Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04535752
Status:
COMPLETED
Last Update Posted:
2021-08-30
First Post:
2020-08-24
Brief Title:
A Single and Multiple Ascending Dose Study of ANX009 in Normal Healthy Volunteers NHV
Sponsor:
Annexon Inc
Organization:
Annexon Inc
Study Overview
Official Title:
A Phase 1 Randomized Double-blind Placebo-controlled Single and Multiple Ascending Dose Study to Assess the Safety Tolerability Pharmacokinetics PK and Pharmacodynamics PD of Subcutaneous ANX009 in Normal Healthy Volunteers NHV
Status:
COMPLETED
Status Verified Date:
2021-08
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:
The purpose of this study is to evaluate the safety tolerability pharmakokinetics and pharmacodynamics of single and repeated doses of ANX009
Detailed Description:
In this first in human phase 1 randomized double-blind placebo-controlled study single and multiple ascending doses of ANX009 or placebo will be administered to 48 healthy subjects
Single Ascending Dose SAD Each SAD subject will participate for approximately 4 weeks 3 nights in-clinic confinement
Multiple Ascending Dose Each MAD subject will participate for approximately 6 weeks 17 nights in-clinic confinement
All subjects will be contacted in clinic visit or phone call 6 months after study completion
Single Ascending Dose SAD Each SAD subject will participate for approximately 4 weeks 3 nights in-clinic confinement
Multiple Ascending Dose Each MAD subject will participate for approximately 6 weeks 17 nights in-clinic confinement
All subjects will be contacted in clinic visit or phone call 6 months after study completion
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?:
False
Is an FDA AA801 Violation?:
None