Status:
COMPLETED
Safety, Tolerability and Pharmacokinetics of LNK01004 Ointment in Adults With Atopic Dermatitis.
Lead Sponsor:
Lynk Pharmaceuticals Co., Ltd
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 Dermatiti...
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 particip...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
July 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2024
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06553287
Start Date
July 12 2023
End Date
June 18 2024
Last Update
August 14 2024
Active Locations (1)
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1
Hospital for skin diseases, Institute of Dermatology, Chinese Academy of Medical Sciences.
Nanjing, China