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

NCT ID: NCT06553287

Last Updated: 2024-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-12
• Study Completion Date: 2024-06-18

Brief Summary

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.

Detailed Description

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

LNK01004 ointment 0.3%

Participants will receive LNK01004 ointment 0.3% twice daily

Group Type: EXPERIMENTAL

LNK01004 ointment 0.3%

Intervention Type: DRUG

LNK01004 ointment 0.3% for topical application

LNK01004 ointment 1.0%

Participants will receive LNK01004 ointment 1.0% twice daily

Group Type: EXPERIMENTAL

LNK01004 ointment 1.0%

Intervention Type: DRUG

LNK01004 ointment 1.0% for topical application

LNK01004 ointment 1.5%

Participants will receive LNK01004 ointment 1.5% twice daily

Group Type: EXPERIMENTAL

LNK01004 ointment 1.5%

Intervention Type: DRUG

LNK01004 ointment 1.5% for topical application

Vehicle

Participants will receive vehicle BID

Group Type: EXPERIMENTAL

Vehicle BID

Intervention Type: DRUG

Inactive vehicle matched to LNK01004 ointment for topical application.

Interventions

LNK01004 ointment 0.3%

LNK01004 ointment 0.3% for topical application

Intervention Type: DRUG

LNK01004 ointment 1.0%

LNK01004 ointment 1.0% for topical application

Intervention Type: DRUG

LNK01004 ointment 1.5%

LNK01004 ointment 1.5% for topical application

Intervention Type: DRUG

Vehicle BID

Inactive vehicle matched to LNK01004 ointment for topical application.

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lynk Pharmaceuticals Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qianjin Lu

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Nanjing, , China

Countries

China

Other Identifiers

LK004102

Identifier Type: -

Identifier Source: org_study_id