NCT07206043

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

Single-Center, Randomized, Cohort, Single-Blind, Comparative Clinical Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of RPH-104 in a New 80 mg/mL Dosage Form Following Single Subcutaneous and Intravenous Administration at Doses of 80 mg, 160 mg, and 320 mg in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: R-Pharm International, LLC · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Detailed description

This clinical study is a single-center, simple-blind, randomized, comparative phase I clinical study conducted in 3 parallel cohorts: In cohort A, a simple blind design is proposed with a single intravenous administration of the study drug at 3 increasing doses (N = 30, 10 volunteers per dose group): 80 mg, 160 mg, 320 mg In cohort B, a simple blind design is proposed with a single subcutaneous administration of the study drug (80 mg/mL; 320 mg) compared to placebo (N = 20, 10 volunteers per drug and placebo group) In cohort C, a simple blind design is proposed with a single subcutaneous administration of the study drug in two dosages (40 mg/mL and 80 mg/mL) in one dose (80 mg) to confirm the equivalence of these dosages (N = 80, 40 volunteers in each group) The study will include the following periods: 1. Screening period: days -6 to -1 (before randomization and inclusion in the study) 2. Randomization: day 0 3. Main study period:days 1 to 50 (± 1) The main period includes a single hospitalization of volunteers for at least 24 hours, as well as 9 outpatient visits in cohort A and 14 outpatient visits in cohorts B and C. It includes procedures related to the administration of the study drug, monitoring the study participant, and taking blood samples to measure the concentration of goflikicept, as well as a safety and immunogenicity panel 4. Safety monitoring period: days 51 - 61 (± 3). On day 61, a phone call will be made to collect information about safety In order to monitor safety during the main sudy period, the following procedures will be carried out: * In Cohort A, vital signs vital signs will be measured before drug administration and 15 min, 1 h, 2 h, 4 h, 12 h and 24 h after drug administration on days 3-50; physical examination will be performed on days 2, 6, 16, 30, 40, 50; electrocardiography (ECG) on days 3, 23, 50 day; assessment of hypersensitivity reactions to the drug in 2 h, 12 h, 24 h after the start of drug administration and on day 3; clinical blood test, biochemical blood test on 3, 6, 16, 23, 50 day; coagulogram on 3, 16, 50 day; general urinalysis on 6, 16, 23, 50 day. * In Cohort B and C, vital signs vital signs will be measured before drug administration and in 2 h, 12 h and 24 h after drug administration on days 3-50; physical examination will be performed on days 2, 6, 16, 30, 40, 50; ECG on days 5, 23, 50 day; assessment of hypersensitivity reactions to the drug in 2 h, 12 h, 24 h after the start of drug administration and on day 3; clinical blood test, biochemical blood test on 5, 9, 16, 30, 50 day; coagulogram on 5, 16, 50 day; general urinalysis on 5, 16, 30, 50 day * Women with preserved reproductive potential will additionally undergo blood analysis for hCG during screening, followed by a urine pregnancy test the day before the administration of RPH-104 (Day 0) and on Day 50 To assess the pharmacokinetics of RPH-104, volunteers will undergo periodic blood sampling (at a total of 18 points during the study for cohort A, and at 18 points for cohorts B and C) * In cohort A, blood samples for the evaluation of RPH-104 pharmacokinetics will be taken before the infusion of RPH-104 on Day 1 (\< 60 min before infusion ) and in 30 min, 1 h (immediately after the end of the infusion), 1 h and 30 min, 2 h, 4 h, 8 h, 12 h, 24 h, 48 h, 72 h, 120 h, 192 h, 360 h, 528 h, 696 h, 936 h and 1176 h after the first administration of the drug (since the start of infusion) * In cohort B and C, blood samples for the evaluation of RPH-104 pharmacokinetics will be taken before the infusion of RPH-104 on Day 1 (\< 60 min before infusion ) and in 4 h, 12 h, 24 h, 48 h, 72 h, 84 h, 96 h, 108 h, 144 h,120 h, 192 h, 264 h, 360 h, 528 h, 696 h, 936 h and 1176 h after the first administration of the drug (since the start of infusion) To assess the immunogenicity of RPH-104, volunteers will undergo periodic blood sampling to determine the concentration of binding and neutralizing antibodies (at a total of 5 points in the study in all cohorts) * In cohort A, blood sampling for immunogenicity testing is performed before the drug is administered (≤60 min before administration) and then in 360 h (day 16) (± 120 min), 696 h (day 30) (±24 h), 936 h (day 40) (±24 h), 1176 h (day 50) (±24 h) after administration of the drug. When binding antibodies are detected, their neutralizing activity (NAT) will additionally be determined * In cohort B and C, blood sampling for immunogenicity testing is performed before the drug is administered (≤60 min before administration) and then in 360 h (day 16) (± 120 min), 696 h (day 30) (±24 h), 936 h (day 40) (±24 h), 1176 h (day 50) (±24 h) after administration of the drug. When binding antibodies are detected, their neutralizing activity (NAT) will additionally be determined

Conditions

• Healthy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-12-03
• Primary completion: 2025-02-27
• Completion: 2025-07-25
• First posted: 2025-10-03
• Last updated: 2025-10-03

Locations

1 site across 1 country: Russia