Safety IssuesPhase 1NCT03908957
to Assess the Safety of Ga68-Dolacga Injection in Healthy Volunteers
A Phase 1 study testing Ga68-Dolacga Injection in people with Safety Issues, run by National Atomic Research Institute, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Safety Issues
- What is being tested?
- Ga68-Dolacga Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Feb 2019to 9 Aug 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Ga68-Dolacga Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ga68-Dolacga InjectionDrug
Also called Ga68-INER038
Ga68-Dolacga Injection, 3.5±0.25 mCi, single dose iv
| Study group | Role | What they receive |
|---|---|---|
| Ga68-Dolacga Injection | Experimental | The healthy volunteer was injected with Ga68-Dolacga Injection iv and performed PET imaging for liver reserve evaluation. Receives: Drug: Ga68-Dolacga Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects reporting clinically significant changes in serum biochemical tests
Measured: from pre-dose to 14±2 days post dose
Number of subjects reporting clinically significant changes in hematological tests
Measured: from pre-dose to 14±2 days post dose
Number of subjects reporting clinically significant changes in urinalysis
Measured: from pre-dose to 14±2 days post dose
Number of subjects with clinically significant changes in systolic blood pressure and diastolic blood pressure
Measured: from pre-dose to 14±2 days post dose
Number of subjects with body temperature abnormalities
Measured: 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
Measured: visit 2 (Day 1)
Number of subjects with clinically significant changes in Heart Rate
Measured: 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)
Measured: 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.
Measured: 14 days
Secondary outcomes (1)
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.
Measured: up to 60 minutes after administration of Ga68-Dolacga Injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start12 Feb 2019
- Primary completion9 Aug 2019
- Study completion9 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Atomic Research Institute, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yao-Ming Wu, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908957
- Sponsor's protocol ID
- PTK16081821
- Status last verified
- Feb 2020
- First submitted
- 25 Feb 2019
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase I Clinical Trial to Assess the Safety of Ga68-Dolacga Injection in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03908957
- Acronym / sponsor ID
- PTK16081821
- Conditions
- Safety Issues
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- National Atomic Research Institute, TaiwanUniversity, hospital or other
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 9 Aug 2019 (actual)
- Study completion
- 9 Aug 2019 (actual)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ga68-Dolacga Injection | Experimental | Drug: Ga68-Dolacga InjectionThe healthy volunteer was injected with Ga68-Dolacga Injection iv and performed PET imaging for liver reserve evaluation. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ga68-Dolacga InjectionAlso: Ga68-INER038Ga68-Dolacga Injection, 3.5±0.25 mCi, single dose iv | Drug | Ga68-Dolacga Injection |
Primary outcome
Number of subjects reporting clinically significant changes in serum biochemical tests
Time frame: from pre-dose to 14±2 days post dose
Number of subjects reporting clinically significant changes in hematological tests
Time frame: from pre-dose to 14±2 days post dose
Number of subjects reporting clinically significant changes in urinalysis
Time frame: from pre-dose to 14±2 days post dose
Number of subjects with clinically significant changes in systolic blood pressure and diastolic blood pressure
Time frame: from pre-dose to 14±2 days post dose
Number of subjects with body temperature abnormalities
Time frame: from pre-dose to 14±2 days post dose
Abnormalities of physical examination in visit 2 (post-treatment) compared with visit 1
Time frame: visit 2 (Day 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
Number of subjects with clinically significant changes in Heart Rate
Time frame: from pre-dose to 14±2 days post dose
Number of subjects with clinically significant changes in electrocardiogram(ECG)
Time frame: from pre-dose to 14±2 days post dose
The ECG parameters include: PR interval (milliseconds), QTc interval (milliseconds), QRS duration (milliseconds)
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 14 days
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.
1 secondary outcome
Establishment of the normal reference range of the percent of injection dose (%ID) in healthy liver
Time frame: up to 60 minutes after administration of Ga68-Dolacga Injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yao-Ming Wu, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ga68-Dolacga Injection in people with Safety Issues, run by National Atomic Research Institute, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects reporting clinically significant changes in serum biochemical tests (time frame: from pre-dose to 14±2 days post dose). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020; AzTrials last refreshed its copy on 8 Nov 2026.