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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NOXXON Pharma AG
ClinicalTrials.gov Identifier:
NCT00976729
First received: September 11, 2009
Last updated: February 12, 2013
Last verified: February 2013

September 11, 2009
February 12, 2013
May 2009
December 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00976729 on ClinicalTrials.gov Archive Site
  • Pharmacokinetic parameters in plasma and urine [ Time Frame: throughout the entire study ] [ Designated as safety issue: No ]
  • Pharmacodynamic profile [ Time Frame: throughout the entire study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
NOX-E36 First-in-Human (FIH) Study
NOX-E36 - A Phase I, Double-Blind, Placebo Controlled, Single Intravenous and Subcutaneous Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Chronic Inflammatory Diseases
  • Type 2 Diabetes Mellitus
  • Systemic Lupus Erythematosus
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00976729
SNOXE36C001
No
NOXXON Pharma AG
NOXXON Pharma AG
Not Provided
Study Director: Grit Landgraf, PhD Noxxon AG
NOXXON Pharma AG
February 2013

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