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Due to the two AEs in Phase IIa study, recruiting was stopped for safety sake. The study was currently terminated.
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This is a Phase I/IIa Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, and Efficacy of AR100DP1 in Health Subjects, and Subjects with Mild to Moderate Atopic Dermatitis.
This phase I/IIa study will be composed of a Phase I study, which includes 14 days of treatment with AR100DP1 followed by 2 weeks of follow-up period to find the maximum tolerated dose (MTD) of AR100DP1 and a following single-arm Phase IIa study with 28 days of treatment followed by 2 weeks of follow-up period to evaluate the efficacy of AR100DP1 with the recommended Phase II dose (RP2D) in treating atopic dermatitis on target lesion. Target lesion area(s) is defined as one or multiple patches of lesion areas selected by the investigator for topical administration of AR100DP1. The size of target lesion area(s) is 0.5-5% body surface area (BSA) and the maximum is 750 cm2 (maximal treated area, inclusive) in this study. Eligible healthy subjects in Phase I will have the test skin area(s) of 750 cm2 from chest and abdomen. Eligible subjects with mild to moderate AD in Phase IIa will have target lesion area(s) selected by the investigator. The skin area treated with AR100DP1 will be recorded for AR100DP1 topical administration before dosing. AR100DP1 should be topically administered twice daily on the test skin area(s) of 750 cm2 of eligible healthy subjects for 14 days in Phase I study. The administration of AR100DP1 should be topically applied twice daily on target lesion area(s) (0.5-5% BSA, maximum as 750 cm2, inclusive) of eligible subjects with mild to moderate AD for 28 days in Phase IIa study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AR100DP1 (1.25%)_Phase I | Experimental | Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 1.25% AR100DP1 topical administration is 31.25 mg/day (1.25% × 1,250 × 2 = 31.25). |
|
| AR100DP1 (2.5%)_Phase I | Experimental | Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 2.5% AR100DP1 topical administration is 62.5 mg/day (2.5% × 1,250 × 2 = 62.5). |
|
| AR100DP1 (5%)_Phase I | Experimental | Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125). |
|
| AR100DP1 (5%)_Phase IIa | Experimental | Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AR100DP1 | Drug | topical ointment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With DLTs | Phase I study included 14 days of treatment with AR100DP1, followed by 2 weeks of follow-up period to find the maximum tolerated dose (MTD) of AR100DP1. DLTs were defined as any adverse event (AE) ≥ Grade 2 (Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, issued by United States Food and Drug Administration in September 2007), that was considered to be causally related (possibly, probably, or definitely related) to AR100DP1 as judged by the investigator up to Day 29. The definition of Grade 5 (death related to AE) was added to this grading system as it was not defined in the guidance. (reported in the subsequent Primary Outcome Measure). MTD is defined as the highest dose level at which < 2 of 6 subjects experienced a dose-limiting toxicity (DLT). | up to Day 29 for each cohort in phase I |
| Maximum Tolerated Dose (MTD) of AR100DP1 | Per protocol, MTD is defined as the highest dose level at which < 2 of 6 subjects experienced a dose-limiting toxicity (DLT). MTD was determined by testing increasing doses up to 125 mg/day via topical administration on AR100DP1_1.25%, 2.5%, and 5% groups with 3 to 6 subjects each. DLTs were defined as any adverse event (AE) ≥ Grade 2 (Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, issued by United States Food and Drug Administration in September 2007), that was considered to be causally related (possibly, probably, or definitely related) to AR100DP1 as judged by the investigator up to Day 29. The definition of Grade 5 (death related to AE) was added to this grading system as it was not defined in the guidance. (reported in the previous Primary Outcome Measure). | up to Day 29 for each cohort in phase I |
| Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 or 1 on Day 29 (Phase IIa) | The IGA is a 5-point scale that provides a global clinical assessment of AD severity based on an ordinal scale, scored by the investigator. The scores of IGA are 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (Severe). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | The IGA is a 5-point scale that provides a global clinical assessment of AD severity based on an ordinal scale, scored by the investigator. The scores of IGA are 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (Severe). | Day 8, Day 15, Day 22, Day 29, Day 36 and Day 43 (Phase IIa) |
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Inclusion Criteria:
Phase I:
At least two forms of effective birth control must be adopted for contraception, and one of which must be a barrier method. Acceptable forms include:
Phase IIa:
At least two forms of effective birth control must be adopted for contraception, and one of which must be a barrier method. Acceptable forms include:
Exclusion Criteria:
Phase I:
Phase IIa:
Unstable or actively infected AD judged by the investigator.
Active or potentially recurrent dermatologic condition other than atopic dermatitis that may confound evaluation (e.g. fungal infection), judged by the investigator.
Received systemic medication including corticosteroid, immunosuppressant, anti-histamine, phototherapy, or other therapy, which could affect AD within 4 weeks before Screening. However, subjects are allowed to enter the study if subjects have been taking at least 2 weeks of fixed dose anti-histamine prior to Screening and this application does not affect the study judged by the investigator
Received topical medication including corticosteroid, immunosuppressant, anti-histamine, phototherapy, calcineurin inhibitors, or other therapy for AD on the target lesion area(s) within 1 week before Screening
The following exclusion criteria are applied for all subjects in Phase I/IIa study:
Plan to receive immunosuppressive agents (including azathioprine, mycophenolate, cyclophosphamide, chlorambucil, methotrexate, cyclosporine), or systemic steroid with equivalent dosage higher than prednisolone 30 mg/day for more than 14 days at Screening
Unwilling or unable to comply with the criteria in Life Style Guidelines during the study
History of use of biologic therapy (including intravenous immunoglobulin) within 12 weeks or 5 half-lives (whichever is longer) prior to Screening
Received any other investigational drug within 4 weeks prior to Screening
Required or received systemic CYP3A4 inhibitors with strong potency within 1 week prior to screening, including but not limited to clarithromycin, itraconazole, nefazodone and atazanavir, evaluated by the investigator
Treatment for any type of cancer (except squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the skin, curatively treated with cryosurgery or surgical excision only) within 5 years before screening
Had surgery within 4 weeks prior to Screening Visit, or plan to have surgery during the study
Allergies requiring acute or chronic treatment at the investigator's discretion
Known hypersensitivity to any of the components of the study drug
Active clinically serious infection or history of human immunodeficiency virus (HIV) infection
Any of the following serum test abnormalities:
With ongoing acute diseases or within the past 2 years serious medical conditions (e.g. concomitant illness) such as cardiovascular (e.g. New York Heart Association (NYHA) grade III or IV), hepatic (e.g. Child-Pugh Class C), psychiatric condition (e.g. alcoholism, drug abuse), medical history, physical findings, or laboratory abnormality that in the investigators' opinion could interfere with the results of the trial or adversely affect the safety of the subject
Female subject who is lactating or has positive urine pregnancy test at screening
Other conditions not suitable for participating in this study judged by the investigator
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arjil Pharmaceuticals LLC. | Hsinchu | Taiwan |
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No screen failure occurred with final 17 eligible subjects.
17 subjects were screened in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | AR100DP1 (1.25%)_Phase I | Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 1.25% AR100DP1 topical administration is 31.25 mg/day (1.25% × 1,250 × 2 = 31.25). |
| FG001 | AR100DP1 (2.5%)_Phase I | Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 2.5% AR100DP1 topical administration is 62.5 mg/day (2.5% × 1,250 × 2 = 62.5). |
| FG002 | AR100DP1 (5%)_Phase I | Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125). |
| FG003 | AR100DP1 (5%)_Phase IIa | Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Final Visit was Visit 6 (Day 29) for Phase I subjects, but Visit 8 (Day 43) for Phase II subjects. One subject in Phase II was early terminated at Visit 5.
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| ID | Title | Description |
|---|---|---|
| BG000 | AR100DP1 (1.25%)_Phase I | Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 1.25% AR100DP1 topical administration is 31.25 mg/day (1.25% × 1,250 × 2 = 31.25) |
| BG001 | AR100DP1 (2.5%)_Phase I |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With DLTs | Phase I study included 14 days of treatment with AR100DP1, followed by 2 weeks of follow-up period to find the maximum tolerated dose (MTD) of AR100DP1. DLTs were defined as any adverse event (AE) ≥ Grade 2 (Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, issued by United States Food and Drug Administration in September 2007), that was considered to be causally related (possibly, probably, or definitely related) to AR100DP1 as judged by the investigator up to Day 29. The definition of Grade 5 (death related to AE) was added to this grading system as it was not defined in the guidance. (reported in the subsequent Primary Outcome Measure). MTD is defined as the highest dose level at which < 2 of 6 subjects experienced a dose-limiting toxicity (DLT). | All subjects received AR100DP1 at least 12 days with at least 85% of compliance. | Posted | Count of Participants | Participants | up to Day 29 for each cohort in phase I |
|
Day -14 to 29 (Phase I); Day -14 to 43 (Phase IIa)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AR100DP1 (1.25%)_Phase I | Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 1.25% AR100DP1 topical administration is 31.25 mg/day (1.25% × 1,250 × 2 = 31.25). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Irritant contact dermatitis | General disorders | MedDRA (23.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| YEH B, WU | Arjil Pharmaceuticals LLC. | +886-3-573-3608 | ybw333@arjilbio.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 10, 2021 | Feb 23, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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Phase I: conventional 3+3 design of dose escalation Phase IIa: single-arm
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| Day 29 (Phase IIa) |
| Change From Baseline in Pruritus Numerical Rating Scale (NRS) of Itch Level on Target Lesions | The pruritus NRS is comprised itch level grading from the numbers 0 ("no itch") to 10 ("worst imaginable itch"). Subjects are asked to rate the intensity of their itch by visits. | Day 8, Day 15, Day 22, Day 29, Day 36 and Day 43 (Phase IIa) |
| Change of IgE Compared to Baseline (Day 1) | Day 15 and 29 (Phase IIa) |
| Fold Change of IL-4 Compared to Baseline (Day 1 ) | Day 15 and 29 (Phase IIa) |
| Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | 4 symptoms of atopic dermatitis (erythema, edema, excoriation and lichenification) will be evaluated on all target lesions and graded from 0 to 3 (none, mild, moderate and severe, respectively), with half points allowed | Day 8, Day 15, Day 22, Day 29, Day 36 and Day 43 (Phase IIa) |
| Change From Baseline in the Total Score of Patient-Oriented Eczema Measure (POEM) | POEM is a validated, patient-derived assessment measure for monitoring atopic eczema severity , available at the HOME (Harmonising Outcome Measures for Eczema) group. It contains seven symptoms of AD on 5-point (0 to 4) scale with total score 0 to 28 during the study. A higher score means a worse outcome, whereas a lower score is a better outcome. | Day 8, Day 15, Day 22, Day 29, Day 36 and Day 43 (Phase IIa) |
| Number of Subjects With AE and SAE | Day -14 to 29 (Phase I); Day -14 to 43 (Phase IIa) |
| Change From Baseline in Vital Signs (Systolic Blood Pressure) | Vital signs measurement will consist of systolic/diastolic blood pressure, respiratory rate, pulse rate or heart rate, and body temperature. | Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa) |
| Number of Subjects With Physical Examination Abnormalities | Physical examination will include the following items: general appearance, skin, eyes, ears, nose, throat, head and neck, heart, chest and lungs, abdomen, extremities, lymph nodes, musculoskeletal, neurological and others. | Day -14 to 29 (Phase I); Day -14 to 43 (Phase IIa) |
| Number of Subjects With 12-lead ECG Abnormalities | ECG will be evaluated by the investigators and noted as "Normal", "Abnormal, non-clinical significant (NCS)" or "Abnormal, clinical significant (CS)" | Day 1, Day 8, Day 15, Day 22, Day 29 (Phase I); Day 1, Day 8, Day 15, Day 22, Day 29, Day 43 (Phase IIa) |
| Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology) | Laboratory tests include hematology (hemoglobin, hematocrit, RBC, platelet, WBC with different counts), biochemistry (total bilirubin, AST, ALT, serum creatinine and albumin) | Day 8 to Day 29 (Phase I); Day 8 to Day 43 (Phase IIa) |
| Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Vital signs measurement will consist of systolic/diastolic blood pressure, respiratory rate, pulse rate or heart rate, and body temperature. | Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa) |
| Change From Baseline in Vital Signs (Pulse Rate) | Vital signs measurement will consist of systolic/diastolic blood pressure, respiratory rate, pulse rate or heart rate, and body temperature. | Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa) |
| Change From Baseline in Vital Signs (Respiration Rate) | Vital signs measurement will consist of systolic/diastolic blood pressure, respiratory rate, pulse rate or heart rate, and body temperature. | Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa) |
| Change From Baseline in Vital Signs (Body Temperature) | Vital signs measurement will consist of systolic/diastolic blood pressure, respiratory rate, pulse rate or heart rate, and body temperature. | Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa) |
| Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry) | Laboratory tests include hematology (hemoglobin, hematocrit, RBC, platelet, WBC with different counts), biochemistry (total bilirubin, AST, ALT, serum creatinine and albumin) | Day 8 to Day 29 (Phase I); Day 8 to Day 43 (Phase IIa) |
| Percentage of Subjects Achieving the Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) on Day 8, Day 15, Day 22, Day 36 and Day 43 (Phase IIa) | The IGA is a 5-point scale that provides a global clinical assessment of AD severity based on an ordinal scale, scored by the investigator. The scores of IGA are 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (Severe). | Day 8, Day 15, Day 22, Day 36 and Day 43 (Phase IIa) |
| Change From Baseline of Target Lesion Area(s) on Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 (Phase IIa) | Day 8, Day 15, Day 22, Day 29, Day 36 and Day 43 (Phase IIa) |
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 2.5% AR100DP1 topical administration is 62.5 mg/day (2.5% × 1,250 × 2 = 62.5). |
| BG002 | AR100DP1 (5%)_Phase I | Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125). |
| BG003 | AR100DP1 (5%)_Phase II | Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125). |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Height (cm) | Mean | Standard Deviation | cm |
|
| Weight (kg) | Mean | Standard Deviation | kg |
|
| Body Mass Index (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
|
| OG000 |
| AR100DP1 (1.25%)_Phase I |
Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 1.25% AR100DP1 topical administration is 31.25 mg/day (1.25% × 1,250 × 2 = 31.25). |
| OG001 | AR100DP1 (2.5%)_Phase I | Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 2.5% AR100DP1 topical administration is 62.5 mg/day (2.5% × 1,250 × 2 = 62.5). |
| OG002 | AR100DP1 (5%)_Phase I | Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125). |
|
|
| Primary | Maximum Tolerated Dose (MTD) of AR100DP1 | Per protocol, MTD is defined as the highest dose level at which < 2 of 6 subjects experienced a dose-limiting toxicity (DLT). MTD was determined by testing increasing doses up to 125 mg/day via topical administration on AR100DP1_1.25%, 2.5%, and 5% groups with 3 to 6 subjects each. DLTs were defined as any adverse event (AE) ≥ Grade 2 (Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, issued by United States Food and Drug Administration in September 2007), that was considered to be causally related (possibly, probably, or definitely related) to AR100DP1 as judged by the investigator up to Day 29. The definition of Grade 5 (death related to AE) was added to this grading system as it was not defined in the guidance. (reported in the previous Primary Outcome Measure). | Posted | Number | mg/day | up to Day 29 for each cohort in phase I |
|
|
|
| Primary | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 or 1 on Day 29 (Phase IIa) | The IGA is a 5-point scale that provides a global clinical assessment of AD severity based on an ordinal scale, scored by the investigator. The scores of IGA are 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (Severe). | Efficacy analyses were conducted in phase IIa. Phase IIa was terminated early because of the safety issue. One subject in phase IIa was withdrawn from the study after Visit 6 (Day 29). | Posted | Count of Participants | Participants | Day 29 (Phase IIa) |
|
|
|
| Secondary | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | The IGA is a 5-point scale that provides a global clinical assessment of AD severity based on an ordinal scale, scored by the investigator. The scores of IGA are 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (Severe). | Efficacy analyses were conducted in phase IIa. Phase IIa was terminated early because of the safety issue. One subject in phase IIa was withdrawn from the study after Visit 6 (Day 29). | Posted | Count of Participants | Participants | Day 8, Day 15, Day 22, Day 29, Day 36 and Day 43 (Phase IIa) |
|
|
|
| Secondary | Change From Baseline in Pruritus Numerical Rating Scale (NRS) of Itch Level on Target Lesions | The pruritus NRS is comprised itch level grading from the numbers 0 ("no itch") to 10 ("worst imaginable itch"). Subjects are asked to rate the intensity of their itch by visits. | Efficacy analyses were conducted in phase IIa. Phase IIa was terminated early because of the safety issue. One subject in phase IIa was withdrawn from the study after Visit 6 (Day 29). | Posted | Mean | Standard Deviation | score on a scale | Day 8, Day 15, Day 22, Day 29, Day 36 and Day 43 (Phase IIa) |
|
|
|
| Secondary | Change of IgE Compared to Baseline (Day 1) | Efficacy analyses were conducted in phase IIa. Phase IIa was terminated early because of the safety issue. One subject in phase IIa was withdrawn from the study after Visit 6 (Day 29). | Posted | Mean | Standard Deviation | IU/mL | Day 15 and 29 (Phase IIa) |
|
|
|
| Secondary | Fold Change of IL-4 Compared to Baseline (Day 1 ) | No source data was collected for IL-4 in this study. | Posted | Day 15 and 29 (Phase IIa) |
|
|
| Secondary | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | 4 symptoms of atopic dermatitis (erythema, edema, excoriation and lichenification) will be evaluated on all target lesions and graded from 0 to 3 (none, mild, moderate and severe, respectively), with half points allowed | Efficacy analyses were conducted in phase IIa. Phase IIa was terminated early because of the safety issue. One subject in phase IIa was withdrawn from the study after Visit 6 (Day 29). | Posted | Mean | Standard Deviation | score on a scale | Day 8, Day 15, Day 22, Day 29, Day 36 and Day 43 (Phase IIa) |
|
|
|
| Secondary | Change From Baseline in the Total Score of Patient-Oriented Eczema Measure (POEM) | POEM is a validated, patient-derived assessment measure for monitoring atopic eczema severity , available at the HOME (Harmonising Outcome Measures for Eczema) group. It contains seven symptoms of AD on 5-point (0 to 4) scale with total score 0 to 28 during the study. A higher score means a worse outcome, whereas a lower score is a better outcome. | Efficacy analyses were conducted in phase IIa. Phase IIa was terminated early because of the safety issue. One subject in phase IIa was withdrawn from the study after Visit 6 (Day 29). | Posted | Mean | Standard Deviation | score on a scale | Day 8, Day 15, Day 22, Day 29, Day 36 and Day 43 (Phase IIa) |
|
|
|
| Secondary | Number of Subjects With AE and SAE | Posted | Count of Participants | Participants | Day -14 to 29 (Phase I); Day -14 to 43 (Phase IIa) |
|
|
|
| Secondary | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Vital signs measurement will consist of systolic/diastolic blood pressure, respiratory rate, pulse rate or heart rate, and body temperature. | Final visit was Visit 6 (Day 29) for Phase I subjects, but Visit 8 (Day 43) for Phase II subjects. Phase IIa was terminated early because of the safety issue. One subject in phase IIa was withdrawn from the study after Visit 6 (Day 29). | Posted | Mean | Standard Deviation | mmHg | Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa) |
|
|
|
| Secondary | Number of Subjects With Physical Examination Abnormalities | Physical examination will include the following items: general appearance, skin, eyes, ears, nose, throat, head and neck, heart, chest and lungs, abdomen, extremities, lymph nodes, musculoskeletal, neurological and others. | Final visit was Visit 6 (Day 29) for Phase I subjects, but Visit 8 (Day 43) for Phase II subjects. Phase IIa was terminated early because of the safety issue. One subject in phase IIa was withdrawn from the study after Visit 6 (Day 29). | Posted | Count of Participants | Participants | Day -14 to 29 (Phase I); Day -14 to 43 (Phase IIa) |
|
|
|
| Secondary | Number of Subjects With 12-lead ECG Abnormalities | ECG will be evaluated by the investigators and noted as "Normal", "Abnormal, non-clinical significant (NCS)" or "Abnormal, clinical significant (CS)" | Final visit was Visit 6 (Day 29) for Phase I subjects, but Visit 8 (Day 43) for Phase II subjects.Phase IIa was terminated early because of the safety issue. One subject in phase IIa was withdrawn from the study after Visit 6 (Day 29). | Posted | Count of Participants | Participants | Day 1, Day 8, Day 15, Day 22, Day 29 (Phase I); Day 1, Day 8, Day 15, Day 22, Day 29, Day 43 (Phase IIa) |
|
|
|
| Secondary | Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology) | Laboratory tests include hematology (hemoglobin, hematocrit, RBC, platelet, WBC with different counts), biochemistry (total bilirubin, AST, ALT, serum creatinine and albumin) | Final Visit was Visit 6 (Day 29) for Phase I subjects, but Visit 8 (Day 43) for Phase II subjects. Phase IIa was terminated early because of the safety issue. One subject in phase IIa was withdrawn from the study after Visit 6 (Day 29). | Posted | Count of Participants | Participants | Day 8 to Day 29 (Phase I); Day 8 to Day 43 (Phase IIa) |
|
|
|
| Secondary | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Vital signs measurement will consist of systolic/diastolic blood pressure, respiratory rate, pulse rate or heart rate, and body temperature. | Final visit was Visit 6 (Day 29) for Phase I subjects, but Visit 8 (Day 43) for Phase II subjects. Phase IIa was terminated early because of the safety issue. One subject in phase IIa was withdrawn from the study after Visit 6 (Day 29). | Posted | Mean | Standard Deviation | mmHg | Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa) |
|
|
|
| Secondary | Change From Baseline in Vital Signs (Pulse Rate) | Vital signs measurement will consist of systolic/diastolic blood pressure, respiratory rate, pulse rate or heart rate, and body temperature. | Final visit was Visit 6 (Day 29) for Phase I subjects, but Visit 8 (Day 43) for Phase II subjects. Phase IIa was terminated early because of the safety issue. One subject in phase IIa was withdrawn from the study after Visit 6 (Day 29). | Posted | Mean | Standard Deviation | beats/min | Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa) |
|
|
|
| Secondary | Change From Baseline in Vital Signs (Respiration Rate) | Vital signs measurement will consist of systolic/diastolic blood pressure, respiratory rate, pulse rate or heart rate, and body temperature. | Final visit was Visit 6 (Day 29) for Phase I subjects, but Visit 8 (Day 43) for Phase II subjects. Phase IIa was terminated early because of the safety issue. One subject in phase IIa was withdrawn from the study after Visit 6 (Day 29). | Posted | Mean | Standard Deviation | breaths/min | Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa) |
|
|
|
| Secondary | Change From Baseline in Vital Signs (Body Temperature) | Vital signs measurement will consist of systolic/diastolic blood pressure, respiratory rate, pulse rate or heart rate, and body temperature. | Final visit was Visit 6 (Day 29) for Phase I subjects, but Visit 8 (Day 43) for Phase II subjects. Phase IIa was terminated early because of the safety issue. One subject in phase IIa was withdrawn from the study after Visit 6 (Day 29). | Posted | Mean | Standard Deviation | degree C | Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa) |
|
|
|
| Secondary | Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry) | Laboratory tests include hematology (hemoglobin, hematocrit, RBC, platelet, WBC with different counts), biochemistry (total bilirubin, AST, ALT, serum creatinine and albumin) | Final Visit was Visit 6 (Day 29) for Phase I subjects, but Visit 8 (Day 43) for Phase II subjects. Phase IIa was terminated early because of the safety issue. One subject in phase IIa was withdrawn from the study after Visit 6 (Day 29). | Posted | Count of Participants | Participants | Day 8 to Day 29 (Phase I); Day 8 to Day 43 (Phase IIa) |
|
|
|
| Secondary | Percentage of Subjects Achieving the Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) on Day 8, Day 15, Day 22, Day 36 and Day 43 (Phase IIa) | The IGA is a 5-point scale that provides a global clinical assessment of AD severity based on an ordinal scale, scored by the investigator. The scores of IGA are 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (Severe). | Efficacy analyses were conducted in phase IIa. Phase IIa was terminated early because of the safety issue. One subject in phase IIa was withdrawn from the study after Visit 6 (Day 29). | Posted | Count of Participants | Participants | Day 8, Day 15, Day 22, Day 36 and Day 43 (Phase IIa) |
|
|
|
| Secondary | Change From Baseline of Target Lesion Area(s) on Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 (Phase IIa) | Efficacy analyses were conducted in phase IIa. Phase IIa was terminated early because of the safety issue. One subject in phase IIa was withdrawn from the study after Visit 6 (Day 29). | Posted | Mean | Standard Deviation | cm^2 | Day 8, Day 15, Day 22, Day 29, Day 36 and Day 43 (Phase IIa) |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | AR100DP1 (2.5%)_Phase I | Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 2.5% AR100DP1 topical administration is 62.5 mg/day (2.5% × 1,250 × 2 = 62.5). | 0 | 3 | 0 | 3 | 0 | 3 |
| EG002 | AR100DP1 (5%)_Phase I | Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125). | 0 | 6 | 0 | 6 | 2 | 6 |
| EG003 | AR100DP1 (5%)_Phase II | Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125). | 0 | 2 | 1 | 2 | 1 | 2 |
| Application site dermatitis | General disorders | MedDRA (23.1) | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
|
Not provided
Not provided
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
|
| Baseline (Phase IIa) : Score 0 (clear) |
|
|
| Baseline (Phase IIa) : Score 1 (almost clear) |
|
|
| Visit 6 (Day 29) (Phase IIa) : Score 0 (clear) |
|
|
| Visit 6 (Day 29) (Phase IIa) : Score 1 (almost clear) |
|
|
| Score 2 (mild) |
|
| Score 3 (moderate) |
|
| Score 4 (severe) |
|
| Baseline (Phase IIa) |
|
|
| Visit 3 (Day 8) (Phase IIa) |
|
|
| Visit 4 (Day 15) (Phase IIa) |
|
|
| Visit 5 (Day 22) (Phase IIa) |
|
|
| Visit 6 (Day 29) (Phase IIa) |
|
|
| Visit 7 (Day 36) (Phase IIa) |
|
|
| Visit 8 (Day 43) (Phase IIa) |
|
|
|
| Visit 3 (Day 8)-Visit 2 (Day 1) (Phase IIa) |
|
|
| Visit 4 (Day 15) (Phase IIa) |
|
|
| Visit 4 (Day 15)-Visit 2 (Day 1) |
|
|
| Visit 5 (Day 22) (Phase IIa) |
|
|
| Visit 5 (Day 22)-Visit 2 (Day 1) (Phase IIa) |
|
|
| Visit 6 (Day 29) (Phase IIa) |
|
|
| Visit 6 (Day 29)-Visit 2 (Day 1) (Phase IIa) |
|
|
| Visit 7 (Day 36) (Phase IIa) |
|
|
| Visit 7 (Day 36)-Visit 2 (Day 1) (Phase IIa) |
|
|
| Visit 8 (Day 43) (Phase IIa) |
|
|
| Visit 8 (Day 43)-Visit 2 (Day 1) (Phase IIa) |
|
|
|
| Visit 4 (Day 15)-Visit 2 (Day 1) (Phase IIa) |
|
|
| Visit 6 (Day 29) (Phase IIa) |
|
|
| Visit 6 (Day 29)-Visit 2 (Day 1) (Phase IIa) |
|
|
|
| Erythema: Visit 3 (Day 8)-Visit 2 (Day 1) (Phase IIa) |
|
|
| Erythema: Visit 4 (Day 15) (Phase IIa) |
|
|
| Erythema: Visit 4 (Day 15)-Visit 2 (Day 1) (Phase IIa) |
|
|
| Erythema: Visit 5 (Day 22) (Phase IIa) |
|
|
| Erythema: Visit 5 (Day 22)-Visit 2 (Day 1) (Phase IIa) |
|
|
| Erythema: Visit 6 (Day 29) (Phase IIa) |
|
|
| Erythema: Visit 6 (Day 29)-Visit 2 (Day 1) (Phase IIa) |
|
|
| Erythema: Visit 7 (Day 36) (Phase IIa) |
|
|
| Erythema: Visit 7 (Day 36)-Visit 2 (Day 1) (Phase IIa) |
|
|
| Erythema: Visit 8 (Day 43) (Phase IIa) |
|
|
| Erythema: Visit 8 (Day 43)-Visit 2 (Day 1) (Phase IIa) |
|
|
| Edema: Visit 2 (Day 1) (Phase IIa) |
|
|
| Edema: Visit 3 (Day 8) (Phase IIa) |
|
|
| Edema: Visit 3 (Day 8)-Visit 2 (Day 1) (Phase IIa) |
|
|
| Edema: Visit 4 (Day 15) (Phase IIa) |
|
|
| Edema: Visit 4 (Day 15)-Visit 2 (Day 1) (Phase IIa) |
|
|
| Edema: Visit 5 (Day 22) (Phase IIa) |
|
|
| Edema: Visit 5 (Day 22)-Visit 2 (Day 1) (Phase IIa) |
|
|
| Edema: Visit 6 (Day 29) (Phase IIa) |
|
|
| Edema: Visit 6 (Day 29)-Visit 2 (Day 1) (Phase IIa) |
|
|
| Edema: Visit 7 (Day 36) (Phase IIa) |
|
|
| Edema: Visit 7 (Day 36)-Visit 2 (Day 1) (Phase IIa) |
|
|
| Edema: Visit 8 (Day 43) (Phase IIa) |
|
|
| Edema: Visit 8 (Day 43)-Visit 2 (Day 1) (Phase IIa) |
|
|
| Excoriation: Visit 2 (Day 1) (Phase IIa) |
|
|
| Excoriation: Visit 3 (Day 8) (Phase IIa) |
|
|
| Excoriation: Visit 3 (Day 8)-Visit 2 (Day 1) (Phase IIa) |
|
|
| Excoriation: Visit 4 (Day 15) (Phase IIa) |
|
|
| Excoriation: Visit 4 (Day 15)-Visit 2 (Day 1) (Phase IIa) |
|
|
| Excoriation: Visit 5 (Day 22) (Phase IIa) |
|
|
| Excoriation: Visit 5 (Day 22)-Visit 2 (Day 1) (Phase IIa) |
|
|
| Excoriation: Visit 6 (Day 29) (Phase IIa) |
|
|
| Excoriation: Visit 6 (Day 29)-Visit 2 (Day 1) (Phase IIa) |
|
|
| Excoriation: Visit 7 (Day 36) (Phase IIa) |
|
|
| Excoriation: Visit 7 (Day 36)-Visit 2 (Day 1) (Phase IIa) |
|
|
| Excoriation: Visit 8 (Day 43) (Phase IIa) |
|
|
| Excoriation: Visit 8 (Day 43)-Visit 2 (Day 1) (Phase IIa) |
|
|
| Lichenification: Visit 2 (Day 1) (Phase IIa) |
|
|
| Lichenification: Visit 3 (Day 8) (Phase IIa) |
|
|
| Lichenification: Visit 3 (Day 8)-Visit 2 (Day 1) (Phase IIa) |
|
|
| Lichenification: Visit 4 (Day 15) (Phase IIa) |
|
|
| Lichenification: Visit 4 (Day 15)-Visit 2 (Day 1) (Phase IIa) |
|
|
| Lichenification: Visit 5 (Day 22) (Phase IIa) |
|
|
| Lichenification: Visit 5 (Day 22)-Visit 2 (Day 1) (Phase IIa) |
|
|
| Lichenification: Visit 6 (Day 29) (Phase IIa) |
|
|
| Lichenification: Visit 6 (Day 29)-Visit 2 (Day 1) (Phase IIa) |
|
|
| Lichenification: Visit 7 (Day 36) (Phase IIa) |
|
|
| Lichenification: Visit 7 (Day 36)-Visit 2 (Day 1) (Phase IIa) |
|
|
| Lichenification: Visit 8 (Day 43) (Phase IIa) |
|
|
| Lichenification: Visit 8 (Day 43)-Visit 2 (Day 1) (Phase IIa) |
|
|
|
| Visit 3 (Day 8)-Visit 2 (Day 1) (Phase IIa) |
|
|
| Visit 4 (Day 15) (Phase IIa) |
|
|
| Visit 4 (Day 15)-Visit 2 (Day 1) (Phase IIa) |
|
|
| Visit 5 (Day 22) (Phase IIa) |
|
|
| Visit 5 (Day 22)-Visit 2 (Day 1) (Phase IIa) |
|
|
| Visit 6 (Day 29) (Phase IIa) |
|
|
| Visit 6 (Day 29)-Visit 2 (Day 1) (Phase IIa) |
|
|
| Visit 7 (Day 36) (Phase IIa) |
|
|
| Visit 7 (Day 36)-Visit 2 (Day 1) (Phase IIa) |
|
|
| Visit 8 (Day 43) (Phase IIa) |
|
|
| Visit 8 (Day 43)-Visit 2 (Day 1) (Phase IIa) |
|
|
| Treatment-related AE |
|
| DLT |
|
| SAE |
|
| SUSAR |
|
| Death |
|
|
| Baseline (Day -14~ Day 1; Phase I) |
|
|
| Visit 2 (Day 1) : 30M after IP Administration (Phase I) |
|
|
| Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase I) |
|
|
| Visit 3 (Day 8) (Phase I) |
|
|
| Visit 3 (Day 8) - Baseline (Phase I) |
|
|
| Visit 4 (Day 15) (Phase I) |
|
|
| Visit 4 (Day 15) - Baseline (Phase I) |
|
|
| Visit 5 (Day 22) (Phase I) |
|
|
| Visit 5 (Day 22) - Baseline (Phase I) |
|
|
| Visit 6 (Day 29) (Phase I) |
|
|
| Visit 6 (Day 29) - Baseline (Phase I) |
|
|
| Visit 1 (Screening, Day -14 ~ -1) (Phase IIa) |
|
|
| Baseline (Day -14~ Day 1; Phase IIa) |
|
|
| Visit 2 (Day 1) : 30M after IP Administration (Phase IIa) |
|
|
| Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase IIa) |
|
|
| Visit 3 (Day 8) (Phase IIa) |
|
|
| Visit 3 (Day 8) - Baseline (Phase IIa) |
|
|
| Visit 4 (Day 15) (Phase IIa) |
|
|
| Visit 4 (Day 15) - Baseline (Phase IIa) |
|
|
| Visit 5 (Day 22) (Phase IIa) |
|
|
| Visit 5 (Day 22) - Baseline (Phase IIa) |
|
|
| Visit 6 (Day 29) (Phase IIa) |
|
|
| Visit 6 (Day 29) - Baseline (Phase IIa) |
|
|
| Visit 7 (Day 36) (Phase IIa) |
|
|
| Visit 7 (Day 36) - Baseline (Phase IIa) |
|
|
| Visit 8 (Day 43) (Phase IIa) |
|
|
| Visit 8 (Day 43) - Baseline (Phase IIa) |
|
|
|
| Visit 2 (Day 1) : before IP Administration (Phase I) |
|
|
| Visit 2 (Day 1) : 30M after IP Administration (Phase I) |
|
|
| Visit 3 (Day 8) (Phase I) |
|
|
| Visit 4 (Day 15) (Phase I) |
|
|
| Visit 5 (Day 22) (Phase I) |
|
|
| Visit 6 (Day 29) (Phase I) |
|
|
| Visit 1 (Screening) (Phase IIa) |
|
|
| Visit 2 (Day 1) : before IP Administration (Phase IIa) |
|
|
| Visit 2 (Day 1) : 30M after IP Administration (Phase IIa) |
|
|
| Visit 3 (Day 8) (Phase IIa) |
|
|
| Visit 4 (Day 15) (Phase IIa) |
|
|
| Visit 5 (Day 22) (Phase IIa) |
|
|
| Visit 6 (Day 29) (Phase IIa) |
|
|
| Visit 7 (Day 36) (Phase IIa) |
|
|
| Visit 8 (Day 43) (Phase IIa) |
|
|
|
| Baseline (Phase I) |
|
|
| Visit 3 (Day 8) (Phase I) |
|
|
| Visit 4 (Day 15) (Phase I) |
|
|
| Visit 5 (Day 22) (Phase I) |
|
|
| Visit 6 (Day 29) (Phase I) |
|
|
| Visit 1 (Screening, Day -14 ~ -1) (Phase IIa) |
|
|
| Baseline (Phase IIa) |
|
|
| Visit 3 (Day 8) (Phase IIa) |
|
|
| Visit 4 (Day 15) (Phase IIa) |
|
|
| Visit 5 (Day 22) (Phase IIa) |
|
|
| Visit 6 (Day 29) (Phase IIa) |
|
|
| Visit 7 (Day 36) (Phase IIa) |
|
|
| Visit 8 (Day 43) (Phase IIa) |
|
|
|
| Visit 3 (Day 8) (Phase I) |
|
|
| Visit 4 (Day 15) (Phase I) |
|
|
| Visit 5 (Day 22) (Phase I) |
|
|
| Visit 6 (Day 29) (Phase I) |
|
|
| Visit 1 (Screening) (Phase IIa) |
|
|
| Visit 3 (Day 8) (Phase IIa) |
|
|
| Visit 4 (Day 15) (Phase IIa) |
|
|
| Visit 5 (Day 22) (Phase IIa) |
|
|
| Visit 6 (Day 29) (Phase IIa) |
|
|
| Visit 7 (Day 36) (Phase IIa) |
|
|
| Visit 8 (Day 43) (Phase IIa) |
|
|
|
| Baseline (Phase I) |
|
|
| Visit 2 (Day 1) : 30M after IP Administration (Phase I) |
|
|
| Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase I) |
|
|
| Visit 3 (Day 8) (Phase I) |
|
|
| Visit 3 (Day 8) - Baseline (Phase I) |
|
|
| Visit 4 (Day 15) (Phase I) |
|
|
| Visit 4 (Day 15) - Baseline (Phase I) |
|
|
| Visit 5 (Day 22) (Phase I) |
|
|
| Visit 5 (Day 22) - Baseline (Phase I) |
|
|
| Visit 6 (Day 29) (Phase I) |
|
|
| Visit 6 (Day 29) - Baseline (Phase I) |
|
|
| Visit 1 (Screening, Day -14 ~ -1) (Phase IIa) |
|
|
| Baseline (Phase IIa) |
|
|
| Visit 2 (Day 1) : 30M after IP Administration (Phase IIa) |
|
|
| Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase IIa) |
|
|
| Visit 3 (Day 8) (Phase IIa) |
|
|
| Visit 3 (Day 8) - Baseline (Phase IIa) |
|
|
| Visit 4 (Day 15) (Phase IIa) |
|
|
| Visit 4 (Day 15) - Baseline (Phase IIa) |
|
|
| Visit 5 (Day 22) (Phase IIa) |
|
|
| Visit 5 (Day 22) - Baseline (Phase IIa) |
|
|
| Visit 6 (Day 29) (Phase IIa) |
|
|
| Visit 6 (Day 29) - Baseline (Phase IIa) |
|
|
| Visit 7 (Day 36) (Phase IIa) |
|
|
| Visit 7 (Day 36) - Baseline (Phase IIa) |
|
|
| Visit 8 (Day 43) (Phase IIa) |
|
|
| Visit 8 (Day 43) - Baseline (Phase IIa) |
|
|
|
| Baseline (Phase I) |
|
|
| Visit 2 (Day 1) : 30M after IP Administration (Phase I) |
|
|
| Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase I) |
|
|
| Visit 3 (Day 8) (Phase I) |
|
|
| Visit 3 (Day 8) - Baseline (Phase I) |
|
|
| Visit 4 (Day 15) (Phase I) |
|
|
| Visit 4 (Day 15) - Baseline (Phase I) |
|
|
| Visit 5 (Day 22) (Phase I) |
|
|
| Visit 5 (Day 22) - Baseline (Phase I) |
|
|
| Visit 6 (Day 29) (Phase I) |
|
|
| Visit 6 (Day 29) - Baseline (Phase I) |
|
|
| Visit 1 (Screening, Day -14 ~ -1) (Phase IIa) |
|
|
| Baseline (Phase IIa) |
|
|
| Visit 2 (Day 1) : 30M after IP Administration (Phase IIa) |
|
|
| Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase IIa) |
|
|
| Visit 3 (Day 8) (Phase IIa) |
|
|
| Visit 3 (Day 8) - Baseline (Phase IIa) |
|
|
| Visit 4 (Day 15) (Phase IIa) |
|
|
| Visit 4 (Day 15) - Baseline (Phase IIa) |
|
|
| Visit 5 (Day 22) (Phase IIa) |
|
|
| Visit 5 (Day 22) - Baseline (Phase IIa) |
|
|
| Visit 6 (Day 29) (Phase IIa) |
|
|
| Visit 6 (Day 29) - Baseline (Phase IIa) |
|
|
| Visit 7 (Day 36) (Phase IIa) |
|
|
| Visit 7 (Day 36) - Baseline (Phase IIa) |
|
|
| Visit 8 (Day 43) (Phase IIa) |
|
|
| Visit 8 (Day 43) - Baseline (Phase IIa) |
|
|
|
| Baseline (Phase I) |
|
|
| Visit 2 (Day 1) : 30M after IP Administration (Phase I) |
|
|
| Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase I) |
|
|
| Visit 3 (Day 8) (Phase I) |
|
|
| Visit 3 (Day 8) - Baseline (Phase I) |
|
|
| Visit 4 (Day 15) (Phase I) |
|
|
| Visit 4 (Day 15) - Baseline (Phase I) |
|
|
| Visit 5 (Day 22) (Phase I) |
|
|
| Visit 5 (Day 22) - Baseline (Phase I) |
|
|
| Visit 6 (Day 29) (Phase I) |
|
|
| Visit 6 (Day 29) - Baseline (Phase I) |
|
|
| Visit 1 (Screening, Day -14 ~ -1) (Phase IIa) |
|
|
| Baseline (Phase IIa) |
|
|
| Visit 2 (Day 1) : 30M after IP Administration (Phase IIa) |
|
|
| Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase IIa) |
|
|
| Visit 3 (Day 8) (Phase IIa) |
|
|
| Visit 3 (Day 8) - Baseline (Phase IIa) |
|
|
| Visit 4 (Day 15) (Phase IIa) |
|
|
| Visit 4 (Day 15) - Baseline (Phase IIa) |
|
|
| Visit 5 (Day 22) (Phase IIa) |
|
|
| Visit 5 (Day 22) - Baseline (Phase IIa) |
|
|
| Visit 6 (Day 29) (Phase IIa) |
|
|
| Visit 6 (Day 29) - Baseline (Phase IIa) |
|
|
| Visit 7 (Day 36) (Phase IIa) |
|
|
| Visit 7 (Day 36) - Baseline (Phase IIa) |
|
|
| Visit 8 (Day 43) (Phase IIa) |
|
|
| Visit 8 (Day 43) - Baseline (Phase IIa) |
|
|
|
| Baseline (Phase I) |
|
|
| Visit 2 (Day 1) : 30M after IP Administration (Phase I) |
|
|
| Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase I) |
|
|
| Visit 3 (Day 8) (Phase I) |
|
|
| Visit 3 (Day 8) - Baseline (Phase I) |
|
|
| Visit 4 (Day 15) (Phase I) |
|
|
| Visit 4 (Day 15) - Baseline (Phase I) |
|
|
| Visit 5 (Day 22) (Phase I) |
|
|
| Visit 5 (Day 22) - Baseline (Phase I) |
|
|
| Visit 6 (Day 29) (Phase I) |
|
|
| Visit 6 (Day 29) - Baseline (Phase I) |
|
|
| Visit 1 (Screening, Day -14 ~ -1) (Phase IIa) |
|
|
| Baseline (Phase IIa) |
|
|
| Visit 2 (Day 1) : 30M after IP Administration (Phase IIa) |
|
|
| Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase IIa) |
|
|
| Visit 3 (Day 8) (Phase IIa) |
|
|
| Visit 3 (Day 8) - Baseline (Phase IIa) |
|
|
| Visit 4 (Day 15) (Phase IIa) |
|
|
| Visit 4 (Day 15) - Baseline (Phase IIa) |
|
|
| Visit 5 (Day 22) (Phase IIa) |
|
|
| Visit 5 (Day 22) - Baseline (Phase IIa) |
|
|
| Visit 6 (Day 29) (Phase IIa) |
|
|
| Visit 6 (Day 29) - Baseline (Phase IIa) |
|
|
| Visit 7 (Day 36) (Phase IIa) |
|
|
| Visit 7 (Day 36) - Baseline (Phase IIa) |
|
|
| Visit 8 (Day 43) (Phase IIa) |
|
|
| Visit 8 (Day 43) - Baseline (Phase IIa) |
|
|
|
| Visit 3 (Day 8) (Phase I) |
|
|
| Visit 4 (Day 15) (Phase I) |
|
|
| Visit 5 (Day 22) (Phase I) |
|
|
| Visit 6 (Day 29) (Phase I) |
|
|
| Visit 1 (Screening) (Phase IIa) |
|
|
| Visit 3 (Day 8) (Phase IIa) |
|
|
| Visit 4 (Day 15) (Phase IIa) |
|
|
| Visit 5 (Day 22) (Phase IIa) |
|
|
| Visit 6 (Day 29) (Phase IIa) |
|
|
| Visit 7 (Day 36) (Phase IIa) |
|
|
| Visit 8 (Day 43) (Phase IIa) |
|
|
|
| Baseline (Phase IIa) : Score 0 (clear) |
|
|
| Baseline (Phase IIa) : Score 1 (almost clear) |
|
|
| Visit 3 (Day 8) (Phase IIa) : Score 0 (clear) |
|
|
| Visit 3 (Day 8) (Phase IIa) : Score 1 (almost clear) |
|
|
| Visit 4 (Day 15) (Phase IIa) : Score 0 (clear) |
|
|
| Visit 4 (Day 15) (Phase IIa) : Score 1 (almost clear) |
|
|
| Visit 5 (Day 22) (Phase IIa) : Score 0 (clear) |
|
|
| Visit 5 (Day 22) (Phase IIa) : Score 1 (almost clear) |
|
|
| Visit 7 (Day 36) (Phase IIa) : Score 0 (clear) |
|
|
| Visit 7 (Day 36) (Phase IIa) : Score 1 (almost clear) |
|
|
| Visit 8 (Day 43) (Phase IIa) : Score 0 (clear) |
|
|
| Visit 8 (Day 43) (Phase IIa) : Score 1 (almost clear) |
|
|
|
| Visit 3 (Day 8) (Phase IIa) |
|
|
| Visit 3 (Day 8) - Baseline (Phase IIa) |
|
|
| Visit 4 (Day 15) (Phase IIa) |
|
|
| Visit 4 (Day 15) - Baseline (Phase IIa) |
|
|
| Visit 5 (Day 22) (Phase IIa) |
|
|
| Visit 5 (Day 22) - Baseline (Phase IIa) |
|
|
| Visit 6 (Day 29) (Phase IIa) |
|
|
| Visit 6 (Day 29) - Baseline (Phase IIa) |
|
|
| Visit 7 (Day 36) (Phase IIa) |
|
|
| Visit 7 (Day 36) - Baseline (Phase IIa) |
|
|
| Visit 8 (Day 43) (Phase IIa) |
|
|
| Visit 8 (Day 43) -Baseline (Phase IIa) |
|
|
| NCS |
|
| CS (Medical History) |
|
| CS (Adverse Event) |
|
| CS (Medical History) |
|
| CS (Adverse Event) |
|
| NCS |
|
| CS (Medical History) |
|
| CS (Adverse Event) |
|
| CS (Medical History) |
|
| CS (Adverse Event) |
|
| CS (Medical History) |
|
| CS (Adverse Event) |
|