None listed
Conditions
Brief summary
Atopic Dermatitis (AD) is a common chronic inflammatory skin disease characterized by recurrence, pleomorphic skin lesions, dry skin, and severe pruritus. In most countries worldwide, the prevalence of atopic dermatitis is 10%–20% in children and 2–8% in adults. At present, there is no curable treatment for atopic dermatitis. The goal of treatment is to relieve or eliminate clinical symptoms, recover skin lesions to the greatest extent, eliminate predisposing and/or aggravating factors, reduce and prevent relapses, and improve the quality of patients’ life. Therefore, identification of new effective and safe therapies is an important area of research.
Interventions
This study will compare two active doses of 1% and 2% SHR0302 to placebo. Part 1 is a randomized, double-blind, vehicle-controlled, single ascending dose trial; it is planned to enroll 32 healthy adult subjects. Part 1 includes a screening period (D-28~D-2), baseline period (D-1), dosing period (D1), observation period (D2~D3), and follow-up period (D4~D7). A total of 4 doses are designed for the single ascending dose study which is carried out in 4 cohorts. Each cohort will be a single dose wit
This study will compare two active doses of 1% and 2% SHR0302 to placebo. Part 1 is a randomized, double-blind, vehicle-controlled, single ascending dose trial; it is planned to enroll 32 healthy adult subjects. Part 1 includes a screening period (D-28~D-2), baseline period (D-1), dosing period (D1), observation period (D2~D3), and follow-up period (D4~D7). A total of 4 doses are designed for the single ascending dose study which is carried out in 4 cohorts. Each cohort will be a single dose with one application on Day 1. The 4 dose groups are 1% SHR0302 base ointment applied to 5% Body Surface Area (BSA), 1% SHR0302 base ointment applied to 10% BSA, 2% SHR0302 base ointment applied to 10% BSA, and 2% SHR0302 base ointment applied to 20% BSA. The ointment will be applied to a different % of body surface area (BSA) depending on the cohort.
Sponsors
Reistone Biopharma Co., Ltd.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adult subjects between 18-55 years of age (inclusive), male or female, at the time of informed consent. 2. The body mass index (BMI equal to body mass/square of body height) of the subjects ranges from 19 to 26 kg/m2 (inclusive), and males of weight less than or equal to 50 kg, females of weight less than or equal to 45 kg. 3. The overall health is good at screening, as determined by medical history, physical examination, vital signs, laboratory examination, 12-lead electrocardiogram (ECG) and chest X-ray at screening. 4. All women of childbearing potential who are not in same-sex relationships and all men with female partner of childbearing potential must be willing to use effective method of contraception from signing of informed consent form, throughout the duration of the study, and for 1 month after last dose of study medication. The subjects understand and comply with the study requirements, voluntarily participate in the study and sign the informed consent form.
Exclusion criteria
Subjects presenting with any of the following items will not be enrolled in this study: 1. Currently having or have a history of any of the following diseases: 1) Suspected allergy to the study drug or any component of the study drug, or allergy constitution; 2) Have a history of malignant tumor; 3) Skin injuries or abnormalities that might affect the evaluation of study drug application site, such as dermatitis, tattoo, scar, excessive hair, birthmark, injury, uneven skin color, sunburn, etc.; 4) In the opinion of the investigator, any clinically relevant skin diseases that are contraindicated in the study or affect the evaluation of application site, including psoriasis, eczema, acne, atopic dermatitis, dysplastic nevus, or other skin lesions, or a history of skin cancer; 5) Subjects with a history of herpes simplex or herpes zoster; 6) Subjects who currently have thyroid disorders (including hyperthyroidism, hypothyroidism, or are currently receiving thyroid replacement therapy. Subjects with abnormal TSH, fT4, and fT3 values on blood tests at screening must be excluded; 7) Subjects who have received any surgical operation within 3 months prior to screening or plan to receive the operation during the study and within 1 month after completing all study visits; 8) Subjects with a history of clinical major heart disease, liver disease, nerve disease, respiratory disease, blood disease, digestive disease, immune disease, kidney disease or mental disease, which is considered by the investigator to confuse the study results or affect absorption, distribution, metabolism and excretion of drug or place the subjects at improper risks; 9) Clinical symptoms, signs, laboratory examination or chest X-ray indicate active tuberculosis; 10) Subjects who have the investigator-judged clinically significant infections within 1 months prior to screening, including acute and chronic infections such as abscess, furuncle, carbuncle, respiratory tract infection, urinary and reproductive infection, and systematic infections, etc. 2. Subjects who are using or have a history of using any of the following drugs: 1) Subjects who are unable to discontinue CYP3A inducer or CYP3A inhibitor 2 weeks prior to the baseline visit and during the study; 2) Subjects who have inoculated any live vaccine within 1 month before screening or need to inoculate live vaccine during the study (including 30 days after the last dose of study drug); 3) Prescription drugs are used within 14 days before baseline; 4) OTC drugs are used within 14 days before baseline, including natural health products (e.g. food supplement and herbal supplement), with the exception of occasional use of paracetamol (up to 2 g per day); 5) Topical skin products (including sun-screening agents, moisturizers, cosmetics, insect repellents, creams, powders, lotions, sprays or gels) are used within 48 hours before baseline; 6) Topical skin drugs (e.g., topical hormones, vitamin A) are used at the study application site within 21 days before baseline 3. Any of the following laboratory endpoints meet the following criteria at screening or baseline examination: 1) The ECG shows QTc greater than 450 ms or any other obvious abnormality, which is determined as clinically significant by the investigator; 2) Blood routine examination shows that the white blood count, neutrophil count, lymphocyte count, or hemoglobin exceed the normal reference range and is clinically significant as determined by the investigator; 3) Alanine aminotransferase (ALT) greater than 1.5×ULN and/or aspartate transaminase (AST) greater than 1.5×ULN and/or bilirubin greater than 1.5×ULN; 4) Estimated glomerular filtration rate (eGFR) calculated by MDRD formula <90 mL/min/1.73 m²; 5) Hepatitis B surface antigen, hepatitis B e antigen, tuberculosis testing (T-SPOT TB/QuantiFERON TB), anti-hepatitis C virus antibody, HIV antibody and syphilis antibody positive; Other laboratory findings which exceed the normal reference range, based on which the investigator determines that the subject is not suitable to participate in this study. 4. General conditions: 1) Subjects with childbearing or sperm donation plan during the study period or within 1 month after the last dose of study drug; 2) Smokers: Over 5 cigarettes per day on average; 3) Drinkers: Alcohol test positive; or long-term drinking over the past 3 months, with the total amount consumed per week by male subjects exceeding 3,465 mL of beer, 1,750 mL of wine, yellow or low-alcohol liquor, or 525 mL of high-alcohol liquor (greater than 40 degrees); 4) Drug abusers: Judged by urine test positive; 5) Women who are pregnant or breastfeeding; 6) Subjects who have donated blood and the blood volume less than or equal to 400 mL, or received infusion of any blood product within 3 months before screening; 7) Subjects who have participated in the clinical trial of any drug or medical device within 3 months before screening.
Outcome results
None listed