CClinicalTrials.gg
Sign In
CompletedNCT00976729Updated Feb 13, 2013

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

A Phase 1 interventional study of NOX-E36 and NOX-E36 in Chronic Inflammatory Diseases, Type 2 Diabetes Mellitus and Systemic Lupus Erythematosus, sponsored by TME Pharma AG. Completed. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-02-13.

Sponsored by TME Pharma AG · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Inflammatory Diseases
  • Type 2 Diabetes Mellitus
  • Systemic Lupus Erythematosus

Keywords

  • monocyte chemoattractant protein-1 (MCP-1)
  • L-oligonucleotide aptamer
  • Spiegelmer
03

In context

Lupus Erythematosus, Systemic

1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's enrollment of 72 is above the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

TME Pharma AG is the lead sponsor of 14 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
72 participants (actual)

Study arms

  • Placebo comparator
    Placebo i.v.

    Drug: Placebo

  • Experimental
    0.03 mg/kg i.v.

    Drug: NOX-E36

  • Experimental
    0.09 mg/kg i.v.

    Drug: NOX-E36

  • Experimental
    0.25 mg/kg i.v.

    Drug: NOX-E36

  • Experimental
    0.5 mg/kg i.v.

    Drug: NOX-E36

  • Experimental
    1.0 mg/kg i.v.

    Drug: NOX-E36

  • Experimental
    2.0 mg/kg i.v.

    Drug: NOX-E36

  • Placebo comparator
    Placebo s.c.

    Drug: Placebo

  • Experimental
    0.25 mg/kg s.c.

    Drug: NOX-E36

  • Experimental
    0.5 mg/kg s.c.

    Drug: NOX-E36

Interventions

  • DrugNOX-E36

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

  • DrugNOX-E36

    single SC doses, at safe and tolerable dose level

  • DrugPlacebo
06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00976729
Lead sponsor
TME Pharma AG
Responsible party
Sponsor
First posted
Sep 14, 2009
Start date
May 2009
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Feb 13, 2013

Study contacts

Grit Landgraf, PhD
study director · Noxxon AG

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Lupus Erythematosus, Systemic→

Other studies from this sponsor

TME Pharma AG

Start the discussion