Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06523088
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
A Phase 1a Study of PN20 in Healthy Adult Volunteers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1a Study to Evaluate the Safety Tolerability Pharmacokinetics Pharmacodynamics and Immunogenicity of PN20 in Healthy Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main aim of this clinical trial is to assess the safety of PN20 in healthy volunteers aged 18 to 50 years The main questions it aims to answer are
Is PN20 safe in adult Researchers will compare PN20 to a placebo a look-alike substance that contains no drug to see if PN20 is safe
Participants will
Receive a single dose injection of PN20 or placebo according to weight
Stay in hospital for assessment
Is PN20 safe in adult Researchers will compare PN20 to a placebo a look-alike substance that contains no drug to see if PN20 is safe
Participants will
Receive a single dose injection of PN20 or placebo according to weight
Stay in hospital for assessment
Detailed Description:
This is a single center randomized double-blind placebo-controlled dose escalation phase 1 clinical study aiming to evaluate the efficacy safety immunogenicity and pharmacokinetic of PN20 in healthy volunteers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None