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A Trial to Compare the Efficacy of Two Formulations of Avotermin Against Placebo

NCT01029158 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2010-12-09

No results posted yet for this study

Summary

RN1006 has been developed as a stabilized formulation of avotermin which, when dosed once in pre-clinical studies in animals, has shown comparable scar improvement efficacy to the standard twice-dosed Juvista formulation. The aim of this trial is to investigate the efficacy of RN1006 compared to Juvista in a human volunteer model

Conditions

  • Scar Improvement

Interventions

DRUG

Juvista (Avotermin)

250 ng, twice, intradermal injection, standard formulation

DRUG

RN1006 (Avotermin)

250 ng, intradermal injection, twice

DRUG

RN1006 (Avotermin)

205 ng, Intradermal injection, once

DRUG

RN1006 (Avotermin)

500ng, intradermal injection, once

DRUG

Juvista (Avotermin)

250 ng, intradermal injection, twice

DRUG

Juvista (Avotermin)

500 ng, intradermal injection, once

DRUG

Juvista (Avotermin)

500 ng, intradermal injection, once

DRUG

RN1006 (Avotermin)

500 ng, intradermal injection, twice

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Renovo

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-09-30
Completion
2010-11-30

Countries

  • United Kingdom

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 NCT01029158 on ClinicalTrials.gov