NCT06463782

Clinical Study of 68Ga-LNC1007 Injection PET/CT

Phase I Clinical Trial of the Safety, Pharmacokinetics, Biodistribution and Dosimetry of 68Ga-LNC1007 Injection in Adult Healthy Volunteers and Solid Tumor Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Yantai LNC Biotechnology Singapore PTE. LTD. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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 Injection.Each subject will participate in the study for approximately 3 weeks, including 2 weeks of screening, 1 week of scanning and safety follow-up.

Conditions

• Healthy Volunteers
• Cancer Patients

Interventions

Type	Name	Description
DRUG	68Ga-LNC1007 Injection	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.

Timeline

• Start date: 2025-01-02
• Primary completion: 2025-05-27
• Completion: 2025-05-27
• First posted: 2024-06-18
• Last updated: 2025-09-03

Locations

1 site across 1 country: Singapore

Regulatory

• FDA-regulated drug study