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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00976729
Recruitment Status : Completed
First Posted : September 14, 2009
Last Update Posted : February 13, 2013
Sponsor:
Information provided by (Responsible Party):
NOXXON Pharma AG

Tracking Information
First Submitted Date  ICMJE September 11, 2009
First Posted Date  ICMJE September 14, 2009
Last Update Posted Date February 13, 2013
Study Start Date  ICMJE May 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00976729 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2009)
  • Pharmacokinetic parameters in plasma and urine [ Time Frame: throughout the entire study ]
  • Pharmacodynamic profile [ Time Frame: throughout the entire study ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NOX-E36 First-in-Human (FIH) Study
Official Title  ICMJE NOX-E36 - A Phase I, Double-Blind, Placebo Controlled, Single Intravenous and Subcutaneous Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects
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.
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: Treatment
Condition  ICMJE
  • Chronic Inflammatory Diseases
  • Type 2 Diabetes Mellitus
  • Systemic Lupus Erythematosus
Intervention  ICMJE
  • Drug: NOX-E36
    single ascending IV doses, ranging from 0.03 mg/kg to 2.0 mg/kg
  • Drug: NOX-E36
    single SC doses, at safe and tolerable dose level
  • Drug: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo i.v.
    Intervention: Drug: Placebo
  • Experimental: 0.03 mg/kg i.v.
    Intervention: Drug: NOX-E36
  • Experimental: 0.09 mg/kg i.v.
    Intervention: Drug: NOX-E36
  • Experimental: 0.25 mg/kg i.v.
    Intervention: Drug: NOX-E36
  • Experimental: 0.5 mg/kg i.v.
    Intervention: Drug: NOX-E36
  • Experimental: 1.0 mg/kg i.v.
    Intervention: Drug: NOX-E36
  • Experimental: 2.0 mg/kg i.v.
    Intervention: Drug: NOX-E36
  • Placebo Comparator: Placebo s.c.
    Intervention: Drug: Placebo
  • Experimental: 0.25 mg/kg s.c.
    Intervention: Drug: NOX-E36
  • Experimental: 0.5 mg/kg s.c.
    Intervention: Drug: NOX-E36
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 Completed
Actual Enrollment  ICMJE
 (submitted: September 11, 2009)
72
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT00976729
Other Study ID Numbers  ICMJE SNOXE36C001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NOXXON Pharma AG
Study Sponsor  ICMJE NOXXON Pharma AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Grit Landgraf, PhD Noxxon AG
PRS Account NOXXON Pharma AG
Verification Date February 2013

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