to Assess the Safety of Ga68-Dolacga Injection in Healthy Volunteers

Ga-68 is a positron-emitting radionuclide with short half-life of 68 minutes. Dolacga is a non-radiolabeled formulated drug product and will be reconstituted to become the finished radiopharmaceutical product Ga68-Dolacga Injection, a PET tracer specifically targeting to surface receptors of hepatocytes. The study aims to evaluate the safety of Ga68-Dolacga Injection in healthy volunteers and to assess the normal reference range and inter-individual variability of the Ga68-Dolacga Injection in estimating liver reserve in healthy volunteers.

Inclusion criteria

• Written informed consent must be obtained before any assessment is performed.
• Male or female subjects aged 20 or above, inclusive, at date of consent.
• Body mass index (BMI) between 18.5 and 23.0, inclusive, (BMI will be calculated as weight in kilogram [kg]/height in meters2 [m2])
• Female subjects must be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral oophorectomy, or tubal ligation) or post-menopausal for at least 1 year or, if they are of child-bearing potential, must commit to use a barrier contraception method for the duration of the study.
• Male subjects and their partners of childbearing potential must commit to the use of two methods of contraception, one of which is a barrier method for male subjects for the study duration.
• Male subjects must not donate sperm for the study duration.
• Willing and able to cooperate with study procedures
• Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, and ECG
• Laboratory values within reference range, unless values are deemed by the Principal Investigator as "Not Clinically Significant"
• Negative result for hepatitis B and C antigen test

Exclusion criteria

• Known or suspected allergy, hypersensitivity, or intolerance to any ingredients of study product as stated in this protocol
• Implantation of metal devices including cardiac pacemaker, intravascular metal devices
• Current or prior history of major psychiatric disorders, epilepsy and major depression
• History of positive test for human immunodeficiency virus (HIV)
• History of chronic alcohol or drug abuse within the last 6 months
• Pregnant women, lactating or breast-feeding women
• Clinically significant abnormal laboratory values and/or clinically significant or unstable medical illness
• General PET exclusion criteria
• Prior participation in nuclear medicine treatments or computer tomography examinations in the last year
• Subject has received an investigational drug or device within 30 days of screening.
• Subjects having high risks for the study according to the PI discretion
• Subjects who can't be followed up for any reason