HealthyPhase 1NCT07206043
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 study testing RPH-104 80 mg, RPH-104 160 mg and RPH-104 320 mg in people with Healthy, run by R-Pharm International, LLC at 1 site in Russia.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- RPH-104 80 mg, RPH-104 160 mg and RPH-104 320 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteRussia
- Study dates
- 3 Dec 2024to 25 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Volunteers had to meet all the following inclusion criteria:
- 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
Subjects were withdrawn from further participation in the study in the following cases:
- 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)
- 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
- 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
- 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 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")
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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:
- Screening period: days -6 to -1 (before randomization and inclusion in the study)
- Randomization: day 0
- 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
- 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
- Being tested
- RPH-104 80 mg, RPH-104 160 mg, RPH-104 320 mg, Placebo
- Keywords
- subcutaneous, intravenous, Anti-IL1, Anti-IL1 beta, RPH-104
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPH-104 80 mgBiological
Also called goflikicept
solution for intravenous injection, 40 mg/mL
RPH-104 160 mgBiological
Also called goflikicept
solution for intravenous injection, 40 mg/mL
RPH-104 320 mgBiological
Also called goflikicept
solution for intravenous injection, 40 mg/mL
RPH-104 320 mgBiological
Also called goflikicept
solution for subcutaneous injection, 80 mg/mL
RPH-104 80 mgBiological
Also called goflikicept
solution for subcutaneous injection, 40 mg/mL
RPH-104 80 mgBiological
Also called goflikicept
solution for subcutaneous injection, 80 mg/mL
PlaceboDrug
0.9% Sodium Chloride solution for Injection
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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) Receives: Biological: RPH-104 320 mg |
| Cohort B: Placebo | Placebo comparator | Placebo Comparator, Placebo Receives: 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) Receives: 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) Receives: Biological: RPH-104 80 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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-∞))
Measured: 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).
Measured: Up to day 61 ± 3
Percentage of volunteers (%) with AEs and SAEs
Percentage of volunteers (%) with AEs and SAEs
Measured: 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
Measured: Up to day 61 ± 3
Percentage of volunteers (%) with ADRs and serious ADRs
Percentage of volunteers (%) with ADRs and serious ADRs
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
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))
Measured: Up to day 50 ± 1
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)
Measured: Up to day 50 ± 1
Apparent total clearance of RPH-104 after a single administration
Apparent total clearance of RPH-104 after a single administration (Cl/F)
Measured: Up to day 50 ± 1
The half-life of RPH-104 after a single administration
The half-life of RPH-104 after a single administration (T1/2)
Measured: Up to day 50 ± 1
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)
Measured: Up to day 50 ± 1
The elimination constant of RPH-104 after a single administration
The elimination constant of RPH-104 after a single administration (λz)
Measured: Up to day 50 ± 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start3 Dec 2024
- Primary completion27 Feb 2025
- Study completion25 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- R-Pharm International, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LLC "Exacte Labs", JSC "R-Pharm", Russia (R-Pharm Group)
- Responsible party
- Sponsor
- Investigators
- Mikhail Samsonov, Study director, R-Pharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206043
- Sponsor's protocol ID
- CL04018366
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07206043
- Acronym / sponsor ID
- CL04018366
- Conditions
- Healthy
- Keywords
- subcutaneous, intravenous, Anti-IL1, Anti-IL1 beta, RPH-104
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- R-Pharm International, LLCIndustry (pharma, biotech, devices)
- Collaborators
- LLC "Exacte Labs", JSC "R-Pharm", Russia (R-Pharm Group)
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Screening period: days -6 to -1 (before randomization and inclusion in the study)
- Randomization: day 0
- 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
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort A: RPH-104, intravenous administration 80 mg | Experimental | Biological: RPH-104 80 mgSubjects 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 |
| Cohort A: RPH-104, intravenous administration 160 mg | Experimental | Biological: RPH-104 160 mgSubjects 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 |
| Cohort A: RPH-104, intravenous administration 320 mg | Experimental | Biological: RPH-104 320 mgSubjects 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 |
| Cohort B: RPH-104, subcutaneous administration 320 mg | Experimental | Biological: RPH-104 320 mgSubjects 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) |
| Cohort B: Placebo | Placebo comparator | Drug: PlaceboPlacebo Comparator, Placebo |
| Cohort C: RPH-104, subcutaneous administration 80 mg (40 mg/mL) | Experimental | Biological: RPH-104 80 mgSubjects 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) |
| Cohort C: RPH-104, subcutaneous administration 80 mg (80 mg/mL) | Experimental | Biological: RPH-104 80 mgSubjects 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) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RPH-104 80 mgAlso: goflikiceptsolution for intravenous injection, 40 mg/mL | Biological | Cohort A: RPH-104, intravenous administration 80 mg |
| RPH-104 160 mgAlso: goflikiceptsolution for intravenous injection, 40 mg/mL | Biological | Cohort A: RPH-104, intravenous administration 160 mg |
| RPH-104 320 mgAlso: goflikiceptsolution for intravenous injection, 40 mg/mL | Biological | Cohort A: RPH-104, intravenous administration 320 mg |
| RPH-104 320 mgAlso: goflikiceptsolution for subcutaneous injection, 80 mg/mL | Biological | Cohort B: RPH-104, subcutaneous administration 320 mg |
| RPH-104 80 mgAlso: goflikiceptsolution for subcutaneous injection, 40 mg/mL | Biological | Cohort C: RPH-104, subcutaneous administration 80 mg (40 mg/mL) |
| RPH-104 80 mgAlso: goflikiceptsolution for subcutaneous injection, 80 mg/mL | Biological | Cohort C: RPH-104, subcutaneous administration 80 mg (80 mg/mL) |
| Placebo0.9% Sodium Chloride solution for Injection | Drug | Cohort B: Placebo |
Primary outcome
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
Time frame: Up to day 61 ± 3
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-∞))
The maximum concentration of RPH-104 in the blood serum after a single injection of RPH-104
Time frame: Up to day 61 ± 3
The maximum concentration of RPH-104 in the blood serum after a single injection of RPH-104 (Cmax).
Percentage of volunteers (%) with AEs and SAEs
Time frame: Up to day 61 ± 3
Percentage of volunteers (%) with AEs and SAEs
Percentage of volunteers (%) with AEs ≥ Grade 3 according to CTCAE 5.0
Time frame: Up to day 61 ± 3
Percentage of volunteers (%) with AEs ≥ Grade 3 according to CTCAE 5.0
Percentage of volunteers (%) with ADRs and serious ADRs
Time frame: Up to day 61 ± 3
Percentage of volunteers (%) with ADRs and serious ADRs
Percentage of volunteers (%) with ADRs ≥ Grade 3 according to CTCAE 5.0
Time frame: Up to day 61 ± 3
Percentage of volunteers (%) with ADRs ≥ Grade 3 according to CTCAE 5.0
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
Percentage of volunteers (%), who prematurely discontinued participation in the study due to AE/SAE and ADR/serious ADR
Percentage of volunteers (%) with AEs of special interest
Time frame: Up to day 61 ± 3
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
Percentage of volunteers (%), who developed binding antibodies to RPH-104
Time frame: Up to day 61 ± 3
Percentage of volunteers (%), who developed binding antibodies to RPH-104
Percentage of volunteers (%), who developed neutralizing antibodies to RPH-104
Time frame: Up to day 61 ± 3
Percentage of volunteers (%), who developed neutralizing antibodies to RPH-104
6 secondary outcomes
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
Time frame: Up to day 50 ± 1
The time to reach the maximum concentration of RPH-104 after a single injection
Time frame: Up to day 50 ± 1
Apparent total clearance of RPH-104 after a single administration
Time frame: Up to day 50 ± 1
The half-life of RPH-104 after a single administration
Time frame: Up to day 50 ± 1
The apparent volume of distribution of RPH-104 after a single administration
Time frame: Up to day 50 ± 1
The elimination constant of RPH-104 after a single administration
Time frame: Up to day 50 ± 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
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Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikhail Samsonov study director
R-Pharm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RPH-104 80 mg, RPH-104 160 mg and RPH-104 320 mg in people with Healthy, run by R-Pharm International, LLC at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Up to day 61 ± 3). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.