NCT06553287

Safety, Tolerability and Pharmacokinetics of LNK01004 Ointment in Adults With Atopic Dermatitis.

A Phase Ib, Randomized, Double-Blind, Vehicle-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LNK01004 Ointment in Adults Patients With Mild to Moderate Atopic Dermatitis.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Lynk Pharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the Safety, Tolerability, and Pharmacokinetics of LNK01004 ointment (0.3%, 1.0%, and 1.5%) vs vehicle twice daily (BID) in Adults Patients with Atopic Dermatitis.

Detailed description

This is a multicenter, randomized, double-blind, vehicle-controlled, dose-escalation study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LNK01004 ointment twice daily (BID) in participants with Mild to Moderate atopic dermatitis as compared with vehicle cream BID.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	LNK01004 ointment 0.3%	LNK01004 ointment 0.3% for topical application
DRUG	LNK01004 ointment 1.0%	LNK01004 ointment 1.0% for topical application
DRUG	LNK01004 ointment 1.5%	LNK01004 ointment 1.5% for topical application
DRUG	Vehicle BID	Inactive vehicle matched to LNK01004 ointment for topical application.

Timeline

• Start date: 2023-07-12
• Primary completion: 2024-06-18
• Completion: 2024-06-18
• First posted: 2024-08-14
• Last updated: 2024-08-14

Locations

1 site across 1 country: China