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NOX-E36 First-in-Human (FIH) Study

Primary Purpose

Chronic Inflammatory Diseases, Type 2 Diabetes Mellitus, Systemic Lupus Erythematosus

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
NOX-E36
NOX-E36
Placebo
Sponsored by
TME Pharma AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Inflammatory Diseases focused on measuring monocyte chemoattractant protein-1 (MCP-1), L-oligonucleotide aptamer, Spiegelmer

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy male and female subjects
  • Body mass index (BMI) between 19.0 and 29.0 kg/m2 inclusive
  • Body weight between 50 and 100 kg inclusive
  • Creatinine clearance of greater than 80 mL/min

Exclusion Criteria:

  • Male and female subjects who are not or whose partners are not willing to use appropriate contraception methods
  • Intake of any prescribed systemic or topical medication within 14 days prior to dosing
  • Intake of any non-prescribed systemic or topical medication (including herbal remedies) within 7 days prior to dosing (with the exception of vitamin/mineral supplements)
  • Supine blood pressure and supine pulse rate higher than 140/90 mmHg and 100 beats per minute (bpm), respectively, or lower than 90/50 mmHg and 40 bpm, respectively, as confirmed by a repeat assessment
  • History of any clinically significant neurological, dermatological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological or other major disorders

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm 9

    Arm 10

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Experimental

    Experimental

    Arm Label

    Placebo i.v.

    0.03 mg/kg i.v.

    0.09 mg/kg i.v.

    0.25 mg/kg i.v.

    0.5 mg/kg i.v.

    1.0 mg/kg i.v.

    2.0 mg/kg i.v.

    Placebo s.c.

    0.25 mg/kg s.c.

    0.5 mg/kg s.c.

    Arm Description

    Outcomes

    Primary Outcome Measures

    Safety and tolerability of NOX-E36 by means of adverse events, vital signs, laboratory parameters, 12-lead ECG and immunogenicity assessment

    Secondary Outcome Measures

    Pharmacokinetic parameters in plasma and urine
    Pharmacodynamic profile

    Full Information

    First Posted
    September 11, 2009
    Last Updated
    February 12, 2013
    Sponsor
    TME Pharma AG
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00976729
    Brief Title
    NOX-E36 First-in-Human (FIH) Study
    Official Title
    NOX-E36 - A Phase I, Double-Blind, Placebo Controlled, Single Intravenous and Subcutaneous Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2009 (undefined)
    Primary Completion Date
    December 2009 (Actual)
    Study Completion Date
    December 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    TME Pharma AG

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is the first time NOX-E36 will be administered to man. The principal aim of this study is to obtain safety and tolerability data when NOX-E36 is administered by single intravenous (IV) and subcutaneous (SC) doses to healthy male and female subjects. This information, together with the pharmacokinetic and pharmacodynamic data, will help establish the doses, dosage regimen and route of administration suitable for multiple dose administration to healthy volunteers, followed by the studies in the patient population.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Inflammatory Diseases, Type 2 Diabetes Mellitus, Systemic Lupus Erythematosus
    Keywords
    monocyte chemoattractant protein-1 (MCP-1), L-oligonucleotide aptamer, Spiegelmer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    72 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo i.v.
    Arm Type
    Placebo Comparator
    Arm Title
    0.03 mg/kg i.v.
    Arm Type
    Experimental
    Arm Title
    0.09 mg/kg i.v.
    Arm Type
    Experimental
    Arm Title
    0.25 mg/kg i.v.
    Arm Type
    Experimental
    Arm Title
    0.5 mg/kg i.v.
    Arm Type
    Experimental
    Arm Title
    1.0 mg/kg i.v.
    Arm Type
    Experimental
    Arm Title
    2.0 mg/kg i.v.
    Arm Type
    Experimental
    Arm Title
    Placebo s.c.
    Arm Type
    Placebo Comparator
    Arm Title
    0.25 mg/kg s.c.
    Arm Type
    Experimental
    Arm Title
    0.5 mg/kg s.c.
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    NOX-E36
    Intervention Description
    single ascending IV doses, ranging from 0.03 mg/kg to 2.0 mg/kg
    Intervention Type
    Drug
    Intervention Name(s)
    NOX-E36
    Intervention Description
    single SC doses, at safe and tolerable dose level
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Safety and tolerability of NOX-E36 by means of adverse events, vital signs, laboratory parameters, 12-lead ECG and immunogenicity assessment
    Time Frame
    throughout the entire study
    Secondary Outcome Measure Information:
    Title
    Pharmacokinetic parameters in plasma and urine
    Time Frame
    throughout the entire study
    Title
    Pharmacodynamic profile
    Time Frame
    throughout the entire study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy male and female subjects Body mass index (BMI) between 19.0 and 29.0 kg/m2 inclusive Body weight between 50 and 100 kg inclusive Creatinine clearance of greater than 80 mL/min Exclusion Criteria: Male and female subjects who are not or whose partners are not willing to use appropriate contraception methods Intake of any prescribed systemic or topical medication within 14 days prior to dosing Intake of any non-prescribed systemic or topical medication (including herbal remedies) within 7 days prior to dosing (with the exception of vitamin/mineral supplements) Supine blood pressure and supine pulse rate higher than 140/90 mmHg and 100 beats per minute (bpm), respectively, or lower than 90/50 mmHg and 40 bpm, respectively, as confirmed by a repeat assessment History of any clinically significant neurological, dermatological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological or other major disorders
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Grit Landgraf, PhD
    Organizational Affiliation
    Noxxon AG
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    NOX-E36 First-in-Human (FIH) Study

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