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

Lynk Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Atopic Dermatitis

Treatments: Drug: Vehicle BID; Drug: LNK01004 ointment 1.5%; Drug: LNK01004 ointment 1.0%; Drug: LNK01004 ointment 0.3%

Study type: Interventional

Funder types: Industry

Identifiers

NCT06553287

LK004102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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28 participants in 4 patient groups

LNK01004 ointment 0.3%

Experimental group

Description:

Participants will receive LNK01004 ointment 0.3% twice daily

Treatment:

Drug: LNK01004 ointment 0.3%

LNK01004 ointment 1.0%

Experimental group

Description:

Participants will receive LNK01004 ointment 1.0% twice daily

Treatment:

Drug: LNK01004 ointment 1.0%

LNK01004 ointment 1.5%

Experimental group

Description:

Participants will receive LNK01004 ointment 1.5% twice daily

Treatment:

Drug: LNK01004 ointment 1.5%

Vehicle

Experimental group

Description:

Participants will receive vehicle BID

Treatment:

Drug: Vehicle BID