NCT02667639

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: R-Pharm · Industry
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	RPH-104	Anti-IL-1 Mab
OTHER	Sodium chloride Sterile Injection 0.9% w/v	Sterile saline solution

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2016-01-29
• Last updated: 2021-12-28
• Results posted: 2019-10-04

Locations

1 site across 1 country: Turkey (Türkiye)