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Safety Study of Repeated, Escalating Doses of Intradermal Avotermin (Juvista)

NCT00978302 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2009-09-16

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and local toleration and histological effects of various dose levels of avotermin (Juvista) injected intradermally in healthy male volunteers.

Conditions

  • Cicatrix
  • Wound Healing

Interventions

DRUG

Avotermin

Intradermal injection, 50ng/100μl/3mm punch biopsy, once at time of biopsy and again 24 h later

DRUG

Avotermin

Intradermal injection, 100ng/100μl/3mm punch biopsy, once at time of biopsy and again 24 h later

DRUG

Avotermin

Intradermal injection, 500ng/100μl/3mm punch biopsy, once at time of biopsy and again 24 h later

DRUG

Avotermin

Intradermal injection, 1000ng/100μl/3mm punch biopsy, once at time of biopsy and again 24 h later

DRUG

Avotermin

Intradermal injection, 1μg/100μl/3mm punch biopsy, once at time of biopsy and again 24 h later

DRUG

Avotermin

Intradermal injection, 10μg/100μl/3mm punch biopsy, once at time of biopsy and again 24 h later

DRUG

Placebo (vehicle)

Intradermal injection at time of biopsy and again 24 h later

Sponsors & Collaborators

  • Renovo

    lead INDUSTRY

Principal Investigators

  • Michael J Davies · Renovo

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2001-05-31
Primary Completion
2001-08-31
Completion
2001-08-31

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 NCT00978302 on ClinicalTrials.gov