NOX-E36 First-in-Human (FIH) Study - Full Text View

Sponsor:	Noxxon Pharma AG
Information provided by:	Noxxon Pharma AG
ClinicalTrials.gov Identifier:	NCT00976729

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 I

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2 Lupus

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 ]

Estimated 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
Experimental: Group A - F	Drug: NOX-E36 single ascending IV doses, ranging from 0.03 mg/kg to 2.0 mg/kg Drug: Placebo
Experimental: Group G - I	Drug: NOX-E36 single SC doses, at safe and tolerable dose level Drug: Placebo

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

Locations

United Kingdom
Covance Clinical Research Unit Ltd.
Leeds, West Yorkshire, United Kingdom, LS2 9LH

Sponsors and Collaborators

Noxxon Pharma AG

Investigators

Principal Investigator:

Joseph AL Chiesa, MD

Covance Clinical Research Unit Ltd., UK

More Information

No publications provided

Responsible Party:	Dr. Joseph Chiesa, MD FFPM, Medical Director, Covance Clinical Research Unit Ltd., Leeds, UK
ClinicalTrials.gov Identifier:	NCT00976729 History of Changes
Other Study ID Numbers:	SNOXE36C001
Study First Received:	September 11, 2009
Last Updated:	February 9, 2010
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 February 09, 2012