Pharmacokinetics and Pharmacodynamics of RPH-104 in Healthy Subjects

R-Pharm35 enrolled

Overview

The 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

RPH-104BIOLOGICAL

Anti-IL-1 Mab

Sodium chloride Sterile Injection 0.9% w/vOTHER

Sterile saline solution

Eligibility

Sex: ALLMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

ARGEFAR

Izmir, Turkey (Türkiye)

Outcomes

Primary Outcomes

Adverse Events

Number of participants with study drug related adverse events

Time frame: Until 60 days after administration

Serious Adverse Events

Number of Participants with Study Drug Related Serious Adverse Events

Time frame: Until 60 days after administration

Respiratory Rate

Percentage of participants with abnormal respiratory rate. The normal respiration rate for an adult at rest is 12 to 20 breaths per minute.