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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

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

Condition or disease Intervention/treatment Phase
Healthy Biological: RPH-104 Other: Sodium chloride Sterile Injection 0.9% w/v Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
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 Start Date : January 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : September 2017

Arm Intervention/treatment
Active Comparator: Treatment
A single dose of RPH-104 (4, 20, 40, 80 or 160 mg) will be administered subcutaneously.
Biological: RPH-104
Placebo Comparator: Placebo
A single 0.9% sodium chloride injection will be administered subcutaneously.
Other: Sodium chloride Sterile Injection 0.9% w/v



Primary Outcome Measures :
  1. 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

  2. Heart rate [ Time Frame: Until 30 days after administration ]
  3. Respiratory rate [ Time Frame: Until 30 days after administration ]
  4. Blood pressure [ Time Frame: Until 30 days after administration ]
  5. Oxygen saturation [ Time Frame: Until 30 days after administration ]
  6. Body temperature [ Time Frame: Until 30 days after administration ]
  7. Clinical laboratory tests [ Time Frame: Until 30 days after administration ]

Secondary Outcome Measures :
  1. RPH-104 - Maximum plasma concentration (Cmax) [ Time Frame: Day 1 ]
  2. RPH-104 - Area Under the Curve (AUC) [ Time Frame: Day 1 ]
  3. RPH-104 - Time to maximum concentration (Tmax) [ Time Frame: Day 1 ]
  4. RPH-104 - Elimination half-life (t1/2) [ Time Frame: Day 1 ]
  5. Levels of C-reactive protein (CRP) [ Time Frame: Until 30 days after administration ]
  6. Levels of serum amyloid A (SAA) [ Time Frame: Until 30 days after administration ]
  7. Levels of S100 calcium binding protein A8 (S100A8) [ Time Frame: Until 30 days after administration ]
  8. Interleukin-6 (IL-6) levels [ Time Frame: One month ]
  9. Interleukin-1alpha (IL-1a) levels [ Time Frame: Until 30 days after administration ]
  10. Interleukin-1beta (IL-1B) levels [ Time Frame: Until 30 days after administration ]
  11. Interleukin-1 receptor antagonist (IL-1RA) levels [ Time Frame: Until 30 days after administration ]
  12. Anti-RPH-104 antibody levels [ Time Frame: Until 30 days after administration ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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-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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02667639


Locations
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Turkey
ARGEFAR
Izmir, Turkey
Sponsors and Collaborators
TRPHARM
MonitorCRO
Investigators
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Principal Investigator: Sibel Goksel, MD, PhD ARGEFAR

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Responsible Party: TRPHARM
ClinicalTrials.gov Identifier: NCT02667639     History of Changes
Other Study ID Numbers: RPH104FIH01
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: April 21, 2017
Last Verified: April 2017

Keywords provided by TRPHARM:
safety
tolerability
RPH-104
RPH104