Magnetic Resonance ImagingEarly Phase 1NCT06010537
Contrast-enhanced Magnetic Resonance Imaging With Polysaccharide Superparamagnetic Iron Oxide Nanoparticle
A Early Phase 1 study testing polysaccharide superparamagnetic iron oxide injection in people with Magnetic Resonance Imaging, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
This is a contrast-enhanced magnetic resonance imaging (MRI) study conducted on a single-administration of polyglucose superparamagnetic iron oxide injection. Two dose groups are set up in this study, 2.5 mg/kg and 3 mg/kg, and two subjects in each group received the test drug for safety evaluation. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Magnetic Resonance Imaging
- What is being tested?
- polysaccharide superparamagnetic iron oxide injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteChina
- Study dates
- 28 Apr 2021to 30 Apr 2021
- Phase
- Early 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 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signing the informed consent form before the trial and fully understanding the content, process and possible adverse effects of the trial;
- Be able to complete the study according to the requirements of the trial protocol;
- Male subjects aged 18 to 40 years old (including the threshold);
- Subjects weighing no less than 50 kilograms. Body mass index (BMI) = weight (kg)/height2 (m2), BMI within the range of 19~26 (including the critical value);
- Health status: no mental abnormality, no history of cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system and metabolic abnormalities;
- Vital signs, physical examination, laboratory tests, electrocardiogram and imaging tests are normal or abnormal without clinical significance;
- No pregnancy and voluntary use of effective contraception for at least 6 months from 2 weeks prior to dosing to the last use of the study drug.
Who cannot join
- Previously suffered from neuropsychiatric, respiratory, cardiovascular, gastrointestinal, hematologic-lymphatic, hepatic or renal insufficiency, endocrine, or musculoskeletal disorders, or other diseases, and in the judgment of the investigator, the previous medical history may have an impact on the magnetic resonance imaging procedure, the quality of the images, or the safety of the subject;
- Subjects with internal metal foreign bodies (dentures, contraceptive rings, metal implants, metal clips, etc.) and persons who are claustrophobic;
- Those who are allergic to the study drug, its metabolites or its excipients;
- Subjects who have smoked more than 5 cigarettes per day for 3 months prior to the trial;
- History of drug and/or alcohol abuse (14 units of alcohol per week: 1 unit = 360 ml of beer or 45 ml of spirits of 40% alcohol or 150 ml of wine);
- Blood donation or significant blood loss (> 450 ml) within 2 months prior to dosing;
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- Use of any drug that alters liver enzyme activity (e.g., liver enzyme inhibitors chlorpromazine, cimetidine, ciprofloxacin, metronidazole, etc.; liver enzyme inducers barbiturates, carbamazepine, rifampicin, dexamethasone, etc.) in the 28 days prior to dosing;
- Use of any prescription medication, over-the-counter medication, any vitamin product or herbal remedy within 14 days prior to dosing;
- The need to use tobacco, alcohol and caffeinated beverages, or certain foods that may affect metabolism (e.g., grapefruit, grapefruit juice, etc.) during the trial period, or a significant change in dietary or exercise habits prior to the trial, or any other factor that affects the absorption, distribution, metabolism, or excretion of the drug;
- Use of an investigational drug or participation in a clinical trial of a drug within 2 months prior to dosing;
- Screening positive for hepatitis (including hepatitis B and C) and for AIDS and syphilis;
- Screening positive for drugs or a history of drug abuse within the past 5 years or drug use within the 3 months prior to the trial;
- Persons who have difficulty with MRI scanning or who cannot tolerate MRI scanning;
- Acute illness occurring during the pre-study screening phase or prior to study drug administration;
- Subjects who are unable or incapable of complying with ward regulations.
- The subject is unable to complete the trial for personal reasons.
- Other circumstances which, in the judgment of the investigator, make enrollment in the study unsuitable.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Randomized, Open-label, Single-dose Study of Polysaccharide Superparamagnetic Iron Oxide Injection in Healthy Subjects to Evaluate Magnetic Resonance Imaging in Multiple Dose Groups
This is a contrast-enhanced magnetic resonance imaging (MRI) study conducted on a single-administration of polyglucose superparamagnetic iron oxide injection. Two dose groups are set up in this study, 2.5 mg/kg and 3 mg/kg, and two subjects in each group received the test drug for safety evaluation.
- Conditions
- Magnetic Resonance Imaging
- Being tested
- polysaccharide superparamagnetic iron oxide injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polysaccharide superparamagnetic iron oxide injectionDrug
Polysaccharide superparamagnetic iron oxide injection is a magnetic resonance contrast agent.
| Study group | Role | What they receive |
|---|---|---|
| polyglucose superparamagnetic iron oxide injection 2.5 mg/kg | Experimental | Intravenous injected polysaccharide superparamagnetic iron oxide injection at 2.5 mg/kg dose; Receives: Drug: polysaccharide superparamagnetic iron oxide injection |
| polyglucose superparamagnetic iron oxide injection 3.0 mg/kg | Experimental | Intravenous injected polysaccharide superparamagnetic iron oxide injection at 3.0 mg/kg dose; Receives: Drug: polysaccharide superparamagnetic iron oxide injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Measured: Baseline up to 144 hours
Secondary outcomes (1)
Contrast-enhanced magnetic resonance angiography (CE-MRA)
CE-MRA of the whole heart and large arteries, coronary angiography and contrast-enhanced scan of the upper abdomen, the aorta and its main branches (left and right renal arteries, celiac trunk, superior mesenteric arteries, bilateral iliac arteries) as well as bilateral femoral arteries of the lower limbs will be evaluated
Measured: Before administration, 5 minutes, 12 hours, 24 hours, 36 hours, 48 hours after administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start28 Apr 2021
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
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.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010537
- Sponsor's protocol ID
- YHT-I-03
- Status last verified
- Aug 2023
- First submitted
- 20 Aug 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Open-label, Single-dose Study of Polysaccharide Superparamagnetic Iron Oxide Injection in Healthy Subjects to Evaluate Magnetic Resonance Imaging in Multiple Dose Groups
- ClinicalTrials.gov ID
- NCT06010537
- Acronym / sponsor ID
- YHT-I-03
- Conditions
- Magnetic Resonance Imaging
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 24 Aug 2023 (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 contrast-enhanced magnetic resonance imaging (MRI) study conducted on a single-administration of polyglucose superparamagnetic iron oxide injection. Two dose groups are set up in this study, 2.5 mg/kg and 3 mg/kg, and two subjects in each group received the test drug for safety evaluation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| polyglucose superparamagnetic iron oxide injection 2.5 mg/kg | Experimental | Drug: polysaccharide superparamagnetic iron oxide injectionIntravenous injected polysaccharide superparamagnetic iron oxide injection at 2.5 mg/kg dose; |
| polyglucose superparamagnetic iron oxide injection 3.0 mg/kg | Experimental | Drug: polysaccharide superparamagnetic iron oxide injectionIntravenous injected polysaccharide superparamagnetic iron oxide injection at 3.0 mg/kg dose; |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Signing the informed consent form before the trial and fully understanding the content, process and possible adverse effects of the trial;
- Be able to complete the study according to the requirements of the trial protocol;
- Male subjects aged 18 to 40 years old (including the threshold);
- Subjects weighing no less than 50 kilograms. Body mass index (BMI) = weight (kg)/height2 (m2), BMI within the range of 19~26 (including the critical value);
- Health status: no mental abnormality, no history of cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system and metabolic abnormalities;
Key exclusion criteria (17 listed)
- Previously suffered from neuropsychiatric, respiratory, cardiovascular, gastrointestinal, hematologic-lymphatic, hepatic or renal insufficiency, endocrine, or musculoskeletal disorders, or other diseases, and in the judgment of the investigator, the previous medical history may have an impact on the magnetic resonance imaging procedure, the quality of the images, or the safety of the subject;
- Subjects with internal metal foreign bodies (dentures, contraceptive rings, metal implants, metal clips, etc.) and persons who are claustrophobic;
- Those who are allergic to the study drug, its metabolites or its excipients;
- Subjects who have smoked more than 5 cigarettes per day for 3 months prior to the trial;
- History of drug and/or alcohol abuse (14 units of alcohol per week: 1 unit = 360 ml of beer or 45 ml of spirits of 40% alcohol or 150 ml of wine);
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 |
|---|---|---|
| polysaccharide superparamagnetic iron oxide injectionPolysaccharide superparamagnetic iron oxide injection is a magnetic resonance contrast agent. | Drug | polyglucose superparamagnetic iron oxide injection 2.5 mg/kg, polyglucose superparamagnetic iron oxide injection 3.0 mg/kg |
Primary outcome
Adverse event rate
Time frame: Baseline up to 144 hours
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
1 secondary outcome
Contrast-enhanced magnetic resonance angiography (CE-MRA)
Time frame: Before administration, 5 minutes, 12 hours, 24 hours, 36 hours, 48 hours after administration.
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 25 Aug 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing polysaccharide superparamagnetic iron oxide injection in people with Magnetic Resonance Imaging, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
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 7 inclusion and 17 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 25 Aug 2023. 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 China. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Adverse event rate (time frame: Baseline up to 144 hours). 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 25 Aug 2023.