NCT05729074.

Study name	A randomized, placebo/active controlled, single/multiple dosing, dose escalation clinical phase 1a/b trial to evaluate the safety, tolerability and pharmacokinetic properties of IN‐A002 ointment in healthy adult male volunteers and mild to moderate atopic dermatitis patients
Methods	Trial design: randomised study Trial registration number: NCT05729074 Country: South Korea Outpatient or hospital: not reported Date trial conducted: from February 2023 Duration of trial participation: 28 days Inclusion criteria: · Adult male aged between 19 and 65 years · BMI between 18.0 and 30.0 kg/m2 · AD according to Hanifin and Rajka criteria; between 5% to 30% BSA involvement · AD diagnosed by EASI score of mild or moderate Exclusion criteria: · Prior/current history of clinically significant skin disorders other than AD, hepatic, renal, neurological, psychiatric, respiratory, endocrine, haematological, malignancy, urogenital, cardiovascular, digestive, or musculoskeletal disease · Clinically significant systemic or topical skin infection · Taken systemic corticosteroids or immunosuppressive agents that can affect AD‐related signs and symptoms within 4 weeks; taken systemic anti‐inflammatory or immunomodulatory drugs and systemic antibiotics that can affect AD‐related signs and symptoms within 2 weeks prior; received UV light therapy to mitigate AD‐related symptoms; expected to take the above drugs or therapy within the study duration · Treatment with oral antihistamines or topical drugs that can affect AD‐related signs and symptoms prior to the expected initial application date or within 5 life‐lives, or expected to take the above drugs within the study duration · Subjects whose hair is in the drug application site from 2 weeks prior to the expected initial application date to PSV · Hypersensitivity to the drugs, including Janus Kinase inhibitors and excipients, and other drugs, or have a history of clinically significant hypersensitivity · Suspected acute viral or bacterial infection within 2 weeks prior, or fever at the time of screening · Has clinically significant findings on 12‐lead ECG at screening · Abnormalities in clinical laboratory tests at the time of screening · Received live vaccines within 3 months prior, or plan to receive live vaccines · History of drug abuse, or who have a positive urine test for drugs of abuse · Abnormal vital signs at screening · Taken prescription drugs or oriental medicines that may affect the characteristics of the investigational product within 2 weeks prior or have taken OTC drugs or vitamin preparations within 10 days prior · Participated in other clinical trials within 6 months prior · Donated whole blood within 2 months prior or received blood transfusion within 1 month or who cannot continuously abstain from blood donation · History of regular alcohol consumption within 6 months prior or who cannot continuously abstain from alcohol consumption · History of average use of 10 cigarettes daily within 3 months prior and who cannot cease smoking · Consumed grapefruit‐containing food from 48 hours prior to the expected initial application date to PSV, or who cannot avoid taking grapefruit‐containing food · Consumed caffeine‐containing food from 24 hours prior to the expected initial application date to the last blood sampling point, or subjects who cannot avoid drinking caffeine‐containing food · Participating in regular strenuous exercise greater than daily physical activity from 48 hours prior to the expected initial application date to PSV, or subjects who cannot abstain from strenuous exercise during this period · Subjects or spouses (or partners) who have a plan for pregnancy or are unable to use a highly effective method of contraception, barrier method over a period from the informed consent to 90 days after the last dose of investigational product Additional design details: none
Participants	Total number randomised, age, sex, ethnicity, duration of eczema, severity of eczema, body site, number of withdrawals: not reported Notes: none
Interventions	Run‐in details: not reported Intervention one: IN‐A002 ointment 1% used twice daily for 28 days · Concurrent treatment: not reported · Other key information: none Intervention two: IN‐A002 ointment 3% used twice daily for 28 days · Concurrent treatment: not reported · Other key information: Comparator: Pimecrolimus 1% cream used twice daily for 28 days · Concurrent treatment: not reported · Other key information: none Concurrent treatments received alongside both intervention and comparator: not reported Notes: IN‐A002 is a JAK inhibitor.
Outcomes	· AE · Physical examination results classified as normal, not clinically significant, or clinically significant by the judgement of the investigator · Clinical laboratory test · Topical Reaction Assessment: the numerical scores on the findings of skin reactions (erythema, papulae, oedema, bulla, blister) after single/multiple dosing of topical IN‐A002 ointment · Each subject will subjectively evaluate the skin irritation intensity (pain) from the range of 1 to 10 using NRS. · Changes in EASI score · IGA changes in score · Changes in Itch Questionnaire: NRS for pruritus, NRS for sleep disturbance, duration of itching · DLQI
Starting date	February 2023
Contact information	Haerim Jang haerim.jang@inno‐n.com
Notes	Funding source: HK inno.N Corporation Declarations of interest: not declared Original language of publication: English Other: none