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

General Electric (GE)

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects (HS)

Treatments: Drug: DaTSCAN™ Ioflupane (123I) Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT04564092

GE-001-023

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

DaTSCAN™ ioflupane (123I) injection

Experimental group

Description:

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.

Treatment:

Drug: DaTSCAN™ Ioflupane (123I) Injection