None listed
Conditions
Brief summary
The primary purpose of this single dose study is to assess the safety and preliminary efficacy of ARG-007 in participants with AIS undergoing endovascular revascularization.
Interventions
Treatment: Drugs - ARG-007
Experimental: ARG-007 - Single intravenous infusion of ARG-007 0.3 mg/kg over 10 minutes, administered in hospital by registered nurse. Participants are to be administered the ARG-007 as soon after randomization as possible but before the completion of endovascular revascularization (using mechanical thrombectomy with or without thrombolysis).
Participants will be followed up in hospital on Day 2, Day 3, Day 6 (or Discharge), Safety assessments including vital signs,
Treatment: Drugs - ARG-007 Experimental: ARG-007 - Single intravenous infusion of ARG-007 0.3 mg/kg over 10 minutes, administered in hospital by registered nurse. Participants are to be administered the ARG-007 as soon after randomization as possible but before the completion of endovascular revascularization (using mechanical thrombectomy with or without thrombolysis). Participants will be followed up in hospital on Day 2, Day 3, Day 6 (or Discharge), Safety assessments including vital signs, NIHSS and laboratory will be carried out during these visits. Additionally, an NCCT will be performed at day 2 and an MRI at day 3. Following discharge participants will be followed up by telephone on Day 30, and Day 90 (End of Study [EoS]). Questionnaires will be collected during these visits to assess safety & efficacy.
Sponsors
Argenica Therapeutics Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Diagnosis of AIS deemed suitable for endovascular revascularization (mechanical thrombectomy with or without a thrombolytic agent). 2) Aged >/= 18 years. 3) Stroke onset (last known well) time < /= 24 hours before randomization. 4) The National Institutes of Health Stroke Scale (NIHSS) >/= 5 points at time of randomization. 5) Pre-stroke modified Rankin Score (mRS) < /= 3. Participant must have been living in their own home, apartment, or a senior’s lodge where no nursing care is required. 6) Confirmed symptomatic intracranial occlusion, based on computed tomographic angiography (CTA), at one or more of the following locations: intracranial internal carotid artery (T/L morphology) or M1 middle cerebral artery. 7) For participants transferring to stroke center from another hospital, CTA for study eligibility is to be performed or repeated at stroke center with endovascular suite onsite if there is a long delay (> 6 hours) from time of first CTA to time of repeat CTA. 8) Signed informed consent from participant or their legally authorized representative, or if required to enable inclusion by applicable national laws and regulations and the applicable Institutional Review Board/Ethics Committee requirements for obtaining consent from the investigator after consultation with an independent physician who is not otherwise participating in the study. 9) Willing (participant and/or caretaker) to commit to follow up assessments.
Exclusion criteria
1) Evidence of a large core of established infarction defined as ASPECTS of 0 to 5. 2) Evidence of intracranial hemorrhage or mass lesion on the qualifying imaging. 3) Endovascular revascularization procedure has already been completed at the time of Screening/randomization or has been completed before administration of study drug. 4) Planned use of an endovascular device that is not approved or does not have clearance by the relevant regulatory authority. 5) Rapid spontaneous improvement of neurological signs during Screening, as defined by a reduction of >/= 8 on the NIHSS between onset of symptoms and randomization. 6) History of stroke (ischemic or hemorrhagic) or penetrating head injury within 90 days before enrollment. 7) Uncontrolled blood pressure (BP) >/= 180/110 mmHg before endovascular revascularization procedure is initiated. 8) No femoral pulses, very difficult endovascular access, or extreme tortuosity of the great vessels that is predicted to result in an inability to timely deliver endovascular therapy. Direct common carotid or radial/brachial/axillary access is permissible. 9) Estimated or known body weight < 45 kg or > 130 kg. 10) Pregnancy: If a woman is of childbearing potential and has a positive point-of-care urine beta-human chorionic gonadotropin (ß-HCG) test or is breastfeeding. 11) Severe known renal impairment defined as requiring dialysis (hemo- or peritoneal) or a creatinine clearance < 29 mL/min. 12) Severe or fatal comorbid illness that will prevent improvement or follow-up. 13) Cannot complete follow-up visits because participant is a visitor to the area, or any other known reason that would prevent attendance at follow-up visits. 14) Received treatment with an investigational drug or device within 30 days before enrollment. 15) Any other condition that, in the opinion of the investigator, may adversely affect the safety of the participant, the participant’s ability to complete the study, or the outcome of the study.
Outcome results
None listed