Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
18F-JNJ-64326067 · 1 trial · 1 indication
The Effective Dose (ED) per organ will be calculated using Organ Level Internal Dose Assessment (OLINDA) software. After injection of 370 megaBecquerel (MBq) of 18F-JNJ-64326067, a series of whole-body positron emission tomography (PET) images will be obtained over a period of up to 6 hours and corrected for attenuation by computed tomography (CT) transmission scans using PET/CT. The unit of radioactivity will be milli Sieverts per mega Becquerel (mSv/MBq) for each organ and the effective dose per participant. The final values will be averaged across the participants.
The ED for whole body will be calculated using OLINDA software. After injection of 370 MBq of 18F-JNJ-64326067, a series of whole-body PET images will be obtained over a period of up to 6 hours and corrected for attenuation by CT transmission scans using PET/CT. The unit of radioactivity will be mSv/MBq for the whole body and the effective dose per participant. The final values will be averaged across the participants.
| Arm | Type | Description |
|---|---|---|
| 18F-JNJ-64326067 | EXPERIMENTAL | Participants will receive single intravenous (IV) bolus injection of 18F-JNJ-64326067 on Day 1. |
| Name | Type | Description |
|---|---|---|
| 18F-JNJ-64326067 | DRUG | 18F-JNJ-64326067 will be administered intravenously between a dose of 185 Megabecquerel (MBq) to 370 MBq. |
Inclusion Criteria: * Otherwise healthy for their age group on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening or Day 1 predose. If there are abnormalities, they must be consistent with the age of the study population. This...
18F-JNJ-64326067 is an investigational small molecule positron emission tomography (PET) ligand being developed by Johnson & Johnson (JNJ). It is designed to study whole body distribution and radiation dosimetry in healthy participants. The drug is currently in Phase 1 clinical development and is not approved for any indication.
18F-JNJ-64326067 is used as a PET imaging ligand to investigate whole body distribution and radiation dosimetry in healthy participants. It is being studied in a Phase 1 clinical trial to understand how the compound behaves in the body, which is essential for its potential future use in diagnostic imaging.
18F-JNJ-64326067 is developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker JNJ. The company is conducting clinical research to evaluate the safety and imaging properties of this investigational PET ligand.
18F-JNJ-64326067 is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. It is being studied in a completed Phase 1 trial that evaluated its whole body distribution and radiation dosimetry in healthy participants.
18F-JNJ-64326067 has one completed clinical trial, identified as NCT03581916. This Phase 1 study investigated the whole body distribution and radiation dosimetry of the PET ligand in healthy participants in the United States. The trial enrolled 6 participants and was an uncontrolled, open-label study.