MH004 Ointment in Healthy Adult Volunteers and Participants With Mild to Moderate Atopic Dermatitis

Assess incidence and severity of treatment-emergent adverse events as determined by CTCAE v5.0 The incidence, nature, and severity of AEs/SAEs including relationship to study treatment from MAD initial study drug administration time of randomization until Day 14 for MAD participants. The incidence, nature, and severity of AEs/SAEs leading to treatment discontinuation from MAD initial study drug administration time of randomisation until Day 7 for MAD participants. Clinically significant changes in laboratory parameters, vital signs, 12-lead ECG, and other safety assessments from initial study drug administration time of randomisation until Day 7 for SAD participants. Clinically significant changes in laboratory parameters, vital signs, 12-lead ECG, and other safety assessments from MAD initial study drug administration time of randomisation until Day 14 for MAD participants.

EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.

Maximum drug concentration (Cmax)

EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.

EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD).

IGA is an assessment scale used to determine severity of atopic dermatitis (AD) and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). An IGA responder was defined as a participant achieving an IGA score of 0 to 1 and an IGA score improvement at least 2 from baseline.

SCORAD is a clinical tool used to assess the severity (range/severity) and subjective signs/symptoms (such as itching/insomnia) of AD. The degree of the lesion was scored using the nine-point method. The severity was determined by grading the severity of six signs (erythema, edema, exudation/scabbing, epidermal exfoliation, lichenification and skin dryness) on a 0-3 subscale. The assessment of each physical sign was scored at the most representative lesion sites. Subjective symptoms were scored using the Visual Analogue Scale (VAS), with 0= no pruritus (or insomnia), and 10= the most severe pruritus (or insomnia). The total score is the sum of 5+7x severity /2+VAS (Symptoms), and the SCORAD score ranges from 0 to 103 points. The higher the score, the more severe the AD.

AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent.