Clinical trial NCT05638165: A Single-center, Randomized, Double-blinded, Placebo-controlled, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of NCP112
Official title: Phase 1 Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of NCP112
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atopic Dermatitis
Lead sponsor: NovaCell Technology Inc.
Sponsor class: INDUSTRY
First posted: 2022-12-06
Enrollment: 18
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Single-center, Randomized, Double-blinded, Placebo-controlled
Primary purpose: TREATMENT

Brief summary: To evaluate safety, tolerability and pharmacokinetics of NCP 112 after single and multiple applications on the skin of healthy male volunteers.

Detailed description: Atopic dermatitis is presented as eczematous lesions. Some rashes, discharge, and blisters appear at the acute stage and skin lesions of lichenification appear as the skin becomes thick and leathery at the chronic stage. If not treated properly, a vicious cycle of inflammation of the immune system and further damage to the skin barrier is produced. In particular, enhanced immune reaction to external environmental stimuli plays a major role in inducing pruritis, an essential feature of atopic dermatitis. Pruritis triggers scratching, which in turn leads to an 'itch-scratch-itch' vicious cycle', resulting in secondary skin changes. Therefore, it is important to break the vicious cycle, which worsens the symptoms by means of an optimal treatment.

NCP112 is a first-in-class drug candidate, with a novel target strategy for atopic dermatitis, different from those of the other currently available drugs; The Investigators believe that NCP112 might show a potential as an effective therapy for atopic dermatitis in animal models. Since the efficacy and safety have not been fully elucidated, new adverse reactions, unidentified from the non-clinical data, could appear later. Provided that NCP112 effectively alleviates atopic dermatitis, an intractable chronic disease, it is presumed that the expected benefits would outweigh the foreseeable risks. In the present trial, safety, including occurrences of adverse drug reactions, was thoroughly observed.

This trial was designed as a single-center, block-randomized, double-blind, placebo-controlled, single and multiple dose-ascending trial in which subjects were allocated to either topical application of NCP112 or placebo (vehicle).

The purpose of the present trial was to primarily access the safety of NCP112, the test drug of the trial, in healthy male adults prior to administer the test drug to the real patients with atopic dermatitis, the proposed indication.

Eligibility criteria: Inclusion Criteria:

1. A Subject who received and fully understood detailed explanations about the present clinical trial, and whose written consent to participate in the trial and adhere to the precautions was voluntarily obtained before any screening procedures
2. A healthy Korean male adult of age 19 to 55 years of age, inclusive, on the day of signing the informed consent form
3. A Subject who did not have any clinically significant abnormalities observed in physical examination, clinical laboratory tests, electrocardiography, and medical history at the investigator's discretion during the screening
4. A Subject who was able to communicate in Korean with the investigator and comply with the requirements of the protocol as judged by the investigator

Exclusion Criteria:

1. A subject who had a body mass index (BMI) outside the 18.0 \~ 27.0 kg/m² at screening.
2. A subject who had a systolic blood pressure outside the 90 \~ 140 mmHg at screening; or A subject who had a diastolic blood pressure outside the 60 \~ 90 mmHg at screening
3. QTc interval exceeding 450 ms on a 12-lead electrocardiogram at screening
4. A subject who did not meet the following criteria as to the clinical laboratory tests at screening

   * ALT, AST ≤ upper normal level (ULN)x 2.0
   * Total bilirubin, Serum Creatinine ≤ upper normal level (ULN)x 1.5
   * eGFR ≥ 60 mL/min/1.73m²
5. A subject who has a history of alcohol or drug abuse; or has a positive test result for drug/alcohol abuse at screening
6. At the discretion of the investigator, the condition for the cutaneous application of the IP is not suitable for assessment due to the following reasons

   * Dermatologic diseases
   * Damaged skin area to be assessed not suitable for assessment due to sun burn, excessive tanning, uneven skin tone, tattoo, scar, excessive body hair or freckles
7. A subject who has a known history of any allergic diseases such as atopic/allergic diseases (asthma, urticaria, eczematous dermatitis) and food allergy; or eczema
8. A subject who has a known history of allergy or hypersensitivity to any component of the formulation of the IP or peptide drug
9. A subject who has taken any medicine (prescription and non-prescription drug, oriental herbal medicine, health supplementary food, nutritional Supplements) within 2 weeks of the IP dosing
10. A subject who has participated in any clinical trial and taken any IP within 6 months of the IP dosing

Primary outcomes:
measure: Safety and Tolerability
timeFrame: Having observe the predefined safety events from Day 1(the first day of dosing) until Day 8(the day following the final dose)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References: