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

NCT ID: NCT04564092

Last Updated: 2023-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-13
• Study Completion Date: 2021-09-04

Brief 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.

Conditions

Healthy Subjects (HS)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

DaTSCAN™ ioflupane (123I) injection

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.

Group Type: EXPERIMENTAL

DaTSCAN™ Ioflupane (123I) Injection

Intervention Type: DRUG

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.

Interventions

DaTSCAN™ Ioflupane (123I) Injection

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.

Intervention Type: DRUG

Other Intervention Names

Ioflupane (123I)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

PPD Development, LP

INDUSTRY

Sponsor Role: collaborator

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Biao LI

Role: PRINCIPAL_INVESTIGATOR

Rujin Hospital

Locations

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

Huangpu, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 37029298 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

GE-001-023

Identifier Type: -

Identifier Source: org_study_id