Dermatitis, Atopic
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGAR100DP1
topical ointment
Sponsors
Arjil Pharmaceuticals LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Phase I: conventional 3+3 design of dose escalation Phase IIa: single-arm
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Phase I: 1. Dated and signed informed consent 2. Either gender, ≥ 20 years old (the legal age of consent majority is 20 years old in Taiwan) 3. Healthy subjects, who have no clinically relevant abnormalities, identified by medical history, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory tests 4. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures 5. Healthy skin on which reddening can be easily recognized in the area of the test fields, evaluated by the investigator 6. Subject of childbearing potential must agree to use abstinence to intercourse, or highly effective contraceptives from signing informed consent to 14 days after the last dose of study drug administration 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: * Established use of oral, injected or implanted hormonal methods of contraception * Placement of an intrauterine device (IUD) or intrauterine system (IUS) * Barrier methods of contraception: condom (highly recommended with spermicide), or occlusive cap (diaphragm or cervical/vault caps) Phase IIa: 1. Dated and signed informed consent 2. Either gender, ≥ 20 years old (the legal age of consent majority is 20 years old in Taiwan) 3. Confirmed clinical diagnosis of atopic dermatitis (based on the criteria of Hanifin and Rajka for AD) 4. With at least 0.5% body surface area (BSA) as target lesion area(s) 5. Clinical diagnosis of AD that has been clinically stable, which means the IGA score stays as 2 or 3 when evaluated for ≥ 4 weeks at the investigator's discretion prior to Screening Visit 6. With Investigator's Global Assessment (IGA) score of 2 (mild) or 3 (moderate) at screening 7. Subject of childbearing potential must agree to use abstinence to intercourse, or highly effective contraceptives from signing informed consent to 14 days after the last dose of study drug administration 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: * Established use of oral, injected or implanted hormonal methods of contraception * Placement of an intrauterine device (IUD) or intrauterine system (IUS) * Barrier methods of contraception: condom (highly recommended with spermicide), or occlusive cap (diaphragm or cervical/vault caps)
Exclusion criteria
Phase I: 1. Subjects who have any visible skin disease at the application site which, in the opinion of the investigator, will interfere with the evaluation of the test site reaction 2. Subjects who have a history of AD, psoriasis and/or active AD/eczema 3. Subjects who have damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site 4. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) Phase IIa: 1. Unstable or actively infected AD judged by the investigator. 2. Active or potentially recurrent dermatologic condition other than atopic dermatitis that may confound evaluation (e.g. fungal infection), judged by the investigator. 3. 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 4. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With DLTs | up to Day 29 for each cohort in phase I | 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). |
| Maximum Tolerated Dose (MTD) of AR100DP1 | up to Day 29 for each cohort in phase I | 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). |
| Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 or 1 on Day 29 (Phase IIa) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 8, Day 15, Day 22, Day 29, Day 36 and Day 43 (Phase IIa) | 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 |
| Change From Baseline in the Total Score of Patient-Oriented Eczema Measure (POEM) | Day 8, Day 15, Day 22, Day 29, Day 36 and Day 43 (Phase IIa) | 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. |
| 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) | Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa) | Vital signs measurement will consist of systolic/diastolic blood pressure, respiratory rate, pulse rate or heart rate, and body temperature. |
| Number of Subjects With Physical Examination Abnormalities | Day -14 to 29 (Phase I); Day -14 to 43 (Phase IIa) | 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. |
| Change From Baseline in Vital Signs (Pulse Rate) | Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa) | Vital signs measurement will consist of systolic/diastolic blood pressure, respiratory rate, pulse rate or heart rate, and body temperature. |
| Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology) | Day 8 to Day 29 (Phase I); Day 8 to Day 43 (Phase IIa) | Laboratory tests include hematology (hemoglobin, hematocrit, RBC, platelet, WBC with different counts), biochemistry (total bilirubin, AST, ALT, serum creatinine and albumin) |
| Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa) | Vital signs measurement will consist of systolic/diastolic blood pressure, respiratory rate, pulse rate or heart rate, and body temperature. |
| Change From Baseline in Vital Signs (Respiration Rate) | Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa) | Vital signs measurement will consist of systolic/diastolic blood pressure, respiratory rate, pulse rate or heart rate, and body temperature. |
| Change From Baseline in Vital Signs (Body Temperature) | Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa) | Vital signs measurement will consist of systolic/diastolic blood pressure, respiratory rate, pulse rate or heart rate, and body temperature. |
| Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry) | Day 8 to Day 29 (Phase I); Day 8 to Day 43 (Phase IIa) | Laboratory tests include hematology (hemoglobin, hematocrit, RBC, platelet, WBC with different counts), biochemistry (total bilirubin, AST, ALT, serum creatinine and albumin) |
| 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) | 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). |
| 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) | — |
| Number of Subjects With 12-lead ECG Abnormalities | 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) | ECG will be evaluated by the investigators and noted as Normal, Abnormal, non-clinical significant (NCS) or Abnormal, clinical significant (CS) |
| Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Day 8, Day 15, Day 22, Day 29, 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). |
| Change From Baseline in Pruritus Numerical Rating Scale (NRS) of Itch Level on Target Lesions | Day 8, Day 15, Day 22, Day 29, Day 36 and Day 43 (Phase IIa) | 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. |
Countries
Taiwan
Participant flow
Recruitment details
17 subjects were screened in this study.
Pre-assignment details
No screen failure occurred with final 17 eligible subjects.
Participants by arm
| Arm | Count |
|---|---|
| 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) | 6 |
| 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). | 3 |
| 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). | 6 |
| 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). | 2 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | AR100DP1 (1.25%)_Phase I | AR100DP1 (2.5%)_Phase I | AR100DP1 (5%)_Phase II | AR100DP1 (5%)_Phase I |
|---|---|---|---|---|---|
| Age, Continuous | 29.9 years STANDARD_DEVIATION 5.48 | 34.8 years STANDARD_DEVIATION 4.07 | 26.7 years STANDARD_DEVIATION 3.79 | 29.0 years STANDARD_DEVIATION 11.31 | 26.8 years STANDARD_DEVIATION 0.98 |
| Body Mass Index (kg/m^2) | 23.7 kg/m^2 STANDARD_DEVIATION 4.25 | 23.7 kg/m^2 STANDARD_DEVIATION 2.63 | 22.5 kg/m^2 STANDARD_DEVIATION 4.71 | 29.9 kg/m^2 STANDARD_DEVIATION 4.99 | 22.3 kg/m^2 STANDARD_DEVIATION 4.35 |
| Height (cm) | 165.4 cm STANDARD_DEVIATION 9.42 | 168.3 cm STANDARD_DEVIATION 11.59 | 164.3 cm STANDARD_DEVIATION 8.5 | 161.8 cm STANDARD_DEVIATION 5.94 | 164.3 cm STANDARD_DEVIATION 9.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 17 Participants | 6 Participants | 3 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Taiwan | 17 Participants | 6 Participants | 3 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Female | 10 Participants | 3 Participants | 2 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Male | 7 Participants | 3 Participants | 1 Participants | 1 Participants | 2 Participants |
| Weight (kg) | 63.15 kg STANDARD_DEVIATION 13.55 | 67.3 kg STANDARD_DEVIATION 10.19 | 60.1 kg STANDARD_DEVIATION 7 | 78.7 kg STANDARD_DEVIATION 18.81 | 61.1 kg STANDARD_DEVIATION 16.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 3 | 0 / 6 | 0 / 2 |
| other Total, other adverse events | 1 / 6 | 0 / 3 | 2 / 6 | 1 / 2 |
| serious Total, serious adverse events | 0 / 6 | 0 / 3 | 0 / 6 | 1 / 2 |
Outcome results
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).
Time frame: up to Day 29 for each cohort in phase I
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AR100DP1 (1.25%)_Phase I | Maximum Tolerated Dose (MTD) of AR100DP1 | 125 mg/day |
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).
Time frame: up to Day 29 for each cohort in phase I
Population: All subjects received AR100DP1 at least 12 days with at least 85% of compliance.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AR100DP1 (1.25%)_Phase I | Number of Subjects With DLTs | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With DLTs | 0 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With DLTs | 0 Participants |
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).
Time frame: Day 29 (Phase IIa)
Population: 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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 or 1 on Day 29 (Phase IIa) | Visit 1 (screening, Da -14~1) (Phase IIa) : Score 0 (clear) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 or 1 on Day 29 (Phase IIa) | Visit 1 (screening, Da -14~1) (Phase IIa) : Score 1 (almost clear) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 or 1 on Day 29 (Phase IIa) | Baseline (Phase IIa) : Score 0 (clear) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 or 1 on Day 29 (Phase IIa) | Baseline (Phase IIa) : Score 1 (almost clear) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 or 1 on Day 29 (Phase IIa) | Visit 6 (Day 29) (Phase IIa) : Score 0 (clear) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 or 1 on Day 29 (Phase IIa) | Visit 6 (Day 29) (Phase IIa) : Score 1 (almost clear) | 0 Participants |
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.
Time frame: Day 8, Day 15, Day 22, Day 29, Day 36 and Day 43 (Phase IIa)
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Pruritus Numerical Rating Scale (NRS) of Itch Level on Target Lesions | Visit 2 (Day 1) (Phase IIa) | 6.50 score on a scale | Standard Deviation 0.707 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Pruritus Numerical Rating Scale (NRS) of Itch Level on Target Lesions | Visit 3 (Day 8) (Phase IIa) | 2.00 score on a scale | Standard Deviation 0 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Pruritus Numerical Rating Scale (NRS) of Itch Level on Target Lesions | Visit 3 (Day 8)-Visit 2 (Day 1) (Phase IIa) | -4.50 score on a scale | Standard Deviation 0.707 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Pruritus Numerical Rating Scale (NRS) of Itch Level on Target Lesions | Visit 4 (Day 15) (Phase IIa) | 5.50 score on a scale | Standard Deviation 6.364 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Pruritus Numerical Rating Scale (NRS) of Itch Level on Target Lesions | Visit 4 (Day 15)-Visit 2 (Day 1) | -1.00 score on a scale | Standard Deviation 5.657 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Pruritus Numerical Rating Scale (NRS) of Itch Level on Target Lesions | Visit 5 (Day 22) (Phase IIa) | 7.50 score on a scale | Standard Deviation 3.536 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Pruritus Numerical Rating Scale (NRS) of Itch Level on Target Lesions | Visit 5 (Day 22)-Visit 2 (Day 1) (Phase IIa) | 1.00 score on a scale | Standard Deviation 2.828 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Pruritus Numerical Rating Scale (NRS) of Itch Level on Target Lesions | Visit 6 (Day 29) (Phase IIa) | 6.00 score on a scale | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Pruritus Numerical Rating Scale (NRS) of Itch Level on Target Lesions | Visit 6 (Day 29)-Visit 2 (Day 1) (Phase IIa) | 0.00 score on a scale | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Pruritus Numerical Rating Scale (NRS) of Itch Level on Target Lesions | Visit 7 (Day 36) (Phase IIa) | 1.00 score on a scale | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Pruritus Numerical Rating Scale (NRS) of Itch Level on Target Lesions | Visit 7 (Day 36)-Visit 2 (Day 1) (Phase IIa) | -5.00 score on a scale | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Pruritus Numerical Rating Scale (NRS) of Itch Level on Target Lesions | Visit 8 (Day 43) (Phase IIa) | 0.00 score on a scale | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Pruritus Numerical Rating Scale (NRS) of Itch Level on Target Lesions | Visit 8 (Day 43)-Visit 2 (Day 1) (Phase IIa) | -6.00 score on a scale | — |
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
Time frame: Day 8, Day 15, Day 22, Day 29, Day 36 and Day 43 (Phase IIa)
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Erythema: Visit 2 (Day 1) (Phase IIa) | 1.50 score on a scale | Standard Deviation 0.707 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Erythema: Visit 3 (Day 8) (Phase IIa) | 0.75 score on a scale | Standard Deviation 1.061 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Erythema: Visit 3 (Day 8)-Visit 2 (Day 1) (Phase IIa) | -0.75 score on a scale | Standard Deviation 0.354 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Erythema: Visit 4 (Day 15) (Phase IIa) | 1.50 score on a scale | Standard Deviation 2.121 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Erythema: Visit 4 (Day 15)-Visit 2 (Day 1) (Phase IIa) | 0.00 score on a scale | Standard Deviation 1.414 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Erythema: Visit 5 (Day 22) (Phase IIa) | 2.00 score on a scale | Standard Deviation 1.414 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Erythema: Visit 5 (Day 22)-Visit 2 (Day 1) (Phase IIa) | 0.50 score on a scale | Standard Deviation 0.707 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Erythema: Visit 6 (Day 29) (Phase IIa) | 2.5 score on a scale | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Erythema: Visit 6 (Day 29)-Visit 2 (Day 1) (Phase IIa) | 1.5 score on a scale | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Erythema: Visit 7 (Day 36) (Phase IIa) | 2.00 score on a scale | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Erythema: Visit 7 (Day 36)-Visit 2 (Day 1) (Phase IIa) | 1.00 score on a scale | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Erythema: Visit 8 (Day 43) (Phase IIa) | 0.50 score on a scale | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Erythema: Visit 8 (Day 43)-Visit 2 (Day 1) (Phase IIa) | -0.50 score on a scale | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Edema: Visit 2 (Day 1) (Phase IIa) | 1.00 score on a scale | Standard Deviation 0 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Edema: Visit 3 (Day 8) (Phase IIa) | 0.75 score on a scale | Standard Deviation 0.354 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Edema: Visit 3 (Day 8)-Visit 2 (Day 1) (Phase IIa) | -0.25 score on a scale | Standard Deviation 0.354 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Edema: Visit 4 (Day 15) (Phase IIa) | 1.25 score on a scale | Standard Deviation 1.768 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Edema: Visit 4 (Day 15)-Visit 2 (Day 1) (Phase IIa) | 0.25 score on a scale | Standard Deviation 1.768 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Edema: Visit 5 (Day 22) (Phase IIa) | 2.00 score on a scale | Standard Deviation 1.414 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Edema: Visit 5 (Day 22)-Visit 2 (Day 1) (Phase IIa) | 1.00 score on a scale | Standard Deviation 1.414 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Edema: Visit 6 (Day 29) (Phase IIa) | 2.00 score on a scale | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Edema: Visit 6 (Day 29)-Visit 2 (Day 1) (Phase IIa) | 1.00 score on a scale | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Edema: Visit 7 (Day 36) (Phase IIa) | 1.00 score on a scale | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Edema: Visit 7 (Day 36)-Visit 2 (Day 1) (Phase IIa) | 0.00 score on a scale | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Edema: Visit 8 (Day 43) (Phase IIa) | 0.00 score on a scale | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Edema: Visit 8 (Day 43)-Visit 2 (Day 1) (Phase IIa) | -1.00 score on a scale | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Excoriation: Visit 2 (Day 1) (Phase IIa) | 1.25 score on a scale | Standard Deviation 1.061 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Excoriation: Visit 3 (Day 8) (Phase IIa) | 0.75 score on a scale | Standard Deviation 0.354 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Excoriation: Visit 4 (Day 15)-Visit 2 (Day 1) (Phase IIa) | -1.00 score on a scale | Standard Deviation 0.707 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Excoriation: Visit 5 (Day 22) (Phase IIa) | 0.50 score on a scale | Standard Deviation 0 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Excoriation: Visit 5 (Day 22)-Visit 2 (Day 1) (Phase IIa) | -0.75 score on a scale | Standard Deviation 1.061 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Excoriation: Visit 6 (Day 29) (Phase IIa) | 3.00 score on a scale | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Excoriation: Visit 6 (Day 29)-Visit 2 (Day 1) (Phase IIa) | 2.50 score on a scale | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Excoriation: Visit 7 (Day 36) (Phase IIa) | 1.00 score on a scale | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Excoriation: Visit 7 (Day 36)-Visit 2 (Day 1) (Phase IIa) | 0.50 score on a scale | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Excoriation: Visit 8 (Day 43) (Phase IIa) | 0.50 score on a scale | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Excoriation: Visit 8 (Day 43)-Visit 2 (Day 1) (Phase IIa) | 0.00 score on a scale | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Lichenification: Visit 2 (Day 1) (Phase IIa) | 1.75 score on a scale | Standard Deviation 0.354 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Lichenification: Visit 3 (Day 8) (Phase IIa) | 1.00 score on a scale | Standard Deviation 0 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Lichenification: Visit 3 (Day 8)-Visit 2 (Day 1) (Phase IIa) | -0.75 score on a scale | Standard Deviation 0.354 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Lichenification: Visit 4 (Day 15)-Visit 2 (Day 1) (Phase IIa) | -1.00 score on a scale | Standard Deviation 0.707 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Lichenification: Visit 5 (Day 22) (Phase IIa) | 0.75 score on a scale | Standard Deviation 0.354 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Lichenification: Visit 5 (Day 22)-Visit 2 (Day 1) (Phase IIa) | -1.00 score on a scale | Standard Deviation 0.707 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Lichenification: Visit 7 (Day 36) (Phase IIa) | 1.00 score on a scale | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Lichenification: Visit 7 (Day 36)-Visit 2 (Day 1) (Phase IIa) | -1.00 score on a scale | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Lichenification: Visit 8 (Day 43) (Phase IIa) | 0.50 score on a scale | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Lichenification: Visit 8 (Day 43)-Visit 2 (Day 1) (Phase IIa) | -1.50 score on a scale | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Excoriation: Visit 3 (Day 8)-Visit 2 (Day 1) (Phase IIa) | -0.50 score on a scale | Standard Deviation 0.707 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Excoriation: Visit 4 (Day 15) (Phase IIa) | 0.25 score on a scale | Standard Deviation 0.354 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Lichenification: Visit 4 (Day 15) (Phase IIa) | 0.75 score on a scale | Standard Deviation 0.354 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Lichenification: Visit 6 (Day 29) (Phase IIa) | 1.00 score on a scale | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions | Lichenification: Visit 6 (Day 29)-Visit 2 (Day 1) (Phase IIa) | -1.00 score on a scale | — |
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.
Time frame: Day 8, Day 15, Day 22, Day 29, Day 36 and Day 43 (Phase IIa)
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AR100DP1 (1.25%)_Phase I | Change From Baseline in the Total Score of Patient-Oriented Eczema Measure (POEM) | Visit 2 (Day 1) (Phase IIa) | 13.50 score on a scale | Standard Deviation 4.95 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in the Total Score of Patient-Oriented Eczema Measure (POEM) | Visit 3 (Day 8) (Phase IIa) | 4.50 score on a scale | Standard Deviation 0.707 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in the Total Score of Patient-Oriented Eczema Measure (POEM) | Visit 3 (Day 8)-Visit 2 (Day 1) (Phase IIa) | -9.00 score on a scale | Standard Deviation 4.243 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in the Total Score of Patient-Oriented Eczema Measure (POEM) | Visit 4 (Day 15) (Phase IIa) | 4.50 score on a scale | Standard Deviation 4.95 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in the Total Score of Patient-Oriented Eczema Measure (POEM) | Visit 4 (Day 15)-Visit 2 (Day 1) (Phase IIa) | -9.00 score on a scale | Standard Deviation 0 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in the Total Score of Patient-Oriented Eczema Measure (POEM) | Visit 5 (Day 22) (Phase IIa) | 7.00 score on a scale | Standard Deviation 2.828 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in the Total Score of Patient-Oriented Eczema Measure (POEM) | Visit 5 (Day 22)-Visit 2 (Day 1) (Phase IIa) | -6.50 score on a scale | Standard Deviation 7.778 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in the Total Score of Patient-Oriented Eczema Measure (POEM) | Visit 6 (Day 29) (Phase IIa) | 25.00 score on a scale | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in the Total Score of Patient-Oriented Eczema Measure (POEM) | Visit 6 (Day 29)-Visit 2 (Day 1) (Phase IIa) | 15.00 score on a scale | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in the Total Score of Patient-Oriented Eczema Measure (POEM) | Visit 7 (Day 36) (Phase IIa) | 11.00 score on a scale | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in the Total Score of Patient-Oriented Eczema Measure (POEM) | Visit 7 (Day 36)-Visit 2 (Day 1) (Phase IIa) | 1.00 score on a scale | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in the Total Score of Patient-Oriented Eczema Measure (POEM) | Visit 8 (Day 43) (Phase IIa) | 0.00 score on a scale | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in the Total Score of Patient-Oriented Eczema Measure (POEM) | Visit 8 (Day 43)-Visit 2 (Day 1) (Phase IIa) | -10.00 score on a scale | — |
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.
Time frame: Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa)
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Visit 3 (Day 8) (Phase I) | 36.30 degree C | Standard Deviation 0.276 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Visit 5 (Day 22) - Baseline (Phase I) | 0.12 degree C | Standard Deviation 0.515 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Visit 3 (Day 8) - Baseline (Phase I) | 0.02 degree C | Standard Deviation 0.376 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Visit 4 (Day 15) (Phase I) | 36.35 degree C | Standard Deviation 0.362 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Visit 5 (Day 22) (Phase I) | 36.40 degree C | Standard Deviation 0.385 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Visit 4 (Day 15) - Baseline (Phase I) | 0.07 degree C | Standard Deviation 0.441 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Visit 1 (Screening, Day -14 ~ -1) (Phase I) | 36.30 degree C | Standard Deviation 0.155 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Visit 6 (Day 29) (Phase I) | 36.52 degree C | Standard Deviation 0.36 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Baseline (Phase I) | 36.28 degree C | Standard Deviation 0.232 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Visit 6 (Day 29) - Baseline (Phase I) | 0.23 degree C | Standard Deviation 0.455 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Visit 2 (Day 1) : 30M after IP Administration (Phase I) | 36.30 degree C | Standard Deviation 0.11 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase I) | 0.02 degree C | Standard Deviation 0.248 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase I) | 0.03 degree C | Standard Deviation 0.473 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Visit 3 (Day 8) (Phase I) | 36.33 degree C | Standard Deviation 0.231 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Visit 1 (Screening, Day -14 ~ -1) (Phase I) | 36.20 degree C | Standard Deviation 0.2 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Visit 5 (Day 22) - Baseline (Phase I) | 0.43 degree C | Standard Deviation 0.252 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Visit 2 (Day 1) : 30M after IP Administration (Phase I) | 36.23 degree C | Standard Deviation 0.321 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Visit 3 (Day 8) - Baseline (Phase I) | 0.13 degree C | Standard Deviation 0.231 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Visit 5 (Day 22) (Phase I) | 36.63 degree C | Standard Deviation 0.153 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Visit 6 (Day 29) - Baseline (Phase I) | 0.33 degree C | Standard Deviation 0.737 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Visit 4 (Day 15) (Phase I) | 36.07 degree C | Standard Deviation 0.289 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Baseline (Phase I) | 36.20 degree C | Standard Deviation 0.4 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Visit 4 (Day 15) - Baseline (Phase I) | -0.13 degree C | Standard Deviation 0.493 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Visit 6 (Day 29) (Phase I) | 36.53 degree C | Standard Deviation 0.379 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Visit 6 (Day 29) - Baseline (Phase I) | -0.45 degree C | Standard Deviation 0.409 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Visit 6 (Day 29) (Phase I) | 35.9 degree C | Standard Deviation 0.141 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Visit 5 (Day 22) - Baseline (Phase I) | -0.25 degree C | Standard Deviation 0.476 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Visit 1 (Screening, Day -14 ~ -1) (Phase I) | 36.13 degree C | Standard Deviation 0.234 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Baseline (Phase I) | 36.35 degree C | Standard Deviation 0.315 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Visit 2 (Day 1) : 30M after IP Administration (Phase I) | 36.10 degree C | Standard Deviation 0.303 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase I) | -0.25 degree C | Standard Deviation 0.532 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Visit 3 (Day 8) (Phase I) | 36.17 degree C | Standard Deviation 0.339 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Visit 3 (Day 8) - Baseline (Phase I) | -0.18 degree C | Standard Deviation 0.204 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Visit 4 (Day 15) (Phase I) | 36.10 degree C | Standard Deviation 0.297 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Visit 4 (Day 15) - Baseline (Phase I) | -0.25 degree C | Standard Deviation 0.302 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Body Temperature) | Visit 5 (Day 22) (Phase I) | 36.10 degree C | Standard Deviation 0.374 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Body Temperature) | Visit 8 (Day 43) (Phase IIa) | 36.60 degree C | — |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Body Temperature) | Visit 2 (Day 1) : 30M after IP Administration (Phase IIa) | 36.30 degree C | Standard Deviation 0.424 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Body Temperature) | Baseline (Phase IIa) | 36.25 degree C | Standard Deviation 0.495 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Body Temperature) | Visit 8 (Day 43) - Baseline (Phase IIa) | 0.70 degree C | — |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Body Temperature) | Visit 1 (Screening, Day -14 ~ -1) (Phase IIa) | 36.65 degree C | Standard Deviation 0.071 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Body Temperature) | Visit 3 (Day 8) (Phase IIa) | 36.25 degree C | Standard Deviation 0.495 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Body Temperature) | Visit 3 (Day 8) - Baseline (Phase IIa) | 0.00 degree C | Standard Deviation 0 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Body Temperature) | Visit 4 (Day 15) (Phase IIa) | 36.45 degree C | Standard Deviation 0.212 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Body Temperature) | Visit 5 (Day 22) (Phase IIa) | 36.55 degree C | Standard Deviation 0.071 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Body Temperature) | Visit 5 (Day 22) - Baseline (Phase IIa) | 0.30 degree C | Standard Deviation 0.424 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Body Temperature) | Visit 6 (Day 29) (Phase IIa) | 36.00 degree C | — |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Body Temperature) | Visit 6 (Day 29) - Baseline (Phase IIa) | 0.10 degree C | — |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Body Temperature) | Visit 7 (Day 36) (Phase IIa) | 36.40 degree C | — |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Body Temperature) | Visit 7 (Day 36) - Baseline (Phase IIa) | 0.50 degree C | — |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Body Temperature) | Visit 4 (Day 15) - Baseline (Phase IIa) | 0.20 degree C | Standard Deviation 0.283 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Body Temperature) | Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase IIa) | 0.05 degree C | Standard Deviation 0.071 |
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.
Time frame: Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa)
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 1 (Screening, Day -14 ~ -1) (Phase I) | 69.00 mmHg | Standard Deviation 7.537 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 4 (Day 15) (Phase I) | 74.83 mmHg | Standard Deviation 5.456 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 5 (Day 22) - Baseline (Phase I) | 6.83 mmHg | Standard Deviation 11.566 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 6 (Day 29) - Baseline (Phase I) | 6.67 mmHg | Standard Deviation 13.779 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 3 (Day 8) - Baseline (Phase I) | 6.67 mmHg | Standard Deviation 7.257 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Baseline (Phase I) | 66.17 mmHg | Standard Deviation 7.167 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 6 (Day 29) (Phase I) | 72.83 mmHg | Standard Deviation 8.864 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 5 (Day 22) (Phase I) | 73.00 mmHg | Standard Deviation 6.986 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 2 (Day 1) : 30M after IP Administration (Phase I) | 68.00 mmHg | Standard Deviation 3.95 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 3 (Day 8) (Phase I) | 72.83 mmHg | Standard Deviation 6.555 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 4 (Day 15) - Baseline (Phase I) | 8.67 mmHg | Standard Deviation 7.737 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase I) | 1.83 mmHg | Standard Deviation 8.329 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase I) | 0.33 mmHg | Standard Deviation 3.215 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 1 (Screening, Day -14 ~ -1) (Phase I) | 76.33 mmHg | Standard Deviation 9.713 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Baseline (Phase I) | 69.00 mmHg | Standard Deviation 9.539 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 2 (Day 1) : 30M after IP Administration (Phase I) | 69.33 mmHg | Standard Deviation 7.572 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 3 (Day 8) (Phase I) | 77.00 mmHg | Standard Deviation 6.245 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 3 (Day 8) - Baseline (Phase I) | 8.00 mmHg | Standard Deviation 9.539 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 4 (Day 15) (Phase I) | 75.33 mmHg | Standard Deviation 10.408 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 4 (Day 15) - Baseline (Phase I) | 6.33 mmHg | Standard Deviation 6.658 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 5 (Day 22) (Phase I) | 63.67 mmHg | Standard Deviation 2.517 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 5 (Day 22) - Baseline (Phase I) | -5.33 mmHg | Standard Deviation 7.095 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 6 (Day 29) (Phase I) | 76.33 mmHg | Standard Deviation 10.263 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 6 (Day 29) - Baseline (Phase I) | 7.33 mmHg | Standard Deviation 19.757 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 6 (Day 29) (Phase I) | 70.00 mmHg | Standard Deviation 6.87 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 5 (Day 22) (Phase I) | 68.33 mmHg | Standard Deviation 6.314 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 6 (Day 29) - Baseline (Phase I) | -2.00 mmHg | Standard Deviation 7.925 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 1 (Screening, Day -14 ~ -1) (Phase I) | 71.83 mmHg | Standard Deviation 7.139 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Baseline (Phase I) | 72.00 mmHg | Standard Deviation 11.9 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 3 (Day 8) (Phase I) | 72.17 mmHg | Standard Deviation 5.672 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 5 (Day 22) - Baseline (Phase I) | -3.67 mmHg | Standard Deviation 6.25 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 3 (Day 8) - Baseline (Phase I) | 0.17 mmHg | Standard Deviation 12.449 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase I) | -1.00 mmHg | Standard Deviation 12.759 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 4 (Day 15) - Baseline (Phase I) | -1.83 mmHg | Standard Deviation 9.042 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 4 (Day 15) (Phase I) | 70.17 mmHg | Standard Deviation 3.43 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 2 (Day 1) : 30M after IP Administration (Phase I) | 71.00 mmHg | Standard Deviation 9.209 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 4 (Day 15) - Baseline (Phase IIa) | -3.50 mmHg | Standard Deviation 14.849 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 5 (Day 22) (Phase IIa) | 78.00 mmHg | Standard Deviation 12.728 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 5 (Day 22) - Baseline (Phase IIa) | -10.50 mmHg | Standard Deviation 14.849 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 6 (Day 29) (Phase IIa) | 90.00 mmHg | — |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 2 (Day 1) : 30M after IP Administration (Phase IIa) | 88.00 mmHg | Standard Deviation 31.113 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 7 (Day 36) (Phase IIa) | 86.00 mmHg | — |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 7 (Day 36) - Baseline (Phase IIa) | -22.00 mmHg | — |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 8 (Day 43) (Phase IIa) | 82.00 mmHg | — |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 8 (Day 43) - Baseline (Phase IIa) | -26.00 mmHg | — |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 1 (Screening, Day -14 ~ -1) (Phase IIa) | 77.50 mmHg | Standard Deviation 19.092 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Baseline (Phase IIa) | 88.50 mmHg | Standard Deviation 27.577 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 6 (Day 29) - Baseline (Phase IIa) | -18.00 mmHg | — |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase IIa) | -0.50 mmHg | Standard Deviation 3.536 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 3 (Day 8) (Phase IIa) | 91.50 mmHg | Standard Deviation 31.82 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 3 (Day 8) - Baseline (Phase IIa) | 3.00 mmHg | Standard Deviation 4.243 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Diastolic Blood Pressure) | Visit 4 (Day 15) (Phase IIa) | 85.00 mmHg | Standard Deviation 12.728 |
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.
Time frame: Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa)
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Visit 4 (Day 15) - Baseline (Phase I) | -6.00 beats/min | Standard Deviation 5.692 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Visit 5 (Day 22) (Phase I) | 68.17 beats/min | Standard Deviation 7.679 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Visit 2 (Day 1) : 30M after IP Administration (Phase I) | 68.33 beats/min | Standard Deviation 6.47 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Visit 5 (Day 22) - Baseline (Phase I) | -7.33 beats/min | Standard Deviation 12.848 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Visit 6 (Day 29) - Baseline (Phase I) | -4.50 beats/min | Standard Deviation 12.865 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Visit 1 (Screening, Day -14 ~ -1) (Phase I) | 68.33 beats/min | Standard Deviation 6.439 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase I) | -7.17 beats/min | Standard Deviation 5.776 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Visit 3 (Day 8) (Phase I) | 71.33 beats/min | Standard Deviation 9.004 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Visit 6 (Day 29) (Phase I) | 71.00 beats/min | Standard Deviation 8.438 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Visit 3 (Day 8) - Baseline (Phase I) | -4.17 beats/min | Standard Deviation 5.193 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Baseline (Phase I) | 75.50 beats/min | Standard Deviation 11.041 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Visit 4 (Day 15) (Phase I) | 69.50 beats/min | Standard Deviation 10.035 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Baseline (Phase I) | 73.67 beats/min | Standard Deviation 1.528 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Visit 4 (Day 15) - Baseline (Phase I) | 3.67 beats/min | Standard Deviation 9.609 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Visit 6 (Day 29) - Baseline (Phase I) | -0.33 beats/min | Standard Deviation 13.577 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase I) | -2.33 beats/min | Standard Deviation 3.512 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Visit 5 (Day 22) (Phase I) | 68.00 beats/min | Standard Deviation 10.392 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Visit 1 (Screening, Day -14 ~ -1) (Phase I) | 74.00 beats/min | Standard Deviation 6.083 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Visit 3 (Day 8) - Baseline (Phase I) | 17.33 beats/min | Standard Deviation 6.506 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Visit 5 (Day 22) - Baseline (Phase I) | -5.67 beats/min | Standard Deviation 10.214 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Visit 6 (Day 29) (Phase I) | 73.33 beats/min | Standard Deviation 13.317 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Visit 2 (Day 1) : 30M after IP Administration (Phase I) | 71.33 beats/min | Standard Deviation 3.215 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Visit 3 (Day 8) (Phase I) | 91.00 beats/min | Standard Deviation 5 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Visit 4 (Day 15) (Phase I) | 77.33 beats/min | Standard Deviation 9.452 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Visit 4 (Day 15) - Baseline (Phase I) | -3.50 beats/min | Standard Deviation 5.822 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Visit 1 (Screening, Day -14 ~ -1) (Phase I) | 72.67 beats/min | Standard Deviation 8.189 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Baseline (Phase I) | 76.33 beats/min | Standard Deviation 11.587 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Visit 2 (Day 1) : 30M after IP Administration (Phase I) | 72.17 beats/min | Standard Deviation 7.278 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase I) | -4.17 beats/min | Standard Deviation 10.666 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Visit 3 (Day 8) (Phase I) | 74.00 beats/min | Standard Deviation 9.143 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Visit 3 (Day 8) - Baseline (Phase I) | -2.33 beats/min | Standard Deviation 7.033 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Visit 4 (Day 15) (Phase I) | 72.83 beats/min | Standard Deviation 9.704 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Visit 5 (Day 22) - Baseline (Phase I) | -0.83 beats/min | Standard Deviation 14.743 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Visit 5 (Day 22) (Phase I) | 75.50 beats/min | Standard Deviation 4.231 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Visit 6 (Day 29) (Phase I) | 75.50 beats/min | Standard Deviation 7.74 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Pulse Rate) | Visit 6 (Day 29) - Baseline (Phase I) | -0.83 beats/min | Standard Deviation 12.416 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Pulse Rate) | Visit 8 (Day 43) - Baseline (Phase IIa) | 15.00 beats/min | — |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Pulse Rate) | Visit 1 (Screening, Day -14 ~ -1) (Phase IIa) | 77.00 beats/min | Standard Deviation 14.142 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Pulse Rate) | Baseline (Phase IIa) | 81.50 beats/min | Standard Deviation 3.536 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Pulse Rate) | Visit 2 (Day 1) : 30M after IP Administration (Phase IIa) | 79.50 beats/min | Standard Deviation 3.536 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Pulse Rate) | Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase IIa) | -2.00 beats/min | Standard Deviation 0 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Pulse Rate) | Visit 3 (Day 8) - Baseline (Phase IIa) | 0.00 beats/min | Standard Deviation 8.485 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Pulse Rate) | Visit 4 (Day 15) (Phase IIa) | 78.00 beats/min | Standard Deviation 8.485 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Pulse Rate) | Visit 4 (Day 15) - Baseline (Phase IIa) | -3.50 beats/min | Standard Deviation 12.021 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Pulse Rate) | Visit 5 (Day 22) (Phase IIa) | 84.50 beats/min | Standard Deviation 0.707 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Pulse Rate) | Visit 5 (Day 22) - Baseline (Phase IIa) | 3.00 beats/min | Standard Deviation 4.243 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Pulse Rate) | Visit 6 (Day 29) (Phase IIa) | 89.00 beats/min | — |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Pulse Rate) | Visit 6 (Day 29) - Baseline (Phase IIa) | 10.00 beats/min | — |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Pulse Rate) | Visit 7 (Day 36) (Phase IIa) | 85.00 beats/min | — |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Pulse Rate) | Visit 7 (Day 36) - Baseline (Phase IIa) | 6.00 beats/min | — |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Pulse Rate) | Visit 8 (Day 43) (Phase IIa) | 94.00 beats/min | — |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Pulse Rate) | Visit 3 (Day 8) (Phase IIa) | 81.50 beats/min | Standard Deviation 4.95 |
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.
Time frame: Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa)
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Visit 4 (Day 15) (Phase I) | 13.67 breaths/min | Standard Deviation 1.506 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Visit 6 (Day 29) (Phase I) | 13.83 breaths/min | Standard Deviation 0.408 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Visit 3 (Day 8) - Baseline (Phase I) | -1.00 breaths/min | Standard Deviation 1.095 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Visit 3 (Day 8) (Phase I) | 13.00 breaths/min | Standard Deviation 1.095 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Visit 6 (Day 29) - Baseline (Phase I) | -0.17 breaths/min | Standard Deviation 2.041 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Visit 4 (Day 15) - Baseline (Phase I) | -0.33 breaths/min | Standard Deviation 2.658 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase I) | -1.67 breaths/min | Standard Deviation 1.966 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Visit 5 (Day 22) - Baseline (Phase I) | -1.00 breaths/min | Standard Deviation 1.673 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Baseline (Phase I) | 14.00 breaths/min | Standard Deviation 1.789 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Visit 5 (Day 22) (Phase I) | 13.00 breaths/min | Standard Deviation 1.095 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Visit 2 (Day 1) : 30M after IP Administration (Phase I) | 12.33 breaths/min | Standard Deviation 0.816 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Visit 1 (Screening, Day -14 ~ -1) (Phase I) | 13.33 breaths/min | Standard Deviation 2.066 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Visit 5 (Day 22) - Baseline (Phase I) | 0.67 breaths/min | Standard Deviation 1.155 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase I) | 0.00 breaths/min | Standard Deviation 2 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Visit 3 (Day 8) - Baseline (Phase I) | 0.67 breaths/min | Standard Deviation 1.155 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Visit 4 (Day 15) (Phase I) | 12.67 breaths/min | Standard Deviation 1.155 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Visit 3 (Day 8) (Phase I) | 13.33 breaths/min | Standard Deviation 1.155 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Visit 2 (Day 1) : 30M after IP Administration (Phase I) | 12.67 breaths/min | Standard Deviation 1.155 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Visit 1 (Screening, Day -14 ~ -1) (Phase I) | 13.33 breaths/min | Standard Deviation 1.155 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Visit 6 (Day 29) (Phase I) | 12.67 breaths/min | Standard Deviation 1.155 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Baseline (Phase I) | 12.67 breaths/min | Standard Deviation 1.155 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Visit 6 (Day 29) - Baseline (Phase I) | 0.00 breaths/min | Standard Deviation 0 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Visit 5 (Day 22) (Phase I) | 13.33 breaths/min | Standard Deviation 1.155 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Visit 4 (Day 15) - Baseline (Phase I) | 0.00 breaths/min | Standard Deviation 0 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Visit 5 (Day 22) - Baseline (Phase I) | 0.17 breaths/min | Standard Deviation 1.941 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Baseline (Phase I) | 13.50 breaths/min | Standard Deviation 1.225 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Visit 2 (Day 1) : 30M after IP Administration (Phase I) | 13.17 breaths/min | Standard Deviation 0.983 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase I) | -0.33 breaths/min | Standard Deviation 1.862 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Visit 3 (Day 8) (Phase I) | 14.17 breaths/min | Standard Deviation 1.169 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Visit 6 (Day 29) (Phase I) | 13.17 breaths/min | Standard Deviation 0.983 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Visit 6 (Day 29) - Baseline (Phase I) | -0.33 breaths/min | Standard Deviation 1.366 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Visit 1 (Screening, Day -14 ~ -1) (Phase I) | 13.33 breaths/min | Standard Deviation 1.033 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Visit 3 (Day 8) - Baseline (Phase I) | 0.67 breaths/min | Standard Deviation 1.751 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Visit 4 (Day 15) (Phase I) | 12.83 breaths/min | Standard Deviation 0.983 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Visit 4 (Day 15) - Baseline (Phase I) | -0.67 breaths/min | Standard Deviation 1.966 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Respiration Rate) | Visit 5 (Day 22) (Phase I) | 13.67 breaths/min | Standard Deviation 1.033 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Respiration Rate) | Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase IIa) | 0.00 breaths/min | Standard Deviation 0 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Respiration Rate) | Baseline (Phase IIa) | 15.50 breaths/min | Standard Deviation 2.121 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Respiration Rate) | Visit 8 (Day 43) - Baseline (Phase IIa) | -2.00 breaths/min | — |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Respiration Rate) | Visit 1 (Screening, Day -14 ~ -1) (Phase IIa) | 16.00 breaths/min | Standard Deviation 1.414 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Respiration Rate) | Visit 2 (Day 1) : 30M after IP Administration (Phase IIa) | 15.50 breaths/min | Standard Deviation 2.121 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Respiration Rate) | Visit 3 (Day 8) - Baseline (Phase IIa) | 0.00 breaths/min | Standard Deviation 0 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Respiration Rate) | Visit 4 (Day 15) (Phase IIa) | 15.50 breaths/min | Standard Deviation 2.121 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Respiration Rate) | Visit 4 (Day 15) - Baseline (Phase IIa) | 0.00 breaths/min | Standard Deviation 0 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Respiration Rate) | Visit 5 (Day 22) (Phase IIa) | 14.50 breaths/min | Standard Deviation 3.536 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Respiration Rate) | Visit 5 (Day 22) - Baseline (Phase IIa) | -1.00 breaths/min | Standard Deviation 1.414 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Respiration Rate) | Visit 6 (Day 29) (Phase IIa) | 13.00 breaths/min | — |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Respiration Rate) | Visit 6 (Day 29) - Baseline (Phase IIa) | -1.00 breaths/min | — |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Respiration Rate) | Visit 7 (Day 36) (Phase IIa) | 12.00 breaths/min | — |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Respiration Rate) | Visit 7 (Day 36) - Baseline (Phase IIa) | -2.00 breaths/min | — |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Respiration Rate) | Visit 3 (Day 8) (Phase IIa) | 15.50 breaths/min | Standard Deviation 2.121 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Respiration Rate) | Visit 8 (Day 43) (Phase IIa) | 12.00 breaths/min | — |
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.
Time frame: Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa)
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 5 (Day 22) (Phase I) | 109.50 mmHg | Standard Deviation 10.654 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 5 (Day 22) - Baseline (Phase I) | -6.83 mmHg | Standard Deviation 3.189 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 6 (Day 29) (Phase I) | 118.17 mmHg | Standard Deviation 9.988 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Baseline (Day -14~ Day 1; Phase I) | 116.33 mmHg | Standard Deviation 11.605 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 6 (Day 29) - Baseline (Phase I) | 1.83 mmHg | Standard Deviation 9.065 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase I) | -1.83 mmHg | Standard Deviation 8.727 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 1 (Screening, Day -14 ~ -1) (Phase I) | 104.17 mmHg | Standard Deviation 5.037 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 3 (Day 8) (Phase I) | 111.83 mmHg | Standard Deviation 11.143 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 3 (Day 8) - Baseline (Phase I) | -4.50 mmHg | Standard Deviation 6.686 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 4 (Day 15) (Phase I) | 116.00 mmHg | Standard Deviation 7.589 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 2 (Day 1) : 30M after IP Administration (Phase I) | 114.50 mmHg | Standard Deviation 9.503 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 4 (Day 15) - Baseline (Phase I) | -0.33 mmHg | Standard Deviation 9.309 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 1 (Screening, Day -14 ~ -1) (Phase I) | 115.67 mmHg | Standard Deviation 12.662 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 5 (Day 22) (Phase I) | 122.67 mmHg | Standard Deviation 5.686 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 4 (Day 15) - Baseline (Phase I) | -0.67 mmHg | Standard Deviation 18.502 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 5 (Day 22) - Baseline (Phase I) | 10.00 mmHg | Standard Deviation 9.165 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 2 (Day 1) : 30M after IP Administration (Phase I) | 116.00 mmHg | Standard Deviation 7.211 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 3 (Day 8) (Phase I) | 121.33 mmHg | Standard Deviation 16.803 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 6 (Day 29) (Phase I) | 122.33 mmHg | Standard Deviation 2.887 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Baseline (Day -14~ Day 1; Phase I) | 112.67 mmHg | Standard Deviation 11.15 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 4 (Day 15) (Phase I) | 112.00 mmHg | Standard Deviation 14.731 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 6 (Day 29) - Baseline (Phase I) | 9.67 mmHg | Standard Deviation 12.423 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 3 (Day 8) - Baseline (Phase I) | 8.67 mmHg | Standard Deviation 27.006 |
| AR100DP1 (2.5%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase I) | 3.33 mmHg | Standard Deviation 5.686 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase I) | -6.17 mmHg | Standard Deviation 16.81 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 5 (Day 22) (Phase I) | 112.83 mmHg | Standard Deviation 9.109 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 1 (Screening, Day -14 ~ -1) (Phase I) | 118.67 mmHg | Standard Deviation 7.09 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Baseline (Day -14~ Day 1; Phase I) | 115.50 mmHg | Standard Deviation 13.157 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 2 (Day 1) : 30M after IP Administration (Phase I) | 109.33 mmHg | Standard Deviation 13.471 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 3 (Day 8) (Phase I) | 111.00 mmHg | Standard Deviation 7.563 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 3 (Day 8) - Baseline (Phase I) | -4.50 mmHg | Standard Deviation 11.64 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 4 (Day 15) (Phase I) | 112.83 mmHg | Standard Deviation 13.167 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 5 (Day 22) - Baseline (Phase I) | -2.67 mmHg | Standard Deviation 13.53 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 6 (Day 29) (Phase I) | 108.67 mmHg | Standard Deviation 8.869 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 6 (Day 29) - Baseline (Phase I) | -6.83 mmHg | Standard Deviation 11.652 |
| AR100DP1 (5%)_Phase I | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 4 (Day 15) - Baseline (Phase I) | -2.67 mmHg | Standard Deviation 11.448 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Baseline (Day -14~ Day 1; Phase IIa) | 130.00 mmHg | Standard Deviation 29.698 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 2 (Day 1) : 30M after IP Administration (Phase IIa) | 136.00 mmHg | Standard Deviation 33.941 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 2 (Day 1) : 30M after IP Administration - Baseline (Phase IIa) | 6.00 mmHg | Standard Deviation 4.243 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 3 (Day 8) (Phase IIa) | 145.00 mmHg | Standard Deviation 32.527 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 3 (Day 8) - Baseline (Phase IIa) | 15.00 mmHg | Standard Deviation 2.828 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 4 (Day 15) (Phase IIa) | 127.00 mmHg | Standard Deviation 11.314 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 4 (Day 15) - Baseline (Phase IIa) | -3.00 mmHg | Standard Deviation 18.385 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 5 (Day 22) (Phase IIa) | 127.00 mmHg | Standard Deviation 19.799 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 5 (Day 22) - Baseline (Phase IIa) | -3.00 mmHg | Standard Deviation 9.899 |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 6 (Day 29) (Phase IIa) | 149.00 mmHg | — |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 6 (Day 29) - Baseline (Phase IIa) | -2.00 mmHg | — |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 7 (Day 36) (Phase IIa) | 142.00 mmHg | — |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 7 (Day 36) - Baseline (Phase IIa) | -9.00 mmHg | — |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 8 (Day 43) (Phase IIa) | 129.00 mmHg | — |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 8 (Day 43) - Baseline (Phase IIa) | -22.00 mmHg | — |
| AR100DP1 (5%)_Phase IIa | Change From Baseline in Vital Signs (Systolic Blood Pressure) | Visit 1 (Screening, Day -14 ~ -1) (Phase IIa) | 130.50 mmHg | Standard Deviation 24.749 |
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)
Time frame: Day 8, Day 15, Day 22, Day 29, Day 36 and Day 43 (Phase IIa)
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AR100DP1 (1.25%)_Phase I | Change From Baseline of Target Lesion Area(s) on Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 (Phase IIa) | Visit 7 (Day 36) - Baseline (Phase IIa) | -28.84 cm^2 | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline of Target Lesion Area(s) on Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 (Phase IIa) | Visit 8 (Day 43) (Phase IIa) | 46.78 cm^2 | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline of Target Lesion Area(s) on Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 (Phase IIa) | Visit 8 (Day 43) -Baseline (Phase IIa) | -103.51 cm^2 | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline of Target Lesion Area(s) on Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 (Phase IIa) | Visit 1 (screening, Da -14~1) (Phase IIa) | 159.16 cm^2 | Standard Deviation 7.87 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline of Target Lesion Area(s) on Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 (Phase IIa) | Baseline (Phase IIa) | 157.93 cm^2 | Standard Deviation 10.805 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline of Target Lesion Area(s) on Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 (Phase IIa) | Visit 3 (Day 8) (Phase IIa) | 113.21 cm^2 | Standard Deviation 19.757 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline of Target Lesion Area(s) on Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 (Phase IIa) | Visit 3 (Day 8) - Baseline (Phase IIa) | -44.72 cm^2 | Standard Deviation 8.952 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline of Target Lesion Area(s) on Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 (Phase IIa) | Visit 4 (Day 15) (Phase IIa) | 287.84 cm^2 | Standard Deviation 349.891 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline of Target Lesion Area(s) on Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 (Phase IIa) | Visit 4 (Day 15) - Baseline (Phase IIa) | 129.91 cm^2 | Standard Deviation 339.086 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline of Target Lesion Area(s) on Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 (Phase IIa) | Visit 5 (Day 22) (Phase IIa) | 540.09 cm^2 | Standard Deviation 145.593 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline of Target Lesion Area(s) on Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 (Phase IIa) | Visit 5 (Day 22) - Baseline (Phase IIa) | 382.16 cm^2 | Standard Deviation 134.789 |
| AR100DP1 (1.25%)_Phase I | Change From Baseline of Target Lesion Area(s) on Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 (Phase IIa) | Visit 6 (Day 29) (Phase IIa) | 291.18 cm^2 | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline of Target Lesion Area(s) on Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 (Phase IIa) | Visit 6 (Day 29) - Baseline (Phase IIa) | 140.89 cm^2 | — |
| AR100DP1 (1.25%)_Phase I | Change From Baseline of Target Lesion Area(s) on Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 (Phase IIa) | Visit 7 (Day 36) (Phase IIa) | 121.45 cm^2 | — |
Secondary
Change of IgE Compared to Baseline (Day 1)
Time frame: Day 15 and 29 (Phase IIa)
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AR100DP1 (1.25%)_Phase I | Change of IgE Compared to Baseline (Day 1) | Visit 2 (Day 1) (Phase IIa) | 7.15 IU/mL | Standard Deviation 0.198 |
| AR100DP1 (1.25%)_Phase I | Change of IgE Compared to Baseline (Day 1) | Visit 4 (Day 15) (Phase IIa) | 7.17 IU/mL | Standard Deviation 0.091 |
| AR100DP1 (1.25%)_Phase I | Change of IgE Compared to Baseline (Day 1) | Visit 4 (Day 15)-Visit 2 (Day 1) (Phase IIa) | 0.02 IU/mL | Standard Deviation 0.106 |
| AR100DP1 (1.25%)_Phase I | Change of IgE Compared to Baseline (Day 1) | Visit 6 (Day 29) (Phase IIa) | 7.09 IU/mL | — |
| AR100DP1 (1.25%)_Phase I | Change of IgE Compared to Baseline (Day 1) | Visit 6 (Day 29)-Visit 2 (Day 1) (Phase IIa) | 0.08 IU/mL | — |
Secondary
Fold Change of IL-4 Compared to Baseline (Day 1 )
Time frame: Day 15 and 29 (Phase IIa)
Population: No source data was collected for IL-4 in this study.
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)
Time frame: 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)
Population: 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).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| AR100DP1 (1.25%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 1 (Screening, Day -14 ~ -1) (Phase I) | Normal | 1 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 5 (Day 22) (Phase I) | Normal | 3 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 4 (Day 15) (Phase I) | CS (Adverse Event) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Baseline (Phase I) | NCS | 4 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 6 (Day 29) (Phase I) | NCS | 5 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 5 (Day 22) (Phase I) | NCS | 3 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 1 (Screening, Day -14 ~ -1) (Phase I) | CS (Medical History) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 5 (Day 22) (Phase I) | CS (Medical History) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 4 (Day 15) (Phase I) | NCS | 2 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 6 (Day 29) (Phase I) | Normal | 1 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 5 (Day 22) (Phase I) | CS (Adverse Event) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Baseline (Phase I) | CS (Medical History) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Baseline (Phase I) | CS (Adverse Event) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 1 (Screening, Day -14 ~ -1) (Phase I) | NCS | 5 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 3 (Day 8) (Phase I) | Normal | 3 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 1 (Screening, Day -14 ~ -1) (Phase I) | CS (Adverse Event) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 3 (Day 8) (Phase I) | NCS | 3 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 3 (Day 8) (Phase I) | CS (Medical History) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 6 (Day 29) (Phase I) | CS (Adverse Event) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 3 (Day 8) (Phase I) | CS (Adverse Event) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Baseline (Phase I) | Normal | 2 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 4 (Day 15) (Phase I) | Normal | 4 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 6 (Day 29) (Phase I) | CS (Medical History) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 4 (Day 15) (Phase I) | CS (Medical History) | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Baseline (Phase I) | CS (Adverse Event) | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 4 (Day 15) (Phase I) | CS (Medical History) | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Baseline (Phase I) | Normal | 1 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 6 (Day 29) (Phase I) | NCS | 3 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 6 (Day 29) (Phase I) | CS (Adverse Event) | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 4 (Day 15) (Phase I) | CS (Adverse Event) | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 3 (Day 8) (Phase I) | CS (Adverse Event) | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 3 (Day 8) (Phase I) | Normal | 2 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 5 (Day 22) (Phase I) | Normal | 1 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Baseline (Phase I) | NCS | 2 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 1 (Screening, Day -14 ~ -1) (Phase I) | Normal | 1 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 5 (Day 22) (Phase I) | NCS | 2 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 6 (Day 29) (Phase I) | CS (Medical History) | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 6 (Day 29) (Phase I) | Normal | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 3 (Day 8) (Phase I) | NCS | 1 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 5 (Day 22) (Phase I) | CS (Medical History) | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 1 (Screening, Day -14 ~ -1) (Phase I) | CS (Adverse Event) | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 4 (Day 15) (Phase I) | NCS | 3 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 3 (Day 8) (Phase I) | CS (Medical History) | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 5 (Day 22) (Phase I) | CS (Adverse Event) | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 1 (Screening, Day -14 ~ -1) (Phase I) | NCS | 2 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Baseline (Phase I) | CS (Medical History) | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 1 (Screening, Day -14 ~ -1) (Phase I) | CS (Medical History) | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 4 (Day 15) (Phase I) | Normal | 0 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 6 (Day 29) (Phase I) | NCS | 4 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 1 (Screening, Day -14 ~ -1) (Phase I) | Normal | 4 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 1 (Screening, Day -14 ~ -1) (Phase I) | NCS | 2 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 1 (Screening, Day -14 ~ -1) (Phase I) | CS (Medical History) | 0 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 1 (Screening, Day -14 ~ -1) (Phase I) | CS (Adverse Event) | 0 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Baseline (Phase I) | Normal | 3 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Baseline (Phase I) | NCS | 3 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Baseline (Phase I) | CS (Medical History) | 0 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Baseline (Phase I) | CS (Adverse Event) | 0 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 3 (Day 8) (Phase I) | Normal | 3 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 3 (Day 8) (Phase I) | NCS | 3 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 3 (Day 8) (Phase I) | CS (Medical History) | 0 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 3 (Day 8) (Phase I) | CS (Adverse Event) | 0 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 4 (Day 15) (Phase I) | Normal | 2 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 4 (Day 15) (Phase I) | NCS | 4 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 4 (Day 15) (Phase I) | CS (Medical History) | 0 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 4 (Day 15) (Phase I) | CS (Adverse Event) | 0 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 5 (Day 22) (Phase I) | Normal | 2 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 5 (Day 22) (Phase I) | NCS | 4 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 5 (Day 22) (Phase I) | CS (Medical History) | 0 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 5 (Day 22) (Phase I) | CS (Adverse Event) | 0 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 6 (Day 29) (Phase I) | Normal | 2 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 6 (Day 29) (Phase I) | CS (Medical History) | 0 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With 12-lead ECG Abnormalities | Visit 6 (Day 29) (Phase I) | CS (Adverse Event) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 8 (Day 43) (Phase IIa) | Normal | 1 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 4 (Day 15) (Phase I) | CS (Adverse Event) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 4 (Day 15) (Phase I) | CS (Medical History) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 4 (Day 15) (Phase I) | NCS | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 6 (Day 29) (Phase I) | NCS | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 4 (Day 15) (Phase I) | Normal | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 3 (Day 8) (Phase I) | CS (Adverse Event) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 8 (Day 43) (Phase IIa) | NCS | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 6 (Day 29) (Phase I) | CS (Medical History) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 3 (Day 8) (Phase I) | CS (Medical History) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Baseline (Phase I) | CS (Adverse Event) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 8 (Day 43) (Phase IIa) | CS (Medical History) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 6 (Day 29) (Phase I) | CS (Adverse Event) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 1 (Screening, Day -14 ~ -1) (Phase IIa) | Normal | 1 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 1 (Screening, Day -14 ~ -1) (Phase IIa) | NCS | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 1 (Screening, Day -14 ~ -1) (Phase IIa) | CS (Medical History) | 1 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 1 (Screening, Day -14 ~ -1) (Phase IIa) | CS (Adverse Event) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Baseline (Phase IIa) | Normal | 1 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Baseline (Phase IIa) | NCS | 1 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Baseline (Phase IIa) | CS (Medical History) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Baseline (Phase IIa) | CS (Adverse Event) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 3 (Day 8) (Phase IIa) | Normal | 1 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 3 (Day 8) (Phase IIa) | NCS | 1 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 3 (Day 8) (Phase IIa) | CS (Medical History) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 3 (Day 8) (Phase IIa) | CS (Adverse Event) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 4 (Day 15) (Phase IIa) | Normal | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 4 (Day 15) (Phase IIa) | NCS | 2 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 4 (Day 15) (Phase IIa) | CS (Medical History) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 4 (Day 15) (Phase IIa) | CS (Adverse Event) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 5 (Day 22) (Phase IIa) | Normal | 2 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 5 (Day 22) (Phase IIa) | NCS | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 5 (Day 22) (Phase IIa) | CS (Medical History) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 6 (Day 29) (Phase IIa) | NCS | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 6 (Day 29) (Phase IIa) | CS (Medical History) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 6 (Day 29) (Phase IIa) | CS (Adverse Event) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 7 (Day 36) (Phase IIa) | Normal | 1 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 7 (Day 36) (Phase IIa) | NCS | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Baseline (Phase I) | CS (Medical History) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Baseline (Phase I) | NCS | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 8 (Day 43) (Phase IIa) | CS (Adverse Event) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Baseline (Phase I) | Normal | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 5 (Day 22) (Phase IIa) | CS (Adverse Event) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 6 (Day 29) (Phase IIa) | Normal | 1 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 7 (Day 36) (Phase IIa) | CS (Medical History) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 7 (Day 36) (Phase IIa) | CS (Adverse Event) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 5 (Day 22) (Phase I) | CS (Adverse Event) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 5 (Day 22) (Phase I) | CS (Medical History) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With 12-lead ECG Abnormalities | Visit 5 (Day 22) (Phase I) | NCS | 0 Participants |
Secondary
Number of Subjects With AE and SAE
Time frame: Day -14 to 29 (Phase I); Day -14 to 43 (Phase IIa)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AR100DP1 (1.25%)_Phase I | Number of Subjects With AE and SAE | SUSAR | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With AE and SAE | Treatment-related AE | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With AE and SAE | DLT | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With AE and SAE | SAE | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With AE and SAE | Death | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With AE and SAE | AE | 1 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With AE and SAE | Death | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With AE and SAE | SAE | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With AE and SAE | DLT | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With AE and SAE | SUSAR | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With AE and SAE | Treatment-related AE | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With AE and SAE | AE | 0 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With AE and SAE | Treatment-related AE | 1 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With AE and SAE | DLT | 0 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With AE and SAE | Death | 0 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With AE and SAE | SAE | 0 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With AE and SAE | SUSAR | 0 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With AE and SAE | AE | 2 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With AE and SAE | SUSAR | 1 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With AE and SAE | DLT | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With AE and SAE | Treatment-related AE | 2 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With AE and SAE | AE | 2 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With AE and SAE | SAE | 1 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With AE and SAE | Death | 0 Participants |
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)
Time frame: Day 8 to Day 29 (Phase I); Day 8 to Day 43 (Phase IIa)
Population: 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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AR100DP1 (1.25%)_Phase I | Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry) | Visit 1 (Screening) (Phase I) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry) | Visit 5 (Day 22) (Phase I) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry) | Visit 4 (Day 15) (Phase I) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry) | Visit 6 (Day 29) (Phase I) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry) | Visit 3 (Day 8) (Phase I) | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry) | Visit 6 (Day 29) (Phase I) | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry) | Visit 1 (Screening) (Phase I) | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry) | Visit 3 (Day 8) (Phase I) | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry) | Visit 4 (Day 15) (Phase I) | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry) | Visit 5 (Day 22) (Phase I) | 0 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry) | Visit 3 (Day 8) (Phase I) | 0 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry) | Visit 6 (Day 29) (Phase I) | 0 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry) | Visit 5 (Day 22) (Phase I) | 0 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry) | Visit 1 (Screening) (Phase I) | 0 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry) | Visit 4 (Day 15) (Phase I) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry) | Visit 8 (Day 43) (Phase IIa) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry) | Visit 3 (Day 8) (Phase IIa) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry) | Visit 4 (Day 15) (Phase IIa) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry) | Visit 5 (Day 22) (Phase IIa) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry) | Visit 6 (Day 29) (Phase IIa) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry) | Visit 7 (Day 36) (Phase IIa) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry) | Visit 1 (Screening) (Phase IIa) | 0 Participants |
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)
Time frame: Day 8 to Day 29 (Phase I); Day 8 to Day 43 (Phase IIa)
Population: 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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AR100DP1 (1.25%)_Phase I | Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology) | Visit 4 (Day 15) (Phase I) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology) | Visit 6 (Day 29) (Phase I) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology) | Visit 3 (Day 8) (Phase I) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology) | Visit 5 (Day 22) (Phase I) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology) | Visit 1 (Screening) (Phase I) | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology) | Visit 5 (Day 22) (Phase I) | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology) | Visit 1 (Screening) (Phase I) | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology) | Visit 6 (Day 29) (Phase I) | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology) | Visit 3 (Day 8) (Phase I) | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology) | Visit 4 (Day 15) (Phase I) | 0 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology) | Visit 6 (Day 29) (Phase I) | 0 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology) | Visit 3 (Day 8) (Phase I) | 0 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology) | Visit 4 (Day 15) (Phase I) | 0 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology) | Visit 5 (Day 22) (Phase I) | 0 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology) | Visit 1 (Screening) (Phase I) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology) | Visit 5 (Day 22) (Phase I) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology) | Visit 4 (Day 15) (Phase I) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology) | Visit 7 (Day 36) (Phase IIa) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology) | Visit 1 (Screening) (Phase I) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology) | Visit 3 (Day 8) (Phase I) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology) | Visit 6 (Day 29) (Phase I) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology) | Visit 1 (Screening) (Phase IIa) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology) | Visit 3 (Day 8) (Phase IIa) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology) | Visit 4 (Day 15) (Phase IIa) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology) | Visit 5 (Day 22) (Phase IIa) | 1 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology) | Visit 6 (Day 29) (Phase IIa) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology) | Visit 8 (Day 43) (Phase IIa) | 0 Participants |
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.
Time frame: Day -14 to 29 (Phase I); Day -14 to 43 (Phase IIa)
Population: 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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AR100DP1 (1.25%)_Phase I | Number of Subjects With Physical Examination Abnormalities | Visit 5 (Day 22) (Phase I) | 1 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With Physical Examination Abnormalities | Visit 2 (Day 1) : 30M after IP Administration (Phase I) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With Physical Examination Abnormalities | Visit 4 (Day 15) (Phase I) | 1 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With Physical Examination Abnormalities | Visit 1 (Screening) (Phase I) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With Physical Examination Abnormalities | Visit 6 (Day 29) (Phase I) | 1 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With Physical Examination Abnormalities | Visit 3 (Day 8) (Phase I) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Number of Subjects With Physical Examination Abnormalities | Visit 2 (Day 1) : before IP Administration (Phase I) | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With Physical Examination Abnormalities | Visit 6 (Day 29) (Phase I) | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With Physical Examination Abnormalities | Visit 4 (Day 15) (Phase I) | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With Physical Examination Abnormalities | Visit 2 (Day 1) : before IP Administration (Phase I) | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With Physical Examination Abnormalities | Visit 1 (Screening) (Phase I) | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With Physical Examination Abnormalities | Visit 5 (Day 22) (Phase I) | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With Physical Examination Abnormalities | Visit 2 (Day 1) : 30M after IP Administration (Phase I) | 0 Participants |
| AR100DP1 (2.5%)_Phase I | Number of Subjects With Physical Examination Abnormalities | Visit 3 (Day 8) (Phase I) | 0 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With Physical Examination Abnormalities | Visit 4 (Day 15) (Phase I) | 0 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With Physical Examination Abnormalities | Visit 1 (Screening) (Phase I) | 0 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With Physical Examination Abnormalities | Visit 2 (Day 1) : before IP Administration (Phase I) | 0 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With Physical Examination Abnormalities | Visit 2 (Day 1) : 30M after IP Administration (Phase I) | 0 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With Physical Examination Abnormalities | Visit 3 (Day 8) (Phase I) | 0 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With Physical Examination Abnormalities | Visit 5 (Day 22) (Phase I) | 1 Participants |
| AR100DP1 (5%)_Phase I | Number of Subjects With Physical Examination Abnormalities | Visit 6 (Day 29) (Phase I) | 1 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With Physical Examination Abnormalities | Visit 2 (Day 1) : 30M after IP Administration (Phase I) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With Physical Examination Abnormalities | Visit 2 (Day 1) : before IP Administration (Phase I) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With Physical Examination Abnormalities | Visit 4 (Day 15) (Phase I) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With Physical Examination Abnormalities | Visit 1 (Screening) (Phase IIa) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With Physical Examination Abnormalities | Visit 2 (Day 1) : before IP Administration (Phase IIa) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With Physical Examination Abnormalities | Visit 2 (Day 1) : 30M after IP Administration (Phase IIa) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With Physical Examination Abnormalities | Visit 3 (Day 8) (Phase IIa) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With Physical Examination Abnormalities | Visit 4 (Day 15) (Phase IIa) | 1 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With Physical Examination Abnormalities | Visit 5 (Day 22) (Phase IIa) | 1 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With Physical Examination Abnormalities | Visit 6 (Day 29) (Phase IIa) | 1 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With Physical Examination Abnormalities | Visit 7 (Day 36) (Phase IIa) | 1 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With Physical Examination Abnormalities | Visit 8 (Day 43) (Phase IIa) | 1 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With Physical Examination Abnormalities | Visit 3 (Day 8) (Phase I) | 0 Participants |
| AR100DP1 (5%)_Phase IIa | Number of Subjects With Physical Examination Abnormalities | Visit 1 (Screening) (Phase I) | 0 Participants |
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).
Time frame: Day 8, Day 15, Day 22, Day 36 and Day 43 (Phase IIa)
Population: 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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AR100DP1 (1.25%)_Phase I | 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) | Visit 1 (screening, Da -14~1) (Phase IIa) : Score 0 (clear) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | 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) | Visit 1 (screening, Da -14~1) (Phase IIa) : Score 1 (almost clear) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | 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) | Baseline (Phase IIa) : Score 0 (clear) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | 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) | Baseline (Phase IIa) : Score 1 (almost clear) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | 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) | Visit 3 (Day 8) (Phase IIa) : Score 0 (clear) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | 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) | Visit 3 (Day 8) (Phase IIa) : Score 1 (almost clear) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | 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) | Visit 4 (Day 15) (Phase IIa) : Score 0 (clear) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | 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) | Visit 4 (Day 15) (Phase IIa) : Score 1 (almost clear) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | 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) | Visit 5 (Day 22) (Phase IIa) : Score 0 (clear) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | 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) | Visit 5 (Day 22) (Phase IIa) : Score 1 (almost clear) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | 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) | Visit 7 (Day 36) (Phase IIa) : Score 0 (clear) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | 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) | Visit 7 (Day 36) (Phase IIa) : Score 1 (almost clear) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | 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) | Visit 8 (Day 43) (Phase IIa) : Score 0 (clear) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | 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) | Visit 8 (Day 43) (Phase IIa) : Score 1 (almost clear) | 0 Participants |
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).
Time frame: Day 8, Day 15, Day 22, Day 29, Day 36 and Day 43 (Phase IIa)
Population: 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).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 1 (screening, Da -14~1) (Phase IIa) | Score 0 (clear) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 1 (screening, Da -14~1) (Phase IIa) | Score 1 (almost clear) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 1 (screening, Da -14~1) (Phase IIa) | Score 2 (mild) | 1 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 1 (screening, Da -14~1) (Phase IIa) | Score 3 (moderate) | 1 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 1 (screening, Da -14~1) (Phase IIa) | Score 4 (severe) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Baseline (Phase IIa) | Score 0 (clear) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Baseline (Phase IIa) | Score 1 (almost clear) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Baseline (Phase IIa) | Score 2 (mild) | 1 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Baseline (Phase IIa) | Score 3 (moderate) | 1 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Baseline (Phase IIa) | Score 4 (severe) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 3 (Day 8) (Phase IIa) | Score 0 (clear) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 3 (Day 8) (Phase IIa) | Score 1 (almost clear) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 3 (Day 8) (Phase IIa) | Score 2 (mild) | 2 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 3 (Day 8) (Phase IIa) | Score 3 (moderate) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 3 (Day 8) (Phase IIa) | Score 4 (severe) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 4 (Day 15) (Phase IIa) | Score 0 (clear) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 4 (Day 15) (Phase IIa) | Score 1 (almost clear) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 4 (Day 15) (Phase IIa) | Score 2 (mild) | 1 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 4 (Day 15) (Phase IIa) | Score 3 (moderate) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 4 (Day 15) (Phase IIa) | Score 4 (severe) | 1 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 5 (Day 22) (Phase IIa) | Score 0 (clear) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 5 (Day 22) (Phase IIa) | Score 1 (almost clear) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 5 (Day 22) (Phase IIa) | Score 2 (mild) | 1 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 5 (Day 22) (Phase IIa) | Score 3 (moderate) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 5 (Day 22) (Phase IIa) | Score 4 (severe) | 1 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 6 (Day 29) (Phase IIa) | Score 0 (clear) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 6 (Day 29) (Phase IIa) | Score 1 (almost clear) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 6 (Day 29) (Phase IIa) | Score 2 (mild) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 6 (Day 29) (Phase IIa) | Score 3 (moderate) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 6 (Day 29) (Phase IIa) | Score 4 (severe) | 1 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 7 (Day 36) (Phase IIa) | Score 0 (clear) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 7 (Day 36) (Phase IIa) | Score 1 (almost clear) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 7 (Day 36) (Phase IIa) | Score 2 (mild) | 1 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 7 (Day 36) (Phase IIa) | Score 3 (moderate) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 7 (Day 36) (Phase IIa) | Score 4 (severe) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 8 (Day 43) (Phase IIa) | Score 0 (clear) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 8 (Day 43) (Phase IIa) | Score 1 (almost clear) | 1 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 8 (Day 43) (Phase IIa) | Score 2 (mild) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 8 (Day 43) (Phase IIa) | Score 3 (moderate) | 0 Participants |
| AR100DP1 (1.25%)_Phase I | Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa) | Visit 8 (Day 43) (Phase IIa) | Score 4 (severe) | 0 Participants |