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NOX-A12 Multiple Ascending Dose Study in Healthy Volunteers

NCT01194934 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2014-06-26

No results posted yet for this study

Summary

This is the second clinical study of NOX-A12. This study intends to provide information on the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of repeated intravenous doses of NOX-A12 (2.0 and 4.0 mg/kg/d) alone and to compare the mobilization of hematopoietic stem cells (HSC) obtained with NOX-A12 alone with that obtained in combination with filgrastim in healthy subjects. A single center, open-label, repeated dose study design is selected to best address the study objectives.The results from this study will establish the basis for further development of NOX-A12 in lymphoma patients undergoing autologous hematopoietic stem cell transplantation

Conditions

  • Hematopoietic Stem Cell Transplantation

Interventions

DRUG

NOX-A12

4 mg/kg daily IV for 5 days

DRUG

NOX-A12

2 mg/kg daily IV for 5 days

DRUG

Filgrastim

5 µg/kg SC daily for 5 days

DRUG

NOX-A12 in combination with Filgrastim

Safe and efficacious dose regimen according to results of groups A and B

Sponsors & Collaborators

  • TME Pharma AG

    lead INDUSTRY

Principal Investigators

  • Frank Fliegert, MD · TME Pharma AG

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

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 NCT01194934 on ClinicalTrials.gov