Ignite Creation Date:
2024-10-25 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06527781
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
A Study of PD5K3 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 PD5K3 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 PD5K3 in patients aged 18 to 65 years The main questions it aims to answer are
Is PD5K3 safe in adult Researchers will compare PD5K3 to an active comparator pegaspargase to see if PD5K3 is safe and active in human
Participants will
Receive a single dose injection of PD5K3 pegaspargase or placebo according to weight
Visit the clinic for assessment
Is PD5K3 safe in adult Researchers will compare PD5K3 to an active comparator pegaspargase to see if PD5K3 is safe and active in human
Participants will
Receive a single dose injection of PD5K3 pegaspargase or placebo according to weight
Visit the clinic for assessment
Detailed Description:
This study is a first-in-human study which is a single-center randomized placebo-controlled double-blind dose escalation clinical study aiming to evaluate the safety tolerability pharmacokinetics pharmacodynamics and immunogenicity of PD5K3 in healthy adult volunteers compared with pegaspargase at the same dose
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