Trial Outcomes & Findings for Topically Applied AMTX-100 CF for Adult Patients With Mild to Moderate Atopic Dermatitis (NCT NCT04313400)
NCT ID: NCT04313400
Last Updated: 2025-05-02
Results Overview
Maximum Tolerable Dose (MTD) by maximum percentage of Body Surface Area (BSA) treated, by evaluation of dose-limiting toxicity (DLT) of AMTX-100 CF (1.1% w/w concentration) based on the safety profile
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
91 participants
Primary outcome timeframe
Over the 7-day treatment period
Results posted on
2025-05-02
Participant Flow
Participant milestones
| Measure |
Part 1 Dose Escalation: Cohort 1
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 3-6% of the BSA (3% BSA ≤ AD Affected Area ≤ 6% BSA)
|
Part 1 Dose Escalation: Cohort 2
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 6-12% of the BSA (6% BSA \< AD Affected Area ≤ 12% BSA)
|
Part 1 Dose Escalation: Cohort 3
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 12-24% of the BSA (12% BSA \< AD Affected Area ≤ 24% BSA)
|
Part 1 Dose Escalation: Cohort 4
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 24-48% of the BSA (24% BSA \< AD Affected Area ≤ 48% BSA)
|
Part 1 Dose Escalation: Cohort 5
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 48-70% of the BSA (48% BSA \< AD Affected Area ≤ 70% BSA)
|
Part 2 Group A: 1.1% w/w
AMTX-100 CF3 (1.1% w/w), topically applied twice a day for 28 consecutive days to all treatable AD affected areas
|
Part 2 Group B: Placebo
Placebo (Vehicle) (0% w/w), topically applied twice a day for 28 consecutive days to all treatable AD affected areas
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
4
|
7
|
33
|
32
|
|
Overall Study
COMPLETED
|
5
|
5
|
5
|
4
|
7
|
27
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
6
|
1
|
Reasons for withdrawal
| Measure |
Part 1 Dose Escalation: Cohort 1
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 3-6% of the BSA (3% BSA ≤ AD Affected Area ≤ 6% BSA)
|
Part 1 Dose Escalation: Cohort 2
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 6-12% of the BSA (6% BSA \< AD Affected Area ≤ 12% BSA)
|
Part 1 Dose Escalation: Cohort 3
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 12-24% of the BSA (12% BSA \< AD Affected Area ≤ 24% BSA)
|
Part 1 Dose Escalation: Cohort 4
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 24-48% of the BSA (24% BSA \< AD Affected Area ≤ 48% BSA)
|
Part 1 Dose Escalation: Cohort 5
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 48-70% of the BSA (48% BSA \< AD Affected Area ≤ 70% BSA)
|
Part 2 Group A: 1.1% w/w
AMTX-100 CF3 (1.1% w/w), topically applied twice a day for 28 consecutive days to all treatable AD affected areas
|
Part 2 Group B: Placebo
Placebo (Vehicle) (0% w/w), topically applied twice a day for 28 consecutive days to all treatable AD affected areas
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
4
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Topically Applied AMTX-100 CF for Adult Patients With Mild to Moderate Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Part 1 Dose Escalation: Cohort 1
n=5 Participants
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 3-6% of the BSA (3% BSA ≤ AD Affected Area ≤ 6% BSA)
|
Part 1 Dose Escalation: Cohort 2
n=5 Participants
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 6-12% of the BSA (6% BSA \< AD Affected Area ≤ 12% BSA)
|
Part 1 Dose Escalation: Cohort 3
n=5 Participants
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 12-24% of the BSA (12% BSA \< AD Affected Area ≤ 24% BSA)
|
Part 1 Dose Escalation: Cohort 4
n=4 Participants
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 24-48% of the BSA (24% BSA \< AD Affected Area ≤ 48% BSA)
|
Part 1 Dose Escalation: Cohort 5
n=7 Participants
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 48-70% of the BSA (48% BSA \< AD Affected Area ≤ 70% BSA)
|
Part 2 Group A: 1.1% w/w
n=33 Participants
AMTX-100 CF3 (1.1% w/w), topically applied twice a day for 28 consecutive days to all treatable AD affected areas
|
Part 2 Group B: Placebo
n=32 Participants
Placebo (Vehicle) (0% w/w), topically applied twice a day for 28 consecutive days to all treatable AD affected areas
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
51.6 years
n=99 Participants
|
41.4 years
n=107 Participants
|
40.6 years
n=206 Participants
|
62.8 years
n=7 Participants
|
49.4 years
n=31 Participants
|
46.1 years
n=30 Participants
|
46.0 years
n=3 Participants
|
47.35 years
n=6 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
20 Participants
n=30 Participants
|
17 Participants
n=3 Participants
|
49 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
13 Participants
n=30 Participants
|
15 Participants
n=3 Participants
|
42 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
10 Participants
n=30 Participants
|
13 Participants
n=3 Participants
|
27 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
23 Participants
n=30 Participants
|
19 Participants
n=3 Participants
|
64 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
12 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
10 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
30 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
13 Participants
n=30 Participants
|
20 Participants
n=3 Participants
|
43 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
|
Height (cm)
|
162.7 centimeter
n=99 Participants
|
171.9 centimeter
n=107 Participants
|
168.0 centimeter
n=206 Participants
|
169.3 centimeter
n=7 Participants
|
167.7 centimeter
n=31 Participants
|
167.5 centimeter
n=30 Participants
|
168.6 centimeter
n=3 Participants
|
167.95 centimeter
n=6 Participants
|
|
Weight (kg)
|
69.0 Kilogram
n=99 Participants
|
88.9 Kilogram
n=107 Participants
|
64.5 Kilogram
n=206 Participants
|
75.4 Kilogram
n=7 Participants
|
80.2 Kilogram
n=31 Participants
|
81.2 Kilogram
n=30 Participants
|
82.3 Kilogram
n=3 Participants
|
78.85 Kilogram
n=6 Participants
|
|
BMI (kg/m2)
|
26.1 kilogram per meter squared
n=99 Participants
|
30.1 kilogram per meter squared
n=107 Participants
|
23.1 kilogram per meter squared
n=206 Participants
|
26.2 kilogram per meter squared
n=7 Participants
|
28.6 kilogram per meter squared
n=31 Participants
|
28.9 kilogram per meter squared
n=30 Participants
|
28.9 kilogram per meter squared
n=3 Participants
|
27.95 kilogram per meter squared
n=6 Participants
|
|
BSA (m2)
|
1.8 meter squared
n=99 Participants
|
2.0 meter squared
n=107 Participants
|
1.7 meter squared
n=206 Participants
|
1.9 meter squared
n=7 Participants
|
1.9 meter squared
n=31 Participants
|
1.9 meter squared
n=30 Participants
|
2.0 meter squared
n=3 Participants
|
1.9 meter squared
n=6 Participants
|
PRIMARY outcome
Timeframe: Over the 7-day treatment periodMaximum Tolerable Dose (MTD) by maximum percentage of Body Surface Area (BSA) treated, by evaluation of dose-limiting toxicity (DLT) of AMTX-100 CF (1.1% w/w concentration) based on the safety profile
Outcome measures
| Measure |
Part 1 Dose Escalation: 3% to 70% of the BSA
n=26 Participants
Open-label, five (5) cohorts were sequentially enrolled. AMTX-100 CF 1.1% w/w, topically applied twice a day for 7 consecutive days to all treatable AD affected areas from 3% to 70% of the Body Surface Area (BSA) (3% BSA ≤ AD Affected Area ≤ 70% BSA)
|
Part 2 Group B: Placebo
Placebo (Vehicle) (0% w/w), topically applied twice a day for 28 consecutive days to all treatable AD affected areas
|
Part 1 Dose Escalation: Cohort 3
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 12-24% of the BSA (12% BSA \< AD Affected Area ≤ 24% BSA)
|
Part 1 Dose Escalation: Cohort 4
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 24-48% of the BSA (24% BSA \< AD Affected Area ≤ 48% BSA)
|
Part 1 Dose Escalation: Cohort 5
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 48-70% of the BSA (48% BSA \< AD Affected Area ≤ 70% BSA)
|
|---|---|---|---|---|---|
|
Part 1 (Phase I) Primary: Maximum Tolerable Dose
|
29.2 Grams of IP per application
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 28Population: There were missing subjects in both groups.
Proportion of responder subjects at Day 28, defined as subjects with both Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) score of 0 (clear) or 1 (almost clear) (on a 5-point scale) and a reduction of ≥ 2 points from baseline Note: Subjects who have received rescue treatments will be considered non-responders Note: We acknowledge that the "percentage" was reported, while the outcome measure indicates "proportion". It was concluded that using "percentage" represents the results more apparent.
Outcome measures
| Measure |
Part 1 Dose Escalation: 3% to 70% of the BSA
n=26 Participants
Open-label, five (5) cohorts were sequentially enrolled. AMTX-100 CF 1.1% w/w, topically applied twice a day for 7 consecutive days to all treatable AD affected areas from 3% to 70% of the Body Surface Area (BSA) (3% BSA ≤ AD Affected Area ≤ 70% BSA)
|
Part 2 Group B: Placebo
n=31 Participants
Placebo (Vehicle) (0% w/w), topically applied twice a day for 28 consecutive days to all treatable AD affected areas
|
Part 1 Dose Escalation: Cohort 3
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 12-24% of the BSA (12% BSA \< AD Affected Area ≤ 24% BSA)
|
Part 1 Dose Escalation: Cohort 4
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 24-48% of the BSA (24% BSA \< AD Affected Area ≤ 48% BSA)
|
Part 1 Dose Escalation: Cohort 5
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 48-70% of the BSA (48% BSA \< AD Affected Area ≤ 70% BSA)
|
|---|---|---|---|---|---|
|
Part 2 (Phase II) Primary: Proportion of Responder Subjects at Day 28
|
3.8 Percentage of Responder Subjects
|
9.7 Percentage of Responder Subjects
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Days 7, 14, 21, 28, and 42Population: There were missing subjects in both groups.
The 5-point Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD™) is a validated measure of disease severity and success of atopic dermatitis treatments in clinical trials. The ratings (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe) are an overall assessment of AD skin lesions, based on the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Outcome measures
| Measure |
Part 1 Dose Escalation: 3% to 70% of the BSA
n=33 Participants
Open-label, five (5) cohorts were sequentially enrolled. AMTX-100 CF 1.1% w/w, topically applied twice a day for 7 consecutive days to all treatable AD affected areas from 3% to 70% of the Body Surface Area (BSA) (3% BSA ≤ AD Affected Area ≤ 70% BSA)
|
Part 2 Group B: Placebo
n=32 Participants
Placebo (Vehicle) (0% w/w), topically applied twice a day for 28 consecutive days to all treatable AD affected areas
|
Part 1 Dose Escalation: Cohort 3
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 12-24% of the BSA (12% BSA \< AD Affected Area ≤ 24% BSA)
|
Part 1 Dose Escalation: Cohort 4
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 24-48% of the BSA (24% BSA \< AD Affected Area ≤ 48% BSA)
|
Part 1 Dose Escalation: Cohort 5
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 48-70% of the BSA (48% BSA \< AD Affected Area ≤ 70% BSA)
|
|---|---|---|---|---|---|
|
Part 2 (Phase II) Secondary Efficacy Endpoints: Percent Change From Baseline in vIGA-AD™ at Days 7, 14, 21, 28, and 42
End of Treatment (Day 28)
|
-14.1 percentage of vIGA-AD change at visits
Standard Deviation 26.54
|
-20.4 percentage of vIGA-AD change at visits
Standard Deviation 27.79
|
—
|
—
|
—
|
|
Part 2 (Phase II) Secondary Efficacy Endpoints: Percent Change From Baseline in vIGA-AD™ at Days 7, 14, 21, 28, and 42
Follow-Up (Day 42)
|
-16.7 percentage of vIGA-AD change at visits
Standard Deviation 30.31
|
-26.1 percentage of vIGA-AD change at visits
Standard Deviation 34.93
|
—
|
—
|
—
|
|
Part 2 (Phase II) Secondary Efficacy Endpoints: Percent Change From Baseline in vIGA-AD™ at Days 7, 14, 21, 28, and 42
Visit 3 (Day 7)
|
-2.6 percentage of vIGA-AD change at visits
Standard Deviation 14.73
|
-5.7 percentage of vIGA-AD change at visits
Standard Deviation 13.79
|
—
|
—
|
—
|
|
Part 2 (Phase II) Secondary Efficacy Endpoints: Percent Change From Baseline in vIGA-AD™ at Days 7, 14, 21, 28, and 42
Visit 4 (Day 14)
|
-6.1 percentage of vIGA-AD change at visits
Standard Deviation 16.66
|
-11.5 percentage of vIGA-AD change at visits
Standard Deviation 19.6
|
—
|
—
|
—
|
|
Part 2 (Phase II) Secondary Efficacy Endpoints: Percent Change From Baseline in vIGA-AD™ at Days 7, 14, 21, 28, and 42
Visit 5 (Day 21)
|
-11.9 percentage of vIGA-AD change at visits
Standard Deviation 22.16
|
-14.1 percentage of vIGA-AD change at visits
Standard Deviation 22.44
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 7, 14, 21, and 28Population: There were missing subjects in both groups.
The 5-point Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD™) is a validated measure of disease severity and success of atopic dermatitis treatments in clinical trials. The ratings (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe) are an overall assessment of AD skin lesions, based on the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Note: We acknowledge that the "percentage" is reported, while the outcome measure indicates "proportion". It was concluded that using "percentage" represents the results more apparent.
Outcome measures
| Measure |
Part 1 Dose Escalation: 3% to 70% of the BSA
n=33 Participants
Open-label, five (5) cohorts were sequentially enrolled. AMTX-100 CF 1.1% w/w, topically applied twice a day for 7 consecutive days to all treatable AD affected areas from 3% to 70% of the Body Surface Area (BSA) (3% BSA ≤ AD Affected Area ≤ 70% BSA)
|
Part 2 Group B: Placebo
n=32 Participants
Placebo (Vehicle) (0% w/w), topically applied twice a day for 28 consecutive days to all treatable AD affected areas
|
Part 1 Dose Escalation: Cohort 3
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 12-24% of the BSA (12% BSA \< AD Affected Area ≤ 24% BSA)
|
Part 1 Dose Escalation: Cohort 4
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 24-48% of the BSA (24% BSA \< AD Affected Area ≤ 48% BSA)
|
Part 1 Dose Escalation: Cohort 5
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 48-70% of the BSA (48% BSA \< AD Affected Area ≤ 70% BSA)
|
|---|---|---|---|---|---|
|
Part 2 (Phase II) Secondary Efficacy Endpoints: Proportion of Subjects at Days 7, 14, 21, 28, and 42 With Both vIGA-AD™ Score of 0 (Clear) or 1 (Almost Clear) on a 5-point Scale and a Reduction of ≥ 1 Point From Baseline
Visit 3 (Day 7)
|
0 Percent of Subjects With vIGA-AD of 0/1
|
3.1 Percent of Subjects With vIGA-AD of 0/1
|
—
|
—
|
—
|
|
Part 2 (Phase II) Secondary Efficacy Endpoints: Proportion of Subjects at Days 7, 14, 21, 28, and 42 With Both vIGA-AD™ Score of 0 (Clear) or 1 (Almost Clear) on a 5-point Scale and a Reduction of ≥ 1 Point From Baseline
Visit 4 (Day 14)
|
6.7 Percent of Subjects With vIGA-AD of 0/1
|
9.4 Percent of Subjects With vIGA-AD of 0/1
|
—
|
—
|
—
|
|
Part 2 (Phase II) Secondary Efficacy Endpoints: Proportion of Subjects at Days 7, 14, 21, 28, and 42 With Both vIGA-AD™ Score of 0 (Clear) or 1 (Almost Clear) on a 5-point Scale and a Reduction of ≥ 1 Point From Baseline
Visit 5 (Day 21)
|
14.3 Percent of Subjects With vIGA-AD of 0/1
|
12.5 Percent of Subjects With vIGA-AD of 0/1
|
—
|
—
|
—
|
|
Part 2 (Phase II) Secondary Efficacy Endpoints: Proportion of Subjects at Days 7, 14, 21, 28, and 42 With Both vIGA-AD™ Score of 0 (Clear) or 1 (Almost Clear) on a 5-point Scale and a Reduction of ≥ 1 Point From Baseline
End of Treatment (Day 28)
|
11.5 Percent of Subjects With vIGA-AD of 0/1
|
25.8 Percent of Subjects With vIGA-AD of 0/1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Days 7, 14, 21, 28, and 42Population: There were missing subjects in both groups.
The Eczema Area and Severity Index (EASI) is a validated measure to assess the severity and extent of AD (Hanifin et al., 2001). The EASI is a composite index with scores ranging from 0 to 72, where a higher score indicates increased extent and severity of atopic dermatitis.
Outcome measures
| Measure |
Part 1 Dose Escalation: 3% to 70% of the BSA
n=33 Participants
Open-label, five (5) cohorts were sequentially enrolled. AMTX-100 CF 1.1% w/w, topically applied twice a day for 7 consecutive days to all treatable AD affected areas from 3% to 70% of the Body Surface Area (BSA) (3% BSA ≤ AD Affected Area ≤ 70% BSA)
|
Part 2 Group B: Placebo
n=32 Participants
Placebo (Vehicle) (0% w/w), topically applied twice a day for 28 consecutive days to all treatable AD affected areas
|
Part 1 Dose Escalation: Cohort 3
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 12-24% of the BSA (12% BSA \< AD Affected Area ≤ 24% BSA)
|
Part 1 Dose Escalation: Cohort 4
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 24-48% of the BSA (24% BSA \< AD Affected Area ≤ 48% BSA)
|
Part 1 Dose Escalation: Cohort 5
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 48-70% of the BSA (48% BSA \< AD Affected Area ≤ 70% BSA)
|
|---|---|---|---|---|---|
|
Part 2 (Phase II) Secondary Efficacy Endpoints: Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Days 7, 14, 21, 28 and 42
Visit 3 (Day 7)
|
-7.7 Percent Change from Baseline in EASI
Standard Deviation 21.4
|
-10.7 Percent Change from Baseline in EASI
Standard Deviation 19.13
|
—
|
—
|
—
|
|
Part 2 (Phase II) Secondary Efficacy Endpoints: Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Days 7, 14, 21, 28 and 42
Visit 4 (Day 14)
|
-16.0 Percent Change from Baseline in EASI
Standard Deviation 22.55
|
-20.9 Percent Change from Baseline in EASI
Standard Deviation 29.27
|
—
|
—
|
—
|
|
Part 2 (Phase II) Secondary Efficacy Endpoints: Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Days 7, 14, 21, 28 and 42
Visit 5 (Day 21)
|
-29.0 Percent Change from Baseline in EASI
Standard Deviation 28.7
|
-23.7 Percent Change from Baseline in EASI
Standard Deviation 35.17
|
—
|
—
|
—
|
|
Part 2 (Phase II) Secondary Efficacy Endpoints: Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Days 7, 14, 21, 28 and 42
End of Treatment (Day 28)
|
-29.9 Percent Change from Baseline in EASI
Standard Deviation 32.98
|
-34.5 Percent Change from Baseline in EASI
Standard Deviation 43.29
|
—
|
—
|
—
|
|
Part 2 (Phase II) Secondary Efficacy Endpoints: Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Days 7, 14, 21, 28 and 42
Follow-Up (Day 42)
|
-32.5 Percent Change from Baseline in EASI
Standard Deviation 39.02
|
-41.9 Percent Change from Baseline in EASI
Standard Deviation 38.27
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 7, 14, 21, 28, and 42Population: There were missing subjects in both groups.
The Eczema Area and Severity Index (EASI) is a validated measure to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, where a higher score indicates increased extent and severity of atopic dermatitis. Note: We acknowledge that the "percentage" is reported, while the outcome measure indicates "proportion". It was concluded that using "percentage" represents the results more apparent.
Outcome measures
| Measure |
Part 1 Dose Escalation: 3% to 70% of the BSA
n=33 Participants
Open-label, five (5) cohorts were sequentially enrolled. AMTX-100 CF 1.1% w/w, topically applied twice a day for 7 consecutive days to all treatable AD affected areas from 3% to 70% of the Body Surface Area (BSA) (3% BSA ≤ AD Affected Area ≤ 70% BSA)
|
Part 2 Group B: Placebo
n=32 Participants
Placebo (Vehicle) (0% w/w), topically applied twice a day for 28 consecutive days to all treatable AD affected areas
|
Part 1 Dose Escalation: Cohort 3
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 12-24% of the BSA (12% BSA \< AD Affected Area ≤ 24% BSA)
|
Part 1 Dose Escalation: Cohort 4
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 24-48% of the BSA (24% BSA \< AD Affected Area ≤ 48% BSA)
|
Part 1 Dose Escalation: Cohort 5
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 48-70% of the BSA (48% BSA \< AD Affected Area ≤ 70% BSA)
|
|---|---|---|---|---|---|
|
Part 2 (Phase II) Secondary Efficacy Endpoints: Proportion of Subjects With EASI-75, Defined as Achieving at Least a 75% Reduction From Baseline in EASI at Days 7, 14, 21, 28, and 42
Visit 3 (Day 7)
|
3.1 Percentage of Subjects With EASI-75
|
3.1 Percentage of Subjects With EASI-75
|
—
|
—
|
—
|
|
Part 2 (Phase II) Secondary Efficacy Endpoints: Proportion of Subjects With EASI-75, Defined as Achieving at Least a 75% Reduction From Baseline in EASI at Days 7, 14, 21, 28, and 42
Visit 4 (Day 14)
|
3.3 Percentage of Subjects With EASI-75
|
3.1 Percentage of Subjects With EASI-75
|
—
|
—
|
—
|
|
Part 2 (Phase II) Secondary Efficacy Endpoints: Proportion of Subjects With EASI-75, Defined as Achieving at Least a 75% Reduction From Baseline in EASI at Days 7, 14, 21, 28, and 42
Visit 5 (Day 21)
|
7.1 Percentage of Subjects With EASI-75
|
9.4 Percentage of Subjects With EASI-75
|
—
|
—
|
—
|
|
Part 2 (Phase II) Secondary Efficacy Endpoints: Proportion of Subjects With EASI-75, Defined as Achieving at Least a 75% Reduction From Baseline in EASI at Days 7, 14, 21, 28, and 42
End of Treatment (Day 28)
|
7.7 Percentage of Subjects With EASI-75
|
12.9 Percentage of Subjects With EASI-75
|
—
|
—
|
—
|
|
Part 2 (Phase II) Secondary Efficacy Endpoints: Proportion of Subjects With EASI-75, Defined as Achieving at Least a 75% Reduction From Baseline in EASI at Days 7, 14, 21, 28, and 42
Follow-Up (Day 42)
|
14.8 Percentage of Subjects With EASI-75
|
20.0 Percentage of Subjects With EASI-75
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 7, 14, 21, 28, and 42Population: There were missing subjects in both groups.
The Eczema Area and Severity Index (EASI) is a validated measure to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, where a higher score indicates increased extent and severity of atopic dermatitis. Note: We acknowledge that the "percentage" is reported, while the outcome measure indicates "proportion". It was concluded that using "percentage" represents the results more apparent.
Outcome measures
| Measure |
Part 1 Dose Escalation: 3% to 70% of the BSA
n=33 Participants
Open-label, five (5) cohorts were sequentially enrolled. AMTX-100 CF 1.1% w/w, topically applied twice a day for 7 consecutive days to all treatable AD affected areas from 3% to 70% of the Body Surface Area (BSA) (3% BSA ≤ AD Affected Area ≤ 70% BSA)
|
Part 2 Group B: Placebo
n=32 Participants
Placebo (Vehicle) (0% w/w), topically applied twice a day for 28 consecutive days to all treatable AD affected areas
|
Part 1 Dose Escalation: Cohort 3
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 12-24% of the BSA (12% BSA \< AD Affected Area ≤ 24% BSA)
|
Part 1 Dose Escalation: Cohort 4
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 24-48% of the BSA (24% BSA \< AD Affected Area ≤ 48% BSA)
|
Part 1 Dose Escalation: Cohort 5
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 48-70% of the BSA (48% BSA \< AD Affected Area ≤ 70% BSA)
|
|---|---|---|---|---|---|
|
Part 2 (Phase II) Secondary Efficacy Endpoints: Proportion of Subjects With EASI-50, Defined as Achieving at Least a 50% Reduction From Baseline in EASI at Days 7, 14, 21, 28, and 42
Visit 3 (Day 7)
|
6.3 Percentage of Subjects With EASI-50
|
3.1 Percentage of Subjects With EASI-50
|
—
|
—
|
—
|
|
Part 2 (Phase II) Secondary Efficacy Endpoints: Proportion of Subjects With EASI-50, Defined as Achieving at Least a 50% Reduction From Baseline in EASI at Days 7, 14, 21, 28, and 42
Visit 4 (Day 14)
|
10.0 Percentage of Subjects With EASI-50
|
21.9 Percentage of Subjects With EASI-50
|
—
|
—
|
—
|
|
Part 2 (Phase II) Secondary Efficacy Endpoints: Proportion of Subjects With EASI-50, Defined as Achieving at Least a 50% Reduction From Baseline in EASI at Days 7, 14, 21, 28, and 42
Visit 5 (Day 21)
|
25.0 Percentage of Subjects With EASI-50
|
28.1 Percentage of Subjects With EASI-50
|
—
|
—
|
—
|
|
Part 2 (Phase II) Secondary Efficacy Endpoints: Proportion of Subjects With EASI-50, Defined as Achieving at Least a 50% Reduction From Baseline in EASI at Days 7, 14, 21, 28, and 42
End of Treatment (Day 28)
|
26.9 Percentage of Subjects With EASI-50
|
45.2 Percentage of Subjects With EASI-50
|
—
|
—
|
—
|
|
Part 2 (Phase II) Secondary Efficacy Endpoints: Proportion of Subjects With EASI-50, Defined as Achieving at Least a 50% Reduction From Baseline in EASI at Days 7, 14, 21, 28, and 42
Follow-Up (Day 42)
|
25.9 Percentage of Subjects With EASI-50
|
46.7 Percentage of Subjects With EASI-50
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Days 7, 14, 21, 28 and 42Population: There were missing subjects in both groups.
The Pruritus Numeric Rating Scale (NRS) is a simple assessment tool that subjects used to report the intensity of their pruritus (itch) during a daily recall period. Subjects were asked the following questions: • For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?" Note: The weekly average of peak daily pruritus NRS was calculated by summing the daily scores for a week and dividing by the number of days with recorded scores, resulting in a range of 0 to 10.
Outcome measures
| Measure |
Part 1 Dose Escalation: 3% to 70% of the BSA
n=33 Participants
Open-label, five (5) cohorts were sequentially enrolled. AMTX-100 CF 1.1% w/w, topically applied twice a day for 7 consecutive days to all treatable AD affected areas from 3% to 70% of the Body Surface Area (BSA) (3% BSA ≤ AD Affected Area ≤ 70% BSA)
|
Part 2 Group B: Placebo
n=32 Participants
Placebo (Vehicle) (0% w/w), topically applied twice a day for 28 consecutive days to all treatable AD affected areas
|
Part 1 Dose Escalation: Cohort 3
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 12-24% of the BSA (12% BSA \< AD Affected Area ≤ 24% BSA)
|
Part 1 Dose Escalation: Cohort 4
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 24-48% of the BSA (24% BSA \< AD Affected Area ≤ 48% BSA)
|
Part 1 Dose Escalation: Cohort 5
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 48-70% of the BSA (48% BSA \< AD Affected Area ≤ 70% BSA)
|
|---|---|---|---|---|---|
|
Part 2 (Phase II) Secondary Efficacy Endpoints: Percent Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) at Days 7, 14, 21, 28, and 42
Visit 3 (Day 7)
|
-15.1 Percent Change from Baseline in NRS
Standard Deviation 28.15
|
-9.9 Percent Change from Baseline in NRS
Standard Deviation 17.22
|
—
|
—
|
—
|
|
Part 2 (Phase II) Secondary Efficacy Endpoints: Percent Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) at Days 7, 14, 21, 28, and 42
Visit 4 (Day 14)
|
-17.1 Percent Change from Baseline in NRS
Standard Deviation 40.83
|
-8.5 Percent Change from Baseline in NRS
Standard Deviation 37.26
|
—
|
—
|
—
|
|
Part 2 (Phase II) Secondary Efficacy Endpoints: Percent Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) at Days 7, 14, 21, 28, and 42
Visit 5 (Day 21)
|
-22.8 Percent Change from Baseline in NRS
Standard Deviation 43.81
|
-18.7 Percent Change from Baseline in NRS
Standard Deviation 26.88
|
—
|
—
|
—
|
|
Part 2 (Phase II) Secondary Efficacy Endpoints: Percent Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) at Days 7, 14, 21, 28, and 42
End of Treatment (Day 28)
|
-25.8 Percent Change from Baseline in NRS
Standard Deviation 47.12
|
-25.2 Percent Change from Baseline in NRS
Standard Deviation 36.25
|
—
|
—
|
—
|
|
Part 2 (Phase II) Secondary Efficacy Endpoints: Percent Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) at Days 7, 14, 21, 28, and 42
Follow-Up (Day 42)
|
-27.6 Percent Change from Baseline in NRS
Standard Deviation 45.28
|
-38.4 Percent Change from Baseline in NRS
Standard Deviation 27.24
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 28 and 42Population: There were missing subjects in both groups.
The Pruritus Numeric Rating Scale (NRS) is a simple assessment tool that subjects used to report the intensity of their pruritus (itch) during a daily recall period. Subjects were asked the following questions: • For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?" Note: The weekly average of peak daily pruritus NRS was calculated by summing the daily scores for a week and dividing by the number of days with recorded scores, resulting in a range of 0 to 10. Note: We acknowledge that the "percentage" is reported, while the outcome measure indicates "proportion". It was concluded that using "percentage" represents the results more apparent.
Outcome measures
| Measure |
Part 1 Dose Escalation: 3% to 70% of the BSA
n=33 Participants
Open-label, five (5) cohorts were sequentially enrolled. AMTX-100 CF 1.1% w/w, topically applied twice a day for 7 consecutive days to all treatable AD affected areas from 3% to 70% of the Body Surface Area (BSA) (3% BSA ≤ AD Affected Area ≤ 70% BSA)
|
Part 2 Group B: Placebo
n=32 Participants
Placebo (Vehicle) (0% w/w), topically applied twice a day for 28 consecutive days to all treatable AD affected areas
|
Part 1 Dose Escalation: Cohort 3
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 12-24% of the BSA (12% BSA \< AD Affected Area ≤ 24% BSA)
|
Part 1 Dose Escalation: Cohort 4
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 24-48% of the BSA (24% BSA \< AD Affected Area ≤ 48% BSA)
|
Part 1 Dose Escalation: Cohort 5
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 48-70% of the BSA (48% BSA \< AD Affected Area ≤ 70% BSA)
|
|---|---|---|---|---|---|
|
Part 2 (Phase II) Secondary Efficacy Endpoints: Proportion of Subjects With Improvement (Reduction) of Weekly Average of Peak Daily Pruritus NRS ≥ 3 From Baseline at Day 28 and 42
End of Treatment (Day 28)
|
18.5 Percentage of Subjects with Improved NRS
|
32.3 Percentage of Subjects with Improved NRS
|
—
|
—
|
—
|
|
Part 2 (Phase II) Secondary Efficacy Endpoints: Proportion of Subjects With Improvement (Reduction) of Weekly Average of Peak Daily Pruritus NRS ≥ 3 From Baseline at Day 28 and 42
Follow-Up (Day 42)
|
20.0 Percentage of Subjects with Improved NRS
|
34.5 Percentage of Subjects with Improved NRS
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 28Population: There were missing subjects in both groups.
The Dermatology Life Quality Index (DLQI) is a 10-item, validated questionnaire to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The format is a simple response (0 to 3 where 0 is "not at all" and 3 is "very much") to 10 questions, which assess QOL over the past week, with an overall scoring system of 0 to 30. A high score is indicative of a poor QOL. For general inflammatory skin conditions, a change in DLQI score of at least 4 points is considered clinically important
Outcome measures
| Measure |
Part 1 Dose Escalation: 3% to 70% of the BSA
n=24 Participants
Open-label, five (5) cohorts were sequentially enrolled. AMTX-100 CF 1.1% w/w, topically applied twice a day for 7 consecutive days to all treatable AD affected areas from 3% to 70% of the Body Surface Area (BSA) (3% BSA ≤ AD Affected Area ≤ 70% BSA)
|
Part 2 Group B: Placebo
n=30 Participants
Placebo (Vehicle) (0% w/w), topically applied twice a day for 28 consecutive days to all treatable AD affected areas
|
Part 1 Dose Escalation: Cohort 3
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 12-24% of the BSA (12% BSA \< AD Affected Area ≤ 24% BSA)
|
Part 1 Dose Escalation: Cohort 4
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 24-48% of the BSA (24% BSA \< AD Affected Area ≤ 48% BSA)
|
Part 1 Dose Escalation: Cohort 5
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 48-70% of the BSA (48% BSA \< AD Affected Area ≤ 70% BSA)
|
|---|---|---|---|---|---|
|
Part 2 (Phase II) Secondary Efficacy Endpoints: Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Day 28
|
-26.6 Percent Change from Baseline in DLQI
Standard Deviation 42.14
|
-36.3 Percent Change from Baseline in DLQI
Standard Deviation 75.35
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Days 28, and 42Population: There were missing subjects in both groups.
For Part 2, BSA affected by AD was assessed by the investigator per calculation of treatable % BSA by the "Rule of Nines" method: Values of 9% or 18% of surface area are assigned to specific regions in the adult (head and neck \[9%\], anterior trunk \[18%\], back \[18%\], upper limbs \[18%\], lower limbs \[36%\], and genitals \[1%\])
Outcome measures
| Measure |
Part 1 Dose Escalation: 3% to 70% of the BSA
n=33 Participants
Open-label, five (5) cohorts were sequentially enrolled. AMTX-100 CF 1.1% w/w, topically applied twice a day for 7 consecutive days to all treatable AD affected areas from 3% to 70% of the Body Surface Area (BSA) (3% BSA ≤ AD Affected Area ≤ 70% BSA)
|
Part 2 Group B: Placebo
n=32 Participants
Placebo (Vehicle) (0% w/w), topically applied twice a day for 28 consecutive days to all treatable AD affected areas
|
Part 1 Dose Escalation: Cohort 3
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 12-24% of the BSA (12% BSA \< AD Affected Area ≤ 24% BSA)
|
Part 1 Dose Escalation: Cohort 4
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 24-48% of the BSA (24% BSA \< AD Affected Area ≤ 48% BSA)
|
Part 1 Dose Escalation: Cohort 5
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 48-70% of the BSA (48% BSA \< AD Affected Area ≤ 70% BSA)
|
|---|---|---|---|---|---|
|
Part 2 (Phase II) Secondary Efficacy Endpoints: Percent Change From Baseline of the Treated BSA With Active AD at Day 28, and 42
End of Treatment (Day 28)
|
-27.6 Percent Change of the Treated BSA
Standard Deviation 35.72
|
-26.9 Percent Change of the Treated BSA
Standard Deviation 33.16
|
—
|
—
|
—
|
|
Part 2 (Phase II) Secondary Efficacy Endpoints: Percent Change From Baseline of the Treated BSA With Active AD at Day 28, and 42
Follow-Up (Day 42)
|
-32.8 Percent Change of the Treated BSA
Standard Deviation 36.03
|
-33.7 Percent Change of the Treated BSA
Standard Deviation 36.04
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 7For Part 1, Body surface area (BSA) affected by AD was assessed by the investigator per calculation of treatable % BSA by the handprint method: "Handprint Method": the area represented by the palm with all five digits adducted together is approximately 1% of the subject's BSA
Outcome measures
| Measure |
Part 1 Dose Escalation: 3% to 70% of the BSA
n=5 Participants
Open-label, five (5) cohorts were sequentially enrolled. AMTX-100 CF 1.1% w/w, topically applied twice a day for 7 consecutive days to all treatable AD affected areas from 3% to 70% of the Body Surface Area (BSA) (3% BSA ≤ AD Affected Area ≤ 70% BSA)
|
Part 2 Group B: Placebo
n=5 Participants
Placebo (Vehicle) (0% w/w), topically applied twice a day for 28 consecutive days to all treatable AD affected areas
|
Part 1 Dose Escalation: Cohort 3
n=5 Participants
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 12-24% of the BSA (12% BSA \< AD Affected Area ≤ 24% BSA)
|
Part 1 Dose Escalation: Cohort 4
n=4 Participants
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 24-48% of the BSA (24% BSA \< AD Affected Area ≤ 48% BSA)
|
Part 1 Dose Escalation: Cohort 5
n=7 Participants
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 48-70% of the BSA (48% BSA \< AD Affected Area ≤ 70% BSA)
|
|---|---|---|---|---|---|
|
Part 1 (Phase I) Exploratory Outcome Measures: Percent Change From Baseline of the Treated BSA With Active AD at Day 7
|
-46.7 percent change at the End of Treatment
Standard Deviation 30.91
|
-44.3 percent change at the End of Treatment
Standard Deviation 44.15
|
-43.3 percent change at the End of Treatment
Standard Deviation 44.62
|
-38.1 percent change at the End of Treatment
Standard Deviation 28.84
|
-21.7 percent change at the End of Treatment
Standard Deviation 32.31
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 7The 5-point Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD™) is a validated measure of disease severity and success of atopic dermatitis treatments in clinical trials. The ratings (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe) are an overall assessment of AD skin lesions, based on the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Outcome measures
| Measure |
Part 1 Dose Escalation: 3% to 70% of the BSA
n=5 Participants
Open-label, five (5) cohorts were sequentially enrolled. AMTX-100 CF 1.1% w/w, topically applied twice a day for 7 consecutive days to all treatable AD affected areas from 3% to 70% of the Body Surface Area (BSA) (3% BSA ≤ AD Affected Area ≤ 70% BSA)
|
Part 2 Group B: Placebo
n=5 Participants
Placebo (Vehicle) (0% w/w), topically applied twice a day for 28 consecutive days to all treatable AD affected areas
|
Part 1 Dose Escalation: Cohort 3
n=5 Participants
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 12-24% of the BSA (12% BSA \< AD Affected Area ≤ 24% BSA)
|
Part 1 Dose Escalation: Cohort 4
n=4 Participants
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 24-48% of the BSA (24% BSA \< AD Affected Area ≤ 48% BSA)
|
Part 1 Dose Escalation: Cohort 5
n=7 Participants
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 48-70% of the BSA (48% BSA \< AD Affected Area ≤ 70% BSA)
|
|---|---|---|---|---|---|
|
Part 1 (Phase I) Exploratory Outcome Measures: Change From Baseline in Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) at Day 7
Baseline-Mild
|
5 number of subjects
|
4 number of subjects
|
1 number of subjects
|
1 number of subjects
|
0 number of subjects
|
|
Part 1 (Phase I) Exploratory Outcome Measures: Change From Baseline in Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) at Day 7
Baseline-Moderate
|
0 number of subjects
|
1 number of subjects
|
4 number of subjects
|
3 number of subjects
|
7 number of subjects
|
|
Part 1 (Phase I) Exploratory Outcome Measures: Change From Baseline in Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) at Day 7
End of Treatment-Clear
|
1 number of subjects
|
1 number of subjects
|
1 number of subjects
|
0 number of subjects
|
0 number of subjects
|
|
Part 1 (Phase I) Exploratory Outcome Measures: Change From Baseline in Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) at Day 7
End of Treatment-Almost Clear
|
3 number of subjects
|
3 number of subjects
|
2 number of subjects
|
1 number of subjects
|
1 number of subjects
|
|
Part 1 (Phase I) Exploratory Outcome Measures: Change From Baseline in Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) at Day 7
End of Treatment-Mild
|
1 number of subjects
|
0 number of subjects
|
0 number of subjects
|
2 number of subjects
|
2 number of subjects
|
|
Part 1 (Phase I) Exploratory Outcome Measures: Change From Baseline in Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) at Day 7
End of Treatment-Moderate
|
0 number of subjects
|
1 number of subjects
|
2 number of subjects
|
1 number of subjects
|
4 number of subjects
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through follow-up (Day 21)An adverse event (AE) was defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the subject to have occurred, or a worsening of a pre-existing condition. Treatment Emergent Adverse Events (TEAEs) were defined as adverse events with onset date on or after the first treatment.
Outcome measures
| Measure |
Part 1 Dose Escalation: 3% to 70% of the BSA
n=5 Participants
Open-label, five (5) cohorts were sequentially enrolled. AMTX-100 CF 1.1% w/w, topically applied twice a day for 7 consecutive days to all treatable AD affected areas from 3% to 70% of the Body Surface Area (BSA) (3% BSA ≤ AD Affected Area ≤ 70% BSA)
|
Part 2 Group B: Placebo
n=5 Participants
Placebo (Vehicle) (0% w/w), topically applied twice a day for 28 consecutive days to all treatable AD affected areas
|
Part 1 Dose Escalation: Cohort 3
n=5 Participants
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 12-24% of the BSA (12% BSA \< AD Affected Area ≤ 24% BSA)
|
Part 1 Dose Escalation: Cohort 4
n=4 Participants
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 24-48% of the BSA (24% BSA \< AD Affected Area ≤ 48% BSA)
|
Part 1 Dose Escalation: Cohort 5
n=7 Participants
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 48-70% of the BSA (48% BSA \< AD Affected Area ≤ 70% BSA)
|
|---|---|---|---|---|---|
|
Part 1 (Phase I) Safety Outcome Measures: Incidence of Treatment-Emergent Adverse Events (TEAEs)
Any TEAE
|
1 number of events
|
3 number of events
|
3 number of events
|
0 number of events
|
2 number of events
|
|
Part 1 (Phase I) Safety Outcome Measures: Incidence of Treatment-Emergent Adverse Events (TEAEs)
Any Related TEAE
|
0 number of events
|
0 number of events
|
0 number of events
|
0 number of events
|
0 number of events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through follow-up (Day 42)An adverse event (AE) was defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the subject to have occurred, or a worsening of a pre-existing condition. Treatment Emergent Adverse Events (TEAEs) were defined as adverse events with onset date on or after the first treatment.
Outcome measures
| Measure |
Part 1 Dose Escalation: 3% to 70% of the BSA
n=33 Participants
Open-label, five (5) cohorts were sequentially enrolled. AMTX-100 CF 1.1% w/w, topically applied twice a day for 7 consecutive days to all treatable AD affected areas from 3% to 70% of the Body Surface Area (BSA) (3% BSA ≤ AD Affected Area ≤ 70% BSA)
|
Part 2 Group B: Placebo
n=32 Participants
Placebo (Vehicle) (0% w/w), topically applied twice a day for 28 consecutive days to all treatable AD affected areas
|
Part 1 Dose Escalation: Cohort 3
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 12-24% of the BSA (12% BSA \< AD Affected Area ≤ 24% BSA)
|
Part 1 Dose Escalation: Cohort 4
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 24-48% of the BSA (24% BSA \< AD Affected Area ≤ 48% BSA)
|
Part 1 Dose Escalation: Cohort 5
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 48-70% of the BSA (48% BSA \< AD Affected Area ≤ 70% BSA)
|
|---|---|---|---|---|---|
|
Part 2 (Phase II) Safety Outcome Measures: Incidence of Treatment-Emergent Adverse Events (TEAEs)
Any TEAE
|
12 number of events
|
3 number of events
|
—
|
—
|
—
|
|
Part 2 (Phase II) Safety Outcome Measures: Incidence of Treatment-Emergent Adverse Events (TEAEs)
Any Related TEAE
|
2 number of events
|
1 number of events
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through follow-up (Day 42)An adverse event (AE) was defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the subject to have occurred, or a worsening of a pre-existing condition. Treatment Emergent Adverse Events (TEAEs) were defined as adverse events with onset date on or after the first treatment.
Outcome measures
| Measure |
Part 1 Dose Escalation: 3% to 70% of the BSA
n=33 Participants
Open-label, five (5) cohorts were sequentially enrolled. AMTX-100 CF 1.1% w/w, topically applied twice a day for 7 consecutive days to all treatable AD affected areas from 3% to 70% of the Body Surface Area (BSA) (3% BSA ≤ AD Affected Area ≤ 70% BSA)
|
Part 2 Group B: Placebo
n=32 Participants
Placebo (Vehicle) (0% w/w), topically applied twice a day for 28 consecutive days to all treatable AD affected areas
|
Part 1 Dose Escalation: Cohort 3
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 12-24% of the BSA (12% BSA \< AD Affected Area ≤ 24% BSA)
|
Part 1 Dose Escalation: Cohort 4
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 24-48% of the BSA (24% BSA \< AD Affected Area ≤ 48% BSA)
|
Part 1 Dose Escalation: Cohort 5
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 48-70% of the BSA (48% BSA \< AD Affected Area ≤ 70% BSA)
|
|---|---|---|---|---|---|
|
Part 2 (Phase II) Safety Outcome Measures: Incidence of Withdrawals From the Study Due to TEAEs
|
1 number of subjects
|
1 number of subjects
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through follow-up (Day 21)An adverse event (AE) was defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the subject to have occurred, or a worsening of a pre-existing condition. Treatment Emergent Adverse Events (TEAEs) were defined as adverse events with onset date on or after the first treatment.
Outcome measures
| Measure |
Part 1 Dose Escalation: 3% to 70% of the BSA
n=5 Participants
Open-label, five (5) cohorts were sequentially enrolled. AMTX-100 CF 1.1% w/w, topically applied twice a day for 7 consecutive days to all treatable AD affected areas from 3% to 70% of the Body Surface Area (BSA) (3% BSA ≤ AD Affected Area ≤ 70% BSA)
|
Part 2 Group B: Placebo
n=5 Participants
Placebo (Vehicle) (0% w/w), topically applied twice a day for 28 consecutive days to all treatable AD affected areas
|
Part 1 Dose Escalation: Cohort 3
n=5 Participants
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 12-24% of the BSA (12% BSA \< AD Affected Area ≤ 24% BSA)
|
Part 1 Dose Escalation: Cohort 4
n=4 Participants
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 24-48% of the BSA (24% BSA \< AD Affected Area ≤ 48% BSA)
|
Part 1 Dose Escalation: Cohort 5
n=7 Participants
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 48-70% of the BSA (48% BSA \< AD Affected Area ≤ 70% BSA)
|
|---|---|---|---|---|---|
|
Part 1 (Phase I) Safety Outcome Measures: Incidence of Withdrawals From the Study Due to TEAEs
|
0 number of subjects
|
0 number of subjects
|
0 number of subjects
|
0 number of subjects
|
0 number of subjects
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (post-dose), End of Treatment (Day 7), and Follow-up (Day 21)Tolerability of topically applied AMTX-100 CF was evaluated based on investigator-assessed application site reactions assessment. Local skin reactions were assessed in all areas treated with AMTX-100 CF and graded by the investigator on a scale of 0 to 4 based on the area with the most severe skin reaction among all treated areas. A grade of 0 represented no reaction, and a grade of 4 indicated a marked and severe skin reaction that extended beyond the treated areas.
Outcome measures
| Measure |
Part 1 Dose Escalation: 3% to 70% of the BSA
n=5 Participants
Open-label, five (5) cohorts were sequentially enrolled. AMTX-100 CF 1.1% w/w, topically applied twice a day for 7 consecutive days to all treatable AD affected areas from 3% to 70% of the Body Surface Area (BSA) (3% BSA ≤ AD Affected Area ≤ 70% BSA)
|
Part 2 Group B: Placebo
n=5 Participants
Placebo (Vehicle) (0% w/w), topically applied twice a day for 28 consecutive days to all treatable AD affected areas
|
Part 1 Dose Escalation: Cohort 3
n=5 Participants
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 12-24% of the BSA (12% BSA \< AD Affected Area ≤ 24% BSA)
|
Part 1 Dose Escalation: Cohort 4
n=4 Participants
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 24-48% of the BSA (24% BSA \< AD Affected Area ≤ 48% BSA)
|
Part 1 Dose Escalation: Cohort 5
n=7 Participants
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 48-70% of the BSA (48% BSA \< AD Affected Area ≤ 70% BSA)
|
|---|---|---|---|---|---|
|
Part 1 (Phase I) Safety Outcome Measures: Changes in Study Treatment Application Site Reaction Assessment
Baseline (Post-dose)
|
-0.2 Units on an ordinal scale
Standard Deviation 1.64
|
-0.4 Units on an ordinal scale
Standard Deviation 1.14
|
-1.8 Units on an ordinal scale
Standard Deviation 0.84
|
-2.0 Units on an ordinal scale
Standard Deviation 2.16
|
-0.9 Units on an ordinal scale
Standard Deviation 0.9
|
|
Part 1 (Phase I) Safety Outcome Measures: Changes in Study Treatment Application Site Reaction Assessment
End of Treatment (Day 7)
|
-0.8 Units on an ordinal scale
Standard Deviation 1.64
|
-0.6 Units on an ordinal scale
Standard Deviation 1.52
|
-3.0 Units on an ordinal scale
Standard Deviation 3.16
|
-4.8 Units on an ordinal scale
Standard Deviation 5.91
|
-1.4 Units on an ordinal scale
Standard Deviation 1.40
|
|
Part 1 (Phase I) Safety Outcome Measures: Changes in Study Treatment Application Site Reaction Assessment
Follow-Up (Day 21)
|
-1.0 Units on an ordinal scale
Standard Deviation 1.73
|
-1.8 Units on an ordinal scale
Standard Deviation 2.77
|
-4.4 Units on an ordinal scale
Standard Deviation 3.91
|
-4.5 Units on an ordinal scale
Standard Deviation 3.51
|
-1.6 Units on an ordinal scale
Standard Deviation 2.37
|
Adverse Events
Part 1 Dose Escalation: Cohort 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1 Dose Escalation: Cohort 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 Dose Escalation: Cohort 3
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1 Dose Escalation: Cohort 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1 Dose Escalation: Cohort 5
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 2 Group A: 1.1% w/w
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 2 Group B: Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1 Dose Escalation: Cohort 1
n=5 participants at risk
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 3-6% of the BSA (3% BSA ≤ AD Affected Area ≤ 6% BSA)
|
Part 1 Dose Escalation: Cohort 2
n=5 participants at risk
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 6-12% of the BSA (6% BSA \< AD Affected Area ≤ 12% BSA)
|
Part 1 Dose Escalation: Cohort 3
n=5 participants at risk
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 12-24% of the BSA (12% BSA \< AD Affected Area ≤ 24% BSA)
|
Part 1 Dose Escalation: Cohort 4
n=4 participants at risk
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 24-48% of the BSA (24% BSA \< AD Affected Area ≤ 48% BSA)
|
Part 1 Dose Escalation: Cohort 5
n=7 participants at risk
Open-label AMTX-100 CF 1.1% w/w, topically applied twice a day for seven consecutive days to all treatable AD affected areas of 48-70% of the BSA (48% BSA \< AD Affected Area ≤ 70% BSA)
|
Part 2 Group A: 1.1% w/w
n=33 participants at risk
AMTX-100 CF3 (1.1% w/w), topically applied twice a day for 28 consecutive days to all treatable AD affected areas
|
Part 2 Group B: Placebo
n=32 participants at risk
Placebo (Vehicle) (0% w/w), topically applied twice a day for 28 consecutive days to all treatable AD affected areas
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Number of events 1 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
40.0%
2/5 • Number of events 2 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
40.0%
2/5 • Number of events 3 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/4 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/7 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/33 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/32 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
|
Nervous system disorders
Syncope
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/4 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/7 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
3.0%
1/33 • Number of events 2 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/32 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/4 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/7 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
3.0%
1/33 • Number of events 1 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
3.1%
1/32 • Number of events 1 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/4 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/7 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
3.0%
1/33 • Number of events 1 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/32 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/4 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/7 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
3.0%
1/33 • Number of events 1 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/32 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/4 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
14.3%
1/7 • Number of events 1 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/33 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/32 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
|
General disorders
Chills
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/4 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
14.3%
1/7 • Number of events 1 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/33 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/32 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
|
General disorders
Application Site Oedema
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/4 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/7 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
3.0%
1/33 • Number of events 1 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/32 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
|
General disorders
Application Site Pruritus
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/4 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/7 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
3.0%
1/33 • Number of events 1 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/32 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
|
General disorders
Influenza Like Illness
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/4 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/7 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/33 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
3.1%
1/32 • Number of events 1 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/4 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/7 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
6.1%
2/33 • Number of events 2 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/32 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/4 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/7 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
3.0%
1/33 • Number of events 1 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/32 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Atopic
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/4 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/7 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
3.0%
1/33 • Number of events 1 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
3.1%
1/32 • Number of events 1 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity Reaction
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/4 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/7 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
3.0%
1/33 • Number of events 1 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/32 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
20.0%
1/5 • Number of events 1 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/5 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/4 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/7 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/33 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
0.00%
0/32 • Phase I (Part 1) Baseline through follow-up (Day 21) Phase II (Part 2) Baseline through follow-up (Day 42)
An adverse event (AE) may or may not be related to the study treatment. All AEs were elicited through direct questioning and subject reports. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment was reported as AEs. Abnormal findings that were not CS were not recorded as an AE.
|
Additional Information
Dr. Ahmad Bayat, Sr Director II, Regulatory Affairs
Amarex Clinical Research, LLC
Phone: 301-956-2523
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigator will refer to the Investigator agreement and clinical trial agreement for the publication and disclosure policy.
- Publication restrictions are in place
Restriction type: OTHER