Trial Outcomes & Findings for A Phase I Study of HY209 Gel in Healthy Male Volunteers for Atopic Dermatitis (NCT NCT03492398)
NCT ID: NCT03492398
Last Updated: 2021-01-29
Results Overview
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
56 participants
Primary outcome timeframe
upto Day 8(single dosing), upto Day 38(multiple dosing)
Results posted on
2021-01-29
Participant Flow
Participant milestones
| Measure |
Cohort A HY209 Placebo
single dose of placebo
total 8 subjects participated.
|
Cohort A HY209 0.05% Gel
single dose of HY209 0.05% gel
total 6 subjects participated.
|
Cohort A HY209 0.1% Gel
single dose of HY209 0.1% gel
total 6 subjects participated.
|
Cohort A HY209 0.3% Gel
single dose of HY209 0.3% gel
total 6 subjects participated.
|
Cohort A HY209 0.5% Gel
single dose of HY209 0.5% gel
total 6 subjects participated.
|
Cohort B Placebo
multiple dose of placebo
total 6 subjects participated.
|
Cohort B HY209 0.1% Gel
multiple dose of HY209 0.1% gel
total 6 subjects participated.
|
Cohort B HY209 0.3% Gel
multiple dose of HY209 0.3% gel
total 6 subjects participated.
|
Cohort B HY209 0.5% Gel
multiple dose of HY209 0.5% gel
total 6 subjects participated.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
8
|
6
|
6
|
6
|
6
|
6
|
5
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cohort A Placebo
n=8 Participants
single dose of placebo 8 subjects
|
Cohort A HY209 0.05% Gel
n=6 Participants
single dose of HY209 0.05% gel 6 subjects
|
Cohort A HY209 0.1% Gel
n=6 Participants
single dose of HY209 0.1% gel 6 subjects
|
Cohort A HY209 0.3% Gel
n=6 Participants
single dose of HY209 0.3% gel 6 subjects
|
Cohort A HY209 0.5% Gel
n=6 Participants
single dose of HY209 0.5% gel 6 subjects
|
Cohort B Placebo
n=6 Participants
multiple dose of placebo 6 subjects
|
Cohort B HY209 0.1% Gel
n=6 Participants
multiple dose of HY209 0.1% gel 6 subjects
|
Cohort B HY209 0.3% Gel
n=6 Participants
multiple dose of HY209 0.3% gel 6 subjects
|
Cohort B HY209 0.5% Gel
n=6 Participants
multiple dose of HY209 0.5% gel 6 subjects
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=56 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=8 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
56 Participants
n=56 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=56 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=56 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=8 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
56 Participants
n=56 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: upto Day 8(single dosing), upto Day 38(multiple dosing)Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
Outcome measures
| Measure |
Cohort A Placebo
n=8 Participants
single dose of placebo
total 8 subjects assigned.
|
Cohort A HY209 0.05% Gel
n=6 Participants
single dose of HY209 0.05% gel
total 6 subjects assigned.
|
Cohort A HY209 0.1% Gel
n=6 Participants
single dose of HY209 0.1% gel
total 6 subjects assigned.
|
Cohort A HY209 0.3% Gel
n=6 Participants
single dose of HY209 0.3% gel
total 6 subjects assigned.
|
Cohort A HY209 0.5% Gel
n=6 Participants
single dose of HY209 0.5% gel
total 6 subjects assinged.
|
Cohort B Placebo
n=6 Participants
multiple dose of placebo
total 6 subjects assigned.
|
Cohort B HY209 0.1% Gel
n=6 Participants
multiple dose of HY209 0.1% gel
total 6 subjects assigned.
|
Cohort B HY209 0.3% Gel
n=6 Participants
multiple dose of HY209 0.3% gel
total 6 subjects assigned.
|
Cohort B HY209 0.5% Gel
n=6 Participants
multiple dose of HY209 0.5% gel
total 6 subjects assigned.
|
|---|---|---|---|---|---|---|---|---|---|
|
Incidence of Treatment Emergent Adverse Events
|
4 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
Adverse Events
Cohort A HY209 Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort A HY209 0.05% Gel
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort A HY209 0.1% Gel
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort A HY209 0.3% Gel
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort A HY209 0.5% Gel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort B Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort B HY209 0.1% Gel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort B HY209 0.3% Gel
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort B HY209 0.5% Gel
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort A HY209 Placebo
n=8 participants at risk
single dose of placebo
total 8 subjects assigned.
|
Cohort A HY209 0.05% Gel
n=6 participants at risk
single dose of HY209 0.05% gel
total 6 subjects assigned.
|
Cohort A HY209 0.1% Gel
n=6 participants at risk
single dose of HY209 0.1% gel
total 6 subjects assigned.
|
Cohort A HY209 0.3% Gel
n=6 participants at risk
single dose of HY209 0.3% gel
total 6 subjects assigned.
|
Cohort A HY209 0.5% Gel
n=6 participants at risk
single dose of HY209 0.5% gel
total 6 subjects assigned.
|
Cohort B Placebo
n=6 participants at risk
multiple dose of placebo
total 6 subjects assigned.
|
Cohort B HY209 0.1% Gel
n=6 participants at risk
multiple dose of HY209 0.1% gel
total 6 subjects assigned.
|
Cohort B HY209 0.3% Gel
n=6 participants at risk
multiple dose of HY209 0.3%
total 6 subjects assigned.
|
Cohort B HY209 0.5% Gel
n=6 participants at risk
multiple dose of HY209 0.5%
total 6 subjects assigned.
|
|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Application site erythema
|
12.5%
1/8 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
|
General disorders
Appication site irritation
|
12.5%
1/8 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
16.7%
1/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
16.7%
1/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
|
General disorders
Application site pruritus
|
0.00%
0/8 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
16.7%
1/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
16.7%
1/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
16.7%
1/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
16.7%
1/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
16.7%
1/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
|
Gastrointestinal disorders
Epigastric discomfort
|
12.5%
1/8 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
1/8 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
0.00%
0/6 • upto Day 8(single dosing), upto Day 38(multiple dosing)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place