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Trial record 1 of 1 for:    RPH104
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First in Human Study for RPH-104

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ClinicalTrials.gov Identifier: NCT02667639
Recruitment Status : Unknown
Verified April 2017 by TRPHARM.
Recruitment status was:  Active, not recruiting
First Posted : January 29, 2016
Last Update Posted : April 21, 2017
Sponsor:
Collaborator:
MonitorCRO
Information provided by (Responsible Party):
TRPHARM

Tracking Information
First Submitted Date  ICMJE January 20, 2016
First Posted Date  ICMJE January 29, 2016
Last Update Posted Date April 21, 2017
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2016)
  • Nature, frequency, severity and relationship to study drug of recorded adverse events [ Time Frame: Until 30 days after administration ]
    Assessment will be in accordance with current MedDRA
  • Heart rate [ Time Frame: Until 30 days after administration ]
  • Respiratory rate [ Time Frame: Until 30 days after administration ]
  • Blood pressure [ Time Frame: Until 30 days after administration ]
  • Oxygen saturation [ Time Frame: Until 30 days after administration ]
  • Body temperature [ Time Frame: Until 30 days after administration ]
  • Clinical laboratory tests [ Time Frame: Until 30 days after administration ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 26, 2016)
  • Nature, frequency, severity and relationship to study drug of recorded adverse events [ Time Frame: Until 30 days after administration ]
    Assessment will be in accordance with current MedDRA
  • Heart rate [ Time Frame: Until 30 days after administration ]
  • Respiratory rate [ Time Frame: Until 30 days after administration ]
  • Blood pressure [ Time Frame: Until 30 days after administration ]
  • Oxygen saturation [ Time Frame: Until 30 days after administration ]
  • Body temperature [ Time Frame: Until 30 days after administration ]
Change History Complete list of historical versions of study NCT02667639 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2016)
  • RPH-104 - Maximum plasma concentration (Cmax) [ Time Frame: Day 1 ]
  • RPH-104 - Area Under the Curve (AUC) [ Time Frame: Day 1 ]
  • RPH-104 - Time to maximum concentration (Tmax) [ Time Frame: Day 1 ]
  • RPH-104 - Elimination half-life (t1/2) [ Time Frame: Day 1 ]
  • Levels of C-reactive protein (CRP) [ Time Frame: Until 30 days after administration ]
  • Levels of serum amyloid A (SAA) [ Time Frame: Until 30 days after administration ]
  • Levels of S100 calcium binding protein A8 (S100A8) [ Time Frame: Until 30 days after administration ]
  • Interleukin-6 (IL-6) levels [ Time Frame: One month ]
  • Interleukin-1alpha (IL-1a) levels [ Time Frame: Until 30 days after administration ]
  • Interleukin-1beta (IL-1B) levels [ Time Frame: Until 30 days after administration ]
  • Interleukin-1 receptor antagonist (IL-1RA) levels [ Time Frame: Until 30 days after administration ]
  • Anti-RPH-104 antibody levels [ Time Frame: Until 30 days after administration ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2016)
  • Maximum plasma concentration (Cmax) [ Time Frame: Day 1 ]
  • Area Under the Curve (AUC) [ Time Frame: Day 1 ]
  • Time to maximum concentration (Tmax) [ Time Frame: Day 1 ]
  • Elimination half-life (t1/2) [ Time Frame: Day 1 ]
  • Levels of C-reactive protein (CRP) [ Time Frame: Until 30 days after administration ]
  • Levels of serum amyloid A (SAA) [ Time Frame: Until 30 days after administration ]
  • Levels of S100 calcium binding protein A8 (S100A8) [ Time Frame: Until 30 days after administration ]
  • Interleukin-6 (IL-6) levels [ Time Frame: One month ]
  • Interleukin-1alpha (IL-1a) levels [ Time Frame: Until 30 days after administration ]
  • Interleukin-1beta (IL-1B) levels [ Time Frame: Until 30 days after administration ]
  • Interleukin-1 receptor antagonist (IL-1RA) levels [ Time Frame: Until 30 days after administration ]
  • Anti-RPH-104 antibody levels [ Time Frame: Until 30 days after administration ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First in Human Study for RPH-104
Official Title  ICMJE 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
Brief Summary The purpose of this fist in human study is to evaluate the safety and tolerability of RPH-104 in humans.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE
  • Biological: RPH-104
  • Other: Sodium chloride Sterile Injection 0.9% w/v
Study Arms  ICMJE
  • Active Comparator: Treatment
    A single dose of RPH-104 (4, 20, 40, 80 or 160 mg) will be administered subcutaneously.
    Intervention: Biological: RPH-104
  • Placebo Comparator: Placebo
    A single 0.9% sodium chloride injection will be administered subcutaneously.
    Intervention: Other: Sodium chloride Sterile Injection 0.9% w/v
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: January 26, 2016)
35
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2017
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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-viral capsid antigen (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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02667639
Other Study ID Numbers  ICMJE RPH104FIH01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party TRPHARM
Study Sponsor  ICMJE TRPHARM
Collaborators  ICMJE MonitorCRO
Investigators  ICMJE
Principal Investigator: Sibel Goksel, MD, PhD ARGEFAR
PRS Account TRPHARM
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP