A Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of IN-A002 Ointment in Healthy Adult Male Volunteers and Mild to Moderate Atopic Dermatitis Patients

NCT05729074 | Unknown Phase 1

• 1 other identifier: IN_JSI_105
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate the safety, tolerability and pharmacokinetic properties of IN-A002 Ointment in healthy adult male volunteers and mild to moderate atopic dermatitis patients

Conditions

Mild to Moderate Atopic Dermatitis

Outcome Measures

Primary Outcomes (9)

• Adverse event

  For all adverse events collected during the study, the investigator will evaluate serious adverse events, severity, or drug relationship.

  Up to post study visit (Day 40)

• Physical examination

  Physical examination results will be classified as normal, not clinically significant, or clinically significant upon a judgment of the investigator after single/multiple dosing of topical IN-A002 Ointment.

  Up to post study visit (Day 40)

• Clinical Laboratory Test

  Clinical laboratory test, the results will be classified as normal, not clinically significant, or clinically significant upon judgment of the investigator after single/multiple dosing of topical IN-A002 Ointment.

  Up to post study visit (Day 40)

• Topical Reaction Assessment

  The numerical scores on the findings of skin reactions (erythema, papule, edema, bulla, blister) after single/multiple dosing of topical IN-A002 Ointment.

  Predose(0h) at Day 1, Day 8, Day 15, and Day 22, Post-dose(0.5h) at Day 1, Day 8, Day 15, and Day 22, Day 28, Day 29(0h, 0.5h), PSV

• NRS (Numerical Pain Rating Scale)

  Each subject will subjectively evaluate the skin irritation intensity (pain) from the range of 1-10 using 'Numerical Rating Score (NRS)'.

  Predose(0h) at Day 1, Day 8, Day 15, and Day 22, Post-dose(0.5h) at Day 1, Day 8, Day 15, and Day 22, Day 28, Day 29(0h, 0.5h), PSV

• EASI score

  Changes in EASI score from the baseline after treatment

  Day 1, Day 8, Day 15, Day 22, Day 29

• IGA score

  Investigator Global Assessment (IGA) Changes in IGA score from the baseline after treatment

  Day 1, Day 8, Day 15, Day 22, Day 29

• Itch Questionnaire

  Changes in Itch Questionnaire from the baseline after treatment * NRS for Pruritus * NRS for Sleep Disturbance * Duration of Itching

  Day 1, Day 8, Day 15, Day 22, Day 29

• Dermatology Life Quality Index (DLQI)

  The DLQI is a 10-question questionnaire used to measure the impact of Atopic Dermatitis(AD) on the quality of life of an AD-affected person for the last week

  Day 1, Day 8, Day 15, Day 22, Day 29

Study Arms (11)

Part A-1(SAD1)

EXPERIMENTAL

IN-A002 Ointment 0.3% or Placebo Ointment, single dose

Drug: IN-A002 Ointment 0.3% or IN-A002 Placebo Ointment

Part A-1(SAD2)

EXPERIMENTAL

IN-A002 Ointment 0.5% or Placebo Ointment, single dose

Drug: IN-A002 Ointment 0.5% or IN-A002 Placebo Ointment

Part A-1(SAD3)

EXPERIMENTAL

IN-A002 Ointment 1% or Placebo Ointment, single dose

Drug: IN-A002 Ointment 1% or IN-A002 Placebo Ointment

Part A-1(SAD4)

EXPERIMENTAL

IN-A002 Ointment 3% or Placebo Ointment, single dose

Drug: IN-A002 Ointment 3% or IN-A002 Placebo Ointment

Part A-1(SAD5)

EXPERIMENTAL

IN-A002 Ointment 5% or Placebo Ointment, single dose

Drug: IN-A002 Ointment 5% or IN-A002 Placebo Ointment

Part A-2(MAD1)

EXPERIMENTAL

IN-A002 Ointment 1% or Placebo Ointment, Twice daily (BID), multiple topical applications for 14 days

Drug: IN-A002 Ointment 1% or IN-A002 Placebo Ointment

Part A-2(MAD2)

EXPERIMENTAL

IN-A002 Ointment 3% or Placebo Ointment, Twice daily (BID), multiple topical applications for 14 days

Drug: IN-A002 Ointment 3% or IN-A002 Placebo Ointment

Part A-2(MAD3)

EXPERIMENTAL

IN-A002 Ointment 5% or Placebo Ointment, Twice daily (BID), multiple topical applications for 14 days

Drug: IN-A002 Ointment 5% or IN-A002 Placebo Ointment

Part B(MAD1)

EXPERIMENTAL

IN-A002 Ointment 1%, Twice daily (BID), multiple topical applications for 28 days

Drug: IN-A002 Ointment 1%

Part B(MAD2)

EXPERIMENTAL

IN-A002 Ointment 3%, Twice daily (BID), multiple topical applications for 28 days

Drug: IN-A002 Ointment 3%

Part B

ACTIVE COMPARATOR

Part B(MAD1), (MAD2): Elidel Cream 1% (pimecrolimus), Twice daily (BID), multiple topical applications for 28 days

Drug: Elidel Cream 1% (pimecrolimus)

Interventions

IN-A002 Ointment 0.3% or IN-A002 Placebo Ointment DRUG

Drug: IN-A002 Ointment 0.3%, 10 g/1000 cm2 Drug: IN-A002 Placebo Ointment, 10 g/1000 cm2

Part A-1(SAD1)

IN-A002 Ointment 0.5% or IN-A002 Placebo Ointment DRUG

Drug: IN-A002 Ointment 0.5%, 10 g/1000 cm2, for 1 day Drug: IN-A002 Placebo Ointment, 10 g/1000 cm2, for 1 day

Part A-1(SAD2)

IN-A002 Ointment 1% or IN-A002 Placebo Ointment DRUG

Drug: IN-A002 Ointment 1%, 10 g/1000 cm2 Drug: IN-A002 Placebo Ointment, 10 g/1000 cm2

Part A-1(SAD3); Part A-2(MAD1)

IN-A002 Ointment 3% or IN-A002 Placebo Ointment DRUG

Drug: IN-A002 Ointment 3%, 10 g/1000 cm2 Drug: IN-A002 Placebo Ointment, 10 g/1000 cm2

Part A-1(SAD4); Part A-2(MAD2)

IN-A002 Ointment 5% or IN-A002 Placebo Ointment DRUG

Drug: IN-A002 Ointment 5%, 10 g/1000 cm2 Drug: IN-A002 Placebo Ointment, 10 g/1000 cm2

Part A-1(SAD5); Part A-2(MAD3)

IN-A002 Ointment 1% DRUG

Drug: IN-A002 Ointment 1%, 3 g/1000 cm2

Part B(MAD1)

IN-A002 Ointment 3% DRUG

Drug: IN-A002 Ointment 3%, 3 g/1000 cm2

Part B(MAD2)

Elidel Cream 1% (pimecrolimus) DRUG

Drug: Elidel Cream 1% (pimecrolimus), 3 g/1000 cm2

Part B

Eligibility Criteria

• Age: 19 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult male volunteers aged 19 years or older when the informed consent is obtained.
• Those whose body weight is above 50.0 kg, with body mass index (BMI) BMI ≥ 18.0 and ≤ 30.0 kg/m2 at screening.
• Those who have no skin disorder or damage (including scars, tattoos, heavy freckle) that may affect the absorption of investigational product, or have no heavy hair in the drug application area.
• Those who have no congenital or chronic disease, or pathological symptoms or findings in the result of medical examination.
• Those who are judged eligible for this study upon judgment of the investigator in screening tests established depending on the characteristics of investigational product (examinations by interview, clinical laboratory test, vital signs, physical examinations, 12-lead electrocardiogram (ECG)).
• Those who have fully understood this clinical trial via detailed explanation, were willing to voluntarily participate in this study, and agreed to give written informed consent prior to the screening procedure.

You may not qualify if:

• Subjects who have the following prior/current history in addition to experience or history of clinically significant hepatic, renal, neurological, psychiatric, respiratory, endocrine, hematological, malignancy, urogenital, cardiovascular, digestive, or musculoskeletal disease:
• ① Atopic dermatitis ② Psoriasis ③ Eczema ④ Contact dermatitis ⑤Thrombocytopenia ⑥ Anemia ⑦ Neutropenia ⑧ Latent or active tuberculosis
• Subjects who have history of hypersensitivity (e.g., anaphylactic reaction or angioedema) to the drugs, including Janus kinase inhibitors and excipients, and other drugs (aspirin, penicillin antibiotics, macrolide antibiotics), or subjects who have history of clinically significant hypersensitivity.
• Suspected acute viral or bacterial infection within 2 weeks prior to the expected initial application date, or fever (body temperature in the tympanic membrane ≥ 38.0ºC) at the time of screening.
• The following clinically significant findings on 12-lead ECG at screening:
• QTc \> 450 ms
• PR interval \> 200 ms
• QRS duration \> 120 ms
• Any of the following abnormalities in clinical laboratory tests at screening:
• Blood count (platelet or ANC level \< 0.5 x lower limit of normal);
• Liver function test (AST, ALT, ALP, γ-GTP, or total bilirubin level is ≥ 2 x upper limit of normal);
• Serum creatinine level that is outside the reference range, or an estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m2 as determined by the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) Equation;
• Positive anti-HCV, HBs Ag, HIV Ag/Ab, Syphilis-RPR, or IGRA test.
• Subjects who received live vaccines within 3 months prior to the expected initial application date, or subjects who have a plan to receive live vaccines over a period from the informed consent to post-study visit (PSV).
• Subjects who have history of drug abuse, or who have a positive urine test for drugs of abuse.

Sponsors & Collaborators

• HK inno.N Corporation: lead

MeSH Terms

Interventions

pimecrolimus

Study Officials

• Min-kyu Park, MD, PhD

  Department of Clinical Pharmacology, Chungbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haerim Jang

CONTACT

+82-2-6477-0206; haerim.jang@inno-n.com

Jiwon Lee

CONTACT

+82-2-6477-0273; jiwon.lee@inno-n.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part A: Double-blind study (Only a person in charge of the IP application is unblinded) Part B: Open Label Study
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 15, 2023
• Study Start: February 13, 2023
• Primary Completion: February 25, 2023
• Study Completion: January 31, 2024
• Last Updated: February 15, 2023

Record last verified: 2023-02