Clinical trial NCT02667639: Pharmacokinetics and Pharmacodynamics of RPH-104 in Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: safety
tolerability
RPH-104
RPH104
Anti-IL1 beta
Anti-IL1
Lead sponsor: R-Pharm
Sponsor class: INDUSTRY
Collaborators: name: MonitorCRO
First posted: 2016-01-29
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this first in human study is to evaluate the safety and tolerability of RPH-104 in humans.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adverse Events
timeFrame: Until 60 days after administration
measure: Serious Adverse Events
timeFrame: Until 60 days after administration
measure: Respiratory Rate
timeFrame: Until 30 days after administration
measure: Blood Pressure
timeFrame: Until 30 days after administration
measure: Oxygen Saturation
timeFrame: Until 30 days after administration
measure: Body Temperature
timeFrame: Until 30 days after administration
measure: Clinical Laboratory Tests
timeFrame: Until 30 days after administration
Secondary outcomes:
measure: RPH-104 - Area Under the Curve (AUC)
timeFrame: Day 1, Day 2, Day3, Day 4, Day 5, Day 6, Day 9, Day 12, Day 15, Day 20, Day 25, Day 30
measure: RPH-104 - Time to Maximum Concentration (Tmax)
timeFrame: Day 1, Day 2, Day3, Day 4, Day 5, Day 6, Day 9, Day 12, Day 15, Day 20, Day 25, Day 30
measure: RPH-104 - Elimination Half-life (t1/2)
timeFrame: Day 1, Day 2, Day3, Day 4, Day 5, Day 6, Day 9, Day 12, Day 15, Day 20, Day 25, Day 30
measure: RPH-104 - Maximum Plasma Concentration (Cmax)
timeFrame: Day 1, Day 2, Day3, Day 4, Day 5, Day 6, Day 9, Day 12, Day 15, Day 20, Day 25, Day 30
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: ARGEFAR
Study officials:
affiliation: ARGEFAR
name: Sibel Goksel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: