CompletedPhase 1

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

China9 participantsStarted 2021-05-13

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

What they're measuring

Number of Participants With Adverse Events (AEs)

Timeframe: 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)

Timeframe: 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

Timeframe: 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

Timeframe: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)

Change From Baseline in Hematology Parameter-C Reactive Protein at Pre-specified Timepoints

Timeframe: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)

Change From Baseline in Hematology Parameter-Hematocrit at Pre-specified Timepoints

Timeframe: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)

Trial details

NCT IDNCT04564092

SponsorGE Healthcare

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-09-04

Results submitted2022-09-02

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