Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Haitao Niu, MD
Age
18–65
Sex
MALE
Healthy volunteers
Accepted
You may be eligible if
Provide signed informed consent prior to the trial, and fully understand the trial content, procedures, and potential adverse reactions.
Be able to complete the study as required by the trial protocol.
Be an adult male aged 18-65 years (inclusive).
Have a body weight ≥50 kg and a body mass index (BMI) of 18-30 kg/m² (calculated as BMI = weight \[kg\]/height² \[m²\]).
Neither the subject nor their partner/spouse plan to conceive or donate sperm from screening until 3 months after the trial completion, and agree to use effective non-pharmacological contraception during the study.
You may not be if
Subjects will be excluded if any of the following apply:
Clinically significant abnormalities (physical exam, vital signs, ECG, labs) or severe medical history (cardiac, hepatic, renal, GI, neurological, respiratory, psychiatric, metabolic) deemed unsuitable by the investigator.
History of allergy (≥2 drugs/foods, milk/pollen), or allergy to investigational drug/components.
Alcohol abuse (\>14 units/week) in prior 3 months or positive breathalyzer.
Positive serology for HBsAg, anti-HCV, anti-HIV, or syphilis.
Positive urine drug screen, drug abuse history (past 5 years), or illicit drug use (past 3 months).
Blood loss \>400 mL or platelet donation (2 therapeutic units) in prior 3/1 months, respectively.
Smoking \>5 cigarettes/day (past 3 months) and inability to abstain.
Surgery within prior 3 months.
Participation in another clinical trial (investigational product) within prior 3 months.
Prescription medication use within prior 1 month.
OTC drugs, herbal supplements, or vitamins within prior 48 hours.
Other conditions deemed unsuitable by the investigator.
Clareo Health | Research on PSMA-Targeted Intraoperative Fluorescent Imaging Agents
