NCT01243502

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

A Multiple Dose, Placebo Controlled Study to Assess the Pharmacokinetics, Safety and Tolerability of Topically Administered CT327 in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Creabilis SA · Industry
• Sex: Male
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2007-09-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2010-11-18
• Last updated: 2010-11-18