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Completed

NCT Number: NCT00976729

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

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.

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Key information

Conditions

Chronic Inflammatory Diseases Autoimmune Diseases Connective Tissue Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Lupus Erythematosus, Systemic Metabolic Diseases Nutritional and Metabolic Diseases Skin and Connective Tissue Diseases Systemic Lupus Erythematosus Type 2 Diabetes Mellitus

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NOX-E36

Drug

single ascending IV doses, ranging from 0.03 mg/kg to 2.0 mg/kg

Placebo

Drug

Primary outcomes

  1. 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 outcomes

  1. Pharmacokinetic parameters in plasma and urine

    Time frame: throughout the entire study

  2. Pharmacodynamic profile

    Time frame: throughout the entire study

Sponsors and collaborators

Lead sponsor

TME Pharma AG

Industry

Registry information

Official study title

NOX-E36 - A Phase I, Double-Blind, Placebo Controlled, Single Intravenous and Subcutaneous Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Sep 14, 2009
Registry last updated
Feb 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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