None listed
Conditions
Brief summary
Patient outcomes following an ischaemic stroke are significantly improved by rescuing the ischaemic penumbra, the severely hypoperfused and hypoxic, electrically silent, at-risk brain tissue. ARG-007 offers the potential to reduce neuronal cell death and preserve still viable tissue in the penumbra in patients by disrupting the excitotoxic pathway that a stroke initiates, resulting in potentially enhanced functional recovery. This is a double-blind, randomized, placebo-controlled, study to assess the safety, tolerability, and pharmacokinetics of single ascending doses of ARG-007 in healthy participants at a single site in Australia. The primary objective of this study is to evaluate the safety and tolerability of single escalating doses of ARG-007 in healthy participants for 8 days, administered by intravenous infusion. The secondary objectives are to determine the pharmacokinetic profile and immune response profile of ARG-007 in healthy participants following single dose administration.
Interventions
Patient outcomes following an ischaemic stroke are significantly improved by rescuing the ischaemic penumbra, the severely hypoperfused and hypoxic, electrically silent, at-risk brain tissue. ARG-007 offers the potential to reduce neuronal cell death and preserve still viable tissue in the penumbra in patients by disrupting the excitotoxic pathway that a stroke initiates, resulting in potentially enhanced functional recovery.
This is a double-blind, randomized, placebo-controlled, study to
Patient outcomes following an ischaemic stroke are significantly improved by rescuing the ischaemic penumbra, the severely hypoperfused and hypoxic, electrically silent, at-risk brain tissue. ARG-007 offers the potential to reduce neuronal cell death and preserve still viable tissue in the penumbra in patients by disrupting the excitotoxic pathway that a stroke initiates, resulting in potentially enhanced functional recovery. This is a double-blind, randomized, placebo-controlled, study to assess the safety, tolerability, and pharmacokinetics of single ascending doses of ARG-007 in healthy participants at a single site in Australia. At least 32 participants will receive either study drug or matched placebo at one of four dose levels (0.03 mg/kg, 0.10 mg/kg, 0.20 mg/kg, 0.30 mg/kg) via slow intravenous infusion over ten minutes. Participants will stay to complete safety assessments up to 48 hours post dose, and then return to the clinical site on Day 8 (± 1 day) for follow up assessments. Trained nurses will be administering the study drugs to the participants.
Sponsors
Argenica Therapeutics Ltd.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Any gender, aged 18 to 65 inclusive at the time of screening; 2. Generally healthy with the exception of those medical conditions allowed as per the inclusion/exclusion criteria; 3. Body mass index 18.0 to 32.0 kg/m2, inclusive at the time of screening and Day -1; 4. Weight between 50.0 to 100.0 kg at the time of screening and at Day -1; 5. Provision of voluntary, written informed consent with comprehension of all aspects of the protocol, prior to any study procedures; 6. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and a negative urine pregnancy test at Day -1 and must not be breastfeeding, lactating or planning pregnancy during the study period. WOCBP must agree to use an acceptable form of contraception during the treatment period and for at least 28 days post dose. 7. A male subject with a female partner of childbearing potential is eligible to participate if he agrees to use acceptable contraception during the treatment period and for at least 90 days post dose and refrain from donating sperm for at least 90 days post-dose. 8. Subjects must have the ability and willingness to attend the necessary visits to the study center.
Exclusion criteria
1. Have any underlying physical or psychological medical condition that, in the opinion of the investigator, would make it unlikely that the subject will complete the study; 2. Any significant past or current cardiac, pulmonary, hepatic, renal or other medical condition which, in the opinion of the investigator, would make participation in this study medically unsafe or compromise the study endpoints; 3. History of significant hypersensitivity such as urticaria, angioedema, or anaphylaxis; 4. Subjects with past medical history of malignancy except basal cell or squamous cell carcinoma of the skin who have had curative surgical treatment and at least 6 months have elapsed since the procedure; 5. Clinically significant laboratory abnormality (as judged by the investigator) at any time prior to dosing. Can be repeated once during screening at the discretion of the investigator; 6. Systolic blood pressure outside 100 to 140 mmHg or diastolic blood pressure outside of 50 to 90 mmHg at any point prior to dosing. Can be repeated at two different timepoints at the discretion of the investigator; 7. Clinically significant ECG abnormality (as judged by the investigator) at any time prior to dosing; 8. Positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C (HCV) antibodies at screening; 9. Use of angiotensin-converting-enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB) to control blood pressure; 10. Use of prescription medicines, over-the-counter medicines, vitamins or supplements within 7 days, or 5 half-lives (whichever is longer) prior to dosing until the EOS visit. The use of hormone replacement therapy, hormonal contraception or paracetamol (less than or equal to 2 g per day) is permitted; 11. Use of alcohol, nicotine and tobacco-containing products, and recreational vaping products from 48 hours prior to Day -1; 12. Unwilling to avoid heavy exercise (eg, marathon runners, weight-lifters) for five days prior to Day -1 until the EOS visit; 13. Alcohol or recreational substance use in the 12 months prior to dosing which has caused medical, psychological or other consequences, or which is considered to possibly impact participant safety or data validity; 14. Positive urine drug screen at screening or Day -1; 15. Blood donation or significant blood loss within 60 days prior to Day -1; 16. Plasma donation within 14 days prior to Day -1; 17. Administration of an investigational product in another study within 30 days or 5 x half-life (whichever is longer) prior to Day -1; 18. Surgery within the past 3 months prior Day -1 determined by the investigator to be clinically relevant; 19. Active infection (diagnosed or suspected) or history of recurrent infection; 20. History of clinically significant acute bacterial, viral, or fungal systemic infections in the 4 weeks prior to screening; 21. Serious local infection or systemic infection requiring antibiotic treatment within 3 months prior to screening; 22. Known alpha 1-antitrypsin deficiency (a1-antitrypsin deficiency); 23. Any vaccination within 2 weeks prior to Day -1, or requiring vaccination during the study or within 2 weeks after completion of the study; 24. Any significant acute illness within 30 days prior to Day -1.
Outcome results
None listed