Pharmacokinetics and Pharmacodynamics of RPH-104 in Healthy Subjects

NCT02667639 | Completed Phase 1 Results DMC

• 1 other identifier: RPH104FIH01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (7)

• Adverse Events

  Number of participants with study drug related adverse events

  Until 60 days after administration

• Serious Adverse Events

  Number of Participants with Study Drug Related Serious Adverse Events

  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.

  Until 30 days after administration

• Blood Pressure

  Percentage of participants with abnormal blood pressure. An optimal blood pressure level is a reading under 120/80 mmHg

  Until 30 days after administration

• Oxygen Saturation

  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.

  Until 30 days after administration

• Body Temperature

  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).

  Until 30 days after administration

• Clinical Laboratory Tests

  Percentage of participants with abnormal clinical laboratory tests. Normal laboratory ranges of the central laboratory were used.

  Until 30 days after administration

Secondary Outcomes (4)

• RPH-104 - Area Under the Curve (AUC)

  Day 1, Day 2, Day3, Day 4, Day 5, Day 6, Day 9, Day 12, Day 15, Day 20, Day 25, Day 30

• RPH-104 - Time to Maximum Concentration (Tmax)

  Day 1, Day 2, Day3, Day 4, Day 5, Day 6, Day 9, Day 12, Day 15, Day 20, Day 25, Day 30

• RPH-104 - Elimination Half-life (t1/2)

  Day 1, Day 2, Day3, Day 4, Day 5, Day 6, Day 9, Day 12, Day 15, Day 20, Day 25, Day 30

• RPH-104 - Maximum Plasma Concentration (Cmax)

  Day 1, Day 2, Day3, Day 4, Day 5, Day 6, Day 9, Day 12, Day 15, Day 20, Day 25, Day 30

Study Arms (2)

Treatment

ACTIVE COMPARATOR

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

Biological: RPH-104

Placebo

PLACEBO COMPARATOR

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

Other: Sodium chloride Sterile Injection 0.9% w/v

Interventions

RPH-104 BIOLOGICAL

Anti-IL-1 Mab

Treatment

Sodium chloride Sterile Injection 0.9% w/v OTHER

Sterile saline solution

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• R-Pharm: lead
• MonitorCRO: collaborator

Study Sites (1)

ARGEFAR

Izmir, Turkey (Türkiye)

Location

Results Point of Contact

• Title: Murat Özdemir
• Organization: Monitor CRO

murato@monitorcro.com

902122341260

Study Officials

• Sibel Goksel, MD, PhD

  ARGEFAR

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: January 29, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: December 28, 2021
• Results First Posted: October 4, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)