None listed
Conditions
Brief summary
The aim of this study is to assess the safety and tolerability of ARG-397, an experimental new medicine being developed to help reduce the formation of blood clots. Blood clots can block blood vessels and may lead to serious medical conditions. This study will involve healthy volunteers who will receive a single dose of ARG-397. Researchers will monitor participants for any side effects, measure how long ARG-397 stays in the bloodstream, and assess whether it affects the blood’s ability to clot.
Interventions
There are six dose cohorts planned for this study. Cohorts 1-4 and 6 will receive single subcutaneous (SC) injections of ARG-397. Cohort 5 (optional) will evaluate a single planned intravenous (IV) dose of ARG-397. A registered nurse will administer the study intervention (ARG-397 or placebo) in the clinical research unit.
The planned SC dose levels include up to 100mg (Cohort 1), 300mg (Cohort 2) and 600mg (Cohort 3). Following a review of the available safety and PK data for Cohorts 1-3, the
There are six dose cohorts planned for this study. Cohorts 1-4 and 6 will receive single subcutaneous (SC) injections of ARG-397. Cohort 5 (optional) will evaluate a single planned intravenous (IV) dose of ARG-397. A registered nurse will administer the study intervention (ARG-397 or placebo) in the clinical research unit. The planned SC dose levels include up to 100mg (Cohort 1), 300mg (Cohort 2) and 600mg (Cohort 3). Following a review of the available safety and PK data for Cohorts 1-3, the Sponsor will determine the doses to be evaluated in 3 subsequent cohorts. All cohorts will enroll 8 participants randomized in a 6:2 ratio of ARG-397 to placebo. For each cohort, two sentinel participants (one randomized to ARG-397 and one randomized to placebo) will be dosed first. Sentinel participants will be monitored and evaluated for safety and tolerability for up to 48 hours following dosing. Participants will remain in the clinical research unit for 7 days following dosing to enable safety surveillance, Pharmacokinetic (PK) sampling and Pharmacodynamic (PD) assessments. After discharge, participants will return for outpatient follow up through 6 months post-dose.
Sponsors
Arguello Biosciences, Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Able to provide written informed consent and willing to comply with trial requirements, 2. Age 18 to 65 years. 3. In good health and able to abstain from prescription and over the counter (OTC) medications. 4. Female participants must have a confirmation of postmenopausal or surgically sterile status. Male participants with female partners of child-bearing potential must agree to meet the contraception requirements from the time of study drug administration until 36 weeks after last dose of study drug.
Exclusion criteria
1. History of an abnormal bleeding after trauma or intervention. 2. Predisposition for bruising or any other kind of spontaneous bleeding. 3. Presence or family history of bleeding disorder, such as Hemophilia A, Hemophilia B, Wiskott-Aldrich syndrome, or von Willebrand disease (vWD). 4. Any planned surgery or any planned buccal, dental, ear, nose, throat, or genitourinary intervention in the 6 months following enrollment (dosing). Routine dental exams, dental cleanings or other checkups are allowed. 5. History of stroke, transient ischemic attack, or traumatic or non-traumatic intracranial bleed. 6. History of acute, subacute, or chronic pericarditis. 7. Regular use of medications that increase the risk of bleeding, including antiplatelet agents (such as aspirin), anticoagulants, or fibrinolytic agents. 8. Chronic use of OTC medications, corticosteroids or NSAIDs within 14 days prior to dosing. 9. History of allergic reactions to monoclonal antibodies or antibody fragments. 10. History of clinically significant cardiovascular disease, peripheral vascular disease, cardiopulmonary disease, diabetes, anemia or thrombocytopenia. 11. History of bone marrow or solid organ transplantation. 12. History of clinically significant ECG abnormalities or significant arrhythmias. Known family history of long QT syndrome. 13. Required a transfusion within 3 months. 14. Recent (within 2 months) bacterial, protozoal, viral, or parasitic infection that required systemic treatment. 15. History of active tuberculosis infection or systemic fungal disease. 16. Human immunodeficiency virus (HIV) infection or HIV seropositivity at Screening. 17. History of malignancy (except non-melanoma skin cancer or cervical in situ). 18. History of significant multiple and/or severe allergies (including latex gloves), anaphylaxis, or had an anaphylactic reaction, significant intolerability or immediate hypersensitivity reaction to prescription or nonprescription drugs or food. 19. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. 20. Participation in any clinical research trial evaluating another investigational drug (including biologics) or therapy (including specific immunotherapy) within 90 days or >/=5 half-lives (whichever is longer), prior to Screening.
Outcome results
None listed