Magnetic Resonance ImagingPhase 1NCT03399214
Phase Ib, Administration the IOP Injection for MRI Contrast Agent in Healthy Subjects
A Phase 1 study testing IOP Injection in people with Magnetic Resonance Imaging, run by MegaPro Biomedical Co. Ltd. at 1 site in Taiwan.
Trial summary
The objective of the study is to assess the dose dependent changes in MRI signal intensity (SI) in liver after IOP Injection intravenous administration in healthy volunteers. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Magnetic Resonance Imaging
- What is being tested?
- IOP 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
- 1 Apr 2018to 31 Jul 2018
- 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 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male, age ≥ 20 ~40 years, BMI=18~27.
- The biochemistry test results, complete blood count (CBC) test results, urinalysis test results, coagulation time test results must within normal range or considered clinically normal by the clinical investigator at screening.
- Male subjects must take reliable contraceptive method(s) during and after the study for a period of 14 days.
- No screening of drug or alcohol abuse within one year prior to study enrollment.
- Subjects are willing to comply with the protocol and sign informed consent form.
Who cannot join
- Subjects have serious allergic history or known allergy to MRI contrast agent.
- Subjects with HBV, HCV, HIV.
- Imaging and/or functional abnormalities of liver and/or spleen.
- Subjects have alcohol or caffeine consumption within 48 hours prior to the administration of study contrast agent.
- Subjects have electronically, magnetically and mechanically activated implanted devices.
- Subjects have participated in other investigational trials or receive any contrast agents within 28 days prior to study enrollment.
- Subjects with active systemic infections, active and clinically significant cardiac diseases, active gastrointestinal ulcers, or medical conditions that may significantly affect action, adequate absorption and elimination of investigational contrast agent.
- Subjects have taken any food 6 hours prior to administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ib Study to Evaluate Safety and Efficacy Profiles of IOP Injection for Magnetic Resonance Imaging (MRI) Contrast Agent in Healthy Subjects.
The objective of the study is to assess the dose dependent changes in MRI signal intensity (SI) in liver after IOP Injection intravenous administration in healthy volunteers.
Read the detailed description
Find the max. signal change after IOP administration
- Conditions
- Magnetic Resonance Imaging
- Being tested
- IOP Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOP InjectionDrug
T1 and T2
| Study group | Role | What they receive |
|---|---|---|
| IOP Injection, Phase 1b, Cohort 1 | Experimental | IV injection, 0.27 mg/kg Receives: Drug: IOP Injection |
| IOP Injection, Phase 1b, Cohort 2 | Experimental | IV injection, 0.54 mg/kg Receives: Drug: IOP Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change of MRI SI (%) in vessels, liver, and spleen
The optimal imaging time of IOP injection for the maximum SI (%)
Measured: Day1: within 60 mins after IOP administration
Secondary outcomes (2)
The changes from baseline in hematology data
Complete blood count and differential count, Reticulocyte count
Measured: within 14 days
The incidence of all treatment-related adverse events (TRAE)
Measured: within 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start1 Apr 2018
- Primary completion1 May 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic Resonance ImagingStudies 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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- MegaPro Biomedical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rheun-Chuan Lee, MD, Principal investigator, rclee@vghtpe.gov.tw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399214
- Sponsor's protocol ID
- IOP-CT-002
- Status last verified
- Aug 2018
- First submitted
- 2 Jan 2018
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study to Evaluate Safety and Efficacy Profiles of IOP Injection for Magnetic Resonance Imaging (MRI) Contrast Agent in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT03399214
- Acronym / sponsor ID
- IOP-CT-002
- Conditions
- Magnetic Resonance Imaging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- MegaPro Biomedical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 16 Jan 2018 (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.
The objective of the study is to assess the dose dependent changes in MRI signal intensity (SI) in liver after IOP Injection intravenous administration in healthy volunteers.
Detailed description
Find the max. signal change after IOP administration
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IOP Injection, Phase 1b, Cohort 1 | Experimental | Drug: IOP InjectionIV injection, 0.27 mg/kg |
| IOP Injection, Phase 1b, Cohort 2 | Experimental | Drug: IOP InjectionIV injection, 0.54 mg/kg |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male, age ≥ 20 ~40 years, BMI=18~27.
- The biochemistry test results, complete blood count (CBC) test results, urinalysis test results, coagulation time test results must within normal range or considered clinically normal by the clinical investigator at screening.
- Male subjects must take reliable contraceptive method(s) during and after the study for a period of 14 days.
- No screening of drug or alcohol abuse within one year prior to study enrollment.
- Subjects are willing to comply with the protocol and sign informed consent form.
Key exclusion criteria (8 listed)
- Subjects have serious allergic history or known allergy to MRI contrast agent.
- Subjects with HBV, HCV, HIV.
- Imaging and/or functional abnormalities of liver and/or spleen.
- Subjects have alcohol or caffeine consumption within 48 hours prior to the administration of study contrast agent.
- Subjects have electronically, magnetically and mechanically activated implanted devices.
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 |
|---|---|---|
| IOP InjectionT1 and T2 | Drug | IOP Injection, Phase 1b, Cohort 1, IOP Injection, Phase 1b, Cohort 2 |
Primary outcome
The Change of MRI SI (%) in vessels, liver, and spleen
Time frame: Day1: within 60 mins after IOP administration
The optimal imaging time of IOP injection for the maximum SI (%)
2 secondary outcomes
The changes from baseline in hematology data
Time frame: within 14 days
The incidence of all treatment-related adverse events (TRAE)
Time frame: within 14 days
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 17 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Rheun-Chuan Lee, MD principal investigator
rclee@vghtpe.gov.tw
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 IOP Injection in people with Magnetic Resonance Imaging, run by MegaPro Biomedical Co. Ltd. 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 5 inclusion and 8 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 17 Aug 2018. 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?
The Change of MRI SI (%) in vessels, liver, and spleen (time frame: Day1: within 60 mins after IOP administration). 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 17 Aug 2018.