Ignite Creation Date:
2024-07-17 @ 11:02 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501573
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-09
Brief Title:
A Study of SGB-9768 in Adult Healthy Volunteers
Sponsor:
Suzhou Sanegene Bio Inc
Organization:
Suzhou Sanegene Bio Inc
Study Overview
Official Title:
A Phase 1 Randomized Double-blind Placebo-controlled Single Ascending Dose Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered SGB-9768 in Healthy Volunteers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 study is a randomized double-blind placebo-controlled single ascending dose study of SGB-9768 in healthy volunteers The purpose is to evaluate the safety tolerability pharmacokinetics and pharmacodynamics of subcutaneously administered SGB-9768
Detailed Description:
It is a phase 1 randomized double-blind placebo-controlled single ascending dose study of SGB-9768 The primary objective is to evaluate the safety tolerability of SGB-9768 when administered subcutaneously as a single dose to healthy volunteers The secondary objective is to characterize the pharmacokinetics and pharmacodynamics of subcutaneously administered SGB-9768 in healthy volunteers
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