HealthyPhase 1NCT03974685
A Study of 99mTc-3PRGD2 Injection in Healthy Volunteers
A Phase 1 study testing 99mTc niacinamide polyethylene glycol bicyclic RGD peptide (99mTc-3PRGD2) in people with Healthy, run by RDO Pharm. at 1 site in China.
Trial summary
The study drug 99mTc-3PRGD2 of this study is a new radioactive diagnostic preparation for clinical use as a nuclear medicine molecular probe for tumor SPECT/CT imaging. After 99mTc-3PRGD2 is injected into the body, it is specifically taken up by integrin receptor-positive tumor tissue, and tumor tissue is developed by… Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 99mTc niacinamide polyethylene glycol bicyclic RGD peptide (99mTc-3PRGD2)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2018to 18 Jan 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers;
- 25 to 45 years of age, male to female ratio 1:1;
- Body mass index (BMI) ranges from 19 to 25 kg/m2 [Body mass index = body weight (kg)/ height squared (m2)];
- Clinical laboratory test results are normal, or laboratory values out of normal range is judged as not relevant for the clinical trial by the investigator;
- Subjects should read, sign an Informed Consent Form and willing to complete the trial according to the regulations.
Who cannot join
- Women who are breastfeeding or pregnant;
- Subjects with primary lesion in important organs;
- Subjects with mental or physical disorders;
- History of alcohol abuse or drug abuse;
- Subjects addict to coffee or smoker;
- Positive result on tests for HIV antibody, HbsAg or anti-hepatitis C virus antibody;
Show all 11Show fewer
- History of allergic reactions to two or more kinds of drugs or foods or allergic to any components of test drug;
- Subjects with diseases (such as insomnia) are receiving other preventive/therapeutic drugs prior to study administration;
- Other reasons which, in the opinion of the investigator, would prevent the subject from participating in the study;
- Any anticipation in other clinical trial within 3 months;
- Subject received isotope treatment or examination before screening, or received X-ray examination more than three times within one year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Open Label Trial of Pharmacokinetics and Safety of 99mTc Niacinamide Polyethylene Glycol Bicyclic RGD Peptide (99mTc-3PRGD2) Injection in Healthy Volunteers
The study drug 99mTc-3PRGD2 of this study is a new radioactive diagnostic preparation for clinical use as a nuclear medicine molecular probe for tumor SPECT/CT imaging.
After 99mTc-3PRGD2 is injected into the body, it is specifically taken up by integrin receptor-positive tumor tissue, and tumor tissue is developed by SPECT/CT, which can be used for molecular imaging diagnosis and individualized treatment of common tumors.
The primary objectives of this study is to examine the pharmacokinetics the safety of 99mTc-3PRGD2 injection in healthy volunteers, as well as the biodistribution in the human body and to estimate the dose of internal radiation absorbed. This study provides the basis for the design of phase II clinical research programs.
Read the detailed description
To a large extent, cancer treatment outcomes depend on the accurate diagnosis and staging of the disease. An important basis for early diagnosis of malignant tumors is medical imaging. Single-Photon Emission Computed Tomography (SPECT) and Positron Emission Tomography (PET) are most well-developed nuclear medicine procedures based on the measurement of radiolabeled tracer molecules.
These radiotracers allow biologic processes to be measured and whole body images to be obtained, which will demonstrate exact locations of radiotracer accumulation. Functional imagings of SPECT and PET provide specific information which is not available from standard medical imaging modalities such as ultrasound, X-ray, computerized tomography (CT) or magnetic resonance imaging (MRI).
The test drug in this study is a new radioactive diagnostic preparation, consisting of radiochemical (Sodium Pertecheetate [99mTc] Injection) and a kit (including Three core ligands, HYNIC-3PRGD2, Tricine, TPPTS). Before administration, 99mTc:HYNIC-3PRGD2:Tricine:TPPTS (1:1:1:1) chelate compound (99mTc-3PRGD2) will be prepared as per standard opration presedure, which will be used as a molecular probe for SPECT/CT imaging.
The core ligand HYNIC-3PRGD2 is a novel RGD dimer that specifically binds to the integrin αvβ3 receptor with high selectivity and affinity. Integrin αvβ3 is highly expressed in tumor neovascularization. After injection, 99mTc-3PRGD2 will be specifically taken up by the integrin receptor-positive tumor tissue, then be imaged by SPECT/CT. The product can be used for molecular imaging diagnosis and individualized treatment for common tumors such as lung cancer and breast cancer are performed.
The primary objectives of this study is to examine the pharmacokinetics the safety of 99mTc-3PRGD2 injection in healthy volunteers, as well as the biodistribution in the human body and to estimate the dose of internal radiation absorbed. This study provides the basis for the design of phase II clinical research programs.
- Conditions
- Healthy
- Being tested
- 99mTc niacinamide polyethylene glycol bicyclic RGD peptide (99mTc-3PRGD2)
- Keywords
- 99mTc-3PRGD2, Integrin ανβ3, Dosimetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99mTc niacinamide polyethylene glycol bicyclic RGD peptide (99mTc-3PRGD2)Drug
Single dose
| Study group | Role | What they receive |
|---|---|---|
| 99mTc-3PRGD2 | Experimental | Volunteers were injected intravenously and then scanned by SPECT/CT. Drugs use generic name：99mTc niacinamide polyethylene glycol bicyclic RGD peptide dosage form:Injection dosage:0.3mCi/kg frequency:single Receives: Drug: 99mTc niacinamide polyethylene glycol bicyclic RGD peptide (99mTc-3PRGD2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(0-t)
Area under the Activity-time curve from Hour 0 to the last measurable activity
Measured: Day 1(dosing day )and Pre-dose,1,2,3,19,33,53,91,120,245 minutes post dose
The %ID(The radioactivity of the urine at each time period/ the total injection activity)
The %ID(The radioactivity of the urine at each time period/ the total injection activity) is calculated
Measured: Day 1(dosing day)and Pre-dose,0-50 minutes,50-120 minutes,2-4 hours, 4-8 hours,8-12 hours,12-24hours post dose
The %ID(The radioactivity of the main organs at each time period/ the total injection activity)
The %ID(The radioactivity of the main organs at each time period/ the total injection activity) is calculated.
Measured: post-intervention at 4 months
The radiation dosimetry of the test drug in organs
The internal radiation dosimetry (Dt,mSv) of each irradiated organ is calculated.
Measured: post-intervention at 4 months
Radiochemical purity
To reflects the stability of the drug in the human body,that Radiochemical purity in urine and blood samples is measured.
Measured: During procedure
Secondary outcomes (1)
Incidence of adverse events
Assessment of adverse events
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start12 Dec 2018
- Primary completion18 Jan 2019
- Study completion18 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Model description
- Single Group Assignment drug:0.3mCi/kg
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- RDO Pharm.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Pharbers Genesis Pharmaceutical Technology Co., Ltd., MedAlly Solutions Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Zhaohui Zhu, professor, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974685
- Sponsor's protocol ID
- FSRDA201801
- Status last verified
- May 2019
- First submitted
- 16 May 2019
- Last updated
- 8 Aug 2019
- 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 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Open Label Trial of Pharmacokinetics and Safety of 99mTc Niacinamide Polyethylene Glycol Bicyclic RGD Peptide (99mTc-3PRGD2) Injection in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03974685
- Acronym / sponsor ID
- FSRDA201801
- Conditions
- Healthy
- Keywords
- 99mTc-3PRGD2, Integrin ανβ3, Dosimetry
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- RDO Pharm.Industry (pharma, biotech, devices)
- Collaborators
- Beijing Pharbers Genesis Pharmaceutical Technology Co., Ltd., MedAlly Solutions Co., Ltd.
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 18 Jan 2019 (actual)
- Study completion
- 18 Jan 2019 (actual)
- First posted
- 5 Jun 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.
The study drug 99mTc-3PRGD2 of this study is a new radioactive diagnostic preparation for clinical use as a nuclear medicine molecular probe for tumor SPECT/CT imaging.
After 99mTc-3PRGD2 is injected into the body, it is specifically taken up by integrin receptor-positive tumor tissue, and tumor tissue is developed by SPECT/CT, which can be used for molecular imaging diagnosis and individualized treatment of common tumors.
The primary objectives of this study is to examine the pharmacokinetics the safety of 99mTc-3PRGD2 injection in healthy volunteers, as well as the biodistribution in the human body and to estimate the dose of internal radiation absorbed. This study provides the basis for the design of phase II clinical research programs.
Detailed description
To a large extent, cancer treatment outcomes depend on the accurate diagnosis and staging of the disease. An important basis for early diagnosis of malignant tumors is medical imaging. Single-Photon Emission Computed Tomography (SPECT) and Positron Emission Tomography (PET) are most well-developed nuclear medicine procedures based on the measurement of radiolabeled tracer molecules.
These radiotracers allow biologic processes to be measured and whole body images to be obtained, which will demonstrate exact locations of radiotracer accumulation. Functional imagings of SPECT and PET provide specific information which is not available from standard medical imaging modalities such as ultrasound, X-ray, computerized tomography (CT) or magnetic resonance imaging (MRI).
The test drug in this study is a new radioactive diagnostic preparation, consisting of radiochemical (Sodium Pertecheetate [99mTc] Injection) and a kit (including Three core ligands, HYNIC-3PRGD2, Tricine, TPPTS). Before administration, 99mTc:HYNIC-3PRGD2:Tricine:TPPTS (1:1:1:1) chelate compound (99mTc-3PRGD2) will be prepared as per standard opration presedure, which will be used as a molecular probe for SPECT/CT imaging.
The core ligand HYNIC-3PRGD2 is a novel RGD dimer that specifically binds to the integrin αvβ3 receptor with high selectivity and affinity. Integrin αvβ3 is highly expressed in tumor neovascularization. After injection, 99mTc-3PRGD2 will be specifically taken up by the integrin receptor-positive tumor tissue, then be imaged by SPECT/CT. The product can be used for molecular imaging diagnosis and individualized treatment for common tumors such as lung cancer and breast cancer are performed.
The primary objectives of this study is to examine the pharmacokinetics the safety of 99mTc-3PRGD2 injection in healthy volunteers, as well as the biodistribution in the human body and to estimate the dose of internal radiation absorbed. This study provides the basis for the design of phase II clinical research programs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment drug:0.3mCi/kg
| Arm | Type | Receives |
|---|---|---|
| 99mTc-3PRGD2 | Experimental | Drug: 99mTc niacinamide polyethylene glycol bicyclic RGD peptide (99mTc-3PRGD2)Volunteers were injected intravenously and then scanned by SPECT/CT. Drugs use generic name：99mTc niacinamide polyethylene glycol bicyclic RGD peptide dosage form:Injection dosage:0.3mCi/kg frequency:single |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy volunteers;
- 25 to 45 years of age, male to female ratio 1:1;
- Body mass index (BMI) ranges from 19 to 25 kg/m2 [Body mass index = body weight (kg)/ height squared (m2)];
- Clinical laboratory test results are normal, or laboratory values out of normal range is judged as not relevant for the clinical trial by the investigator;
- Subjects should read, sign an Informed Consent Form and willing to complete the trial according to the regulations.
Key exclusion criteria (11 listed)
- Women who are breastfeeding or pregnant;
- Subjects with primary lesion in important organs;
- Subjects with mental or physical disorders;
- History of alcohol abuse or drug abuse;
- Subjects addict to coffee or smoker;
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 |
|---|---|---|
| 99mTc niacinamide polyethylene glycol bicyclic RGD peptide (99mTc-3PRGD2)Single dose | Drug | 99mTc-3PRGD2 |
Primary outcome
AUC(0-t)
Time frame: Day 1(dosing day )and Pre-dose,1,2,3,19,33,53,91,120,245 minutes post dose
Area under the Activity-time curve from Hour 0 to the last measurable activity
The %ID(The radioactivity of the urine at each time period/ the total injection activity)
Time frame: Day 1(dosing day)and Pre-dose,0-50 minutes,50-120 minutes,2-4 hours, 4-8 hours,8-12 hours,12-24hours post dose
The %ID(The radioactivity of the urine at each time period/ the total injection activity) is calculated
The %ID(The radioactivity of the main organs at each time period/ the total injection activity)
Time frame: post-intervention at 4 months
The %ID(The radioactivity of the main organs at each time period/ the total injection activity) is calculated.
The radiation dosimetry of the test drug in organs
Time frame: post-intervention at 4 months
The internal radiation dosimetry (Dt,mSv) of each irradiated organ is calculated.
Radiochemical purity
Time frame: During procedure
To reflects the stability of the drug in the human body,that Radiochemical purity in urine and blood samples is measured.
1 secondary outcome
Incidence of adverse events
Time frame: 3 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 8 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Zhaohui Zhu, professor principal investigator
Peking Union Medical College 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 99mTc niacinamide polyethylene glycol bicyclic RGD peptide (99mTc-3PRGD2) in people with Healthy, run by RDO Pharm. 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 5 inclusion and 11 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 8 Aug 2019. 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?
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?
AUC(0-t) (time frame: Day 1(dosing day )and Pre-dose,1,2,3,19,33,53,91,120,245 minutes post dose). The study lists 5 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 8 Aug 2019.