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

An Open-label Phase I Clinical Trial to Assess the Safety of Ga68-Dolacga Injection in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Safety Issues
• Intervention / Treatment: Drug: Ga68-Dolacga Injection

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Taiwan
  • Taipei City, Taiwan, 10617
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ga68-Dolacga Injection; The healthy volunteer was injected with Ga68-Dolacga Injection iv and performed PET imaging for liver reserve evaluation.	Drug: Ga68-Dolacga Injection; Ga68-Dolacga Injection, 3.5±0.25 mCi, single dose iv; Other Names: Ga68-INER038

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects reporting clinically significant changes in serum biochemical tests		from pre-dose to 14±2 days post dose
Number of subjects reporting clinically significant changes in hematological tests		from pre-dose to 14±2 days post dose
Number of subjects reporting clinically significant changes in urinalysis		from pre-dose to 14±2 days post dose
Number of subjects with clinically significant changes in systolic blood pressure and diastolic blood pressure		from pre-dose to 14±2 days post dose
Number of subjects with body temperature abnormalities		from pre-dose to 14±2 days post dose
Abnormalities of physical examination in visit 2 (post-treatment) compared with visit 1	Including the examination of general appearance, skin, neck (including thyroid), eyes, ears, nose, throat, lungs, heart, abdomen, back, lymph nodes, extremities, vascular and neurological	visit 2 (Day 1)
Number of subjects with clinically significant changes in Heart Rate		from pre-dose to 14±2 days post dose
Number of subjects with clinically significant changes in electrocardiogram(ECG)	The ECG parameters include: PR interval (milliseconds), QTc interval (milliseconds), QRS duration (milliseconds)	from pre-dose to 14±2 days post dose
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)	All laboratory abnormalities which are compared with screening values and out of the reference range will be considered as AE and will be assessed its relationship to the study drug. Any ECG changes including ECG waveform will be assessed as AE(s) and will be followed to assess whether they resolved and when they resolved.	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establishment of the normal reference range of the percent of injection dose (%ID) in healthy liver	The normal reference range will be measured by the mean +/- standard deviation of the liver %ID of all of the phase 1 volunteers.	up to 60 minutes after administration of Ga68-Dolacga Injection

Collaborators and Investigators

• Sponsor: Institute of Nuclear Energy Research, Taiwan
• Investigators: Principal Investigator: Yao-Ming Wu, MD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 12, 2019
• Primary Completion (ACTUAL): August 9, 2019
• Study Completion (ACTUAL): August 9, 2019

Study Registration Dates

• First Submitted: February 25, 2019
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (ACTUAL): April 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2020
• Last Update Submitted That Met QC Criteria: February 12, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: PTK16081821

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No