Magnetic Resonance ImagingPhase 1NCT02744248
Phase I , MTD, Pharmacokinetic, Safety/Tolerability, Efficacy of IOP Injection for MRI in Healthy Subjects
A Phase 1 study testing IOP Injection and 0.9% normal saline in people with Magnetic Resonance Imaging, run by MegaPro Biomedical Co. Ltd. at 1 site in Taiwan.
Trial summary
Study Objectives Primary: To determine MTD and dose limiting toxicities (DLTs) of IOP magnetic resonance imaging (MRI) contrast agent in healthy subjects. Secondary: 1. To characterize the pharmacokinetic profiles of IOP MRI contrast agent in healthy subjects. 2. 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 and 0.9% normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2016to Dec 2017
- 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 old with BMI between 18 and 27.
- Subject must be in good general health condition (i.e., full physical examinations, medical history, vital signs, ECG, and clinical laboratory tests performed at screening) as determined by the investigator. Normal ECG is defined as normal cardiac conduction parameters including resting heart rate between 50 and 100 bpm, Fridericia-corrected QT interval (QTcF) ≤ 450 milliseconds, and QRS interval < 120 milliseconds.
- Subject shows normal biochemistry test results (within normal range or considered clinically normal by the clinical investigator) at screening including items as listed below:
- Blood urea nitrogen (BUN), creatinine, and uric acid.
- Albumin and total protein.
- Alkaline phosphatase, ALT,AST, and total bilirubin.
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- Serum iron, total iron-binding capacity, serum ferritin,percent transferrin saturation (TSAT), and transferrin.
- Human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), Antibody HBsAg (anti-HBs),and antibodies against HCV (anti-HCV).
- Subject shows normal complete blood count (CBC) test results (within normal range or considered clinically normal by the clinical investigator) at screening including items as listed below:
- Red blood cell (RBC) count and reticulocyte count.
- White blood cell (WBC) count with differential.
- Hemoglobin and hematocrit.
- Platelet count.
- Subject shows normal urinalysis test results (within normal range or considered clinically normal by the clinical investigator) at screening including items as listed below:
- pH, color, appearance, and gravity
- Erythrocyte, leukocyte, glucose, protein, ketones, and nitrite
- Drug and alcohol abuse screening test including morphine, 3,4 methylenedioxymethamphetamine(MDMA), 3,4-methylenedioxyamphetamine (MDA),ketamine, codeine and alcohol.
- Subject shows normal bleeding time test results (within normal range or considered clinically normal by the clinical investigator) at screening including prothrombin (PT) and activated partial thromboplastin time (APTT).
- 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 similar ingredients of the study contrast agent (i.e.,Gd-based and SPIO particles contrast agents).
- Subjects have been diagnosed of Hepatitis B or C, venereal disease laboratory screens or have been determined of positive result of human immunodeficiency virus test.
- Imaging and/or functional abnormalities of liver and/or spleen. That is,
- Subjects have been diagnosed of abnormal liver function and appearances through medical histories, clinical laboratory tests, and imaging test including mild fatty liver, iron deposition or any acute/chronic liver change.
- Subjects have signs of splenomegaly, enlargement of the spleen, or clinical laboratory tests showing signs of spleen functional abnormalities.
- Subjects have been performed with any examinations with contrast agents applied within 28 days before study.
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- Subjects have alcohol or caffeine consumption within 48 hours prior to the administration of study contrast agent.
- Subjects are unable to undergo an MRI scan.
- Subjects have electronically, magnetically and mechanically activated implanted devices, including but not limited to automatic cardioverter defibrillators, cardiac pacemakers,insulin pumps, metallic splinters in the eye, ferromagnetic haemostatic clips in central nervous systems or vascular vessels.
- Subjects have participated in other investigational trials 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.
- Subject with conditions judged by the investigator as unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study to Determine the MTD and to Evaluate Pharmacokinetic, Safety/Tolerability, and Efficacy Profiles of IOP Injection for MRI Contrast Agent in Healthy Subjects
Study Objectives Primary: To determine MTD and dose limiting toxicities (DLTs) of IOP magnetic resonance imaging (MRI) contrast agent in healthy subjects.
Secondary:
- To characterize the pharmacokinetic profiles of IOP MRI contrast agent in healthy subjects.
- To evaluate safety/tolerability profiles of IOP MRI contrast agent in healthy subjects.
- To explore efficacy profiles of IOP MRI contrast agent for liver organ in healthy subjects.
Read the detailed description
Iron Oxide Nano Particle m-PEG-silane (IOP) Injection belongs to Superparamagnetic iron oxide (SPIO) can shorten the T2 relaxation time very effectively and reduces signal intensity in normal tissues. The mechanism of action increases after the particles have been phagocytosed by cells of the RES. Tissues with decreased RES function (e.g., metastases, primary liver cancer, cysts and various benign tumors, adenomas, and hyperplasia) retain their native signal intensity. In this study, investigators will characterize the PK profile, iron metabolism and preliminary efficacy of IOP Injection.
- Conditions
- Magnetic Resonance Imaging
- Being tested
- IOP Injection, 0.9% normal saline
- Keywords
- Magnetic Resonance Imaging (MRI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOP InjectionDrug
Also called Iron oxide nano particle m-PEG-silane
IOP Injection 20 mg Fe/ml, intravenous injection
0.9% normal salineDrug
Also called Sodium Chloride
0.9% normal saline 10 ml, intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| IOP Injection | Active comparator | Participants will receive 1 injection of the IOP at Days 1,once time. Receives: Drug: IOP Injection |
| 0.9% normal saline | Placebo comparator | Participants will receive 1 injection of 0.9% normal saline at Days 1,once time. Receives: Drug: 0.9% normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicities (DLTs) of IOP
DLT is defined as any grade 2 or above toxicity by NCI-CTCAE version 4.03, as determined by the investigator and sponsor, to be at least possibly related in causality to the administered investigational product IOP
Measured: Up to 14 days post-IOP injection
Maximum tolerated dose (MTD) of IOP
MTD is defined as the prior dose level below the dose level at which 2/6 subjects suffer dose limiting toxicities
Measured: Up to 14 days post-IOP injection
Secondary outcomes (6)
Pharmacokinetic parameters-Cmax
Cmax: the observed maximum drug concentration in plasma after dosing
Measured: Up to 3 days post-IOP injection
Pharmacokinetic parameters-Tmax
Tmax: the time at which Cmax was reached
Measured: Up to 3 days post-IOP injection
Pharmacokinetic parameters-AUC0-t
the truncated area under the plasma concentration-time curve from the beginning of dosing to time t
Measured: Up to 3 days post-IOP injection
Pharmacokinetic parameters-AUC0-inf
the area under the plasma concentration-time curve from the beginning of dosing to time t (AUC0-t) extrapolated to time infinity
Measured: Up to 3 days post-IOP injection
Pharmacokinetic parameters-T1/2
terminal elimination half-life
Measured: Up to 3 days post-IOP injection
Changes in laboratory safety tests (hematology, biochemistry, urinalysis, bleeding time) from baseline
Measured: Up to 14 days post-IOP injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2016
- Study completionDec 2017
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- MegaPro Biomedical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rheun-Chuan Lee, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744248
- Sponsor's protocol ID
- CEECTTA20100721
- Other IDs
- IOP-CT-001
- Status last verified
- Aug 2018
- First submitted
- 24 Mar 2016
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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 I Study to Determine the MTD and to Evaluate Pharmacokinetic, Safety/Tolerability, and Efficacy Profiles of IOP Injection for MRI Contrast Agent in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02744248
- Acronym / sponsor ID
- CEECTTA20100721
- Conditions
- Magnetic Resonance Imaging
- Keywords
- Magnetic Resonance Imaging (MRI)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- MegaPro Biomedical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 20 Apr 2016 (estimated)
- 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.
Study Objectives Primary: To determine MTD and dose limiting toxicities (DLTs) of IOP magnetic resonance imaging (MRI) contrast agent in healthy subjects.
Secondary:
- To characterize the pharmacokinetic profiles of IOP MRI contrast agent in healthy subjects.
- To evaluate safety/tolerability profiles of IOP MRI contrast agent in healthy subjects.
- To explore efficacy profiles of IOP MRI contrast agent for liver organ in healthy subjects.
Detailed description
Iron Oxide Nano Particle m-PEG-silane (IOP) Injection belongs to Superparamagnetic iron oxide (SPIO) can shorten the T2 relaxation time very effectively and reduces signal intensity in normal tissues. The mechanism of action increases after the particles have been phagocytosed by cells of the RES. Tissues with decreased RES function (e.g., metastases, primary liver cancer, cysts and various benign tumors, adenomas, and hyperplasia) retain their native signal intensity. In this study, investigators will characterize the PK profile, iron metabolism and preliminary efficacy of IOP Injection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IOP Injection | Active comparator | Drug: IOP InjectionParticipants will receive 1 injection of the IOP at Days 1,once time. |
| 0.9% normal saline | Placebo comparator | Drug: 0.9% normal salineParticipants will receive 1 injection of 0.9% normal saline at Days 1,once time. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- Male, age ≥ 20 ~40 years old with BMI between 18 and 27.
- Subject must be in good general health condition (i.e., full physical examinations, medical history, vital signs, ECG, and clinical laboratory tests performed at screening) as determined by the investigator. Normal ECG is defined as normal cardiac conduction parameters including resting heart rate between 50 and 100 bpm, Fridericia-corrected QT interval (QTcF) ≤ 450 milliseconds, and QRS interval < 120 milliseconds.
- Subject shows normal biochemistry test results (within normal range or considered clinically normal by the clinical investigator) at screening including items as listed below:
- Subject shows normal complete blood count (CBC) test results (within normal range or considered clinically normal by the clinical investigator) at screening including items as listed below:
- Subject shows normal urinalysis test results (within normal range or considered clinically normal by the clinical investigator) at screening including items as listed below:
Key exclusion criteria (13 listed)
- Subjects have serious allergic history or known allergy to similar ingredients of the study contrast agent (i.e.,Gd-based and SPIO particles contrast agents).
- Subjects have been diagnosed of Hepatitis B or C, venereal disease laboratory screens or have been determined of positive result of human immunodeficiency virus test.
- Imaging and/or functional abnormalities of liver and/or spleen. That is,
- Subjects have been performed with any examinations with contrast agents applied within 28 days before study.
- Subjects have alcohol or caffeine consumption within 48 hours prior to the administration of study contrast agent.
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 InjectionAlso: Iron oxide nano particle m-PEG-silaneIOP Injection 20 mg Fe/ml, intravenous injection | Drug | IOP Injection |
| 0.9% normal salineAlso: Sodium Chloride0.9% normal saline 10 ml, intravenous injection | Drug | 0.9% normal saline |
Primary outcome
Dose limiting toxicities (DLTs) of IOP
Time frame: Up to 14 days post-IOP injection
DLT is defined as any grade 2 or above toxicity by NCI-CTCAE version 4.03, as determined by the investigator and sponsor, to be at least possibly related in causality to the administered investigational product IOP
Maximum tolerated dose (MTD) of IOP
Time frame: Up to 14 days post-IOP injection
MTD is defined as the prior dose level below the dose level at which 2/6 subjects suffer dose limiting toxicities
6 secondary outcomes
Pharmacokinetic parameters-Cmax
Time frame: Up to 3 days post-IOP injection
Pharmacokinetic parameters-Tmax
Time frame: Up to 3 days post-IOP injection
Pharmacokinetic parameters-AUC0-t
Time frame: Up to 3 days post-IOP injection
Pharmacokinetic parameters-AUC0-inf
Time frame: Up to 3 days post-IOP injection
Pharmacokinetic parameters-T1/2
Time frame: Up to 3 days post-IOP injection
Changes in laboratory safety tests (hematology, biochemistry, urinalysis, bleeding time) from baseline
Time frame: Up to 14 days post-IOP 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 17 Aug 2018.
- 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.
Rheun-Chuan Lee principal investigator
Taipei Veterans General Hospital, Taiwan
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 and 0.9% normal saline 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 21 inclusion and 13 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. Some participants in this study may receive a placebo. 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?
Dose limiting toxicities (DLTs) of IOP (time frame: Up to 14 days post-IOP injection). The study lists 2 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 17 Aug 2018.