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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

NCT04463251 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2024-06-24

Study results available
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Summary

The goal of the study was 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)

Conditions

  • Acute ST Segment Elevation Myocardial Infarction

Interventions

BIOLOGICAL

RPH-104 80 mg

solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL transparent glass vial

DRUG

Placebo

Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial

Sponsors & Collaborators

  • Cromos Pharma LLC

    collaborator INDUSTRY

  • Data Management 365

    collaborator INDUSTRY

  • Keystat, LLC

    collaborator INDUSTRY

  • R-Pharm

    collaborator INDUSTRY

  • K-Research, LLC

    collaborator INDUSTRY

  • R-Pharm Overseas, Inc.

    lead INDUSTRY

Principal Investigators

  • Yan Lavrovsky · R-Pharm Overseas, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-07
Primary Completion
2021-11-03
Completion
2022-10-10
FDA Drug
Yes

Countries

  • United States
  • Russia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04463251 on ClinicalTrials.gov