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Healthy VolunteersPhase 1NCT06471712

Clinical Study of 18F-LNC1007 Injection PET/CT

A Phase 1 study testing 18F-LNC1007 Injection in people with Healthy Volunteers and Cancer Patients, run by Yantai LNC Biotechnology Singapore PTE. LTD. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a single-arm, single-center trial aimed at evaluating the pharmacokinetics, bio-distribution, dosimetry, and safety of 18F-LNC1007 injection in healthy volunteers and light tumor burden cancer patients, as defined by <5 lesions on a conventional PET/CT done for clinical purposes and molecular imaging… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers, Cancer Patients
What is being tested?
18F-LNC1007 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteAustralia
Study dates
29 Jul 2024to 2 Mar 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Express willingness and ability to comply with all study procedures and restrictions.
  • Be healthy adult volunteers, or light tumour burden cancer patients, as defined by <5 lesions and MITV of <10ml on a PET/CT performed for clinical purposes. Eligibility includes adults of any gender.
  • Have a Body Mass Index (BMI) between 19-28 (inclusive).
  • Be capable of lying on the scanner for the duration of the PET/CT procedure, which is approximately one hour.
  • Subjects must have an adequate organ function before the administration of the 18F-LNC1007 (in the absence of blood transfusion, hematopoietic stimulating and hepatoprotective agents), as defined by:
  • White blood cell (WBC) count ≥ 3×109/L or absolute neutrophil count (ANC) > 1.5×109/L, platelets ≥ 100×109/L, hemoglobin (Hb) > 10.0g/dL
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  • Serum albumin > 3.0 g/dL, total bilirubin < 1.5×ULN, alanine aminotransferase (ALT) < 3×ULN, aspartate aminotransferase (AST) < 3×ULN
  • Creatinine clearance ≥ 60 mL/min (calculated using the Cockcroft-Gault formula).
  • Provide informed signed consent.
  • All females of childbearing potential (defined as premenopausal or less than 2 years post-menopausal who have not undergone surgical sterilization) must undergo a blood pregnancy test during the screening period (within 7 days before the administration of the drug). The result of the pregnancy test must be negative.

Who cannot join

  • Contraindications to PET/CT scan, which include, but are not limited to, conditions like claustrophobia and pregnancy.
  • A medical history of epilepsy or seizures, excluding febrile convulsions during childhood.
  • Blood donation or experienced major blood loss (> 400 mL) within 3 months prior to the screening or during the study period.
  • For healthy volunteers: participants with a clinically significant disease or medical history as determined by the trial investigator. This includes, but is not limited to:
  • Conditions related to circulatory, respiratory, digestive, urinary, hematological, neurological, endocrine, and musculoskeletal systems.
  • History of mental disorders or any other disease with clinical significance.
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  • History of major surgery or anticipated major surgery within 1 month prior to the screening or during the study period.
  • For healthy volunteers: medical comorbidities that may interfere with the absorption or metabolism of the investigational drug, limit the interpretation of the trial results, and/or are deemed clinically significant by the investigator.
  • For healthy volunteers: abnormal findings in physical examination, vital signs, laboratory tests, or 12-lead ECG during the screening period, considered clinically significant by the investigator (Baseline physical examination, laboratory tests, and 12-lead ECG can accept results from Day -7 to Day -1).
  • For healthy volunteers: use of any prescription drugs, over-the-counter drugs, or traditional herbal medicine within 14 days before administration.
  • 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).
  • Female participants who are pregnant (positive pregnancy test at screening) or lactating, or are of childbearing potential (premenopausal or less than 2 years post-menopausal and have not undergone surgical sterilization), who do not agree to use effective contraception (such as complete abstinence, condom use, IUD, etc.) during the trial (from the signing of the informed consent) and for one month after administration.
  • Male participants with plans for procreation or sperm donation during the trial (from the signing of the informed consent) and one month after administration or who do not wish to take effective contraceptive measures (such as complete abstinence, condom use, surgical sterilization, etc.).
  • Subjects with a history of allergies that the investigator believes could increase the trial risk.
  • Clinically significant abnormalities on electrocardiogram (ECG) at screening including QTcF > 470 ms, and subjects who cannot tolerate high volume load.
  • Subjects who have undergone radioactive drug imaging (other than 18F-FDG) or treatment within 7 days prior to screening.
  • Subjects who have participated in other clinical trials within the past 1 month before the screening visit.
  • Participation in clinical trials of radiopharmaceuticals within 1 year prior to screening.
  • History of long exposure to high-dose radiation.
  • Subjects with a history of drug or alcohol abuse within the past year or a long-term history of drug use.
  • For light tumor burden patients: concurrent anti-cancer treatment;
  • For light tumor burden patients: previous major surgeries or anticipated major surgery within 1 month prior to the screening or during the study period.
  • Other conditions that the investigator believes render the participant not suitable for participating in the trial.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Precision Molecular Imaging & Theranostics (trading as Melbourne Theranostic Innovation Centre)

    Melbourne

Other trials in Australia

About this study

Official title: A Phase I Clinical Trial of 18F-LNC1007 Injection PET/CT in Healthy Volunteers and Light Tumor Burden Patients for Evaluating Its Pharmacokinetics, Biodistribution,Dosimetry and Safety

This study is a single-arm, single-center trial aimed at evaluating the pharmacokinetics, bio-distribution, dosimetry, and safety of 18F-LNC1007 injection in healthy volunteers and light tumor burden cancer patients, as defined by <5 lesions on a conventional PET/CT done for clinical purposes and molecular imaging tumor volume of <10ml.

All participants must provide a signed consent form before enrolling in the trial.

For each participant, the study duration will be about 3 weeks including 2 weeks' screening, 1 week of scanning and safety follow-up.

Being tested
18F-LNC1007 Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 18F-LNC1007 InjectionDrug

    Healthy volunteers will receive 1 MBq/kg and cancer patients will receive 3.7 MBq/kg. The injection will be carried out on the scan bed via an IV indwelling catheter. A 10 mL normal saline flush will be given after the completion of the injection to ensure the residue is injected.

Study groups in NCT06471712
Study groupRoleWhat they receive
18F-LNC1007 InjectionExperimentala single dose of 18F-LNC1007 Injection will be administered
Receives: Drug: 18F-LNC1007 Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the safety of 18F-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.

    Measured: Through study completion, assessed up to 2 years

Secondary outcomes (6)

  1. Evaluate the radioactivity of 18F-LNC1007 injection

    Patient blood samples wil be collected at 5 min , 10min , 30 min , 60 min , 120 min , 180 min , 240 min after the administration of 18F-LNC1007 Injection Patient urine samples at 0-1.5 h, 1.5-3 h and 3-4 h after the administration of 18F-LNC1007.

    All samples will be drawn for radioactivity by a gamma counter.

    Measured: Through study completion, assessed up to 2 years

  2. Evaluate the metabolites of 18F-LNC1007 injection

    Patient blood samples wil be collected at 5 min , 30 min , 60 min , 120 min , 180 min , 240 min after the administration of 18F-LNC1007 Injection Patient urine samples at 0-1.5 h, 1.5-3 h and 3-4 h after the administration of 18F-LNC1007.

    The major metabolites will be conducted by radioHPLC.

    Measured: Through study completion, assessed up to 2 years

  3. Evaluate total source organ counts of 18F-LNC1007 injection

    Total source organ counts based on an individualized VOI template

    Measured: Through study completion, assessed up to 2 years

  4. Evaluate the SUV values of 18F-LNC1007 Injection

    The SUV values (SUVmax, SUVmean) of each organ will be summarized to reflect the biodistribution of 18F-LNC 1007 Injection in the human body.

    Measured: Through study completion, assessed up to 2 years

  5. Evaluate the image quality of 18F-LNC1007 injection

    The imaging variables include scoring of overall quality using Likert 5-point scale and scoring of the noise (coefficient of variance in liver).

    Measured: Through study completion, assessed up to 2 years

  6. Evaluate the effective dose of 18F-LNC1007 injection

    Effective absorbed dose of the major organs (mSv/MBq) and total body effective dose (mSv/MBq)

    Measured: Through study completion, assessed up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2024
  2. Study start29 Jul 2024
  3. Primary completion2 Mar 2025
  4. Study completion2 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06471712
Sponsor's protocol ID
18F-LNC1007-001
Status last verified
Sep 2025
First submitted
4 Jun 2024
Last updated
8 Sep 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 18F-LNC1007 Injection in people with Healthy Volunteers and Cancer Patients, run by Yantai LNC Biotechnology Singapore PTE. LTD. at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the safety of 18F-LNC1007 injection (time frame: Through study completion, assessed up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06471712.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.

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