Ignite Creation Date:
2024-07-17 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06463782
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-04
Brief Title:
Clinical Study of 68Ga-LNC1007 Injection PETCT
Sponsor:
Yantai LNC Biotechnology Singapore PTE LTD
Organization:
Yantai LNC Biotechnology Singapore PTE LTD
Study Overview
Official Title:
Phase I Clinical Trial of the Safety Pharmacokinetics Biodistribution and Dosimetry of 68Ga-LNC1007 Injection in Adult Healthy Volunteers and Solid Tumor Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 study is a single-arm single-center trial aimed at evaluating the safety pharmacokinetics biodistribution and dosimetry of 68Ga-LNC1007 Injection in adult healthy volunteers and solid tumor patients
All participants must provide a signed informed consent form before enrolling in the trial
A total of 8 adult healthy volunteers and solid tumor patients will be involved in the trial There should be no less than 3 and no more than 5 participants in either group If any participant drops out during the trial or an effective scan image becomes unavailable additional volunteers will be recruited to ensure the sample size The participant will receive a single intravenous injection with 68Ga-LNC1007 InjectionEach subject will participate in the study for approximately 3 weeks including 2 weeks of screening 1 week of scanning and safety follow-up
All participants must provide a signed informed consent form before enrolling in the trial
A total of 8 adult healthy volunteers and solid tumor patients will be involved in the trial There should be no less than 3 and no more than 5 participants in either group If any participant drops out during the trial or an effective scan image becomes unavailable additional volunteers will be recruited to ensure the sample size The participant will receive a single intravenous injection with 68Ga-LNC1007 InjectionEach subject will participate in the study for approximately 3 weeks including 2 weeks of screening 1 week of scanning and safety follow-up
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