Subjects
Sponsor:
Zenas BioPharma (USA), LLC
Organization:
Study Overview
Official Title:
A Single Ascending Dose, Safety, and Pharmacokinetic Study of ZB001 in Healthy Chinese Subjects
Status:
COMPLETED
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:
The investigational drug, ZB001 is a humanized IgG1κ monoclonal antibody (mAb) targeting human IGF-1R. This clinical trial will examine the safety, tolerability, and pharmacokinetics (PK) of single ascending doses of ZB001 in healthy Chinese subjects.
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?: