Phase 1
Completed N=9
A Study to Evaluate the Safety, Biodistribution, Internal Radiation Dosimetry, and Effective Dose of DaTSCAN™ Ioflupane (123I) Injection in Chinese Healthy Volunteers.
Healthy Subjects (HS)
Source: ClinicalTrials.gov NCT04564092 ↗
Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) — 7 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
7 | — |
| PRIMARY 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) |
0.0; 0.1; 0.1; 0.1; 0.0; 0.0 | — |
| PRIMARY Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings Pre-specified Timepoints |
0; 0; 0 | — |
| PRIMARY Change From Baseline in Hematology Parameters at Pre-specified Timepoints |
29.68; -0.40; 0.06; 0.11; 11.75; -0.16 | — |
| PRIMARY Change From Baseline in Hematology Parameter-C Reactive Protein at Pre-specified Timepoints |
0.906; -0.106; -0.219; -0.231 | — |
| PRIMARY Change From Baseline in Hematology Parameter-Hematocrit at Pre-specified Timepoints |
0.4184; -0.0128; 0.0075; -0.0140 | — |
| PRIMARY Change From Baseline in Hematology Parameter-Erythrocytes at Pre-specified Timepoints |
4.711; -0.098; 0.099; -0.143 | — |
| PRIMARY Change From Baseline in Hematology Parameters- Leukocytes, Platelets at Pre-specified Timepoints |
6.933; -0.280; -1.173; -0.384; 255.8; -30.1 | — |
| PRIMARY Change From Baseline in Hematology Parameters- Fibrinogen, Hemoglobin at Pre-specified Timepoints |
2.61; -0.19; -0.08; -0.26; 141.3; -3.3 | — |
| PRIMARY Change From Baseline in Serum Chemistry Parameters- Albumin, Protein at Pre-specified Timepoints |
45.8; -1.3; 0.3; 0.1; 73.3; -2.1 | — |
| PRIMARY Change From Baseline in Serum Chemistry Parameters- Thyroxine, Free and Triiodothyronine, Free at Pre-specified Timepoints |
12.580; -0.208; 4.400; -0.179 | — |
| PRIMARY Change From Baseline in Serum Chemistry Parameters at Pre-specified Timepoints |
17.6; -0.1; -1.6; -1.4; 72.3; -3.9 | — |
| PRIMARY Change From Baseline in Serum Chemistry Parameters- Thyroxine and Triiodothyronine at Pre-specified Timepoints |
91.024; -1.670; 1.458; -0.035 | — |
| PRIMARY Change From Baseline in Serum Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, and Urate at Pre-specified Timepoints |
15.21; -1.54; -1.70; -1.30; 71.9; -10.5 | — |
| PRIMARY Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints |
25.31; 1.04; 1.87; 1.40; 2.355; -0.035 | — |
| PRIMARY Change From Baseline in Serum Chemistry Parameters- Thyrotropin at Pre-specified Timepoints |
2.50395; 0.33034 | — |
| PRIMARY Change From Baseline in Serum Chemistry Parameters- Amylase at Pre-specified Timepoints |
77.1; 18.9; 3.8; 2.0 | — |
| PRIMARY Number of Participants With Clinically Significant Abnormal Urinalysis Parameters - pH and Specific Gravity at Pre-specified Timepoints |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants Who Reported Abnormal Injection Site Monitoring Findings at Pre-specified Timepoints |
— | — |
| PRIMARY Change From Baseline in Vital Sign-Systolic Blood Pressure at Pre-specified Timepoints |
109.6; -3.4; -5.0; -5.8; 1.0; -1.1 | — |
| PRIMARY Change From Baseline in Vital Sign-Diastolic Blood Pressure at Pre-specified Timepoints |
77.8; -3.3; -3.6; -5.5; -2.3; -1.8 | — |
| PRIMARY Change From Baseline in Vital Sign-Heart Rate at Pre-specified Timepoints |
74.4; 0.0; -2.1; -4.6; -5.9; -4.0 | — |
| PRIMARY Change From Baseline in Vital Sign-Temperature at Pre-specified Timepoints |
36.45; 0.14; 0.13; 0.13; 0.13; 0.10 | — |
| PRIMARY Change From Baseline in Vital Sign-Respiratory Rate at Pre-specified Timepoints |
18.4; -0.9; -1.0; -1.4; -1.1; -0.8 | — |
| PRIMARY Change From Baseline in Oxygen Saturation at Pre-specified Timepoints |
98.0; -0.5; 0.0; -0.8; 0.1; 0.1 | — |
| PRIMARY Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints |
161.3; -4.8; -8.8; 93.0; -3.5; -1.0 | — |
| SECONDARY Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Blood (Plasma and Whole Blood) |
0.016; 2.769; 1.686; 1.350; 1.351; 1.375 | — |
| SECONDARY Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image |
0.63; 0.59; 0.59; 0.64; 0.60; 0.45 | — |
| SECONDARY Biodistribution by Source Regions Measured by Decay Corrected Normalized Cumulative Activity |
0.5480; 0.6598; 0.0466; 1.2551; 0.4605; 1.664 | — |
| SECONDARY Biodistribution as Measured by Decay-corrected Cumulative 123I Activity Concentration in Excreted Urine |
0.00; 0.83; 2.76; 4.97; 6.28; 8.37 | — |
| SECONDARY Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry |
0.0157; 0.0217; 0.0092; 0.0301; 0.0240; 0.0132 | — |
| SECONDARY Effective Dose (ED) of Ioflupane (123I) Injection After IV Administration |
0.0280 | — |
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
Data sourced from ClinicalTrials.gov (NCT04564092). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.