Clinical trial NCT03908957: to Assess the Safety of Ga68-Dolacga Injection in Healthy Volunteers
Official title: An Open-label Phase I Clinical Trial to Assess the Safety of Ga68-Dolacga Injection in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Safety Issues
Lead sponsor: National Atomic Research Institute, Taiwan
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a phase 1 study 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Written informed consent must be obtained before any assessment is performed.
2. Male or female subjects aged 20 or above, inclusive, at date of consent.
3. Body mass index (BMI) between 18.5 and 23.0, inclusive, (BMI will be calculated as weight in kilogram \[kg\]/height in meters2 \[m2\])
4. 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.
5. 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.
6. Male subjects must not donate sperm for the study duration.
7. Willing and able to cooperate with study procedures
8. Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, and ECG
9. Laboratory values within reference range, unless values are deemed by the Principal Investigator as "Not Clinically Significant"
10. Negative result for hepatitis B and C antigen test

Exclusion Criteria:

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

Primary outcomes:
measure: Number of subjects reporting clinically significant changes in serum biochemical tests
timeFrame: from pre-dose to 14±2 days post dose
measure: Number of subjects reporting clinically significant changes in hematological tests
timeFrame: from pre-dose to 14±2 days post dose
measure: Number of subjects reporting clinically significant changes in urinalysis
timeFrame: from pre-dose to 14±2 days post dose
measure: Number of subjects with clinically significant changes in systolic blood pressure and diastolic blood pressure
timeFrame: from pre-dose to 14±2 days post dose
measure: Number of subjects with body temperature abnormalities
timeFrame: from pre-dose to 14±2 days post dose
measure: Abnormalities of physical examination in visit 2 (post-treatment) compared with visit 1
timeFrame: visit 2 (Day 1)
measure: Number of subjects with clinically significant changes in Heart Rate
timeFrame: from pre-dose to 14±2 days post dose
measure: Number of subjects with clinically significant changes in electrocardiogram(ECG)
timeFrame: from pre-dose to 14±2 days post dose
measure: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 14 days
Secondary outcomes:
measure: Establishment of the normal reference range of the percent of injection dose (%ID) in healthy liver
timeFrame: up to 60 minutes after administration of Ga68-Dolacga Injection
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yao-Ming Wu, MD
role: PRINCIPAL_INVESTIGATOR
References: