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A single-center,single-arm,open-label,first-in-human study to evaluate safety and dosimetry of [18F] AF78 for healthy volunteer(AF78-P1)

Basic Information

Recruitment status	Not Recruiting
Health condition(s) or Problem(s) studied	Healthy volunteer (male)
Date of first enrollment	11/06/2025
Target sample size	4
Countries of recruitment
Study type	Interventional
Intervention(s)	A single dose of [18F]AF78 injection is administered through a pre-secured intravenous route, and images are acquired by PET/CT.

Outcome(s)

Primary Outcome	Accumulation of [18F] AF78 in myocardium and other major organs and its temporal variation
Secondary Outcome	(1) Organ estimated doses and effective dose of [18F]AF78 (2) Safety of [18F]AF78

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 65age old
Gender	Male
Include criteria	Healthy male subjects who meet all the following criteria during the screening test: (1) Aged between 18 and 65 years at the time of consent (2) Height between 160 cm and 183 cm (3) Body weight between 47 kg and 99 kg (4) Body mass index between 18.9 and 30.0 (5) Determined by the principal investigator or sub-investigator, based on physical examination and medical interview, to have no medical conditions that could affect this study (6) Able to provide written informed consent based on sufficient understanding and their voluntary decision (7) Deemed cooperative for the study by the principal investigator or sub-investigator
Exclude criteria	Subjects who meet any of the following conditions will be excluded from the study (1) Presence of any disease that may affect the study (2) History of disease, including prior organ resection, that may affect the study (3) Drug dependence (4) Habitual heavy alcohol consumption (daily intake of pure alcohol >=40 g) (5) Excessive alcohol consumption (>=60 g of pure alcohol in a single day) within 7 days prior to the PET exam (6) Presence of abnormal findings in the screening test that are deemed to affect the study by the investigator (7) Planned to engage in strenuous exercise within 24 hours before the administration of [18F]AF78 (8) Blood donation of >=200 mL within 10 days before the PET scan (9) Alcohol sensitivity (10) Claustrophobia preventing the subject from entering the PET/CT scanner (11) Inability to maintain a supine position for 90 consecutive minutes (12) Estimated medical radiation exposure exceeding 20 mSv over the past five years (13) Participation in another clinical study (including interventional clinical trials) at the time of consent (14) Any other condition that the principal investigator or sub-investigator considers inappropriate for study participation