Safety, Tolerability and Pharmacokinetics of LNK01004 Ointment in Adults With Atopic Dermatitis.

Lynk Pharmaceuticals Co., Ltd28 enrolled

Overview

The purpose of the study is to evaluate the Safety, Tolerability, and Pharmacokinetics of LNK01004 ointment (0.3%, 1.0%, and 1.5%) vs vehicle twice daily (BID) in Adults Patients with Atopic Dermatitis.

This is a multicenter, randomized, double-blind, vehicle-controlled, dose-escalation study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LNK01004 ointment twice daily (BID) in participants with Mild to Moderate atopic dermatitis as compared with vehicle cream BID.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Atopic Dermatitis

Interventions

LNK01004 ointment 0.3%DRUG

LNK01004 ointment 0.3% for topical application

LNK01004 ointment 1.0%DRUG

LNK01004 ointment 1.0% for topical application

LNK01004 ointment 1.5%DRUG

LNK01004 ointment 1.5% for topical application

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants were diagnosed with atopic dermatitis (AD) for at least 6 months. * Participants with an Investigator's Global Assessment (IGA) score of 2 to 3 at screening and baseline. * Participants with body surface area (BSA) of AD involvement, excluding the scalp, face, and intertriginous areas, of 3% to 20% at screening and baseline. * BMI of 18.0-30.0 kg/m2, with body weight ≥ 50 kg for man and ≥ 40 kg for woman. * Be willing to comply with the study lifestyle restraints, e.g., no washing of the administered area within 6 hours of study drug administration, no sweaty exercise. Exclusion Criteria: * Participants with a physical condition which, in the Investigator´s opinion, might interfere with the assessment of atopic dermatitis or expose the patient to an unacceptable risk by study participation. * Participants with current evidence of any acute skin infection with a history of recurrent or chronic severe skin infection. * Participants with known allergies to components or excipients of the test drug. * Participants who are pregnant, nursing, or planning a pregnancy during the study period. * Systemic immunosuppressive or immunomodulating drugs (eg, oral or injectable corticosteroids, mycophenolate mofetil, PDE4 inhibitor) used for atopic dermatitis within 4 weeks or 5 half-lives of baseline (whichever is longer). * Participants with the following hematologic abnormities at screening: * Leukocytes \< 3.0 × 10\^9/L. * Neutrophils \< lower limit of normal. * Hemoglobin \< 10 g/dL. * Lymphocytes \< 0.8 × 10\^9/L * Platelets \< 100 × 10\^9/L. * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 × upper limit of normal. * TBiL ≥ 1.5 × ULN, or ULN \< TBiL \< 1.5 × ULN but judged by the investigator to be abnormal clinically significant;

Locations (1)

Hospital for skin diseases, Institute of Dermatology, Chinese Academy of Medical Sciences.

Nanjing, China

Outcomes

Primary Outcomes

Treatment-Emergent Adverse Events (TEAE)

Number of participants with at least one TEAE.

Time frame: Baseline up to week 4

Secondary Outcomes

Maximum concentration (Cmax) for LNK01004 in plasma

Cmax is defined as the maximum observed plasma concentration for LNK01004

Time frame: Day1 and Day 7

Area under plasma concentration versus time curve, time zero to infinity

The area under the plasma concentration-time curve is a method of measurement of the total exposure of a drug in plasma

Time frame: Day 1 and Day7

Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score

The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.

Time frame: Baseline and Weeks 1, 2, and 4

Number of Participants Achieving a 75% Decrease From Baseline in EASI Score (EASI-75)

The number of participants with a decrease of at least 75% from the baseline EASI total score is presented. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease), with positive results indicating an increase from baseline in EASI total score (i.e., increased symptoms) and negative results indicating a decrease from baseline score (i.e., decreased symptoms). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.

Data from ClinicalTrials.gov

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