A Study for AR100DP1 in Atopic Dermatitis (AD)

• Status: Not yet recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase I/IIa Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, and Efficacy of AR100DP1 in Subjects with Atopic Dermatitis.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arjil Pharmaceuticals LLC
• Treatments: Iclaprim

Criteria

Inclusion Criteria:

1. Dated and signed informed consent

2. Either gender, ≥ 20 years old (the legal age of consent majority is 20 years old in Taiwan)

3. Clinical diagnosis of atopic dermatitis (according to the diagnostic standard of Hanifin and Rajka for AD)

4. Clinical diagnosis of AD that has been clinically stable, which means the ISGA score stays as 2 or 3 when evaluated for ≥ 4 weeks prior to screening visit

5. With Investigator's Static Global Assessment (ISGA) score of 2 (mild) or 3 (moderate) at screening

6. Subject of childbearing potential must agree to use highly effective contraceptives from signing informed consent to 14 days after the last dose of study drug administration. At least two forms of birth control must be adopted and one of which must be a barrier method.

Exclusion Criteria:

1. Unstable or actively infected AD judged by the investigator

2. Active or potentially recurrent dermatologic condition other than atopic dermatitis that may confound evaluation, judged by the investigator

3. Received systemic medication including corticosteroid, immunosuppressant, anti-histamine, phototherapy, or other therapy, which could affect AD within 4 weeks before screening. However, subjects are allowed to enter the study if subjects have routine usage of anti-histamine and this application does not affect the study judged by the investigator

4. Received topical medication including corticosteroid, immunosuppressant, anti-histamine, phototherapy, calcineurin inhibitors, or other therapy for AD on the target lesions within 1 week before screening

5. History of use of biologic therapy (including intravenous immunoglobulin) within 12 weeks or 5 half-lives (whichever is longer)prior to screening

6. Received any other investigational drug within 4 weeks prior to screening

7. Required or received systemic CYP3A4 inhibitors with strong potency within 1 week prior to screening, including but not limited to clarithromycin, itraconazole, nefazodone and atazanavir, evaluated by the investigator

8. Treatment for any type of cancer (except squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the skin, curatively treated with cryosurgery or surgical excision only) within 5 years before screening

9. Allergies requiring acute or chronic treatment at the investigator's discretion

10. Known hypersensitivity to any of the components of the study drug

11. Active clinically serious infection or history of human immunodeficiency virus (HIV) infection

12. Any of the following serum test abnormalities:

• Total bilirubin > 1.5 × ULN

• AST or ALT > 3.0 × ULN

• Serum albumin < 2.5 g/dL

• Creatinine > 1.5 × ULN

• Any other ≥ Grade 2 (according to CTCAE v5.0) laboratory abnormality at baseline (other than those listed above)

13. With ongoing acute diseases or within the past 2 years serious medical conditions (e.g. concomitant illness) such as cardiovascular (e.g. New York Heart Association grade III or IV), hepatic (e.g. Child-Pugh Class C), psychiatric condition (e.g. alcoholism, drug abuse), medical history, physical findings, or laboratory abnormality that in the investigators' opinion could interfere with the results of the trial or adversely affect the safety of the subject

14. Female subject who is lactating or has positive urine pregnancy test at screening

15. Other conditions not suitable for participating in this study judged by the investigator