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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Inflammatory Diseases
Type 2 Diabetes Mellitus
Systemic Lupus Erythematosus
 Drug: NOX-E36
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Noxxon Pharma AG:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 72
Study Start Date: May 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo i.v. Drug: Placebo
Experimental: 0.03 mg/kg i.v. Drug: NOX-E36
single ascending IV doses, ranging from 0.03 mg/kg to 2.0 mg/kg
Experimental: 0.09 mg/kg i.v. Drug: NOX-E36
single ascending IV doses, ranging from 0.03 mg/kg to 2.0 mg/kg
Experimental: 0.25 mg/kg i.v. Drug: NOX-E36
single ascending IV doses, ranging from 0.03 mg/kg to 2.0 mg/kg
Experimental: 0.5 mg/kg i.v. Drug: NOX-E36
single ascending IV doses, ranging from 0.03 mg/kg to 2.0 mg/kg
Experimental: 1.0 mg/kg i.v. Drug: NOX-E36
single ascending IV doses, ranging from 0.03 mg/kg to 2.0 mg/kg
Experimental: 2.0 mg/kg i.v. Drug: NOX-E36
single ascending IV doses, ranging from 0.03 mg/kg to 2.0 mg/kg
Placebo Comparator: Placebo s.c. Drug: Placebo
Experimental: 0.25 mg/kg s.c. Drug: NOX-E36
single SC doses, at safe and tolerable dose level
Experimental: 0.5 mg/kg s.c. Drug: NOX-E36
single SC doses, at safe and tolerable dose level

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00976729

Sponsors and Collaborators
Noxxon Pharma AG
Investigators
Study Director: Grit Landgraf, PhD Noxxon AG
  More Information

No publications provided

Responsible Party: Noxxon Pharma AG
ClinicalTrials.gov Identifier: NCT00976729     History of Changes
Other Study ID Numbers: SNOXE36C001
Study First Received: September 11, 2009
Last Updated: February 12, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Noxxon Pharma AG:
monocyte chemoattractant protein-1 (MCP-1)
L-oligonucleotide aptamer
Spiegelmer

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Lupus Erythematosus, Systemic
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013