Healthy Subjects (HS)Phase 1NCT04564092

A Study to Evaluate the Safety, Biodistribution, Internal Radiation Dosimetry, and Effective Dose of DaTSCAN™ Ioflupane (123I) Injection in Chinese Healthy Volunteers.

A Phase 1 study testing DaTSCAN™ Ioflupane (123I) Injection in people with Healthy Subjects (HS), run by GE Healthcare at 1 site in China.

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 is a phase 1, single-centre, single-group, nonrandomized, noncomparative, open-label, single-dose study to evaluate the safety, biodistribution, internal radiation dosimetry, and effective dose of DaTSCAN™ ioflupane (123I) injection in Chinese Healthy Volunteers. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Subjects (HS)
What is being tested?: DaTSCAN™ Ioflupane (123I) Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteChina
Study dates: 13 May 2021to 4 Sep 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Chinese male or female who has agreed to sign and date the written informed consent form
Age 18-70 years
Body mass index (BMI) of 18-30 kg/m^2
General good state of health as judged by a qualified physician after completing physical examination
Fit, co-operative, and able to provide consent

Who cannot join

Sensitivity to DaTSCAN™ ioflupane (123I) injection or any of its ingredients
A history of motor disturbances
A history of pulmonary, cardiovascular, neurological, renal or hepatic, hormonal or coagulation disorders or hyperthyroidism
A history of drug, alcohol, or solvent abuse
The subject has been previously enrolled in this study or participated in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening
Radionuclide injection within a minimum of 5 radioactive half-lives prior to screening

Show all 10Show fewer

Use of any medication (except paracetamol [acetaminophen] or oral contraceptive), including traditional Chinese medicine, within 2 weeks prior to the imaging visit
Classification as a radiation worker
Women of child-bearing potential not accepting a highly effective method of birth control (A woman is considered of child-bearing potential, i.e., fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Postmenopausal is defined as 12 months with no menses without an alternative medical cause, in International Council on Harmonisation (ICH) M3 (R2); A highly effective method of birth control is defined as one which results in a low failure rate (i.e., less than 1 % per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomised partner, in ICH M3 (R2).
Pregnant or lactating women

Trial locations and contacts

1 site in 1 country.

China1 site

Rujin hospital, affiliated to Shanghai Jiaotong University, School of Medicine
Huangpu, Shanghai Municipality, 200025

Other trials in China

About this study

Official title: A Phase 1, Non-randomised, Noncomparative, Open-label Study to Assess the Safety, Biodistribution, and Internal Radiation Dosimetry of a Single Dose of DaTSCAN™ Ioflupane (123I) Injection in Chinese Healthy Volunteers

Conditions: Healthy Subjects (HS)
Being tested: DaTSCAN™ Ioflupane (123I) Injection
Keywords: Single photon emission computed tomography (SPECT), Healthy Volunteer (HV)

What participants receive

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

DaTSCAN™ Ioflupane (123I) InjectionDrug
Also called Ioflupane (123I)
Each participant will receive a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV injection with a nominal iodine (123I) activity of 111 MBq ±10%, in a maximum volume of 5 mL.

Study groups in NCT04564092
Study group	Role	What they receive
DaTSCAN™ ioflupane (123I) injection	Experimental	Participants will receive a single intravenous (IV) injection of DaTSCAN™ ioflupane (123I) injection into an arm vein, followed by planar whole-body imaging at prespecified time points over a period of 48 hours after administration. Brain SPECT imaging will be acquired at 3 and 6 hours after administration. Receives: Drug: DaTSCAN™ Ioflupane (123I) Injection

What is being measured

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

Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in participants or clinical investigation participant which did not necessarily have to have been related to the investigational medical product (IMP). AEs were recorded from time of informed consent through the follow-up visit at 2 weeks (±2 days) after IMP administration.
Measured: Baseline up to 2 weeks after IMP administration (i.e., up to 16 days)
Change From Baseline in Tolerability Questionnaire Score at Approximately 15 Minutes, 1, 4, 24, 48 Hours After DaTSCAN™ Ioflupane (123I) Injection as Measured by VAS (Visual Analogue Scale)
Tolerability questionnaire evaluated participants mood, pain at injection site, itchiness of injection site, loss of function at injection site and quality of sleep using 100 millimeter (mm) VAS. VAS is a continuous scale comprised of a horizontal line, usually 100 mm in length, where "0" stands for bad, and 100 mm stands for good. Higher score indicated better health outcomes.
Measured: 1 hour before injection (baseline), and at approximately 15 minutes, 1, 4, 24, 48 hours after DaTSCAN™ ioflupane (123I) injection
Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings Pre-specified Timepoints
Physical examination included recording an assessment for the presence of abnormalities of the following: general appearance, skin, lungs, cardiovascular system, back and spine, abdomen, extremities, lymph nodes, and neurological exam. Clinical significance was determined by investigator.
Measured: Baseline, 4 hours after injection and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change From Baseline in Hematology Parameters at Pre-specified Timepoints
Change from baseline in activated partial thromboplastin time, prothrombin time, thrombin time were reported.
Measured: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change From Baseline in Hematology Parameter-C Reactive Protein at Pre-specified Timepoints
Change from baseline in C reactive protein were reported.
Measured: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change From Baseline in Hematology Parameter-Hematocrit at Pre-specified Timepoints
Change from baseline in hematocrit were reported.
Measured: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change From Baseline in Hematology Parameter-Erythrocytes at Pre-specified Timepoints
Change from baseline in erythrocytes were reported.
Measured: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change From Baseline in Hematology Parameters- Leukocytes, Platelets at Pre-specified Timepoints
Change from baseline in leukocytes, platelets timepoints were reported.
Measured: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change From Baseline in Hematology Parameters- Fibrinogen, Hemoglobin at Pre-specified Timepoints
Change from baseline in fibrinogen, hemoglobin were reported.
Measured: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change From Baseline in Serum Chemistry Parameters- Albumin, Protein at Pre-specified Timepoints
Change from baseline in albumin, protein were reported.
Measured: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change From Baseline in Serum Chemistry Parameters- Thyroxine, Free and Triiodothyronine, Free at Pre-specified Timepoints
Change from baseline in thyroxine, free and triiodothyronine, free were reported.
Measured: Baseline, and at 48 hours after DaTSCAN™ ioflupane (123I) injection
Change From Baseline in Serum Chemistry Parameters at Pre-specified Timepoints
Change from baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase, gamma glutamyl transferase, lactate dehydrogenase were reported.
Measured: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change From Baseline in Serum Chemistry Parameters- Thyroxine and Triiodothyronine at Pre-specified Timepoints
Change from baseline in thyroxine and triiodothyronine were reported.
Measured: Baseline, and at 48 hours after DaTSCAN™ ioflupane (123I) injection
Change From Baseline in Serum Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, and Urate at Pre-specified Timepoints
Change from baseline in bilirubin, creatinine, direct bilirubin, and urate were reported.
Measured: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints
Change from baseline in bicarbonate, calcium, chloride, glucose, phosphate, potassium, sodium, urea nitrogen were reported.
Measured: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change From Baseline in Serum Chemistry Parameters- Thyrotropin at Pre-specified Timepoints
Change from baseline in thyrotropin were reported.
Measured: Baseline, and at 48 hours after DaTSCAN™ ioflupane (123I) injection
Change From Baseline in Serum Chemistry Parameters- Amylase at Pre-specified Timepoints
Change from baseline in amylase were reported.
Measured: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Number of Participants With Clinically Significant Abnormal Urinalysis Parameters - pH and Specific Gravity at Pre-specified Timepoints
Number of participants with clinically significant abnormal pH and specific gravity were reported. Clinical significance was determined by investigator.
Measured: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Number of Participants Who Reported Abnormal Injection Site Monitoring Findings at Pre-specified Timepoints
Any radiopharmaceutical extravasation, bleeding, hematoma, redness, infection, or other findings were considered as abnormal findings.
Measured: Baseline, up to 4 hours after DaTSCAN™ ioflupane (123I) injection
Change From Baseline in Vital Sign-Systolic Blood Pressure at Pre-specified Timepoints
Change from baseline in systolic blood pressure were reported.
Measured: Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change From Baseline in Vital Sign-Diastolic Blood Pressure at Pre-specified Timepoints
Change from baseline in diastolic blood pressure were reported.
Measured: Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change From Baseline in Vital Sign-Heart Rate at Pre-specified Timepoints
Change from baseline in heart rate were reported.
Measured: Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change From Baseline in Vital Sign-Temperature at Pre-specified Timepoints
Change from baseline in temperature were reported.
Measured: Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change From Baseline in Vital Sign-Respiratory Rate at Pre-specified Timepoints
Change from baseline in respiratory rate were reported.
Measured: Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change From Baseline in Oxygen Saturation at Pre-specified Timepoints
Change from baseline in oxygen saturation were reported.
Measured: Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints
Change from baseline in PR interval, QRS interval, QT interval, QTC interval, RR interval, QTCF interval, QTCB interval were reported.
Measured: Baseline, 2 and 5 hours after DaTSCAN™ ioflupane (123I) injection

Secondary outcomes (6)

Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Blood (Plasma and Whole Blood)
The decay-corrected %IA was measured by planar scintigraphy. The biodistribution as measured by the decay-corrected %IA in the plasma and whole blood at specified timepoints were reported.
Measured: Pre-dose, 5, 15, 30 minutes and 1, 2, 3, 4, 5, 24, and 48 hours after DaTSCAN™ ioflupane (123I) injection
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
The decay-corrected %IA was measured by planar scintigraphy. The biodistribution as measured by the decay-corrected %IA in the whole-body image which included background, heart, intestines, liver, lungs, salivary glands, stomach, striatum, thyroid, whole body, whole brain) at specified timepoints were reported.
Measured: 10 minutes and 1, 2, 4, 5, 24, and 48 hours after DaTSCAN™ ioflupane (123I) injection
Biodistribution by Source Regions Measured by Decay Corrected Normalized Cumulative Activity
Biodistribution measured by decay corrected normalized cumulative activity in bladder content, brain, gallbladder, liver, lower large intestine, lungs, remainder, small intestine, upper large intestine was reported.
Measured: Up to 48 hours after DaTSCAN™ ioflupane (123I) injection
Biodistribution as Measured by Decay-corrected Cumulative 123I Activity Concentration in Excreted Urine
Excretion of 123I following the IV administration of ioflupane (123I) Injection was determined by measuring the 123I activity within the intestinal contents and the sum of the 123I activities in the voided urine up to 48 hours post-injection.
Measured: 10 minutes and 1, 2, 3, 4, 5, 5 to 24, and 24 to 48 hours after DaTSCAN™ ioflupane (123I) injection
Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry
Sex-averaged normalized organ absorbed doses calculated according to Medical Internal Radiation Dose (MIRD) method.
Measured: Up to 48 hours after DaTSCAN™ ioflupane (123I) injection
Effective Dose (ED) of Ioflupane (123I) Injection After IV Administration
The ED per unit of administered activity was evaluated from the ensemble of absorbed dose data.
Measured: Up to 48 hours after DaTSCAN™ ioflupane (123I) injection

Timeline

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

13 May 20214 Sep 2021

First posted25 Sep 2020
Study start13 May 2021
Primary completion4 Sep 2021
Study completion4 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy Subjects (HS)Studies of the same condition, open and under way.
More trials run by GE HealthcareThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04564092
Sponsor's protocol ID: GE-001-023
Status last verified: Aug 2023
First submitted: 30 Jul 2020
Last updated: 2 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Zhang M, Wang Y, Wang J, Li X, Li B. Safety, biodistribution and radiation dosimetry of [123I]ioflupane in healthy Chinese volunteers. EJNMMI Res. 2023 Apr 7;13(1):30. doi: 10.1186/s13550-023-00978-3.
PubMed 37029298

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Non-randomised, Noncomparative, Open-label Study to Assess the Safety, Biodistribution, and Internal Radiation Dosimetry of a Single Dose of DaTSCAN™ Ioflupane (123I) Injection in Chinese Healthy Volunteers
ClinicalTrials.gov ID: NCT04564092
Acronym / sponsor ID: GE-001-023
Conditions: Healthy Subjects (HS)
Keywords: Single photon emission computed tomography (SPECT), Healthy Volunteer (HV)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 9 participants (actual)
Lead sponsor: GE HealthcareIndustry (pharma, biotech, devices)
Collaborators: PPD Development, LP
Study start: 13 May 2021 (actual)
Primary completion: 4 Sep 2021 (actual)
Study completion: 4 Sep 2021 (actual)
First posted: 25 Sep 2020 (actual)
Results: Posted 2 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
DaTSCAN™ ioflupane (123I) injection	Experimental	Drug: DaTSCAN™ Ioflupane (123I) InjectionParticipants will receive a single intravenous (IV) injection of DaTSCAN™ ioflupane (123I) injection into an arm vein, followed by planar whole-body imaging at prespecified time points over a period of 48 hours after administration. Brain SPECT imaging will be acquired at 3 and 6 hours after administration.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Chinese male or female who has agreed to sign and date the written informed consent form
Age 18-70 years
Body mass index (BMI) of 18-30 kg/m^2
General good state of health as judged by a qualified physician after completing physical examination
Fit, co-operative, and able to provide consent

Key exclusion criteria (10 listed)

Sensitivity to DaTSCAN™ ioflupane (123I) injection or any of its ingredients
A history of motor disturbances
A history of pulmonary, cardiovascular, neurological, renal or hepatic, hormonal or coagulation disorders or hyperthyroidism
A history of drug, alcohol, or solvent abuse
The subject has been previously enrolled in this study or participated in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DaTSCAN™ Ioflupane (123I) InjectionAlso: Ioflupane (123I)Each participant will receive a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV injection with a nominal iodine (123I) activity of 111 MBq ±10%, in a maximum volume of 5 mL.	Drug	DaTSCAN™ ioflupane (123I) injection

Primary outcome

Number of Participants With Adverse Events (AEs)
Time frame: Baseline up to 2 weeks after IMP administration (i.e., up to 16 days)
An AE was defined as any untoward medical occurrence in participants or clinical investigation participant which did not necessarily have to have been related to the investigational medical product (IMP). AEs were recorded from time of informed consent through the follow-up visit at 2 weeks (±2 days) after IMP administration.
Change From Baseline in Tolerability Questionnaire Score at Approximately 15 Minutes, 1, 4, 24, 48 Hours After DaTSCAN™ Ioflupane (123I) Injection as Measured by VAS (Visual Analogue Scale)
Time frame: 1 hour before injection (baseline), and at approximately 15 minutes, 1, 4, 24, 48 hours after DaTSCAN™ ioflupane (123I) injection
Tolerability questionnaire evaluated participants mood, pain at injection site, itchiness of injection site, loss of function at injection site and quality of sleep using 100 millimeter (mm) VAS. VAS is a continuous scale comprised of a horizontal line, usually 100 mm in length, where "0" stands for bad, and 100 mm stands for good. Higher score indicated better health outcomes.
Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings Pre-specified Timepoints
Time frame: Baseline, 4 hours after injection and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Physical examination included recording an assessment for the presence of abnormalities of the following: general appearance, skin, lungs, cardiovascular system, back and spine, abdomen, extremities, lymph nodes, and neurological exam. Clinical significance was determined by investigator.
Change From Baseline in Hematology Parameters at Pre-specified Timepoints
Time frame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change from baseline in activated partial thromboplastin time, prothrombin time, thrombin time were reported.
Change From Baseline in Hematology Parameter-C Reactive Protein at Pre-specified Timepoints
Time frame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change from baseline in C reactive protein were reported.
Change From Baseline in Hematology Parameter-Hematocrit at Pre-specified Timepoints
Time frame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change from baseline in hematocrit were reported.
Change From Baseline in Hematology Parameter-Erythrocytes at Pre-specified Timepoints
Time frame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change from baseline in erythrocytes were reported.
Change From Baseline in Hematology Parameters- Leukocytes, Platelets at Pre-specified Timepoints
Time frame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change from baseline in leukocytes, platelets timepoints were reported.
Change From Baseline in Hematology Parameters- Fibrinogen, Hemoglobin at Pre-specified Timepoints
Time frame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change from baseline in fibrinogen, hemoglobin were reported.
Change From Baseline in Serum Chemistry Parameters- Albumin, Protein at Pre-specified Timepoints
Time frame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change from baseline in albumin, protein were reported.
Change From Baseline in Serum Chemistry Parameters- Thyroxine, Free and Triiodothyronine, Free at Pre-specified Timepoints
Time frame: Baseline, and at 48 hours after DaTSCAN™ ioflupane (123I) injection
Change from baseline in thyroxine, free and triiodothyronine, free were reported.
Change From Baseline in Serum Chemistry Parameters at Pre-specified Timepoints
Time frame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change from baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase, gamma glutamyl transferase, lactate dehydrogenase were reported.
Change From Baseline in Serum Chemistry Parameters- Thyroxine and Triiodothyronine at Pre-specified Timepoints
Time frame: Baseline, and at 48 hours after DaTSCAN™ ioflupane (123I) injection
Change from baseline in thyroxine and triiodothyronine were reported.
Change From Baseline in Serum Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, and Urate at Pre-specified Timepoints
Time frame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change from baseline in bilirubin, creatinine, direct bilirubin, and urate were reported.
Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints
Time frame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change from baseline in bicarbonate, calcium, chloride, glucose, phosphate, potassium, sodium, urea nitrogen were reported.
Change From Baseline in Serum Chemistry Parameters- Thyrotropin at Pre-specified Timepoints
Time frame: Baseline, and at 48 hours after DaTSCAN™ ioflupane (123I) injection
Change from baseline in thyrotropin were reported.
Change From Baseline in Serum Chemistry Parameters- Amylase at Pre-specified Timepoints
Time frame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change from baseline in amylase were reported.
Number of Participants With Clinically Significant Abnormal Urinalysis Parameters - pH and Specific Gravity at Pre-specified Timepoints
Time frame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Number of participants with clinically significant abnormal pH and specific gravity were reported. Clinical significance was determined by investigator.
Number of Participants Who Reported Abnormal Injection Site Monitoring Findings at Pre-specified Timepoints
Time frame: Baseline, up to 4 hours after DaTSCAN™ ioflupane (123I) injection
Any radiopharmaceutical extravasation, bleeding, hematoma, redness, infection, or other findings were considered as abnormal findings.
Change From Baseline in Vital Sign-Systolic Blood Pressure at Pre-specified Timepoints
Time frame: Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change from baseline in systolic blood pressure were reported.
Change From Baseline in Vital Sign-Diastolic Blood Pressure at Pre-specified Timepoints
Time frame: Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change from baseline in diastolic blood pressure were reported.
Change From Baseline in Vital Sign-Heart Rate at Pre-specified Timepoints
Time frame: Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change from baseline in heart rate were reported.
Change From Baseline in Vital Sign-Temperature at Pre-specified Timepoints
Time frame: Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change from baseline in temperature were reported.
Change From Baseline in Vital Sign-Respiratory Rate at Pre-specified Timepoints
Time frame: Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change from baseline in respiratory rate were reported.
Change From Baseline in Oxygen Saturation at Pre-specified Timepoints
Time frame: Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change from baseline in oxygen saturation were reported.
Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints
Time frame: Baseline, 2 and 5 hours after DaTSCAN™ ioflupane (123I) injection
Change from baseline in PR interval, QRS interval, QT interval, QTC interval, RR interval, QTCF interval, QTCB interval were reported.

6 secondary outcomes

Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Blood (Plasma and Whole Blood)
Time frame: Pre-dose, 5, 15, 30 minutes and 1, 2, 3, 4, 5, 24, and 48 hours after DaTSCAN™ ioflupane (123I) injection
Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image
Time frame: 10 minutes and 1, 2, 4, 5, 24, and 48 hours after DaTSCAN™ ioflupane (123I) injection
Biodistribution by Source Regions Measured by Decay Corrected Normalized Cumulative Activity
Time frame: Up to 48 hours after DaTSCAN™ ioflupane (123I) injection
Biodistribution as Measured by Decay-corrected Cumulative 123I Activity Concentration in Excreted Urine
Time frame: 10 minutes and 1, 2, 3, 4, 5, 5 to 24, and 24 to 48 hours after DaTSCAN™ ioflupane (123I) injection
Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry
Time frame: Up to 48 hours after DaTSCAN™ ioflupane (123I) injection
Effective Dose (ED) of Ioflupane (123I) Injection After IV Administration
Time frame: Up to 48 hours after DaTSCAN™ ioflupane (123I) injection

Results and safety

Results posted to the registry on 2 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DaTSCAN™ Ioflupane (123I) Injection	9	8

Primary outcome: Number of Participants With Adverse Events (AEs)

Time frame: Baseline up to 2 weeks after IMP administration (i.e., up to 16 days). Count of participants. Unit: Participants

Measure	DaTSCAN™ Ioflupane (123I) Injection n = 8
Value	7

Population analysed: The safety population included all participants who received ioflupane (123I) injection.

Primary outcome: Change From Baseline in Tolerability Questionnaire Score at Approximately 15 Minutes, 1, 4, 24, 48 Hours After DaTSCAN™ Ioflupane (123I) Injection as Measured by VAS (Visual Analogue Scale)

Time frame: 1 hour before injection (baseline), and at approximately 15 minutes, 1, 4, 24, 48 hours after DaTSCAN™ ioflupane (123I) injection. Mean (Standard Deviation). Unit: millimeter (mm)

Measure	DaTSCAN™ Ioflupane (123I) Injection n = 8
Itchiness of Injection Site: At Baseline	0.0 (0.00)
Itchiness of Injection Site: Change at 15 minutes	0.1 (0.35)
Itchiness of Injection Site: Change at 1 hour	0.1 (0.35)
Itchiness of Injection Site: Change at 4 hours	0.1 (0.35)
Itchiness of Injection Site: Change at 24 hours	0.0 (0.00)
Itchiness of Injection Site: Change at 48 hours	0.0 (0.00)
Loss of Function at Injection Site: At Baseline	0.0 (0.00)
Loss of Function at Injection Site: Change at 15 minutes	0.0 (0.00)

Population analysed: The safety population included all participants who received ioflupane (123I) injection. Here, number analyzed signifies participants who were evaluable for given categories at specified timepoints and "0" in the number analyzed field denotes that none of the participants were assessed at the specified timepoint.

Primary outcome: Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings Pre-specified Timepoints

Time frame: Baseline, 4 hours after injection and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days). Count of participants. Unit: Participants

Measure	DaTSCAN™ Ioflupane (123I) Injection n = 8
At Baseline	0
At 4 hours	0
At 2 weeks	0

Population analysed: The safety population included all participants who received ioflupane (123I) injection.

Primary outcome: Change From Baseline in Hematology Parameters at Pre-specified Timepoints

Time frame: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days). Mean (Standard Deviation). Unit: seconds

Measure	DaTSCAN™ Ioflupane (123I) Injection n = 8
Activated Partial Thromboplastin Time: At Baseline	29.68 (2.241)
Activated Partial Thromboplastin Time: Change at 3 Hours	-0.40 (2.316)
Activated Partial Thromboplastin Time: Change at 48 Hours	0.06 (2.410)
Activated Partial Thromboplastin Time: Change at 2 weeks	0.11 (2.395)
Prothrombin Time: At Baseline	11.75 (0.472)
Prothrombin Time: Change at 3 Hours	-0.16 (0.715)
Prothrombin Time: Change at 48 Hours	0.06 (0.370)
Prothrombin Time: Change at 2 weeks	0.28 (0.365)

Population analysed: The safety population included all participants who received ioflupane (123I) injection.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to 2 weeks after IMP administration (i.e., up to 16 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DaTSCAN™ Ioflupane (123I) Injection	0 of 8 (0%)	7 of 8 (87.5%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37029298Zhang M, Wang Y, Wang J, Li X, Li B. Safety, biodistribution and radiation dosimetry of [123I]ioflupane in healthy Chinese volunteers. EJNMMI Res. 2023 Apr 7;13(1):30. doi: 10.1186/s13550-023-00978-3.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Biao LI principal investigator

Rujin Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DaTSCAN™ Ioflupane (123I) Injection in people with Healthy Subjects (HS), run by GE Healthcare at 1 site in China.

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 5 inclusion and 10 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 2 Aug 2023. 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 China. 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?

Yes. Results are posted in the registry (first posted 2 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Adverse Events (AEs) (time frame: Baseline up to 2 weeks after IMP administration (i.e., up to 16 days)). The study lists 26 primary outcomes in all. 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 NCT04564092, which also lists 1 linked publication.

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 2 Aug 2023.