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

NCT07206043 | Completed Phase 1

• 1 other identifier: CL04018366
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

subcutaneous; intravenous; Anti-IL1; Anti-IL1 beta; RPH-104

Outcome Measures

Primary Outcomes (10)

• The area under the plasma drug concentration-time curve (AUC) of RPH-104 from the moment of administration to infinity after a single injection of RPH-104

  The area under the plasma drug concentration-time curve (AUC) of RPH-104 from the moment of administration to infinity after a single injection of RPH-104 (AUC(0-∞))

  Up to day 61 ± 3

• The maximum concentration of RPH-104 in the blood serum after a single injection of RPH-104

  The maximum concentration of RPH-104 in the blood serum after a single injection of RPH-104 (Cmax).

  Up to day 61 ± 3

• Percentage of volunteers (%) with AEs and SAEs

  Percentage of volunteers (%) with AEs and SAEs

  Up to day 61 ± 3

• Percentage of volunteers (%) with AEs ≥ Grade 3 according to CTCAE 5.0

  Percentage of volunteers (%) with AEs ≥ Grade 3 according to CTCAE 5.0

  Up to day 61 ± 3

• Percentage of volunteers (%) with ADRs and serious ADRs

  Percentage of volunteers (%) with ADRs and serious ADRs

  Up to day 61 ± 3

• Percentage of volunteers (%) with ADRs ≥ Grade 3 according to CTCAE 5.0

  Percentage of volunteers (%) with ADRs ≥ Grade 3 according to CTCAE 5.0

  Up to day 61 ± 3

• Percentage of volunteers (%), who prematurely discontinued participation in the study due to AE/SAE and ADR/serious ADR

  Percentage of volunteers (%), who prematurely discontinued participation in the study due to AE/SAE and ADR/serious ADR

  Up to day 61 ± 3

• Percentage of volunteers (%) with AEs of special interest

  AEs of special interests include allergic and anaphylactic reactions, injection site reactions, infections, increased blood lipid levels, increased liver enzyme levels, drug-induced liver injury, neutropenia

  Up to day 61 ± 3

• Percentage of volunteers (%), who developed binding antibodies to RPH-104

  Percentage of volunteers (%), who developed binding antibodies to RPH-104

  Up to day 61 ± 3

• Percentage of volunteers (%), who developed neutralizing antibodies to RPH-104

  Percentage of volunteers (%), who developed neutralizing antibodies to RPH-104

  Up to day 61 ± 3

Secondary Outcomes (6)

• The area under the plasma drug concentration-time curve (AUC) of RPH-104 from the moment of administration to the last time point of sampling

  Up to day 50 ± 1

• The time to reach the maximum concentration of RPH-104 after a single injection

  Up to day 50 ± 1

• Apparent total clearance of RPH-104 after a single administration

  Up to day 50 ± 1

• The half-life of RPH-104 after a single administration

  Up to day 50 ± 1

• The apparent volume of distribution of RPH-104 after a single administration

  Up to day 50 ± 1

Study Arms (7)

Cohort A: RPH-104, intravenous administration 80 mg

EXPERIMENTAL

Subjects received RPH-104 Intravenously once as a 60-minute infusion at a dosage of 40 mg/mL, at a dose of 80 mg. The volume of the infusion solution was 100 ± 8 mL

Biological: RPH-104 80 mg

Cohort A: RPH-104, intravenous administration 160 mg

EXPERIMENTAL

Subjects received RPH-104 Intravenously once as a 60-minute infusion at a dosage of 40 mg/mL, at a dose of 160 mg. The volume of the infusion solution was 100 ± 8 mL

Biological: RPH-104 160 mg

Cohort A: RPH-104, intravenous administration 320 mg

EXPERIMENTAL

Subjects received RPH-104 Intravenously once as a 60-minute infusion at a dosage of 40 mg/mL, at a dose of 320 mg. The volume of the infusion solution was 100 ± 8 mL

Biological: RPH-104 320 mg

Cohort B: RPH-104, subcutaneous administration 320 mg

EXPERIMENTAL

Subjects received a single subcutaneous injection of either RPH-104 at a dosage of 80 mg/mL, at a dose of 320 mg (2 injections of 2 mL), or a placebo (2 injections of 2 mL)

Biological: RPH-104 320 mg

Cohort B: Placebo

PLACEBO COMPARATOR

Placebo Comparator, Placebo

Drug: Placebo

Cohort C: RPH-104, subcutaneous administration 80 mg (40 mg/mL)

EXPERIMENTAL

Subjects received a single subcutaneous injection of either RPH-104 at a dosage of 40 mg/mL, at a dose of 80 mg (1 injection of 2 mL)

Biological: RPH-104 80 mg

Cohort C: RPH-104, subcutaneous administration 80 mg (80 mg/mL)

EXPERIMENTAL

Subjects received a single subcutaneous injection RPH-104 at a dosage of 80 mg/mL, at a dose of 80 mg (1 injection of 1 mL)

Biological: RPH-104 80 mg

Interventions

RPH-104 80 mg BIOLOGICAL

solution for intravenous injection, 40 mg/mL

Also known as: goflikicept

Cohort A: RPH-104, intravenous administration 80 mg

RPH-104 160 mg BIOLOGICAL

solution for intravenous injection, 40 mg/mL

Also known as: goflikicept

Cohort A: RPH-104, intravenous administration 160 mg

RPH-104 320 mg BIOLOGICAL

solution for intravenous injection, 40 mg/mL

Also known as: goflikicept

Cohort A: RPH-104, intravenous administration 320 mg

Placebo DRUG

0.9% Sodium Chloride solution for Injection

Cohort B: Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed and dated Informed Consent Form in duplicate
• Males and females aged 18-45 years inclusive
• Body mass index:
• Cohorts A and B: normal range (18.5-29.9 kg/m²)
• Cohort C: normal range (18.5-29.9 kg/m²), body mass ≥55 and ≤100 kg
• Verified "healthy" diagnosis per standard clinical, laboratory, and instrumental examinations:
• Normal results for complete blood count, blood chemistry, coagulation tests, urinalysis, and ECG per center standards (screening tests performed ≤7 days before enrollment)
• Normal vital signs: SBP 90-129 mmHg, DBP 60-85 mmHg, pulse 60-100 bpm, body temperature 36.1-37.0℃, respiratory rate 12-20 breaths/min
• No tuberculosis (active, latent, or history) or other chronic infections/inflammatory diseases
• Satisfactory health status (per volunteer's opinion) for 30 days prior to consent
• "Normal" result for physical examination by investigator's judgment at screening
• Agreement to abstain from alcohol for 72 hours pre-dose until final PK blood sampling
• Willingness to comply with protocol procedures per investigator's judgment
• Agreement (by volunteers and their partners of reproductive potential for male volunteers) to abstain from heterosexual intercourse or use highly effective contraception from consent until 3 months post-goflikicept administration
• For female volunteers: willingness to consent to pregnancy outcome data collection and provide obstetric/pediatric clinic contacts if pregnancy occurs post-dosing

You may not qualify if:

• If the subject withdraws their consent to participate in the study
• If AEs or SAEs, laboratory abnormalities, or concomitant diseases are identified in the subject, which, in the opinion of the investigator or the Sponsor, make continued participation impossible or dangerous, or not in the best interest of the subject's welfare and safety
• If the study is terminated by decision of LLC "R-Pharm International", local ethics committees, or regulatory authorities
• In case of use of drugs prohibited by the Protocol
• If there is suspicion of concurrent participation in another clinical study, including indirect laboratory evidence
• If the result of a test for alcohol, narcotic, or psychotropic substances is positive before administration of the study drug
• If SARS-CoV-2 is detected via PCR test or rapid antigen test prior to administration of the study drug
• If other reasons arise during the study that prevent the study from being conducted according to the protocol
• In the event of the subject's death
• For female subjects a positive pregnancy test (test strip), performed at the center prior to administration of the study drug
• In case of missed blood sample collections (applicable only for Cohort C)

Sponsors & Collaborators

• R-Pharm International, LLC: lead
• LLC "Exacte Labs": collaborator
• JSC "R-Pharm", Russia (R-Pharm Group): collaborator

Study Sites (1)

Llc "Research Lab"

Moscow, 127521, Russia

Location

Study Officials

• Mikhail Samsonov

  R-Pharm

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: October 3, 2025
• Study Start: December 3, 2024
• Primary Completion: February 27, 2025
• Study Completion: July 25, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

RU (1)