NCT04369846

A Phase I/IIa Study to Investigate the GM-XANTHO in Healthy Volunteers and Atopic Dermatitis Patients

A Phase I/IIa Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GM-XANTHO in Healthy Volunteers and to Investigate Its Efficacy and Safety Profile in Atopic Dermatitis Patients

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Xantho Biotechnology Co., LTD · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

Summary

A Phase I/IIa Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GM-XANTHO in Healthy Volunteers and to Investigate its Efficacy and Safety Profile in Atopic Dermatitis Patients

Detailed description

The Phase I study is randomized, double-blind, placebo-controlled, dose escalating. There will be 3 dose cohorts, 4 (up to 8) subjects will be randomized in a 3:1 (GM-XANTHO to placebo) ratio in each cohort.The total study will take at least 23 days, conducted in National Taiwan University Hospital with 2-24 healthy subjects being enrolled.The Phase IIa study is randomized, double-blind, placebo-controlled, parallel. 2:1 ratio for GM-XANTHO to placebo control. The total study will take at least 43 days, conducted in National Taiwan University Hospital, Taipei Medical University Hospital, Ministry of Health and Welfare Shuang-Ho Hospital, and Linkou Chang-Gung Memorial Hospital with 102 Atopic Dermatitis patients being enrolled.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	GM-XANTHO onitment	Onitment application
DRUG	Placebo onitment	Onitment application

Timeline

• Start date: 2020-05-04
• Primary completion: 2025-01-22
• Completion: 2025-02-24
• First posted: 2020-04-30
• Last updated: 2025-04-06

Locations

4 sites across 1 country: Taiwan

Regulatory

• FDA-regulated drug study