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

NCT03492398 | Completed Phase 1 Results

• 1 other identifier: HY209-202
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment Emergent Adverse Events

  Number of participants with abnormal laboratory values and/or adverse events that are related to treatment

  upto Day 8(single dosing), upto Day 38(multiple dosing)

Study Arms (7)

Cohort A HY209 0.05% gel

EXPERIMENTAL

single dose of HY209 0.05% gel or single dose of placebo

Drug: HY209

Cohort A HY209 0.1% gel

EXPERIMENTAL

single dose of HY209 0.1% gel or single dose of placebo

Drug: HY209

Cohort A HY209 0.3% gel

EXPERIMENTAL

single dose of HY209 0.3% gel or single dose of placebo

Drug: HY209

Cohort A HY209 0.5% gel

EXPERIMENTAL

single dose of HY209 0.5% gel or single dose of placebo

Drug: HY209

Cohort B HY209 0.1% gel

EXPERIMENTAL

multiple dose of HY209 0.1% gel or multiple dose of placebo

Drug: HY209

Cohort B HY209 0.3% gel

EXPERIMENTAL

multiple dose of HY209 0.3% gel or multiple dose of placebo

Drug: HY209

Cohort B HY209 0.5% gel

EXPERIMENTAL

multiple dose of HY209 0.5% gel or multiple dose of placebo

Drug: HY209

Interventions

HY209 DRUG

6 subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.

Also known as: HY209 gel

Cohort A HY209 0.05% gel; Cohort A HY209 0.1% gel; Cohort A HY209 0.3% gel; Cohort A HY209 0.5% gel; Cohort B HY209 0.1% gel; Cohort B HY209 0.3% gel; Cohort B HY209 0.5% gel

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shaperon: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, 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

Results Point of Contact

• Title: Inseung Jeon
• Organization: Seoul National University Hospital

isjeon0127@snu.ac.kr

82-2-2072-1920

Study Officials

• Kyungsang Yu, Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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 randomized, double blind, placebo-controlled, single and multiple dosing, dose escalation study

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: April 10, 2018
• Study Start: January 29, 2018
• Primary Completion: March 21, 2019
• Study Completion: May 28, 2019
• Last Updated: January 29, 2021
• Results First Posted: October 19, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)