Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398730
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-23
Brief Title:
A Phase 1 Dose-Escalation Positron Emission Tomography Study to Assess the Safety Pharmacokinetics Dosimetry and Biodistribution of GEH200521 18F Injection Co-Administered With GEH200520 Injection in Healthy Volunteers
Sponsor:
GE Healthcare
Organization:
GE Healthcare
Study Overview
Official Title:
A Phase 1 Single-Center Open-Label Single-Arm Dose-Escalation Positron Emission Tomography Study to Assess the Safety and Tolerability Immunogenicity Pharmacokinetics Dosimetry and Biodistribution Following GEH200521 18F Injection Co-Administered With GEH200520 Injection in Healthy Volunteers
Status:
RECRUITING
Status Verified Date:
2024-07
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:
This is a Phase 1 single-center open-label single-arm dose-escalation positron emission tomography study to assess the safety and tolerability immunogenicity Pharmacokinetics dosimetry and biodistribution after GEH200521 18F Injection is co-administered with GEH200520 Injection in healthy volunteers
The estimated study duration for each subject is approximately 28 days
The primary study objective is to evaluate the safety and tolerability of the IMPs the selected mass doses of GEH200520 Injection co-administered with a fixed dose of GEH200521 18F Injection
The estimated study duration for each subject is approximately 28 days
The primary study objective is to evaluate the safety and tolerability of the IMPs the selected mass doses of GEH200520 Injection co-administered with a fixed dose of GEH200521 18F Injection
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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