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

GE Healthcare9 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Healthy Subjects (HS)

Interventions

DaTSCAN™ Ioflupane (123I) InjectionDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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

Locations (1)

Rujin hospital, affiliated to Shanghai Jiaotong University, School of Medicine

Huangpu, Shanghai Municipality, China

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.