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

  • STATUS
    Recruiting
  • End date
    Jun 1, 2023
  • participants needed
    62
  • sponsor
    Xantho Biotechnology Co., LTD
Updated on 27 April 2022
platelet count
body mass index
corticosteroids
tubal ligation
hysterectomy
hormonal contraception
immunosuppressive agents
blood test
antihistamines
atopy
eczema
topical corticosteroid
topical agents
Accepts healthy volunteers

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

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 with 38 Atopic Dermatitis patients being enrolled.

Details
Condition Atopic Dermatitis
Treatment GM-XANTHO onitment, Placebo onitment
Clinical Study IdentifierNCT04369846
SponsorXantho Biotechnology Co., LTD
Last Modified on27 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Subject's medical history shows no contraindication to the test medications
BMI = Body Weight (kg) / [Height (m) × Height (m)]2
Subjects judged to be in good health by the investigator based upon the results of
Subjects did not take any of the following medications in the specified durations
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
Phase IIa
hemoglobin, hematocrit and platelet count. Assessment items of urinalysis include pH
color, appearance, gravity, erythrocyte, leukocyte, glucose, protein, ketones and
nitrite
Female subjects show negative pregnancy test results and all male and female subjects
with child-bearing potential (between puberty and 2 years after menopause) should use
at least any one of the appropriate contraception methods as shown in inclusion
criteria #12 of phase IIa prior to the first study dose
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
Placement of an intrauterine device (IUD) or intrauterine system (IUS)
Female or male, age ≥ 20 years old
Patients who are diagnosed of atopic dermatitis based on the Hanifin and Rajka
Criteria
Patients with IGA score between mild (2) to moderate (3) and the Eczema Area and
Severity Indices (EASI) are ≤ 20
Patients who have body surface area of atopic dermatitis involvement ≥ 2%, ≤ 20%
Patients who agree discontinuation of all treatment modalities, such as topical
antihistamines, topical antimicrobials, topical corticosteroid and light treatments
during the study period for/on the affected site(s) (except the rescue medication
prescribed by the study Investigator(s))
Patients who agree discontinuation of systemic corticosteroids, systemic
antihistamines, and systemic immune modulating agents during the study period (except
the standard medication oral antihistamine levocetirizine and rescue medication
prescribed by the study Investigator(s))
Patients are required to stop using treatment drugs listed in criteria #5 for at least
days (or longer if the treatment half-life requires so; 7 half-life should have
elapsed) and treatment drugs listed in criteria #6 for 28 days before the first
investigational drug dose administration
Subject is judged to be in general good health (without clinically significant
abnormalities) by the Investigator based on medical history, PEs, ECG, and routine
laboratory tests at screening
Patients who stopped immunosuppressant drugs for at least 28 days prior to the first
dosing
Patients who have taken oral antihistamine of levocetirizine 5 mg once daily for at
least 7 days before initiating the study treatment
Patients who are eligible and able to participate in the study and accept to enter the
study by signing written informed consent forms
All male patients and female patients with child-bearing potential (between puberty
and 2 years after menopause) should use at least any one of the appropriate
contraception methods shown below, for during and at least 4 weeks after GM-XANTHO
treatment
Total abstinence [when this is in line with the preferred and usual lifestyle of
the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal
post-ovulation methods) and withdrawal are not acceptable methods of
contraception]
Female sterilization (have had surgical bilateral oophorectomy with or without
hysterectomy) or tubal ligation at least six weeks before taking study treatment
In case of oophorectomy alone, only when the reproductive status of the woman has
been confirmed by follow up hormone level assessment
Male sterilization. For female subjects on the study, the vasectomized male
partner should be the sole partner for that subject
Combination of any two of the following listed methods: (d.1+d.2 or d.1+d.3, or
d.2+d.3)
Use of oral, injected or implanted hormonal methods of contraception or
other forms of hormonal contraception that have comparable efficacy (failure
rate <1%), for example hormone vaginal ring or transdermal hormone
contraception
Barrier methods of contraception: Condom or Occlusive cap (diaphragm or
cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal
suppository

Exclusion Criteria

Phase I
presence of open sores
obvious differences in skin color between applications sites
excessive hair
scar tissue tattoo
coloration
Subjects who have been tested positive for the following tests
Human immunodeficiency virus (HIV)
Hepatitis B virus (HBV): HBsAg and anti-HBc
Hepatitis C virus (HCV)
Phase IIa
Patients who have active infection on the atopic dermatitis site(s) at baseline
Patients who have known hypersensitivity to the study medication
Patients with chronic condition(s) which either is not stable or not well controlled
Patients having positive results for HBV, HCV or HIV screens
Patients who are pregnant or breast feeding
Subjects with the following conditions at the application site(s) that would interfere
with the IP administration, skin assessment, or reaction to IPs
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
Patients had participated in investigational drug trials and took any investigational
drugs within 30 days or within 5 half-lives of the investigational drugs prior to the
screening visit
Patients who have any concurrent skin condition that will interfere with assessment of
treatment
Patients who are inevitable to engage activities involving excessive or prolonged
exposure to sunlight
Patients carry history of malignancy of any organ system (other than cervical
carcinoma in situ or localized prostate cancer) within 5 years prior to study entry
Patients who are not suitable to participate in the trial as judged by the
Investigator(s)
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