Jaktinib Hydrochloride Cream For Atopic Dermatitis

A Phase I/II Study Of The Efficacy,Safety and PharmacokineticsOf Jaktinib Hydrochloride Cream In Subjects With Mild To Moderate Atopic Dermatitis

In the dose-increasing part, a multicenter, dose-increasing, randomized, double-blind, placebo-parallel control design was adopted. Subjects were enrolled into different dose groups in sequence according to the inclusion sequence, and each group was scheduled to give the drug for 8 weeks.Subjects in each group were observed for 4 weeks after administration. When the number of ≥2 grade drug-related adverse events (cases) was less than 50%, subjects in the next group could be enrolled.Otherwise, IDMC will decide whether to continue the next set of tests.Subjects in each group were randomly assigned to receive either Jaktinib cream (6 cases) or placebo (2 cases) in a ratio of 3 to 1.A total of 32 subjects are expected to be enrolled in 6 centers. The dose expansion was a multicenter, randomized, double-blind, placebo-parallel control design in which subjects were randomly assigned to 3 groups (1 placebo group and 2 experimental drugs group).It is estimated that a total of 60 subjects will be enrolled in about 15 centers. This part is divided into two stages.Stage 2 test (9 ~ 16 weeks) : Extension test.

Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 0.5% Cream will be applied topically twice daily.

Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 1.5% Cream will be applied topically twice daily.

Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 2.5% Cream will be applied topically Once daily.

Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 2.5% Cream will be applied topically twice daily.

X% based on results of part 1. The Jaktinib Hydrochloride X% Cream will be applied topically twice daily

Y% based on results of part 1. The Jaktinib Hydrochloride Y% Cream will be applied topically twice daily

Proportion of Participants Achieving Physician's Global Assessment (PGA) Response of Clear or Almost Clear

Inclusion Criteria: 18~ 65 years old (including boundary value), gender is not limited; Have a clinical diagnosis of atopic dermatitis; Have a PGA(Physician's Global Assessment) score of 2 (mild) or 3 (moderate) at baseline; The total area of atopic dermatitis is about 10%~20% of the total area of the body surface at baseline. Exclusion Criteria: Evidence of certain skin conditions/infections at baseline; Have certain laboratory abnormalities at baseline; Females who are pregnant, breastfeeding, or are of childbearing potential not using highly effective contraception; Other conditions that the investigators considered inappropriate to participate in the trial.