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Clinical Study of 68Ga-LNC1007 Injection PET/CT

NCT06463782 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-09-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Yantai LNC Biotechnology Singapore PTE. LTD.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-02
Primary Completion
2025-05-27
Completion
2025-05-27
FDA Drug
Yes

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06463782 on ClinicalTrials.gov