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Pharmacokinetics and Pharmacodynamics of RPH-104 in Healthy Subjects

NCT ID: NCT02667639

Last Updated: 2021-12-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy

Keywords

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safety tolerability RPH-104 RPH104 Anti-IL1 beta Anti-IL1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment

A single dose of RPH-104 (4, 20, 40, 80 or 160 mg) will be administered subcutaneously.

Group Type ACTIVE_COMPARATOR

RPH-104

Intervention Type BIOLOGICAL

Anti-IL-1 Mab

Placebo

A single 0.9% sodium chloride injection will be administered subcutaneously.

Group Type PLACEBO_COMPARATOR

Sodium chloride Sterile Injection 0.9% w/v

Intervention Type OTHER

Sterile saline solution

Interventions

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RPH-104

Anti-IL-1 Mab

Intervention Type BIOLOGICAL

Sodium chloride Sterile Injection 0.9% w/v

Sterile saline solution

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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MonitorCRO

INDUSTRY

Sponsor Role collaborator

R-Pharm

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sibel Goksel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

ARGEFAR

Locations

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ARGEFAR

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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RPH104FIH01

Identifier Type: -

Identifier Source: org_study_id