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NOX-A12 First-in-human (FIH) Study

NCT00976378 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2014-06-26

No results posted yet for this study

Summary

This is the first time NOX-A12 will be administered to man. The principal aim of this study is to obtain safety and tolerability data when NOX-A12 is administered by single intravenous (IV) doses to healthy male and female subjects. This information, together with the pharmacokinetic and pharmacodynamic data, will help establish the doses and dosage regimen of administration suitable for subsequent studies in the patient population.

Conditions

  • Autologous Stem Cell Transplantation

Interventions

DRUG

NOX-A12

single ascending IV doses, ranging from 0.05 mg/kg to 10.8 mg/kg

DRUG

NOX-A12

single IV dose, at efficacious dose level

Sponsors & Collaborators

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • TME Pharma AG

    lead INDUSTRY

Principal Investigators

  • Stefan Zeitler, MD · TME Pharma AG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • Germany

Study Locations

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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 NCT00976378 on ClinicalTrials.gov