Ignite Creation Date:
2024-05-06 @ 3:14 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04568174
Status:
TERMINATED
Last Update Posted:
2021-10-15
First Post:
2020-09-08
Brief Title:
First in Human Study to Test the Safety and Preliminary Efficacy of PPSGG in Patients With Anti-MAG Neuropathy
Sponsor:
Polyneuron Pharmaceuticals AG
Organization:
Polyneuron Pharmaceuticals AG
Study Overview
Official Title:
First in Human Study to Evaluate the Safety Tolerability Pharmacokinetics Pharmacodynamics and Preliminary Efficacy of PPSGG PN-1007 in Anti-MAG Neuropathy Patients
Status:
TERMINATED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Data dont support further development
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study the new drug called PPSGG PN-1007 will be tested Preliminary studies conducted in animals suggest PPSGG PN-1007 might be a good treatment for reducing levels of anti-MAG antibodies in patients with anti-MAG neuropathy
This is the first research of PPSGG PN-1007 in people and its main purpose is to test its safety and acceptability in patients In this study it will be examined how the drug is changed by and removed from the body and checked for signs that the drug may be truly effective against anti-MAG neuropathy PPSGG PN-1007 will be tested at several different doses
This is the first research of PPSGG PN-1007 in people and its main purpose is to test its safety and acceptability in patients In this study it will be examined how the drug is changed by and removed from the body and checked for signs that the drug may be truly effective against anti-MAG neuropathy PPSGG PN-1007 will be tested at several different doses
Detailed Description:
PPSGG PN-1007 is intended to bind anti-MAG IgM autoantibodies the underlying cause of anti-MAG neuropathy in a highly selective manner resulting in their neutralization and removal from the circulation This allows specific targeting of anti-MAG IgM in the circulation and circumvents unspecific immunosuppression associated with current treatment strategies
This is a Phase IIIa First in Human FiH multicenter single and multiple ascending dose escalation trial of PPSGG PN-1007 an antibody scavenger of pathogenic anti-MAG immunoglobulin M IgM autoantibodies for treatment of anti-MAG neuropathy The aim of the study is to assess the safety and tolerability pharmacokinetics PK pharmacodynamics PD and preliminary efficacy of PPSGG PN-1007 in a SAD and a MAD phase in an adaptive trial in anti-MAG neuropathy patients
This is a Phase IIIa First in Human FiH multicenter single and multiple ascending dose escalation trial of PPSGG PN-1007 an antibody scavenger of pathogenic anti-MAG immunoglobulin M IgM autoantibodies for treatment of anti-MAG neuropathy The aim of the study is to assess the safety and tolerability pharmacokinetics PK pharmacodynamics PD and preliminary efficacy of PPSGG PN-1007 in a SAD and a MAD phase in an adaptive trial in anti-MAG neuropathy patients
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