NCT00976729

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2009

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

February 13, 2013

Status Verified

February 1, 2013

Enrollment Period

7 months

First QC Date

September 11, 2009

Last Update Submit

February 12, 2013

Conditions

Chronic Inflammatory DiseasesType 2 Diabetes MellitusSystemic Lupus Erythematosus

Keywords

monocyte chemoattractant protein-1 (MCP-1)L-oligonucleotide aptamerSpiegelmer

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of NOX-E36 by means of adverse events, vital signs, laboratory parameters, 12-lead ECG and immunogenicity assessment

    throughout the entire study

Secondary Outcomes (2)

  • Pharmacokinetic parameters in plasma and urine

    throughout the entire study

  • Pharmacodynamic profile

    throughout the entire study

Study Arms (10)

Placebo i.v.

PLACEBO COMPARATOR
Drug: Placebo

0.03 mg/kg i.v.

EXPERIMENTAL
Drug: NOX-E36

0.09 mg/kg i.v.

EXPERIMENTAL
Drug: NOX-E36

0.25 mg/kg i.v.

EXPERIMENTAL
Drug: NOX-E36

0.5 mg/kg i.v.

EXPERIMENTAL
Drug: NOX-E36

1.0 mg/kg i.v.

EXPERIMENTAL
Drug: NOX-E36

2.0 mg/kg i.v.

EXPERIMENTAL
Drug: NOX-E36

Placebo s.c.

PLACEBO COMPARATOR
Drug: Placebo

0.25 mg/kg s.c.

EXPERIMENTAL
Drug: NOX-E36

0.5 mg/kg s.c.

EXPERIMENTAL
Drug: NOX-E36

Interventions

NOX-E36DRUG

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

0.03 mg/kg i.v.0.09 mg/kg i.v.0.25 mg/kg i.v.0.5 mg/kg i.v.1.0 mg/kg i.v.2.0 mg/kg i.v.
PlaceboDRUG
Placebo i.v.Placebo s.c.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Grit Landgraf, PhD

    Noxxon AG

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2009

First Posted

September 14, 2009

Study Start

May 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

February 13, 2013

Record last verified: 2013-02