PAOD - Peripheral Arterial Occlusive DiseasePhase 1NCT03668353
Recombinant SeV-hFGF2/dF Injection for PAOD
A Phase 1 study testing Recombinant SeV-hFGF2/dF Injection in people with PAOD - Peripheral Arterial Occlusive Disease and PAD, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
Lower extremity arteriosclerosis obliterans is due to the formation of atherosclerotic plaque in the lower extremities, resulting in the stenosis and occlusion of the artery, leading to chronic ischemia of the limbs. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- PAOD - Peripheral Arterial Occlusive Disease, PAD, Critical Limb Ischemia
- What is being tested?
- Recombinant SeV-hFGF2/dF 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 siteChina
- Study dates
- 5 Sep 2018to 1 Sep 2020
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 18-80 years old, weighing > 50kg, with an expected survival of more than 1 year;
- diagnosed as Lower extremity arterial occlusive disease (ASO , DAO , TAO) , and Rutherford grade 2 to 5 (moderate intermittent claudication - mild tissue defect), if both of the subject's limbs have lower extremity arterial ischemic disease, the limb that could not be revascularized or more severe one to study by the investigator;
- Patients are not eligible for revascularization (eg, interventional endovascular treatment or surgery); or patients who have failed previous revascularization treatment;
- For patients who are taking cilostazol, prostaglandins or sarpogrelate for the treatment of lower limb ischemia, a stable dose should be used for at least 1 month before the test drug is injected ;
- Before enrollment, confirmed by DSA or CTA as the superficial femoral artery ( ie, the femoral artery below the branch of the deep femoral artery), one or more stenosis of the radial artery and its lower artery ≥ 75% or occlusion;
- The intended to treat lower extremity ABI ≤ 0.9 ;
- Volunteer to participate in the trial and sign the informed consent form.
Who cannot join
- Patients with malignant tumors or clinically significant history of a hematological disease, or clinically significant results of tumor screening tests;
- Patients with a history of alcohol or drug abuse in the last 12 months;
- The affected limb may need an amputation in 4 weeks;
- Acute lower extremity arterial ischemic disease or acute progressive disease of lower extremity arterial ischemic disease;
- The index limb has serious infections ( such as cellulitis, osteomyelitis, etc.), distal fascia or bone exposure;
- Cardiac function is classified as grade III or IV heart failure according to the New York Heart Association (NYHA) ;
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- Patients with cerebral infarction, cerebral hemorrhage, myocardial infarction, and unstable angina in the past 3 months;
- Type I diabetes patients;
- Poorly controlled hypertension up to three antihypertensive drugs combined, defined as those at screening or baseline testing: systolic blood pressure > 160 mmHg or diastolic blood pressure > 110 mmHg ;
- Patients with grade 3 and above proliferative retinopathy history;
- Currently receiving immunosuppressive agents or radiotherapy and chemotherapy;
- Antiviral drugs, drugs for inhibiting u-PA activity, such as diuretics, amiloride, and suramin, were used within 2 weeks before administration ;
- Subjects included: HIV, hepatitis B, hepatitis C, routine hematology laboratory tests found that patients with significant clinical significance ( hepatitis B virus carriers can be selected); or blood routine, blood biochemistry, liver function, etc. Any of the following abnormalities (if the investigator judges that the abnormality may be caused by the inspection operation, still exists after one retest):
- TBIL exceeds 1.5 times the normal upper limit or ALT/AST exceeds 2.5 times the upper limit of normal
- Serum creatinine or urea nitrogen > 1.2 times the upper limit of normal
- Hemoglobin (Hb) < 8.5 g/dL
- White blood cell count < 3 × 10 9 /L
- Platelet count < 75 × 10 9 / L
- Fasting blood glucose > 13.9 mmol/L
- HbA1c > 10%
- Donate blood in last 1 month or participate in other intervention clinical trials;
- Childbearing age (male/female) do not agree to adopt recognized effective contraceptives during study treatment and at least 6 months after completion of the study , and / or women of childbearing age who are unwilling or unable to undergo pregnancy tests; pregnancy, Lactating women ( where pregnancy is defined as a positive blood test ) ;
- Other clinically uncontrollable diseases, including but not limited to: a severe liver disease with decompensated cirrhosis, jaundice, ascites or hemorrhagic varices;
- Patients undergoing dialysis;
- a history of allergic to lidocaine, or patients whose may be allergic to the study drug or its components determined by the investigator;
- Other factors that may affect drug safety, effectiveness, and drug metabolism evaluation determined by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100006
Weibo Xia, Dr., 010-65296114
About this study
Official title: Recombinant SeV-hFGF2 / dF Injection (BF30) Single-dose Therapy in Patients With Peripheral Arterial Occlusive Disease, a Dose Escalation, Safety, Tolerability Phase I Clinical Trial
Lower extremity arteriosclerosis obliterans is due to the formation of atherosclerotic plaque in the lower extremities, resulting in the stenosis and occlusion of the artery, leading to chronic ischemia of the limbs. Although bypass surgery and angioplasty ( or interventional therapy ) are effective methods for vascular treatment in patients with PAD to revascularize, a significant proportion of patients with the arterial disease are not eligible for direct arterial surgery. Meanwhile, there are many patients who suffer from diffuse arterial disease or severe peripheral disease not suitable for interventional therapy. Stimulation of arteriogenesis( blood bypassing the occluded arteries through a large number of collateral vessels ) and angiogenesis ( generating new small blood vessels ) have become the focus of research.
Our recombinant SeV-hFGF2/dF injection (R\&D code BF30 ) uses the human basic fibroblast growth factor ( FGF2 ) gene to express the target protein FGF2 locally by intramuscular injection. The preparation can efficiently express FGF2 in infected cells and secrete it to the periphery and be fixed in the intercellular substance. Since FGF2 is in the upstream regulatory pathway of VEGF, HGF and other factors, it can regulate the coordinated expression of these cytokines related to the growth and function of new blood vessels, and finally, produce mature blood vessels.
Read more
To evaluate the safety ( tolerance), pharmacokinetics (PK), biological activity, and immunogenicity of BF30 in patients with lower extremity arterial occlusive disease, and to explore clinical benefits.
MAIN OBJECTIVE: To evaluate the safety ( tolerability ) of single-dose BF30 in patients with lower extremity arterial occlusive disease, and to provide evidence for the dose of subsequent clinical trials.
Secondary objective: To explore the pharmacokinetics (PK), biological activity, the immunogenicity of BF30, and to initially explore clinical benefits.
- Being tested
- Recombinant SeV-hFGF2/dF Injection
- Medical subject headings
- Peripheral Arterial Occlusive Disease 1, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant SeV-hFGF2/dF InjectionBiological
Also called BF30
intramuscular injection of investigator drugs
| Study group | Role | What they receive |
|---|---|---|
| treatment 1 | Experimental | Recombinant SeV-hFGF2/dF Injection 2×10 8CIU Receives: Biological: Recombinant SeV-hFGF2/dF Injection |
| treatment 2 | Experimental | Recombinant SeV-hFGF2/dF Injection 1×10 9CIU Receives: Biological: Recombinant SeV-hFGF2/dF Injection |
| treatment 3 | Experimental | Recombinant SeV-hFGF2/dF Injection 5×10 9CIU Receives: Biological: Recombinant SeV-hFGF2/dF Injection |
| treatment 4 | Experimental | Recombinant SeV-hFGF2/dF Injection 1×10 10CIU Receives: Biological: Recombinant SeV-hFGF2/dF Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment- Emergent Adverse Events [Safety and Tolerability]
AE incidence, inject site reactions
Measured: 6 months
Secondary outcomes (6)
Maximum Plasma Concentration [Cmax]
serum concentration of total RNA
Measured: 6 months after drug administration
Area Under the Curve [AUC]
serum concentration of total RNA
Measured: 6 months after drug administration
antibody of the SeV
Immunogenecity
Measured: 6 months after drug administration
walking distance
walking function
Measured: 6 months after drug administration
pain scale
using VAS scale
Measured: 6 months after drug administration
Ruthorford staging
improvements after study drug use.
Measured: 6 months after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start5 Sep 2018
- Primary completion5 Mar 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PAOD - Peripheral Arterial Occlusive DiseaseStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- dose escalation
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668353
- Sponsor's protocol ID
- BF30A101
- Status last verified
- Sep 2018
- First submitted
- 8 Sep 2018
- Last updated
- 25 Oct 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 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recombinant SeV-hFGF2 / dF Injection (BF30) Single-dose Therapy in Patients With Peripheral Arterial Occlusive Disease, a Dose Escalation, Safety, Tolerability Phase I Clinical Trial
- ClinicalTrials.gov ID
- NCT03668353
- Acronym / sponsor ID
- BF30A101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 5 Mar 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 12 Sep 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.
Lower extremity arteriosclerosis obliterans is due to the formation of atherosclerotic plaque in the lower extremities, resulting in the stenosis and occlusion of the artery, leading to chronic ischemia of the limbs. Although bypass surgery and angioplasty ( or interventional therapy ) are effective methods for vascular treatment in patients with PAD to revascularize, a significant proportion of patients with the arterial disease are not eligible for direct arterial surgery. Meanwhile, there are many patients who suffer from diffuse arterial disease or severe peripheral disease not suitable for interventional therapy. Stimulation of arteriogenesis( blood bypassing the occluded arteries through a large number of collateral vessels ) and angiogenesis ( generating new small blood vessels ) have become the focus of research.
Our recombinant SeV-hFGF2/dF injection (R\&D code BF30 ) uses the human basic fibroblast growth factor ( FGF2 ) gene to express the target protein FGF2 locally by intramuscular injection. The preparation can efficiently express FGF2 in infected cells and secrete it to the periphery and be fixed in the intercellular substance. Since FGF2 is in the upstream regulatory pathway of VEGF, HGF and other factors, it can regulate the coordinated expression of these cytokines related to the growth and function of new blood vessels, and finally, produce mature blood vessels.
To evaluate the safety ( tolerance), pharmacokinetics (PK), biological activity, and immunogenicity of BF30 in patients with lower extremity arterial occlusive disease, and to explore clinical benefits.
MAIN OBJECTIVE: To evaluate the safety ( tolerability ) of single-dose BF30 in patients with lower extremity arterial occlusive disease, and to provide evidence for the dose of subsequent clinical trials.
Secondary objective: To explore the pharmacokinetics (PK), biological activity, the immunogenicity of BF30, and to initially explore clinical benefits.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- dose escalation
| Arm | Type | Receives |
|---|---|---|
| treatment 1 | Experimental | Biological: Recombinant SeV-hFGF2/dF InjectionRecombinant SeV-hFGF2/dF Injection 2×10 8CIU |
| treatment 2 | Experimental | Biological: Recombinant SeV-hFGF2/dF InjectionRecombinant SeV-hFGF2/dF Injection 1×10 9CIU |
| treatment 3 | Experimental | Biological: Recombinant SeV-hFGF2/dF InjectionRecombinant SeV-hFGF2/dF Injection 5×10 9CIU |
| treatment 4 | Experimental | Biological: Recombinant SeV-hFGF2/dF InjectionRecombinant SeV-hFGF2/dF Injection 1×10 10CIU |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, aged 18-80 years old, weighing > 50kg, with an expected survival of more than 1 year;
- diagnosed as Lower extremity arterial occlusive disease (ASO , DAO , TAO) , and Rutherford grade 2 to 5 (moderate intermittent claudication - mild tissue defect), if both of the subject's limbs have lower extremity arterial ischemic disease, the limb that could not be revascularized or more severe one to study by the investigator;
- Patients are not eligible for revascularization (eg, interventional endovascular treatment or surgery); or patients who have failed previous revascularization treatment;
- For patients who are taking cilostazol, prostaglandins or sarpogrelate for the treatment of lower limb ischemia, a stable dose should be used for at least 1 month before the test drug is injected ;
- Before enrollment, confirmed by DSA or CTA as the superficial femoral artery ( ie, the femoral artery below the branch of the deep femoral artery), one or more stenosis of the radial artery and its lower artery ≥ 75% or occlusion;
Key exclusion criteria (26 listed)
- Patients with malignant tumors or clinically significant history of a hematological disease, or clinically significant results of tumor screening tests;
- Patients with a history of alcohol or drug abuse in the last 12 months;
- The affected limb may need an amputation in 4 weeks;
- Acute lower extremity arterial ischemic disease or acute progressive disease of lower extremity arterial ischemic disease;
- The index limb has serious infections ( such as cellulitis, osteomyelitis, etc.), distal fascia or bone exposure;
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 |
|---|---|---|
| Recombinant SeV-hFGF2/dF InjectionAlso: BF30intramuscular injection of investigator drugs | Biological | treatment 1, treatment 2, treatment 3, treatment 4 |
Primary outcome
Incidence of Treatment- Emergent Adverse Events [Safety and Tolerability]
Time frame: 6 months
AE incidence, inject site reactions
6 secondary outcomes
Maximum Plasma Concentration [Cmax]
Time frame: 6 months after drug administration
Area Under the Curve [AUC]
Time frame: 6 months after drug administration
antibody of the SeV
Time frame: 6 months after drug administration
walking distance
Time frame: 6 months after drug administration
pain scale
Time frame: 6 months after drug administration
Ruthorford staging
Time frame: 6 months after drug administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 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.
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 Recombinant SeV-hFGF2/dF Injection in people with PAOD - Peripheral Arterial Occlusive Disease and PAD, run by Shenzhen Salubris Pharmaceuticals 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 26 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: status not confirmed, as of the sponsor's last update on 25 Oct 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Ye (86-13601158377, yewill18@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment- Emergent Adverse Events [Safety and Tolerability] (time frame: 6 months). 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 Oct 2018.