Atopic DermatitisPhase 1NCT05638165
A Single-center, Randomized, Double-blinded, Placebo-controlled, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of NCP112
A Phase 1 study testing NCP112 in people with Atopic Dermatitis, run by NovaCell Technology Inc. at 1 site in South Korea.
Trial summary
To evaluate safety, tolerability and pharmacokinetics of NCP 112 after single and multiple applications on the skin of healthy male volunteers. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- NCP112
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Oct 2021to 20 Nov 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of NCP112
To evaluate safety, tolerability and pharmacokinetics of NCP 112 after single and multiple applications on the skin of healthy male volunteers.
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- NCP112
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NCP112Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort QD, NCP112 Gel 0.05% | Experimental | Single dose of NCP112 Gel 0.05% or Single dose of Placebo Receives: Drug: NCP112 |
| Cohort BID, NCP112 Gel 0.05% | Experimental | Multiple dose of NCP112 Gel 0.05% or Multiple dose of Placebo Receives: Drug: NCP112 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Occurrences of 'dosage limiting' toxicity will evaluate in the subjects included in the Safety Set.
Measured: Having observe the predefined safety events from Day 1(the first day of dosing) until Day 8(the day following the final dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start13 Oct 2021
- Primary completion20 Nov 2021
- Study completion20 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Single-center, Randomized, Double-blinded, Placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovaCell Technology Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638165
- Sponsor's protocol ID
- NCP112-101
- Status last verified
- Nov 2022
- First submitted
- 25 Nov 2022
- Last updated
- 19 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of NCP112
- ClinicalTrials.gov ID
- NCT05638165
- Acronym / sponsor ID
- NCP112-101
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- NovaCell Technology Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Oct 2021 (actual)
- Primary completion
- 20 Nov 2021 (actual)
- Study completion
- 20 Nov 2021 (actual)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A Single-center, Randomized, Double-blinded, Placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Cohort QD, NCP112 Gel 0.05% | Experimental | Drug: NCP112Single dose of NCP112 Gel 0.05% or Single dose of Placebo |
| Cohort BID, NCP112 Gel 0.05% | Experimental | Drug: NCP112Multiple dose of NCP112 Gel 0.05% or Multiple dose of Placebo |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
- A subject who has a history of alcohol or drug abuse; or has a positive test result for drug/alcohol abuse at screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NCP112The 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. | Drug | Cohort BID, NCP112 Gel 0.05%, Cohort QD, NCP112 Gel 0.05% |
Primary outcome
Safety and Tolerability
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)
Occurrences of 'dosage limiting' toxicity will evaluate in the subjects included in the Safety Set.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NCP112 in people with Atopic Dermatitis, run by NovaCell Technology Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2022.