> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/pharmacokinetics-safety-and-immunogenicity-of-rph-104-at-a-d366901b-6f0a-4479-9f1c-9cd7dabf8c95 > Record changed: 2026-11-04 # Pharmacokinetics, Safety and Immunogenicity of RPH-104 at a New Dosage and Different Doses Via Single Subcutaneous and Intravenous Administration in Healthy Volunteers NCT07206043 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) Participants 130 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) Lead sponsor R-Pharm International, LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) Start date 2024-12-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) ## Title and summary **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) **Short title** Pharmacokinetics, Safety and Immunogenicity of RPH-104 at a New Dosage and Different Doses Via Single Subcutaneous and Intravenous Administration in Healthy Volunteers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) ## Dates **Completion date** 2025-07-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) **First posted** 2025-10-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) **Registry last updated** 2025-10-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) **Primary completion date** 2025-02-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) **Start date** 2024-12-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) ## Size and sites **Actual participants** 130 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) **Participants** 130 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) **Lead sponsor** R-Pharm International, LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) ## Identifiers **Registry ID** NCT07206043 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) **ClinicalTrials.gov ID** NCT07206043 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Single masking **Masked roles** Participants Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) ## Outcomes ### 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 Timeframe: 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-∞)) 2. The maximum concentration of RPH-104 in the blood serum after a single injection of RPH-104 Timeframe: Up to day 61 ± 3 The maximum concentration of RPH-104 in the blood serum after a single injection of RPH-104 (Cmax). 3. Percentage of volunteers (%) with AEs and SAEs Timeframe: Up to day 61 ± 3 Percentage of volunteers (%) with AEs and SAEs 4. Percentage of volunteers (%) with AEs ≥ Grade 3 according to CTCAE 5.0 Timeframe: Up to day 61 ± 3 Percentage of volunteers (%) with AEs ≥ Grade 3 according to CTCAE 5.0 5. Percentage of volunteers (%) with ADRs and serious ADRs Timeframe: Up to day 61 ± 3 Percentage of volunteers (%) with ADRs and serious ADRs 6. Percentage of volunteers (%) with ADRs ≥ Grade 3 according to CTCAE 5.0 Timeframe: Up to day 61 ± 3 Percentage of volunteers (%) with ADRs ≥ Grade 3 according to CTCAE 5.0 7. Percentage of volunteers (%), who prematurely discontinued participation in the study due to AE/SAE and ADR/serious ADR Timeframe: Up to day 61 ± 3 Percentage of volunteers (%), who prematurely discontinued participation in the study due to AE/SAE and ADR/serious ADR 8. Percentage of volunteers (%) with AEs of special interest Timeframe: 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 9. Percentage of volunteers (%), who developed binding antibodies to RPH-104 Timeframe: Up to day 61 ± 3 Percentage of volunteers (%), who developed binding antibodies to RPH-104 10. Percentage of volunteers (%), who developed neutralizing antibodies to RPH-104 Timeframe: Up to day 61 ± 3 Percentage of volunteers (%), who developed neutralizing antibodies to RPH-104 ### 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 Timeframe: Up to day 50 ± 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 (AUC(0-1176)) 2. The time to reach the maximum concentration of RPH-104 after a single injection Timeframe: Up to day 50 ± 1 The time to reach the maximum concentration of RPH-104 after a single injection (Tmax) 3. Apparent total clearance of RPH-104 after a single administration Timeframe: Up to day 50 ± 1 Apparent total clearance of RPH-104 after a single administration (Cl/F) 4. The half-life of RPH-104 after a single administration Timeframe: Up to day 50 ± 1 The half-life of RPH-104 after a single administration (T1/2) 5. The apparent volume of distribution of RPH-104 after a single administration Timeframe: Up to day 50 ± 1 The apparent volume of distribution of RPH-104 after a single administration (Vd/F) 6. The elimination constant of RPH-104 after a single administration Timeframe: Up to day 50 ± 1 The elimination constant of RPH-104 after a single administration (λz) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 45 Years **Healthy volunteers** Yes Volunteers had to meet all the following inclusion criteria: 1. Signed and dated Informed Consent Form in duplicate 2. Males and females aged 18-45 years inclusive 3. 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 4. Verified "healthy" diagnosis per standard clinical, laboratory, and instrumental examinations: 1. Normal results for complete blood count, blood chemistry, coagulation tests, urinalysis, and ECG 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 reproductive potential for male volunteers) to abstain from heterosexual intercourse or use highly effective contraception 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) Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) ## Sites - Llc "Research Lab"Moscow, Russia Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07206043) ## Related records ### Drugs (1) - [Goflikicept](https://trialight.com/data/asset/goflikicept-e963ad9a-7ff2-45a8-8ded-8a16527fb620.md) ### Collaborators (2) - JSC "R-Pharm", Russia (R-Pharm Group) - LLC "Exacte Labs" ### Lead sponsors (1) - [R-Pharm International, LLC](https://trialight.com/data/company/r-pharm-international-llc-0504db2a-0107-4761-aaf0-83968f87aba8.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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