Study to Evaluate the Effect on Parameters of Systemic Inflammation and Disease Outcomes and Safety of RPH-104 in Subjects With Acute ST-elevation Myocardial Infarction

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of the study is to evaluate the effect of single administration of RPH-104 at 80 mg and 160 mg on parameters of systemic inflammation and outcomes of the disease in subjects with ST-segment elevation myocardial infarction (STEMI)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: R-Pharm Overseas, Inc.
• Collaborators: Cromos Pharma LLC; Cromos Pharma, LLC; DM 365, LLC; Keystat, LLC

Criteria

Inclusion Criteria:

• Subjects who gave voluntary written Informed consent to participate in the study and to follow all Protocol procedures.

• STEMI diagnosis defined as chest pain or its equivalent with debut no more than 12 hours before randomization and ECG findings evidencing ST elevation (>1 mm) in two or more consecutive leads or acute left bunch branch block (LBBB) according the investigator's judgement.

• Percutaneous coronary intervention (PCI) with stenting was performed within no more than 12 hours after onset of chest pain or its equivalent before randomization.

• Consent of female subjects with childbearing potential defined as all female subjects with physiological potential to conceive, to use highly effective contraceptive methods throughout the study starting from screening (signing Informed Consent Form) and negative pregnancy test.

Highly effective contraceptive methods include combination of two of the following methods (a+b or a+c or b+c):

1. oral, injection or implanted hormonal contraceptives; in case of oral contraceptives, the female subjects should administer the same product for at least 3 months prior to the study therapy;

2. intrauterine device or contraceptive system;

3. barrier methods: condom or occlusive cap (diaphragm or cervical cap / vaginal fornix cap) with spermicidal foam/gel/film/cream/vaginal suppository

• Ability and willingness of the subject, according to the reasonable investigator's judgment, to attend the study site at all scheduled visits, undergo the study procedures and follow the protocol requirements including subcutaneous injections by qualified site personnel.

Exclusion Criteria:

• Hypersensitivity to test product (RPH-104) and/or its ingredients/excipients.

• Pregnancy and breastfeeding.

• Verified chronic heart failure (The American Heart Association / The American College of Cardiology (AHA/ACC) A-D class, New York Heart Association (NYHA) Functional class (FC) I-IV)

• Pre-existing decompensated heart defects.

• History of STEMI

• Complications of acute myocardial infarction in the form of acute left ventricular failure and cardiogenic shock defined as stable blood pressure decrease (SBP<90 mm Hg) associated with signs of hypoperfusion as well as cases when inotropic and/or mechanical support is required to maintain SBP; and / or unstable hemodynamics.

• Active infections (acute or chronic); active tuberculosis

• Recent (less than 5 half-life periods) or current administration of agents with an immunosuppressant mechanism of action, including, but not limited to, high doses of glucocorticoids (> 1 mg/kg of methylprednisolone equivalent),Tumour Necrosis Factor (TNF) alpha blockers, Interleukin-1 (IL-1) and other biological drugs, cyclosporine and other immunosuppressants. NSAIDs are allowed.

• Immunization with live vaccines within 90 days prior to the study product administration.

• Chronic systemic autoimmune or autoinflammatory diseases

• Suspected necessity in cardiosurgery

• Oncology (or diagnosis of oncology within the last 5 years).

• History of organ transplantation or necessity in transplantation at the screening initiation or scheduled transplantation during the study.

• Neutropenia (absolute neutrophil count <1800/mm3).

• Participation in another clinical study within the previous 3 months prior to Screening visit.

• Other medical or mental conditions or abnormal laboratory findings which may increase the risk for the subject associated with the study participation or administration of the study products or which may affect interpretation of the study results and, according to the investigator, render the subject ineligible for the study.

• The subjects working at the study site or subjects working for Sponsor directly involved in this clinical study.