drugset / Trial / NCT01243502

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

NCT01243502

Phase 1 Completed 16 enrolled Creabilis SA LCG Bioscience · collab
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2007-09
Primary completion
2007-11
Completion
2007-11

Drugs

EvaluationDrugModalityDoseRoute
Subject CT327 Unknown 0.001 % Topical
Subject CT327 Unknown 0.01 % Topical

Indications

No indication recorded.