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

NCT07206043
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Phase
Phase 1
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Recruitment status
Completed
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Participants
130
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Lead sponsor
R-Pharm International, LLC
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Start date
2024-12-03
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Number of sites
1
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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
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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
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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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1
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Study type
Interventional
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Completion date
2025-07-25
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First posted
2025-10-03
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Registry last updated
2025-10-03
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Primary completion date
2025-02-27
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Start date
2024-12-03
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Actual participants
130
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Participants
130
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Participant count basis
Actual
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Protocol amendments
0
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Number of sites
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
R-Pharm International, LLC
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07206043
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ClinicalTrials.gov ID
NCT07206043
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Single masking
Masked roles
Participants
Sources for study design
clinicaltrials.gov

  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

  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
clinicaltrials.gov

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
clinicaltrials.gov

  • Llc "Research Lab"Moscow, Russia
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Collaborators (2)

Lead sponsors (1)