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CompletedNCT07206043Updated Oct 3, 2025

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

A Phase 1 interventional study of RPH-104 80 mg and RPH-104 160 mg in Healthy, sponsored by R-Pharm International, LLC. Completed at 1 site in Russia. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-03.

Sponsored by R-Pharm International, LLC (part of R-Pharm) · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Dec 2024, registered Sep 2025).
Phase
Phase 1
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

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

Read the 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
02

Conditions studied

  • Healthy

Keywords

  • subcutaneous
  • intravenous
  • Anti-IL1
  • Anti-IL1 beta
  • RPH-104
03

In context

Lead sponsor

R-Pharm International, LLC is the lead sponsor of 17 studies on the registry; 4 are open to participants now.

Browse R-Pharm International, LLC studies →All R-Pharm studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Volunteers had to meet all the following inclusion criteria:

  1. Signed and dated Form in duplicate
  2. Males and females aged 18-45 years inclusive

  3. :

    • 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

  4. Verified "healthy" diagnosis per standard clinical, laboratory, and instrumental examinations:

    1. Normal results for complete blood count, blood chemistry, coagulation tests, urinalysis, and per center standards (screening tests performed ≤7 days before enrollment)
    2. 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
    3. No tuberculosis (active, latent, or history) or other chronic infections/inflammatory diseases
    4. Satisfactory health status (per volunteer's opinion) for 30 days prior to consent
    5. "Normal" result for physical examination by investigator's judgment at screening
  5. Agreement to abstain from alcohol for 72 hours pre-dose until final PK blood sampling
  6. Willingness to comply with protocol procedures per investigator's judgment
  7. Agreement (by volunteers and their partners of for male volunteers) to abstain from heterosexual intercourse or use highly effective from consent until 3 months post-goflikicept administration
  8. For female volunteers: willingness to consent to pregnancy outcome data collection and provide obstetric/pediatric clinic contacts if pregnancy occurs post-dosing

Subjects were withdrawn from further participation in the study in the following cases:

  1. Detection, after inclusion of the subject in the study, of non-compliance with the inclusion criteria or presence, at the time of inclusion, of compliance with the exclusion criteria (as decided by LLC "R-Pharm International", including retrospective analysis of information entered into the eCRF database)
  2. If the subject withdraws their consent to participate in the study
  3. 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
  4. In case of subject non-compliance (in this case, exclusion of the subject must be agreed upon with representatives of LLC "R-Pharm International", see Section 6.3 of the Clinical Study Protocol), or in the case of systematic major deviations in the timing of scheduled visits (more than 3 deviations from scheduled visit dates). For Cohort C: in case of missing any of Visits 09, missing two consecutive Visits 1015, or missing any 3 visits during the study
  5. If the study is terminated by decision of LLC "R-Pharm International", local ethics committees, or regulatory authorities
  6. In case of use of drugs prohibited by the Protocol
  7. If restrictions for study subjects are violated (in this case, exclusion of the subject must be agreed upon with representatives of LLC "R-Pharm International", see Section 6.2.3 of the Clinical Study Protocol "Other restrictions for study subjects")
  8. If there is suspicion of concurrent participation in another clinical study, including indirect laboratory evidence
  9. If the result of a test for alcohol, narcotic, or psychotropic substances is positive before administration of the study drug
  10. If SARS-CoV-2 is detected via PCR test or rapid antigen test prior to administration of the study drug
  11. If other reasons arise during the study that prevent the study from being conducted according to the protocol
  12. In the event of the subject's death
  13. For female subjects a positive pregnancy test (test strip), performed at the center prior to administration of the study drug
  14. In case of missed blood sample collections (applicable only for Cohort C)
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
130 participants (actual)

Study arms

  • Experimental
    Cohort A: RPH-104, intravenous administration 80 mg

    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

  • Experimental
    Cohort A: RPH-104, intravenous administration 160 mg

    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

  • Experimental
    Cohort A: RPH-104, intravenous administration 320 mg

    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

  • Experimental
    Cohort B: RPH-104, subcutaneous administration 320 mg

    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

  • Placebo comparator
    Cohort B: Placebo

    Placebo Comparator, Placebo

    Drug: Placebo

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

    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

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

    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

  • BiologicalRPH-104 80 mg

    solution for intravenous injection, 40 mg/mL

    Also known as: goflikicept

  • BiologicalRPH-104 160 mg

    solution for intravenous injection, 40 mg/mL

    Also known as: goflikicept

  • BiologicalRPH-104 320 mg

    solution for intravenous injection, 40 mg/mL

    Also known as: goflikicept

  • BiologicalRPH-104 320 mg

    solution for subcutaneous injection, 80 mg/mL

    Also known as: goflikicept

  • BiologicalRPH-104 80 mg

    solution for subcutaneous injection, 40 mg/mL

    Also known as: goflikicept

  • BiologicalRPH-104 80 mg

    solution for subcutaneous injection, 80 mg/mL

    Also known as: goflikicept

  • DrugPlacebo

    0.9% Sodium Chloride solution for Injection

06

What researchers measure

Primary outcomes

  1. 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-∞))

    Time frame: Up to day 61 ± 3

  2. 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).

    Time frame: Up to day 61 ± 3

  3. Percentage of volunteers (%) with AEs and SAEs

    Percentage of volunteers (%) with AEs and SAEs

    Time frame: Up to day 61 ± 3

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

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

    Time frame: Up to day 61 ± 3

  5. Percentage of volunteers (%) with ADRs and serious ADRs

    Percentage of volunteers (%) with ADRs and serious ADRs

    Time frame: Up to day 61 ± 3

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

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

    Time frame: Up to day 61 ± 3

  7. 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

    Time frame: Up to day 61 ± 3

  8. 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

    Time frame: Up to day 61 ± 3

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

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

    Time frame: Up to day 61 ± 3

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

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

    Time frame: Up to day 61 ± 3

Secondary outcomes

  1. 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

    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 (AUC(0-1176))

    Time frame: Up to day 50 ± 1

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

    The time to reach the maximum concentration of RPH-104 after a single injection (Tmax)

    Time frame: Up to day 50 ± 1

  3. Apparent total clearance of RPH-104 after a single administration

    Apparent total clearance of RPH-104 after a single administration (Cl/F)

    Time frame: Up to day 50 ± 1

  4. The half-life of RPH-104 after a single administration

    The half-life of RPH-104 after a single administration (T1/2)

    Time frame: Up to day 50 ± 1

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

    The apparent volume of distribution of RPH-104 after a single administration (Vd/F)

    Time frame: Up to day 50 ± 1

  6. The elimination constant of RPH-104 after a single administration

    The elimination constant of RPH-104 after a single administration (λz)

    Time frame: Up to day 50 ± 1

07

Study locations

1 site
  • Llc "Research Lab"
    Moscow, 127521, Russia
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2024 to primary completion in Feb 2025, 2 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 26, 2025
First posted
Oct 3, 2025
StartActual
Dec 3, 2024
Primary completionActual
Feb 27, 2025
CompletionActual
Jul 25, 2025
Last update
Oct 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07206043
Lead sponsor
R-Pharm International, LLC
Collaborators
LLC "Exacte Labs", JSC "R-Pharm", Russia (R-Pharm Group)
Responsible party
Sponsor
First posted
Oct 3, 2025
Start date
Dec 3, 2024
Primary completion
Feb 27, 2025
Completion
Jul 25, 2025
Last update
Oct 3, 2025

Study contacts

Mikhail Samsonov
study director · R-Pharm

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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