Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06523101
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
A Study of PJ009 in Healthy Adult Volunteers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Study to Evaluate the Safety Tolerability and Pharmacokinetics of PJ009 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 PJ009 in healthy adult volunteers aged 18-45 The main questions it aims to answer are
Is PJ009 safe in healthy adult Participants will
Receive single dose of PJ009 or placebo according to weight and then multiple doses daily for 7 days
Stay in hospital for assessment
Is PJ009 safe in healthy adult Participants will
Receive single dose of PJ009 or placebo according to weight and then multiple doses daily for 7 days
Stay in hospital for assessment
Detailed Description:
This is a single center randomized double-blind placebo-controlled phase 1 clinical study aiming to evaluate the safety tolerability pharmacokinetics and immunogenicity of PJ009 in healthy adult 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