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Safety and Efficacy of RN1001(Avotermin) in Healthy Male Subjects

NCT00847925 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2009-02-19

No results posted yet for this study

Summary

A double blind, Placebo (Vehicle) and Standard Care controlled, randomised study to investigate the clinical safety and toleration (including systemic pharmacokinetics), wound healing and antiscarring potential of two applications of intradermal RN1001 in healthy male subjects

Conditions

  • Cicatrix

Interventions

DRUG

Avotermin (RN1001)

100ul/linear cm of wound. Dosed before surgery and 24h later

Sponsors & Collaborators

  • Renovo

    lead INDUSTRY

Principal Investigators

  • Jonathan Duncan, MB BCh · Renovo

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-11-30
Primary Completion
2003-09-30
Completion
2003-09-30

Countries

  • United Kingdom

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 NCT00847925 on ClinicalTrials.gov