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

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.

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.

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 activated partial thromboplastin time, prothrombin time, thrombin time were reported.

Change from baseline in C reactive protein were reported.

Change from baseline in hematocrit were reported.

Change from baseline in erythrocytes were reported.

Change from baseline in leukocytes, platelets timepoints were reported.

Change from baseline in fibrinogen, hemoglobin were reported.

Change from baseline in albumin, protein were reported.

Change from baseline in thyroxine, free and triiodothyronine, free were reported.

Change from baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase, gamma glutamyl transferase, lactate dehydrogenase were reported.

Change from baseline in thyroxine and triiodothyronine were reported.

Change from baseline in bilirubin, creatinine, direct bilirubin, and urate were reported.

Change from baseline in bicarbonate, calcium, chloride, glucose, phosphate, potassium, sodium, urea nitrogen were reported.

Change from baseline in thyrotropin were reported.

Change from baseline in amylase were reported.

Number of participants with clinically significant abnormal pH and specific gravity were reported. Clinical significance was determined by investigator.

Any radiopharmaceutical extravasation, bleeding, hematoma, redness, infection, or other findings were considered as abnormal findings.

Change from baseline in systolic blood pressure were reported.

Change from baseline in diastolic blood pressure were reported.

Change from baseline in heart rate were reported.

Change from baseline in temperature were reported.

Change from baseline in respiratory rate were reported.

Change from baseline in oxygen saturation were reported.

Change from baseline in PR interval, QRS interval, QT interval, QTC interval, RR interval, QTCF interval, QTCB interval were reported.

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.

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.

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.

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.

Sex-averaged normalized organ absorbed doses calculated according to Medical Internal Radiation Dose (MIRD) method.

The ED per unit of administered activity was evaluated from the ensemble of absorbed dose data.