Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06014736
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2023-08-16
Brief Title:
A Phase I Study of XJ101 in Chinese Healthy Subjects
Sponsor:
Starmab biologicsShanghaiColtd
Organization:
Starmab biologicsShanghaiColtd
Study Overview
Official Title:
A Phase I Study to Evaluate the Safety Tolerability Pharmacokinetics and Immunogenicity of XJ101 in Chinese Healthy Subjects
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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 randomized double-blind placebo-parallel intervention clinical study that will include approximately 38 healthy subjects based on inclusion and exclusion criteria Subjects will be assigned to one of four different dosage cohorts Subjects in each cohort will randomly be given experimental drug or a placebo
Detailed Description:
None
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?:
None