Trial Outcomes & Findings for Trial to Investigate GZ21T in Healthy Volunteers (NCT NCT06888362)
NCT ID: NCT06888362
Last Updated: 2026-01-28
Results Overview
Number of reported adverse events (AEs).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
41 participants
Primary outcome timeframe
Day 1 to Day 7
Results posted on
2026-01-28
Participant Flow
Participant milestones
| Measure |
Part A, Cohort 1
25.5 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% body surface area (BSA) and 23 g cream.
|
Part A, Cohort 2
25.5 mg/cm2 GZ21T was applied to 1350 cm2 of the skin, corresponding to approximately 7.5% BSA and 35 g cream.
|
Part A, Cohort 3
25.5 mg/cm2 GZ21T was applied to 1800 cm2 of the skin, corresponding to approximately 10% BSA and 46 g cream.
|
Part A, Cohort 4
25.5 mg/cm2 GZ21T was applied to the face, corresponding to approximately 3-3.5% BSA and 16 g cream.
|
Part A: Placebo
Corresponding amount of placebo was applied to the corresponding treatment area as the active treatment in Cohorts 1-4 in Part A.
|
Part B, Cohort 1
13 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% BSA and 12 g cream.
|
Part B, Cohort 2
8 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% BSA and 7 g cream.
|
Part B, Cohort 3
6,5 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% BSA and 6 g cream.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
8
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
8
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial to Investigate GZ21T in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Part A, Cohort 1
n=6 Participants
25.5 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% body surface area (BSA) and 23 g cream.
|
Part A, Cohort 2
n=6 Participants
25.5 mg/cm2 GZ21T was applied to 1350 cm2 of the skin, corresponding to approximately 7.5% BSA and 35 g cream.
|
Part A, Cohort 3
n=6 Participants
25.5 mg/cm2 GZ21T was applied to 1800 cm2 of the skin, corresponding to approximately 10% BSA and 46 g cream.
|
Part A, Cohort 4
n=6 Participants
25.5 mg/cm2 GZ21T was applied to the face, corresponding to approximately 3-3.5% BSA and 16 g cream.
|
Part A: Placebo
n=8 Participants
Corresponding amount of placebo was applied to the corresponding treatment area as the active treatment in Cohorts 1-4 in Part A.
|
Part B, Cohort 1
n=3 Participants
13 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% BSA and 12 g cream.
|
Part B, Cohort 2
n=3 Participants
8 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% BSA and 7 g cream.
|
Part B, Cohort 3
n=3 Participants
6,5 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% BSA and 6 g cream.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=158 Participants
|
3 Participants
n=157 Participants
|
5 Participants
n=315 Participants
|
6 Participants
n=153 Participants
|
8 Participants
n=11 Participants
|
2 Participants
n=12 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=158 Participants
|
3 Participants
n=157 Participants
|
1 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=11 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Age, Continuous
|
35.5 years
STANDARD_DEVIATION 16.6 • n=158 Participants
|
62.2 years
STANDARD_DEVIATION 5.8 • n=157 Participants
|
47.0 years
STANDARD_DEVIATION 21.6 • n=315 Participants
|
39.7 years
STANDARD_DEVIATION 9.9 • n=153 Participants
|
39.5 years
STANDARD_DEVIATION 17.8 • n=11 Participants
|
25.0 years
STANDARD_DEVIATION 2.6 • n=12 Participants
|
20.3 years
STANDARD_DEVIATION 1.2 • n=4 Participants
|
37.3 years
STANDARD_DEVIATION 27.5 • n=5 Participants
|
40.7 years
STANDARD_DEVIATION 17.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=158 Participants
|
3 Participants
n=157 Participants
|
3 Participants
n=315 Participants
|
6 Participants
n=153 Participants
|
6 Participants
n=11 Participants
|
3 Participants
n=12 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=158 Participants
|
3 Participants
n=157 Participants
|
3 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
2 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=158 Participants
|
6 Participants
n=157 Participants
|
6 Participants
n=315 Participants
|
6 Participants
n=153 Participants
|
8 Participants
n=11 Participants
|
3 Participants
n=12 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=158 Participants
|
6 Participants
n=157 Participants
|
6 Participants
n=315 Participants
|
6 Participants
n=153 Participants
|
8 Participants
n=11 Participants
|
3 Participants
n=12 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Sweden
|
6 participants
n=158 Participants
|
6 participants
n=157 Participants
|
6 participants
n=315 Participants
|
6 participants
n=153 Participants
|
8 participants
n=11 Participants
|
3 participants
n=12 Participants
|
3 participants
n=4 Participants
|
3 participants
n=5 Participants
|
41 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 7Population: Full analysis set (FAS) consisted of all enrolled participants who received IMP.
Number of reported adverse events (AEs).
Outcome measures
| Measure |
Part A, Cohort 1
n=6 Participants
25.5 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% body surface area (BSA) and 23 g cream.
|
Part A, Cohort 2
n=6 Participants
25.5 mg/cm2 GZ21T was applied to 1350 cm2 of the skin, corresponding to approximately 7.5% BSA and 35 g cream.
|
Part A, Cohort 3
n=6 Participants
25.5 mg/cm2 GZ21T was applied to 1800 cm2 of the skin, corresponding to approximately 10% BSA and 46 g cream.
|
Part A, Cohort 4
n=6 Participants
25.5 mg/cm2 GZ21T was applied to the face, corresponding to approximately 3-3.5% BSA and 16 g cream.
|
Part A: Placebo
n=8 Participants
Corresponding amount of placebo was applied to the corresponding treatment area as the active treatment in Cohorts 1-4 in Part A.
|
Part B, Cohort 1
n=3 Participants
13 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% BSA and 12 g cream.
|
Part B, Cohort 2
n=3 Participants
8 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% BSA and 7 g cream.
|
Part B, Cohort 3
n=3 Participants
6,5 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% BSA and 6 g cream.
|
|---|---|---|---|---|---|---|---|---|
|
AE
Severity: mild
|
3 participants
|
0 participants
|
2 participants
|
3 participants
|
3 participants
|
1 participants
|
1 participants
|
0 participants
|
|
AE
Any AE
|
3 participants
|
0 participants
|
2 participants
|
3 participants
|
3 participants
|
1 participants
|
1 participants
|
0 participants
|
|
AE
Any SAE
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
AE
Causality: not related
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
|
AE
Causality: unlikely related
|
3 participants
|
0 participants
|
1 participants
|
2 participants
|
2 participants
|
0 participants
|
1 participants
|
0 participants
|
|
AE
Causality: possibly related
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
AE
Causality: probably related
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
AE
Causality: definetly related
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
AE
Severity: moderate
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
AE
Severity: severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
AE
Severity: life-threatening
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
AE
Severity: death
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 7.Population: Full analysis set (FAS) consisted of all enrolled participants who received IMP.
Local tolerability reactions, such as Erythema, swelling, pruritus, burning, blistering and urticaria, discolouration and dryness (Investigator's assessment 0-3 none/mild/moderate/severe).
Outcome measures
| Measure |
Part A, Cohort 1
n=6 Participants
25.5 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% body surface area (BSA) and 23 g cream.
|
Part A, Cohort 2
n=6 Participants
25.5 mg/cm2 GZ21T was applied to 1350 cm2 of the skin, corresponding to approximately 7.5% BSA and 35 g cream.
|
Part A, Cohort 3
n=6 Participants
25.5 mg/cm2 GZ21T was applied to 1800 cm2 of the skin, corresponding to approximately 10% BSA and 46 g cream.
|
Part A, Cohort 4
n=6 Participants
25.5 mg/cm2 GZ21T was applied to the face, corresponding to approximately 3-3.5% BSA and 16 g cream.
|
Part A: Placebo
n=8 Participants
Corresponding amount of placebo was applied to the corresponding treatment area as the active treatment in Cohorts 1-4 in Part A.
|
Part B, Cohort 1
n=3 Participants
13 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% BSA and 12 g cream.
|
Part B, Cohort 2
n=3 Participants
8 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% BSA and 7 g cream.
|
Part B, Cohort 3
n=3 Participants
6,5 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% BSA and 6 g cream.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Reported Skin Reactions
Any erythema
|
2 participants
|
0 participants
|
0 participants
|
4 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Reported Skin Reactions
Any swelling
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Reported Skin Reactions
Any pruritus
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Reported Skin Reactions
Any burning
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Reported Skin Reactions
Any blistering
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Reported Skin Reactions
Any urticaria
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Reported Skin Reactions
Any discoloration
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Reported Skin Reactions
Any dryness
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 7.Population: Full analysis set (FAS) consisted of all enrolled participants who received IMP.
Number of participants in Part A with clinically significant changes from baseline in vital signs (systolic, diastolic blood pressure and pulse)
Outcome measures
| Measure |
Part A, Cohort 1
n=6 Participants
25.5 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% body surface area (BSA) and 23 g cream.
|
Part A, Cohort 2
n=6 Participants
25.5 mg/cm2 GZ21T was applied to 1350 cm2 of the skin, corresponding to approximately 7.5% BSA and 35 g cream.
|
Part A, Cohort 3
n=6 Participants
25.5 mg/cm2 GZ21T was applied to 1800 cm2 of the skin, corresponding to approximately 10% BSA and 46 g cream.
|
Part A, Cohort 4
n=6 Participants
25.5 mg/cm2 GZ21T was applied to the face, corresponding to approximately 3-3.5% BSA and 16 g cream.
|
Part A: Placebo
n=8 Participants
Corresponding amount of placebo was applied to the corresponding treatment area as the active treatment in Cohorts 1-4 in Part A.
|
Part B, Cohort 1
13 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% BSA and 12 g cream.
|
Part B, Cohort 2
8 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% BSA and 7 g cream.
|
Part B, Cohort 3
6,5 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% BSA and 6 g cream.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Signs
Systolic blood pressure
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Changes in Vital Signs
Diastolic blood pressure
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Changes in Vital Signs
Pulse
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 7.Population: Full analysis set (FAS) consisted of all enrolled participants who received IMP.
Number of participants in Part A with clinically significant changes from baseline in ECG results (resting heart rate, PQ/PR, QRS, QT and QTcF).
Outcome measures
| Measure |
Part A, Cohort 1
n=6 Participants
25.5 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% body surface area (BSA) and 23 g cream.
|
Part A, Cohort 2
n=6 Participants
25.5 mg/cm2 GZ21T was applied to 1350 cm2 of the skin, corresponding to approximately 7.5% BSA and 35 g cream.
|
Part A, Cohort 3
n=6 Participants
25.5 mg/cm2 GZ21T was applied to 1800 cm2 of the skin, corresponding to approximately 10% BSA and 46 g cream.
|
Part A, Cohort 4
n=6 Participants
25.5 mg/cm2 GZ21T was applied to the face, corresponding to approximately 3-3.5% BSA and 16 g cream.
|
Part A: Placebo
n=8 Participants
Corresponding amount of placebo was applied to the corresponding treatment area as the active treatment in Cohorts 1-4 in Part A.
|
Part B, Cohort 1
13 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% BSA and 12 g cream.
|
Part B, Cohort 2
8 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% BSA and 7 g cream.
|
Part B, Cohort 3
6,5 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% BSA and 6 g cream.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Electrocardiograms (ECGs)
QTcF
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Changes in Electrocardiograms (ECGs)
Resting heart rate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Changes in Electrocardiograms (ECGs)
PQ/PR
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Changes in Electrocardiograms (ECGs)
QRS
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Changes in Electrocardiograms (ECGs)
QT
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 7.Population: Full analysis set (FAS) consisted of all enrolled participants who received IMP.
Number of participants in Part A with clinically significant abnormal laboratory tests results (clinical chemistry, hematology and coagulation parameters).
Outcome measures
| Measure |
Part A, Cohort 1
n=6 Participants
25.5 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% body surface area (BSA) and 23 g cream.
|
Part A, Cohort 2
n=6 Participants
25.5 mg/cm2 GZ21T was applied to 1350 cm2 of the skin, corresponding to approximately 7.5% BSA and 35 g cream.
|
Part A, Cohort 3
n=6 Participants
25.5 mg/cm2 GZ21T was applied to 1800 cm2 of the skin, corresponding to approximately 10% BSA and 46 g cream.
|
Part A, Cohort 4
n=6 Participants
25.5 mg/cm2 GZ21T was applied to the face, corresponding to approximately 3-3.5% BSA and 16 g cream.
|
Part A: Placebo
n=8 Participants
Corresponding amount of placebo was applied to the corresponding treatment area as the active treatment in Cohorts 1-4 in Part A.
|
Part B, Cohort 1
13 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% BSA and 12 g cream.
|
Part B, Cohort 2
8 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% BSA and 7 g cream.
|
Part B, Cohort 3
6,5 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% BSA and 6 g cream.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormal Laboratory Test Results (Haematology, Clinical Chemistry, Coagulation)
Haematology
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Abnormal Laboratory Test Results (Haematology, Clinical Chemistry, Coagulation)
Clinical chemistry
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Abnormal Laboratory Test Results (Haematology, Clinical Chemistry, Coagulation)
Coagulation
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 7.Population: Full analysis set (FAS) consisted of all enrolled participants who received IMP.
Number of participants in Part A with clinically significant changes from baseline in physical examination findings.
Outcome measures
| Measure |
Part A, Cohort 1
n=6 Participants
25.5 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% body surface area (BSA) and 23 g cream.
|
Part A, Cohort 2
n=6 Participants
25.5 mg/cm2 GZ21T was applied to 1350 cm2 of the skin, corresponding to approximately 7.5% BSA and 35 g cream.
|
Part A, Cohort 3
n=6 Participants
25.5 mg/cm2 GZ21T was applied to 1800 cm2 of the skin, corresponding to approximately 10% BSA and 46 g cream.
|
Part A, Cohort 4
n=6 Participants
25.5 mg/cm2 GZ21T was applied to the face, corresponding to approximately 3-3.5% BSA and 16 g cream.
|
Part A: Placebo
n=8 Participants
Corresponding amount of placebo was applied to the corresponding treatment area as the active treatment in Cohorts 1-4 in Part A.
|
Part B, Cohort 1
13 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% BSA and 12 g cream.
|
Part B, Cohort 2
8 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% BSA and 7 g cream.
|
Part B, Cohort 3
6,5 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% BSA and 6 g cream.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Physical Examination Findings.
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0-2 hours after IMP administrationPopulation: All participants in Part B.
Cream absorption measured on a 4-point scale: "1= not absorbed"; "2= somewhat absorbed"; "3= mostly absorbed"; "4= completely absorbed". This outcome was prespecified to be assessed only for Part B.
Outcome measures
| Measure |
Part A, Cohort 1
n=3 Participants
25.5 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% body surface area (BSA) and 23 g cream.
|
Part A, Cohort 2
n=3 Participants
25.5 mg/cm2 GZ21T was applied to 1350 cm2 of the skin, corresponding to approximately 7.5% BSA and 35 g cream.
|
Part A, Cohort 3
n=3 Participants
25.5 mg/cm2 GZ21T was applied to 1800 cm2 of the skin, corresponding to approximately 10% BSA and 46 g cream.
|
Part A, Cohort 4
25.5 mg/cm2 GZ21T was applied to the face, corresponding to approximately 3-3.5% BSA and 16 g cream.
|
Part A: Placebo
Corresponding amount of placebo was applied to the corresponding treatment area as the active treatment in Cohorts 1-4 in Part A.
|
Part B, Cohort 1
13 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% BSA and 12 g cream.
|
Part B, Cohort 2
8 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% BSA and 7 g cream.
|
Part B, Cohort 3
6,5 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% BSA and 6 g cream.
|
|---|---|---|---|---|---|---|---|---|
|
Amount of Cream Absorbed After Single Dose Applications.
30 min postdose. Score 3 - mostly absorbed
|
0 participants
|
0 participants
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Cream Absorbed After Single Dose Applications.
30 min postdose. Score 4 - completely absorbed
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Cream Absorbed After Single Dose Applications.
1 hour post-dose. Score 1 - not absorbed
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Cream Absorbed After Single Dose Applications.
2 hours postdose. Score 2 - somewhat absorbed
|
3 participants
|
3 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Cream Absorbed After Single Dose Applications.
30 min post-dose. Score 1 - not absorbed
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Cream Absorbed After Single Dose Applications.
30 min postdose. Score 2 - somewhat absorbed
|
3 participants
|
3 participants
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Cream Absorbed After Single Dose Applications.
1 hour postdose. Score 2 - somewhat absorbed
|
3 participants
|
3 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Cream Absorbed After Single Dose Applications.
1 hour postdose. Score 3 - mostly absorbed
|
0 participants
|
0 participants
|
3 participants
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Cream Absorbed After Single Dose Applications.
1 hour postdose. Score 4 - completely absorbed
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Cream Absorbed After Single Dose Applications.
2 hours post-dose. Score 1 - not absorbed
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Cream Absorbed After Single Dose Applications.
2 hours postdose. Score 3 - mostly absorbed
|
0 participants
|
0 participants
|
3 participants
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Cream Absorbed After Single Dose Applications.
2 hours postdose. Score 4 - completely absorbed
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 7.Plasma concentrations of GZ21T after single dose applications.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 to Day 7.PK parameters after a single dose application (to be calculated if data permits): area under the plasma concentration curve from time 0 to infinity (AUCinf).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 to Day 7.PK parameters after a single dose application (to be calculated if data permits): AUC from time 0 to the last measurable concentration (AUClast).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 to Day 7.PK parameters after a single dose application (to be calculated if data permits): maximum plasma concentration (Cmax).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 to Day 7.PK parameters after a single dose application (to be calculated if data permits): time to Cmax (Tmax).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 to Day 7.PK parameters after a single dose application (to be calculated if data permits): terminal elimination half-life (T½).
Outcome measures
Outcome data not reported
Adverse Events
Part A, Cohort 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A, Cohort 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A, Cohort 3
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A, Cohort 4
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part B, Cohort 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B, Cohort 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B, Cohort 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A, Cohort 1
n=6 participants at risk
25.5 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% body surface area (BSA) and 23 g cream.
|
Part A, Cohort 2
n=6 participants at risk
25.5 mg/cm2 GZ21T was applied to 1350 cm2 of the skin, corresponding to approximately 7.5% BSA and 35 g cream.
|
Part A, Cohort 3
n=6 participants at risk
25.5 mg/cm2 GZ21T was applied to 1800 cm2 of the skin, corresponding to approximately 10% BSA and 46 g cream.
|
Part A, Cohort 4
n=6 participants at risk
25.5 mg/cm2 GZ21T was applied to the face, corresponding to approximately 3-3.5% BSA and 16 g cream.
|
Part A: Placebo
n=8 participants at risk
Corresponding amount of placebo was applied to the corresponding treatment area as the active treatment in Cohorts 1-4 in Part A.
|
Part B, Cohort 1
n=3 participants at risk
13 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% BSA and 12 g cream.
|
Part B, Cohort 2
n=3 participants at risk
8 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% BSA and 7 g cream.
|
Part B, Cohort 3
n=3 participants at risk
6,5 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% BSA and 6 g cream.
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
Catheter site thrombosis
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
16.7%
1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/8 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
Other adverse events
| Measure |
Part A, Cohort 1
n=6 participants at risk
25.5 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% body surface area (BSA) and 23 g cream.
|
Part A, Cohort 2
n=6 participants at risk
25.5 mg/cm2 GZ21T was applied to 1350 cm2 of the skin, corresponding to approximately 7.5% BSA and 35 g cream.
|
Part A, Cohort 3
n=6 participants at risk
25.5 mg/cm2 GZ21T was applied to 1800 cm2 of the skin, corresponding to approximately 10% BSA and 46 g cream.
|
Part A, Cohort 4
n=6 participants at risk
25.5 mg/cm2 GZ21T was applied to the face, corresponding to approximately 3-3.5% BSA and 16 g cream.
|
Part A: Placebo
n=8 participants at risk
Corresponding amount of placebo was applied to the corresponding treatment area as the active treatment in Cohorts 1-4 in Part A.
|
Part B, Cohort 1
n=3 participants at risk
13 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% BSA and 12 g cream.
|
Part B, Cohort 2
n=3 participants at risk
8 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% BSA and 7 g cream.
|
Part B, Cohort 3
n=3 participants at risk
6,5 mg/cm2 GZ21T was applied to 900 cm2 of the skin, corresponding to approximately 5% BSA and 6 g cream.
|
|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
16.7%
1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
25.0%
2/8 • Number of events 2 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
|
Nervous system disorders
Migraine
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
16.7%
1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/8 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
|
General disorders
Application site pruritus
|
16.7%
1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/8 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
|
General disorders
Tenderness
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
12.5%
1/8 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
33.3%
2/6 • Number of events 3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
12.5%
1/8 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
2/6 • Number of events 2 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/8 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
16.7%
1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/8 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
|
Gastrointestinal disorders
Stomatitis
|
16.7%
1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/8 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
16.7%
1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/8 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
16.7%
1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/8 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
|
General disorders
Application site warmth
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/8 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
33.3%
1/3 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/8 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
33.3%
1/3 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/6 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/8 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
33.3%
1/3 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
0.00%
0/3 • AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit of each part, from day 1 to day 7.
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as not related, unlikely related, or possibly, probably or definitely related to the IMP.
|
Additional Information
Cameron West, Chief Operating Officer
Ankh Life Sciences Limited
Phone: +1 620
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The results from this trial may be submitted for publication at the discretion of the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER