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

• Status: Completed
• Trial end date: 2021-11-20
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: NovaCell Technology Inc.

Criteria

Inclusion Criteria:

1. 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

2. A healthy Korean male adult of age 19 to 55 years of age, inclusive, on the day of signing the informed consent form

3. 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

4. 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:

1. A subject who had a body mass index (BMI) outside the 18.0 ~ 27.0 kg/m² at screening.

2. 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

3. QTc interval exceeding 450 ms on a 12-lead electrocardiogram at screening

4. 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

5. A subject who has a history of alcohol or drug abuse; or has a positive test result for drug/alcohol abuse at screening

6. 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

7. 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

8. A subject who has a known history of allergy or hypersensitivity to any component of the formulation of the IP or peptide drug

9. 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

10. A subject who has participated in any clinical trial and taken any IP within 6 months of the IP dosing