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A Study to Assess the Pharmacokinetics, Safety and Tolerability of CT327 in Healthy Male Volunteers

NCT01243502 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2010-11-18

No results posted yet for this study

Summary

K-252a is a potent inhibitor of nerve growth factor (NGF) and therefore has the ability to inhibit keratinocyte proliferation. K-252a is strongly lipophilic and therefore passes freely into the cell membranes of keratinocytes and accumulates at a systemic level. In order to reduce the dermal absorption and reduce the possible long-term systemic toxicity this study will assess a PEGylated derivative of K-252a named CT327. This approach should improve the safety profile of the K-252a molecule while maintaining its activity. The primary objective is to assess the safety and tolerability of single and repeat doses of CT327 when applied topically to the skin of healthy male volunteers.

The secondary objective is to evaluate the eventual systemic absorption (pharmacokinetics; PK) of CT327 following single and repeat doses in healthy male subjects.

Conditions

  • Safety

Interventions

DRUG

0.01% CT327 (or placebo)

Cream (10 g) was applied at an even thickness over a test area on the back of 10 x 10 cm to give an exposure of 1000 μg/dm2.

DRUG

0.001% CT327 (or placebo)

Cream (10 g) was applied at an even thickness over a test area on the back of 10 x 10 cm to give an exposure of 100 μg/dm2.

Sponsors & Collaborators

  • LCG Bioscience

    collaborator UNKNOWN

  • Creabilis SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2007-11-30
Completion
2007-11-30

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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 NCT01243502 on ClinicalTrials.gov