None listed
Conditions
Interventions
Drug : There's 1 type of intervention, IP, and all participants will receive a single intravenous administration of the investigational medicinal product [18F]iN1011-N17 at a dose of 370 ± 37 MBq (10
Sponsors
iN Therapeutics
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy adult males aged 19 to 55 years at the time of screening. 2. Individuals with a body weight of 55.0 kg or more and a Body Mass Index (BMI) of 18.0 kg/m² or more and less than 27.0 kg/m² at the time of screening. ? BMI(kg/m2) = Weight (kg) / {Height (m)}² 3. Subjects who have heard a detailed explanation of this clinical trial, fully understood it, voluntarily decided to participate, and provided written informed consent before any screening procedures.
Exclusion criteria
Exclusion criteria: 1. Subjects with a current or past medical history of clinically significant diseases of the hematologic/oncologic, immune, endocrine, psychiatric, neurological, cardiovascular, respiratory, gastrointestinal, hepatobiliary, renal, or urogenital systems. 2. Subjects with a past history of gastrointestinal disorders (e.g., gastric ulcer, gastritis, gastroparesis, gastroesophageal reflux disease, Crohn's disease, etc.) or surgery (excluding simple appendectomy or hernia repair) that could affect the safety evaluation of the investigational medicinal product. 3. Subjects with a history of clinically significant hypersensitivity reactions to the active ingredient ([18F]iN1011-N17) or any excipients of the investigational medicinal product. 4. Subjects with a history of clinically significant hypersensitivity reactions to sulfonamide drugs. 5. Subjects who are deemed unsuitable as study subjects based on the following findings from screening tests conducted within 28 days prior to the administration of the investigational medicinal product: - AST or ALT > 1.5 times the upper limit of normal (ULN). - Estimated Glomerular Filtration Rate (eGFR) 450 ms. - Positive results on serological tests for Hepatitis B virus, Hepatitis C virus, Human Immunodeficiency Virus (HIV), or syphilis. - Vital signs measured in a seated position after resting for at least 3 minutes showing systolic blood pressure > 150 mmHg or 100 mmHg or < 50 mmHg. 6. Subjects who are currently taking or have plan to take P-glycoprotein (P-gp) inhibitors or inducers and cannot discontinue their use from 14 days prior to the first administration of the investigational medicinal product until the end of the clinical trial. - P-gp inhibitors include, but are not limited to: ritonavir, cyclosporine A, ketoconazole, itraconazole, erythromycin, verapamil, quinidine, tacrolimus, nelfinavir, saquinavir, amiodarone, azithromycin, lapatinib, propafenone. - P-gp inducers include, but are not limited to: rifampicin, carbamazepine, phenytoin, phenobarbital, St. John’s wort. 7. Subjects who are currently taking or will be taking CYP2D6 inhibitors or inducers and cannot discontinue their use from 14 days prior to the first administration of the investigational medicinal product until the end of the clinical trial. - CYP2D6 inhibitors include, but are not limited to: fluoxetine, quinidine, paroxetine, mirabegron, bupropion, terbinafine. - CYP2D6 inducers include, but are not limited to: dexamethasone, rifampin. 8. Subjects with a history of drug abuse within 1 year prior to screening or who test positive on a urine drug screen. 9. Subjects who have taken prescription drugs or herbal medicines within 14 days prior to the first administration of the investigational medicinal product, or over-the-counter drugs including health supplements and vitamins within 7 days prior to the first administration, if the investigator determines that the medication could interfere with the study or affect the safety of the subject. 10. Subjects who have participated in another clinical trial and received an investigational medicinal product within 180 days prior to the first administration of the investigational medicinal product in this study. 11. Subjects who have donated whole blood within 60 days prior to the first administration of the investigational medicinal prod
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The whole-body PET scan using [18F]iN1011-N17 will be performed to assess the systemic drug distribution of iN1011-N17, as well as its specific accumulation in the trigeminal ganglia and dorsal root ganglia. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameteres- Primary parameters: Cmax and AUClast of [18F]iN1011-N17. ;Pharmacokinetic parameteres- Secondary parameters: AUCinf, Tmax, t1/2, Vd, and CL of [18F]iN1011-N17;Safety Assessment- Adverse events;Safety Assessment- Physical examination;Safety Assessment- Vital signs: blood pressure, pulse rate, body temperature;Safety Assessment- Clinical laboratory tests: hematology, general chemistry, urinalysis -12-lead electrocardiogram (ECG). | — |
Countries
Korea, Republic of
Contacts
Public ContactHyunjoon Lee
Seoul National University Bundang Hospital
Outcome results
None listed