Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Dose Ascending, 3-cohort Parallel Group Study to Measure the Systemic Cortisol Profile and Evaluate the Safety, Tolerability and Pharmacokinetics of GW870086X, Administered as Single Doses (12mg and 15mg), and Repeat Doses Over 3 Days (6mg, 12mg and 15mg) in Healthy Male Subjects
Brief Summary: GW870086X is a novel inhaled steroid that has an improved safety profile over other steroids but is also less potent. This study will look at higher doses to confirm the improved safety profile.


Options:
A: Inclusion Criteria:

* Males or females 2 years and older
* Has a clinical diagnosis of AD according to the criteria of Hanifin and Rajka
* Has AD involvement ≥ 5% Treatable %BSA (excluding the scalp)
* Has an ISGA score of Mild (2) or Moderate (3) at Baseline/Day 1
* All female subjects of childbearing potential must use acceptable methods of contraception from the Screening Visit continuously until 30 days after stopping study drug

Exclusion Criteria:

* As determined by the study doctor, a medical history that may interfere with study objectives
* Unstable AD or any consistent requirement for high potency topical corticosteroids
* History of use of biologic therapy (including intravenous immunoglobulin)
* Recent or anticipated concomitant use of systemic or topical therapies that might alter the course of AD
* Recent or current participation in another research study
* Females who are breastfeeding, pregnant, or with plans to get pregnant during the participation in the study
* Participation in a previous AN2728 clinical trial
B: Inclusion Criteria:

* Adolescents aged ≥ 12 to 17 years, inclusive, and men and women aged ≥ 18 years.
* Participants diagnosed with atopic dermatitis (AD) as defined by the Hanifin and Rajka criteria.
* AD duration of at least 2 years.
* Participants with an Investigator's Global Assessment (IGA) score of 2 to 3 at Screening and Baseline (VC Period) and 0 to 4 at Week 8 (LTS Period).
* Participants with percentage body surface area (%BSA) (excluding scalp) of AD involvement of 3% to 20% at Screening and Baseline (VC Period) and 0% to 20% at Week 8 (LTS Period).
* Participants who agree to discontinue all agents used to treat AD from Screening through the final follow-up visit.
* Participants who have at least 1 "target lesion" that measures approximately 10 cm\^2 or more at Screening and Baseline. Lesion must be representative of the participant's disease state and not be located on the hands, feet, or genitalia.
* Willingness to avoid pregnancy or fathering of children.

Exclusion Criteria:

* Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to Baseline.
* Concurrent conditions and history of other diseases:

  * Immunocompromised.
  * Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before Baseline.
  * Active acute bacterial, fungal, or viral skin infection within 1 week before Baseline.
  * Any other concomitant skin disorder, pigmentation, or extensive scarring that, in the opinion of the investigator, may interfere with the evaluation of AD lesions or compromise participant safety.
  * Presence of AD lesions only on the hands or feet without prior history of involvement of other classical areas of involvement such as the face or the folds.
  * Other types of eczema.
* Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
* Use of any of the following treatments within the indicated washout period before Baseline:

  * 5 half-lives or 12 weeks, whichever is longer - biologic agents (e.g. dupilumab).
  * 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogs, cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (e.g. mycophenolate or tacrolimus).
  * 2 weeks - immunizations and sedating antihistamines, unless on long-term stable regimen (nonsedating antihistamines are permitted).
  * 1 week - use of other topical treatments for AD (other than bland emollients). Diluted sodium hypochlorite "bleach" baths are allowed as long as they do not exceed 2 baths per week and their frequency remains the same throughout the study.
* Participants who have previously received Janus kinase (JAK) inhibitors, systemic or topical.
* Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation within 2 weeks prior to Baseline and/or intention to have such exposure during the study, which is thought by the investigator to potentially impact the participant's AD.
* Positive serology test results at screening for human immunodeficiency virus (HIV) antibody.
* Liver function tests: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2 × upper limit of normal (ULN); alkaline phosphatase and/or bilirubin \> 1.5 × ULN (isolated bilirubin \> 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin \< 35%).
* Pregnant or lactating participants, or those considering pregnancy.
* History of alcoholism or drug addiction within 1 year before screening or current alcohol or drug use that, in the opinion of the investigator, will interfere with the participant's ability to comply with the administration schedule and study assessments.
* Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before Baseline with another investigational medication or current enrollment in another investigational drug protocol.
C: Inclusion criteria:

* Healthy male subjects
* Liver function tests normal
* 18 - 45 years old
* Non smoker
* Can provide written informed consent
* Available to complete the whole trial
* Can use the inhalation device correctly
* Able to read, understand and write English

Exclusion criteria:

* Deemed suitable healthy subject
* History to sensitivity to the study medication
* Any history of breathing problems in adult life
* Participated in another trial within 30 days or 5 half-lives of the new chemical entity
* Exposed to more than 4 new chemical entities within 12 months
* Donated \>500 mL blood within 2 months of screening
* Haemoglobin level \< 13g/dl
* Use of prescription or non-prescription drugs within 7 days of first dose
* Taking drugs that significantly inhibit cytochrome P450 subfamily enzyme CYP3A4
* Drinks more than 4 units a day or 28 units a week
* Cannot use DISKHALER device correctly
* Positive HepB, HepC within 3 months of screening
* Positive HIV test
* Positive pre study drug/alcohol screen
* Significant cardiac conduction abnormalities
* Risk of non-compliance
D: Inclusion Criteria:

* Participants diagnosed with atopic dermatitis (AD) as defined by the Hanifin and Rajka criteria.
* Participants with a history of AD for at least 2 years.
* Participants with an Investigator's Global Assessment (IGA) score of 2 to 3 at screening and baseline.
* Participants with body surface area (BSA) of AD involvement, excluding the face and intertriginous areas, of 3% to 20% at screening and baseline.
* Participants who agree to discontinue all agents used to treat AD from screening through the final follow-up visit.

Exclusion Criteria:

* Participants with evidence of active acute or chronic infections.
* Use of topical treatments for AD (other than bland emollients) within 2 weeks of baseline.
* Systemic immunosuppressive or immunomodulating drugs (eg, oral or injectable corticosteroids, methotrexate, cyclosporine, mycophenolate mofetil, azathioprine) within 4 weeks or 5 half-lives of baseline (whichever is longer).
* Participants with other dermatologic disease besides AD whose presence or treatments could complicate the assessment of disease (eg, psoriasis).
* Participants with a history of other diseases besides dermatologic disorders (eg, other autoimmune diseases) taking treatments that could complicate assessments.
* Participants with cytopenias at screening, defined as:

  * Leukocytes \< 3.0 × 10\^9/L.
  * Neutrophils \< lower limit of normal.
  * Hemoglobin \< 10 g/dL.
  * Lymphocytes \< 0.8 × 10\^9/L
  * Platelets \< 100 × 10\^9/L.
* Participants with severely impaired liver function (Child-Pugh Class C) or end-stage renal disease (ESRD) on dialysis or at least 1 of the following:

  * Serum creatinine \> 1.5 mg/dL.
  * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 × upper limit of normal.
* Participants taking potent systemic cytochrome P450 3A4 inhibitors or fluconazole within 2 weeks or 5 half-lives, whichever is longer, before the baseline visit (topical agents with limited systemic availability are permitted).
* Participants who have previously received Janus kinase (JAK) inhibitors, systemic or topical (e.g., ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib).

Answer: C