NCT03575780

Single-Center Study Evaluating Systemic Exposure and Safety of KX2-391 Ointment 1% on the Face or Balding Scalp in Subjects With Actinic Keratosis

A Phase 1 Open-label, Uncontrolled, Non-randomized, Maximal Use Pharmacokinetic Study to Evaluate the Systemic Exposure and Safety of KX2-391 Ointment 1% When Applied to 25 cm2 of the Face or Balding Scalp in Subjects With Actinic Keratosis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Athenex, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase I study is designed to evaluate the systemic exposure and safety of KX2-391 Ointment in adult subjects when applied to an area of skin containing at least 5 clinically typical, visible, and discrete Actinic Keratosis lesions on the face or balding scalp.

Detailed description

This study will be a open-label, single center, pharmacokinetic, and safety study of KX2-391 Ointment administered topically to the face or balding scalp of subjects with actinic keratosis. The study consists of Screening, Treatment, and Follow-up Periods. Eligible subjects will receive 5 consecutive days of topical treatment, to be applied at the same location. Activity (lesion counts) and safety evaluations will be performed.

Conditions

• Actinic Keratoses

Interventions

Type	Name	Description
DRUG	KX2-391 Ointment 1%	The experimental drug, KX2-391 Ointment 1% will be used in subjects with Clinically typical Actinic Keratosis on the face or balding scalp.

Timeline

• Start date: 2018-09-07
• Primary completion: 2019-04-25
• Completion: 2019-10-10
• First posted: 2018-07-03
• Last updated: 2019-12-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study