Ignite Creation Date:
2024-05-06 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03668353
Status:
UNKNOWN
Last Update Posted:
2018-10-25
First Post:
2018-09-08
Brief Title:
Recombinant SeV-hFGF2dF Injection for PAOD
Sponsor:
Shenzhen Salubris Pharmaceuticals Co Ltd
Organization:
Shenzhen Salubris Pharmaceuticals Co Ltd
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2018-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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-hFGF2dF injection RD 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
Our recombinant SeV-hFGF2dF injection RD 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None