A Phase I Clinical Trial to Evaluate CU-10101 Unguent

Prior treatment

• 4.Previous or current significant or clinically significant diseases/abnormalities, including, but not limited to, heart/cardiocerebrovascular, respiratory, endocrine, gastrointestinal, kidney, liver, gallbladder, dermatological, hematological, immune, neurological or psychiatric diseases/abnormalities, or, as judged by the investigator, there is a safety risk or impact on safety, tolerability or pharmacokinetic assessment;
• 5.Participants with a prior diagnosis of malignancy;
• 8.Those who smoke more than 5 cigarettes per day for 3 months prior to screening or cannot stop using any tobacco products during the study;
• 9.Frequent drinkers within 3 months prior to screening, i.e., more than 14 units of alcohol per week (1 unit = 360 mL beer or 45 mL of spirits with 40% alcohol or 150 mL of wine) or who were unable to discontinue use of any alcoholic product during the study or had a positive alcohol breath test at screening;
• 10.Previous history of drug abuse, drug use within 3 months prior to screening, or positive urine drug screen at screening;
• 11.Donation of blood or massive blood loss (≥ 400 mL) within 3 months prior to screening;
• 12.Participation in other clinical trials within 3 months prior to screening or during the study;
• 13.Major surgery within 3 months prior to screening (major surgery is defined in accordance with the Medical Journal of Medicine, May 1, 2009 Grade 3 and 4 surgery specified in the Measures for the Administration of Clinical Application of Therapeutic Techniques), or who plan to undergo surgery during the study;
• 14.Those who have received live (attenuated) vaccines within 4 weeks prior to screening, or plan to receive live (attenuated) vaccines during treatment and within 4 weeks after the last dose of investigational product;
• 15.Received any other medication, including herbal and dietary supplements, within 2 weeks or 5 times the elimination half-life prior to screening, whichever is longer;
• 16.Consumption of excessive amounts of tea, coffee, and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day for 2 weeks prior to screening;
• 17.Participants who have taken food or beverages (e.g. grapefruit, grapefruit juice, etc.) or any food or drink containing or metabolized to produce caffeine or xanthine (e.g. coffee, tea, chocolate) within 48 hours prior to dosing;
• History of allergy to the ingredients or excipients of the investigational product;
• Previous history of clinically significant cardiac, hepatic, neurological, respiratory, blood, digestive, immune, renal or psychiatric disorders, which, in the opinion of the investigator, increases safety risks, affects safety, tolerability, or pharmacokinetics;
• Participants with a prior diagnosis of malignancy;
• Participants with acute-phase atopic dermatitis whose rash was predominantly erosive, exudative, or had a new skin rash 2 weeks before screening;
• Those who smoke more than 5 cigarettes per day for 3 months prior to screening or cannot stop using any tobacco products during the study;
• Frequent drinkers within 3 months prior to screening, i.e., more than 14 units of alcohol per week (1 unit = 360 mL beer or 45 mL of spirits with 40% alcohol or 150 mL of wine) or who were unable to discontinue use of any alcoholic product during the study or had a positive alcohol breath test at screening;
• Previous history of drug abuse, drug use within 3 months prior to screening, or positive urine drug screen at screening;
• Donation of blood or massive blood loss (≥ 400 mL) within 3 months prior to screening;
• Participation in other clinical trials within 3 months prior to screening or during the study;
• Major surgery within 3 months prior to screening (major surgery defined by reference to 01 May 2009 Grade 3 and 4 surgery specified in the Measures for the Administration of Clinical Application of Medical Technology), or who plan to undergo surgery during the study;
• Those who have received live (attenuated) vaccines within 4 weeks prior to screening, or plan to receive live (attenuated) vaccines during treatment and within 4 weeks after the last dose of investigational product;
• Systemic systemic therapy (e.g., biologics, small molecule targeted, immunosuppressants, and other systemic therapies, etc.) for any of AD within 4 weeks (or 5 half-lives, whichever is longer) prior to screening;
• Has received phototherapy (narrow-band ultraviolet B \[NBUVB\], ultraviolet B \[UVB\], ultraviolet A1 \[UVA1\], psoralen + ultraviolet A \[PUVA\]), tanning beds, or any other light-emitting device within 4 weeks prior to screening;
• Those who have used any strong inhibitor or inducer of any CYP3A4 enzyme within 4 weeks prior to screening (strong inhibitors include clarithromycin, itraconazole, ketoconazole, ritonavir, and strong inducers include rifampin and phenytoin);
• Received topical drug therapies known or likely to affect AD within 2 weeks (or 5 half-lives, whichever is longer) before screening, including but not limited to topical TCS, TCI, topical PDE-4 inhibitors, topical JAK inhibitors, etc.;
• Consumption of excessive amounts of tea, coffee, and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day for 2 weeks prior to screening;

Other illness

• Part 1 ：1.Allergic constitution (e.g., allergy to two or more drugs, food and pollen), or allergy to the ingredients or excipients of the investigational medicinal product;
• 2.Those who cannot tolerate venipuncture, or have a history of needle sickness and blood sickness;
• 3.Subjects with skin damage, atopic dermatitis, eczema, rash, pigmentation and tattoos at the administration site, or other conditions judged by the investigator to be likely to affect drug absorption or affect skin tolerance;
• 7.Hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HBsAg), treponema pallidum (TP) antibody, human immunodeficiency virus (HIV) antibody were positive;
• 19.Other conditions or treatments that, as assessed by the investigator, may affect the results of the study, interfere with the participation of participants in the trial, etc.
• Those who cannot tolerate venipuncture, or have a history of needle sickness and blood sickness;
• Any active skin diseases, such as psoriasis, lupus erythematosus, seborrheic dermatitis, that may have affected the evaluation of the study results;
• Active infection or any viral, bacterial, fungal infection (e.g., herpes simplex, herpes zoster, varicella) requiring treatment at screening;
• Hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HBsAg), treponema pallidum (TP) antibody, human immunodeficiency virus (HIV) antibody were positive;
• Other conditions or treatments that, as assessed by the investigator, may affect the results of the study, interfere with the participation of participants in the trial, etc.

Lab values

• Those who are judged by the investigator to be abnormal and clinically significant at screening or baseline clinical or laboratory tests;

Other

• 6.Lactating women or women with positive pregnancy results, or women who plan to become pregnant during the study;
• 18.Those who have special requirements for diet and cannot comply with the unified diet;
• Part 2：
• Skin lesions were limited to the head, hands, feet, genitalia and intertriginous areas;
• Lactating women or women with positive pregnancy results, or women who plan to become pregnant during the study;
• Intake of food or beverages (e.g. tea, coffee, cola, energy drinks or chocolate) containing grapefruit and/or grapefruit, caffeine, and/or xanthine from 48 h before dosing until leaving the ward;

• Part 1：1.Subjects were 18-45 years of age (inclusive), male or female, at the time of signing the informed consent form;
• 2.Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg; body mass index in the range of 18.0-27.0 kg/m2 (including cut-off);
• 3.Based on physical examination, vital signs, electrocardiogram, and laboratory results, it was shown to be in good health without clinically significant abnormalities (as judged by the investigator);
• 4.Ability to fully understand the contents of the study, voluntarily participate in the study, and sign the informed consent form. Follow protocol procedures to complete relevant visits during the study;
• 5.Female participants of childbearing potential and male participants with partners of childbearing potential must consent from signing the informed consent form and no childbearing plan and voluntary use of appropriate contraception up to 3 months after the last dose.
• Part 2：1.Subjects were 18-65 years of age (inclusive), male or female, at the time of signing the informed consent form;
• 2.Diagnosed with AD according to Hanifin-Rajka diagnostic criteria and a history of AD assessed by the investigator for ≥ 6 months;
• 3.Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg; body mass index in the range of 18.0-27.0 kg/m2 (including cut-off);
• 4.Investigator Global Assessment (IGA) score of 2 or 3 at screening and baseline;
• 5.At screening and baseline, BSA was 5% -40% (excluding the area of lesions on the scalp, face, genitalia and intertriginous sites \[e.g., axillary, inguinal, elbow fossa, etc.\] when calculating the lesion area);
• 6.Ability to fully understand the contents of the study, voluntarily participate in the study, and sign the informed consent form. Follow protocol procedures to complete relevant visits during the study;
• 7.Female participants of childbearing potential and male participants with partners of childbearing potential must consent from signing the informed consent form and no childbearing plan and voluntary use of appropriate contraception up to 3 months after the last dose.