We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00976729
First Posted: September 14, 2009
Last Update Posted: February 13, 2013
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.
Information provided by (Responsible Party):
NOXXON Pharma AG
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


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 ]

Secondary Outcome Measures:
  • Pharmacokinetic parameters in plasma and urine [ Time Frame: throughout the entire study ]
  • Pharmacodynamic profile [ Time Frame: throughout the entire study ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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): NCT00976729


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

Responsible Party: NOXXON Pharma AG
ClinicalTrials.gov Identifier: NCT00976729     History of Changes
Other Study ID Numbers: SNOXE36C001
First Submitted: September 11, 2009
First Posted: September 14, 2009
Last Update Posted: February 13, 2013
Last Verified: February 2013

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