A Study to Evaluate the Safety, Biodistribution, Internal Radiation Dosimetry, and Effective Dose of DaTSCAN™ Ioflupane (123I) Injection in Chinese Healthy Volunteers.
Condition: Healthy Subjects (HS)
Intervention: DaTSCAN™ Ioflupane (123I) Injection
Intervention description: 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.
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Single photon emission computed tomography (SPECT); Healthy Volunteer (HV)

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.
    

Eligibility criteria:

        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