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

Not Applicable

Completed

• Conditions: Diseases of the skin and subcutaneous tissue

• Registration Number: KCT0006615
• Lead Sponsor: Yonsei University Health System, Severance Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-03-18
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 18

Inclusion Criteria

[Part. A]
A Korean male between the ages of 19 and 55, who has no clinically significant abnormalities as judged by the examiner during screening, such as physical examination, clinical laboratory examination, electrocardiogram examination, and medical history.

Exclusion Criteria

[Part A]
1) Those whose body mass index (BMI) is outside the range of 18.0 ~ 27.0kg/m2 at screening
2) Those with systolic blood pressure outside the range of 90 ~ 140 mmHg at screening, or those with diastolic blood pressure outside the range of 60 ~ 90 mmHg
3) At screening, QTc interval on 12-lead electrocardiogram exceeds 450 ms
4) Those who do not meet the following criteria in clinical laboratory tests at screening
• ALT, AST = 2.0 times the upper limit of normal (ULN)
• Total bilirubin, Serum Creatinine = 1.5 times the upper limit of normal (ULN)
• eGFR = 60 mL/min/1.73 m2
5) A person who has a history of alcohol or drug abuse or who has tested positive in a drug/alcohol screening test
6) When it is difficult for the investigator to evaluate the response to the drug because the site of application of the drug for clinical investigation falls under the following cases
• If you have a skin condition
• Damage to the appearance of the evaluation area that affects the evaluation, such as sunburn, excessive tanning, uneven skin tone, tattoos, scars, excessive body hair or freckles
7) Those with a previous history of atopic allergy (including asthma, urticaria, and eczema dermatitis), any type of allergic disease including food allergy, or psoriasis

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
[Part A] Safety evaluation

Secondary Outcome Measures

Name	Time	Method
[Part A] Tolerability evaluation