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

NCT04369846 | Completed Phase 1 FDA Drug

• 1 other identifier: XANGMXA20160505
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 4

Brief 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

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• treatment emergent adverse events (TEAEs)

  Number of treatment emergent adverse events (TEAEs) occurring during the Phase I

  7 days for Phase I

• IGA

  Number of patients achieving IGA of 0 or 1 with a ≥2 point improvement in Phase IIa study

  28 days for Phase IIa

Study Arms (2)

Test drug group

EXPERIMENTAL

The arm applies the test drug of GM-XANTHO

Drug: GM-XANTHO onitment

Placebo group

PLACEBO COMPARATOR

The arm applies the placebo

Drug: Placebo onitment

Interventions

GM-XANTHO onitment DRUG

Onitment application

Also known as: Drawing blood

Test drug group

Placebo onitment DRUG

Onitment application

Also known as: Drawing blood

Placebo group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Phase I Number of patients achieving IGA of 0 or 1 with a ≥2 point improvement in Phase IIa study
• Female or male, age ≥ 20 years old
• Subjects whose body mass index (BMI) at screening is within a range of ≥ 18.5 kg/m2 and \<30.0 kg/m2.
• BMI = Body Weight (kg) / \[Height (m) × Height (m)\]2
• Subject's medical history shows no contraindication to the test medications.
• Subjects judged to be in good health by the investigator based upon the results of physical examinations (PEs), electrocardiogram (ECG) test, and all items of routine laboratory tests, including serum biochemistry, hematology and urinalysis, are within normal range as judged by the site. Assessment items of blood biochemistry include albumin, total protein, total bilirubin, ALP, SGOT, SGPT, BUN, serum creatinine. Assessment items of hematology tests include RBC count, WBC with differential counts, hemoglobin, hematocrit and platelet count. Assessment items of urinalysis include pH, color, appearance, gravity, erythrocyte, leukocyte, glucose, protein, ketones and nitrite.
• Subjects did not take any of the following medications in the specified durations:
• Exposure of test sites to topical medications within 14 days prior to the application of IPs
• Any systemically-absorbed medication (excluding vitamins, food supplements, and hormone contraceptives for birth control) within 14 days prior to the first dose of the study
• Any enzyme inducer/inhibitor and/or known hepatic or renal clearance-altering agents within 30 days prior to the first dose of the study
• Subjects are willing to comply with protocol-stated requirements, instructions and restrictions, followed by understanding and signing the written informed consent form.
• Phase IIa
• Female or male, age ≥ 20 years old
• Subjects who are diagnosed of atopic dermatitis based on the Hanifin and Rajka Criteria.
• Subjects who are with IGA score between mild (2) to moderate (3) and the Eczema Area and Severity Indices (EASI) are ≤ 20.

You may not qualify if:

• Phase I:
• Subjects with the following conditions at the application site(s) that would interfere with the IP administration, skin assessment, or reaction to IPs:
• presence of open sores
• obvious differences in skin color between applications sites
• excessive hair
• scar tissue tattoo
• coloration
• Subjects with any properly diagnosed disease within 30 days prior to the first dose of the study
• Subjects with any diagnosed dermatological or allergic diseases within 180 days prior to the first study dose
• Subjects with any clinically significant hematological, endocrine, cardiovascular, hepatic, renal, gastrointestinal, and/or pulmonary disorder; subjects with any predisposing condition that might interfere with the absorption, distribution, metabolism and excretion of drugs
• Subjects had participated in investigational drug trials and took any investigational drug within 60 days prior to the first study dose.
• Subjects had blood donation for more than 250 mL within 60 days or 500 mL within 90 days prior to the first study dose.
• Subjects had a history of drug abuse or alcohol abuse according to the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) criteria.
• Subjects cannot stop smoking and caffeine-intakes for 48 hours prior to the first study dose and during the entire study period, and 48 hours after the last dose administration of IPs.
• Subjects who are inappropriate to participate in this study, as judged by the clinical Investigator

Sponsors & Collaborators

• Xantho Biotechnology Co., LTD: lead
• Virginia Contract Research Organization Co., Ltd.: collaborator

Study Sites (4)

Ministry of Health and Welfare Shuang-Ho Hospital

New Taipei City, New Taipei, 235041, Taiwan

Location

National Taiwan University Hospital

Taipei, Taipei, 100225, Taiwan

Location

Taipei Medical University Hospital

Taipei, Taipei, 110301, Taiwan

Location

Linkou Chang-Gung Memorial Hospital

Taoyuan District, Taoyuan, 333423, Taiwan

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: April 30, 2020
• Study Start: May 4, 2020
• Primary Completion: January 22, 2025
• Study Completion: February 24, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (4)