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A Single-center, Randomized, Double-blinded, Placebo-controlled, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of NCP112

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
NCP112
Sponsored by
NovaCell Technology Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

19 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: 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 A healthy Korean male adult of age 19 to 55 years of age, inclusive, on the day of signing the informed consent form 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 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: A subject who had a body mass index (BMI) outside the 18.0 ~ 27.0 kg/m² at screening. 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 QTc interval exceeding 450 ms on a 12-lead electrocardiogram at screening 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 A subject who has a history of alcohol or drug abuse; or has a positive test result for drug/alcohol abuse at screening 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 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 A subject who has a known history of allergy or hypersensitivity to any component of the formulation of the IP or peptide drug 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 A subject who has participated in any clinical trial and taken any IP within 6 months of the IP dosing

Sites / Locations

  • Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort QD, NCP112 Gel 0.05%

Cohort BID, NCP112 Gel 0.05%

Arm Description

Single dose of NCP112 Gel 0.05% or Single dose of Placebo

Multiple dose of NCP112 Gel 0.05% or Multiple dose of Placebo

Outcomes

Primary Outcome Measures

Safety and Tolerability
Occurrences of 'dosage limiting' toxicity will evaluate in the subjects included in the Safety Set.

Secondary Outcome Measures

Full Information

First Posted
November 25, 2022
Last Updated
December 15, 2022
Sponsor
NovaCell Technology Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05638165
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 13, 2021 (Actual)
Primary Completion Date
November 20, 2021 (Actual)
Study Completion Date
November 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NovaCell Technology Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
A Single-center, Randomized, Double-blinded, Placebo-controlled
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort QD, NCP112 Gel 0.05%
Arm Type
Experimental
Arm Description
Single dose of NCP112 Gel 0.05% or Single dose of Placebo
Arm Title
Cohort BID, NCP112 Gel 0.05%
Arm Type
Experimental
Arm Description
Multiple dose of NCP112 Gel 0.05% or Multiple dose of Placebo
Intervention Type
Drug
Intervention Name(s)
NCP112
Intervention Description
The first two subjects for sentinel dosing are randomly assigned to either the test drug or placebo in a 1:1 ratio. After safety and tolerability were reviewed for sentinel participants up to 24 hours after dosing, the subsequent 7 subjects are randomized to the remaining treatment allocations, with 5 subjects to the test drug and 2 to the placebo.
Primary Outcome Measure Information:
Title
Safety and Tolerability
Description
Occurrences of 'dosage limiting' toxicity will evaluate in the subjects included in the Safety Set.
Time Frame
Having observe the predefined safety events from Day 1(the first day of dosing) until Day 8(the day following the final dose)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 A healthy Korean male adult of age 19 to 55 years of age, inclusive, on the day of signing the informed consent form 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 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: A subject who had a body mass index (BMI) outside the 18.0 ~ 27.0 kg/m² at screening. 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 QTc interval exceeding 450 ms on a 12-lead electrocardiogram at screening 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 A subject who has a history of alcohol or drug abuse; or has a positive test result for drug/alcohol abuse at screening 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 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 A subject who has a known history of allergy or hypersensitivity to any component of the formulation of the IP or peptide drug 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 A subject who has participated in any clinical trial and taken any IP within 6 months of the IP dosing
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Single-center, Randomized, Double-blinded, Placebo-controlled, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of NCP112

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