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

NCT00976729 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2013-02-13

No results posted yet for this 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.

Conditions

Interventions

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

DRUG

Placebo

Sponsors & Collaborators

  • TME Pharma AG

    lead INDUSTRY

Principal Investigators

  • Grit Landgraf, PhD · Noxxon AG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2009-12-31
Completion
2009-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00976729 on ClinicalTrials.gov