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

PHASE1CompletedINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

December 3, 2024

Primary Completion Date

February 27, 2025

Study Completion Date

July 25, 2025

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

Trial Locations (1)

127521

"Llc Research Lab", Moscow

All Listed Sponsors
collaborator

"LLC Exacte Labs"

UNKNOWN

collaborator

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

UNKNOWN

lead

R-Pharm International, LLC

INDUSTRY

NCT07206043 - Pharmacokinetics, Safety and Immunogenicity of RPH-104 at a New Dosage and Different Doses Via Single Subcutaneous and Intravenous Administration in Healthy Volunteers | Biotech Hunter | Biotech Hunter