Title
Pharmacokinetics and Pharmacodynamics of RPH-104 in Healthy Subjects
A Randomized, Double-blind, Placebo-controlled, Single-center, Phase I, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RPH-104 in Healthy Subjects
Phase
Phase 1Lead Sponsor
TRPHARMStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
HealthyIntervention/Treatment
Goflikicept sodium chloride ...Study Participants
35The purpose of this first in human study is to evaluate the safety and tolerability of RPH-104 in humans.
RPH-104 is a macromolecular compound with a molecular weight of 152.715 kilodalton (Data on file) and is capable of binding human interleukin-1 beta (IL-1β). It has also been shown in vitro to be a highly potent inhibitor of IL-1β signalling pathway, with low picomolar inhibitor activity. In this First in Human study, RPH-104 will be evaluated primarily for its safety and tolerability. In a phase I study conducted with health volunteers, a similar monoclonal antibody, canakinumab, was investigated in terms of pharmacokinetics and pharmacodynamics besides efficacy and safety. Similarly, this aimed to investigate effects of RPH-104 on selected pharmacodynamic parameters, including Anti-Drug Antibodies (ADA) along with obtaining first human data on pharmacokinetics of RPH-104 in humans will be investigated in the same study.
Anti-IL-1 Mab
Sterile saline solution
A single dose of RPH-104 (4, 20, 40, 80 or 160 mg) will be administered subcutaneously.
A single 0.9% sodium chloride injection will be administered subcutaneously.
Inclusion Criteria: Healthy subjects. Male or female subjects between 18 and 35 years old (inclusive). Subject who has normal body weight as determined by a body mass index (BMI) of between 18 kg/m² and 30 kg/m² (inclusive) and within a body weight of ≥50kg and ≤120kg. Exclusion Criteria: Subject who has a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, dermatological, neurological, psychiatric, and hematological or immunological disorder(s), and/or any condition that could constitute a potential safety risk factor or could alter the absorption, distribution, metabolism or elimination of the study drugs. Subject who has positive immunoglobulin-M (IgM) antibodies against Epstein-Barr virus (EBV)-viral capsid antigen (VCA) (IgM-anti-EBV-VCA) and Cytomegalovirus (CMV). Subject who has a positive Quantiferon TB-Gold (TB) test Subject who is positive to Human Immunodeficiency Virus-1/2 antibody (HIV-1/2Ab). Subject who has serum hepatitis, or is a carrier of the Hepatitis B surface antigen (HBsAg), or is Hepatitis C virus antibody (HCV-Ab) positive.
| Event Type | Organ System | Event Term | Treatment | Placebo |
|---|
Number of participants with study drug related adverse events
Number of Participants with Study Drug Related Serious Adverse Events
Percentage of participants with abnormal respiratory rate. The normal respiration rate for an adult at rest is 12 to 20 breaths per minute.
Percentage of participants with abnormal blood pressure. An optimal blood pressure level is a reading under 120/80 mmHg
Percentage of participants with abnormal oxygen saturation. Normal pulse oximeter readings usually range from 95 to 100 percent. Values under 90 percent are considered low.
Percentage of participants with abnormal body temperature. Among adults, the average body temperature ranges from 97°F (36.1°C) to 99°F (37.2°C).
Percentage of participants with abnormal clinical laboratory tests. Normal laboratory ranges of the central laboratory were used.
Mean AUC 0-t (area under the concentration- time curve from time zero to day 30)
Median Tmax. Definition of Tmax is time at which Cmax occurs.
Mean t½. Definition of t½ is terminal elimination half-life.
Mean Cmax. Highest concentration determined in the measuring interval.
