Trials Sponsors Conditions Drugs Pricing

Conditions

Cancer Patients Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

Evaluate the safety of 68Ga-LNC1007 Injection.
The safety assessments of this phase I trial are based on systemic safety evaluation. The frequency and severity of Treatment emergent adverse events (TEAE) will be classified according to Common Toxicity Criteria for Adverse Events 5.0. The seriousness and relationship of study treatment will be assessed.
Through study completion, assessed up to 2 years

Secondary Outcomes (4)

Evaluate the radioactivity of 68Ga-LNC1007 Injection.
Through study completion, assessed up to 2 years
Evaluate the metabolites of 68Ga-LNC1007 Injection.
Through study completion, assessed up to 2 years
Evaluate the radioactive counts of each target organ of 68Ga-LNC1007 Injection.
Through study completion, assessed up to 2 years
Evaluate the SUV values of 68Ga-LNC1007 Injection.
Through study completion, assessed up to 2 years

Study Arms (1)

68Ga-LNC1007 Injection

EXPERIMENTAL

a single dose of 68Ga-LNC1007 Injection will be administered

Drug: 68Ga-LNC1007 Injection

Interventions

68Ga-LNC1007 InjectionDrug

The participant will receive a single intravenous injection with 0.05 mCi/kg (according to the participants' body weight) 68Ga-LNC1007 Injection on the scan bed. The final dose of the drug is allowed to fluctuate within the 20% range, but not below 3 mCi. A 10 mL normal saline flush will be given after the completion of the injection to ensure the residue is injected.

68Ga-LNC1007 Injection

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age21 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Understand the study procedures and agree to participate by providing a signed informed consent form.
Be willing and able to comply with all study procedures and restrictions.

Sponsors & Collaborators

Yantai LNC Biotechnology Singapore PTE. LTD.
Industrylead

Study Sites (1)

Clinical Imaging Research Centre (CIRC) ；National University of Singapore.

Singapore, Singapore

Enrollment

8 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: DIAGNOSTIC
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 4, 2024

First Posted

June 18, 2024

Study Start

January 2, 2025

Actual (reported)

Primary Completion

You may not qualify if:

Contraindications to PET/CT scan, which include, but are not limited to, conditions like claustrophobia.
A medical history of epilepsy or seizures, excluding febrile convulsions during childhood.
Blood donation or otherwise major blood loss (\> 400 mL) within 3 months prior to the screening or during the study period.
Active and clinically significant bacterial, fungal, or viral infections, including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness (patients with treated HIV and hepatitis B or C could be included).
Insufficient venous access (two different venous accesses are required for the injection of the experimental drug and PK blood sampling).
Females who are pregnant (positive pregnancy test at screening period), lactating, or have fertility potential (premenopausal or less than 2 years post-menopausal and have not undergone surgical sterilization) and refusal to use effective contraception (such as complete abstinence, condom use, IUD, etc.) during the trial (from the signing of the informed consent form) and three months after administration.
Males with plans for procreation or sperm donation during the trial (from the signing of the informed consent form) and three months after administration. Males who do not wish to take effective contraceptive measures should be excluded as well (such as complete abstinence, condom use, surgical sterilization, etc.).
History of alcohol allergy, polyethylene glycol (PEG) allergy or other allergies that the investigator considers could increase the trial risk.
Radioactive drug imaging or treatment within 7 days prior to screening.
Participation in other clinical trials within the past 1 months before screening visit.
Participation in clinical trials of radiopharmaceuticals within 1 year prior to screening.
History of drug or alcohol abuse within the past year, or a long-term history of illegal drug use.
History of long exposure to high-dose radiation.
Other conditions that the investigator believes make the subject unsuited for participating in the trial. For example, active infections requiring intravenous antibiotic treatment 14 days prior to administration.
Clinically significant disease or medical history as determined by the trial investigator. This includes, but is not limited to:
+10 more criteria

Clinical Study of 68Ga-LNC1007 Injection PET/CT

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

68Ga-LNC1007 Injection

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

68Ga-LNC1007 Injection

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations