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

NCT05638165 | Completed Phase 1 DMC

• 1 other identifier: NCP112-101
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability

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

  Having observe the predefined safety events from Day 1(the first day of dosing) until Day 8(the day following the final dose)

Study Arms (2)

Cohort QD, NCP112 Gel 0.05%

EXPERIMENTAL

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

Drug: NCP112

Cohort BID, NCP112 Gel 0.05%

EXPERIMENTAL

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

Drug: NCP112

Interventions

NCP112 DRUG

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.

Cohort BID, NCP112 Gel 0.05%; Cohort QD, NCP112 Gel 0.05%

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NovaCell Technology Inc.: lead

Study Sites (1)

Severance Hospital

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Single-center, Randomized, Double-blinded, Placebo-controlled

Study Record Dates

• First Submitted: November 25, 2022
• First Posted: December 6, 2022
• Study Start: October 13, 2021
• Primary Completion: November 20, 2021
• Study Completion: November 20, 2021
• Last Updated: December 19, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)