A Phase I Study of HY209 Gel in Healthy Male Volunteers for Atopic Dermatitis

• Status: Completed
• Trial end date: 2019-05-28
• Target enrollment: 0
• Participant gender: Male

Summary

A randomized, double-blind, placebo-controlled single and multiple dosing, dose escalation phase I clinical trial to investigate the safety/tolerability and pharmacokinetics of HY209 gel after transdermal administration in healthy male volunteers as a possible treatment option for atopic dermatitis

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

Details

• Lead Sponsor: Shaperon

Criteria

Inclusion Criteria:

• Healthy male aged from 20 to 50 at screening test

• Weight 45kg ~ 90kg with BMI 17kg/m2 ~ 27kg/m2

• No skin diseases, no skin damages(scars, tattoo, etc), no hairy skin

Exclusion Criteria:

• Those who have a history of hypersensitivity or clinically significant hypersensitivity reactions to generic drugs (aspirin, antibiotics, etc.)

• Those who have clinically significant liver, kidney, respiratory, endocrine, neurologic diseases or hematologic diseases, mental diseases, especially hemorrhagic diseases (hemophilia, von Willebrand disease, etc.), cardiovascular diseases (coronary artery disease, Congestive heart failure, arrhythmia, cerebrovascular disease, etc.) or who have a history of those diseases

• Those who had clinical symptoms suspected of acute infectious disease within 2 weeks before the scheduled date of the first administration, or whose temperature measured by the screening test (eardrum) was 38.0 ° C or higher

• Those who have taken any prescription drugs, herbal medicines, crude drugs within 2 weeks before the scheduled date of administration of the medicines for clinical trials , or over-the-counter medicines or vitamin preparations within 1 week.

• Those who have a history of substance abuse, or positive urine screening tests (cannabinoid, opiates, amphetamine, cocaine, barbiturate, benzodiazepine)

• Those who have a history of smoking within 3 months (However, if they quit smoking three months before the first scheduled medication, they are eligible for selection)

• Those who have been found to be positive in serological tests (HBs antigen, hepatitis C virus antibody and HIV antibody)

• Those who drink continuously (above 21 units / week, 1 unit = 10 g of pure alcohol)

• Those who have been taking medicines by participating in other clinical trials or bioequivalence studies within 3 months prior to the date of first dosing

• Those who have been bleeding, blood drawings or blood donation of 400mL or more within 8 weeks before the scheduled date of administration of the drug for clinical trials

• Those who have vital signs measured at sitting position after the break for more than 3 minutes,

• Low blood pressure (systolic blood pressure <90 mmHg, diastolic blood pressure <50 mmHg)

• High blood pressure (systolic blood pressure greater than 150 mmHg, diastolic blood pressure greater than 100 mmHg)

• Test subjects who are deemed unsuitable for participating in clinical trials due to clinical laboratory tests, ECG results, or other reasons