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Pharmacokinetics, Safety and Immunogenicity of RPH-104 at a New Dosage and Different Doses Via Single Subcutaneous and Intravenous Administration in Healthy Volunteers

NCT07206043 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2025-10-03

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, immunogenicity and pharmacokinetics of RPH-104 after single intravenous and subcutaneous administration to healthy volunteers at different doses

Conditions

  • Healthy

Interventions

BIOLOGICAL

RPH-104 80 mg

solution for intravenous injection, 40 mg/mL

BIOLOGICAL

RPH-104 160 mg

solution for intravenous injection, 40 mg/mL

BIOLOGICAL

RPH-104 320 mg

solution for intravenous injection, 40 mg/mL

BIOLOGICAL

RPH-104 320 mg

solution for subcutaneous injection, 80 mg/mL

BIOLOGICAL

RPH-104 80 mg

solution for subcutaneous injection, 40 mg/mL

BIOLOGICAL

RPH-104 80 mg

solution for subcutaneous injection, 80 mg/mL

DRUG

Placebo

0.9% Sodium Chloride solution for Injection

Sponsors & Collaborators

  • LLC "Exacte Labs"

    collaborator UNKNOWN

  • JSC "R-Pharm", Russia (R-Pharm Group)

    collaborator UNKNOWN

  • R-Pharm International, LLC

    lead INDUSTRY

Principal Investigators

  • Mikhail Samsonov · R-Pharm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-03
Primary Completion
2025-02-27
Completion
2025-07-25

Countries

  • 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 NCT07206043 on ClinicalTrials.gov