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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0006615

Enrollment

Registered

2021-09-29

Start date

2021-10-13

Completion date

Unknown

Last updated

2022-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : This study is conducted in two phases. First, a single and repeated dosing test was performed on a small number of healthy subjects to evaluate safety, tolerability, and pharmacokinetic propert

Eligibility

Sex/Gender

Male

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
[Part A] Safety evaluation	—

Secondary

Measure	Time frame
[Part A] Tolerability evaluation	—

Countries

Korea, Republic of

Contacts

Public ContactMin Soo Park

Yonsei University Health System, Severance Hospital

minspark@yuhs.ac+82-2-2228-0401

Outcome results