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

February 12, 2013 updated by: TME Pharma AG

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: NOX-E36
single SC doses, at safe and tolerable dose level
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
Drug: NOX-E36
single SC doses, at safe and tolerable dose level
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
Drug: NOX-E36
single SC doses, at safe and tolerable dose level
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
Drug: NOX-E36
single SC doses, at safe and tolerable dose level
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
Drug: NOX-E36
single SC doses, at safe and tolerable dose level
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
Drug: NOX-E36
single SC doses, at safe and tolerable dose level
Placebo Comparator: Placebo s.c.
Drug: Placebo
Experimental: 0.25 mg/kg s.c.
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
Experimental: 0.5 mg/kg s.c.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
throughout the entire study

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic parameters in plasma and urine
Time Frame: throughout the entire study
throughout the entire study
Pharmacodynamic profile
Time Frame: throughout the entire study
throughout the entire study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TME Pharma AG

Investigators

  • Study Director: Grit Landgraf, PhD, Noxxon AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

September 11, 2009

First Submitted That Met QC Criteria

September 11, 2009

First Posted (Estimate)

September 14, 2009

Study Record Updates

Last Update Posted (Estimate)

February 13, 2013

Last Update Submitted That Met QC Criteria

February 12, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNOXE36C001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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