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

NCT ID: NCT03908957

Last Updated: 2020-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-12
• Study Completion Date: 2019-08-09

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.

Conditions

Safety Issues

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Ga68-Dolacga Injection

The healthy volunteer was injected with Ga68-Dolacga Injection iv and performed PET imaging for liver reserve evaluation.

Group Type: EXPERIMENTAL

Ga68-Dolacga Injection

Intervention Type: DRUG

Ga68-Dolacga Injection, 3.5±0.25 mCi, single dose iv

Interventions

Ga68-Dolacga Injection

Ga68-Dolacga Injection, 3.5±0.25 mCi, single dose iv

Intervention Type: DRUG

Other Intervention Names

Ga68-INER038

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

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Atomic Research Institute, Taiwan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yao-Ming Wu, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

PTK16081821

Identifier Type: -

Identifier Source: org_study_id