Trial Outcomes & Findings for Safety, Tolerability and Pharmacokinetics of MK-0873 Following Patch Application in Healthy Participants and Psoriasis Participants (MK-0873-020) (NCT NCT01140061)
NCT ID: NCT01140061
Last Updated: 2019-02-08
Results Overview
Following topical administration of MK-0873 or matching placebo patches once daily for 21 days, the number of participants with an adverse event of erythema was recorded. An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
42 participants
Primary outcome timeframe
Up to Day 22 in Part 1
Results posted on
2019-02-08
Participant Flow
Participant milestones
| Measure |
Panel A - MK-0873 5.1 mg
In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
|
Panel A - Placebo
In Part I, healthy participants received skin patches containing nothing (plain patch) and placebo once daily for 21 days.
|
Panel B - MK-0873 25 mg
In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
|
Panel B - Placebo
In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
|
Panel C - MK-0873 100 mg
In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
|
Panel C - Placebo
In Part II, healthy participants received skin application of placebo cream once daily for 10 days.
|
Panel D - MK-0873 200 mg
In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
|
Panel D - Placebo
In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
|
Panel E and Extension - MK-0873 200 mg
In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
|
Panel E and Extension - Placebo
In Part III, participants with mild psoriasis received skin application of placebo cream twice daily for up to 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part I
STARTED
|
7
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part I
COMPLETED
|
6
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part I
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part II
STARTED
|
0
|
0
|
6
|
2
|
6
|
2
|
6
|
2
|
0
|
0
|
|
Part II
COMPLETED
|
0
|
0
|
6
|
2
|
6
|
2
|
6
|
2
|
0
|
0
|
|
Part II
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part III
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
2
|
|
Part III
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
2
|
|
Part III
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Extension
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
2
|
|
Extension
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
1
|
|
Extension
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Panel A - MK-0873 5.1 mg
In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
|
Panel A - Placebo
In Part I, healthy participants received skin patches containing nothing (plain patch) and placebo once daily for 21 days.
|
Panel B - MK-0873 25 mg
In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
|
Panel B - Placebo
In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
|
Panel C - MK-0873 100 mg
In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
|
Panel C - Placebo
In Part II, healthy participants received skin application of placebo cream once daily for 10 days.
|
Panel D - MK-0873 200 mg
In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
|
Panel D - Placebo
In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
|
Panel E and Extension - MK-0873 200 mg
In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
|
Panel E and Extension - Placebo
In Part III, participants with mild psoriasis received skin application of placebo cream twice daily for up to 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part I
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Extension
Laboratory Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Safety, Tolerability and Pharmacokinetics of MK-0873 Following Patch Application in Healthy Participants and Psoriasis Participants (MK-0873-020)
Baseline characteristics by cohort
| Measure |
Panel A - MK-0873 5.1 mg
n=7 Participants
In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
|
Panel A - Placebo
n=2 Participants
In Part I, healthy participants received skin patches containing nothing (plain patch) and placebo once daily for 21 days
|
Panel B - MK-0873 25 mg
n=6 Participants
In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
|
Panel B - Placebo
n=2 Participants
In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
|
Panel C - MK-0873 100 mg
n=6 Participants
In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
|
Panel C - Placebo
n=2 Participants
In Part II, healthy participants received skin application of placebo cream once daily for 10 days.
|
Panel D - MK-0873 200 mg
n=6 Participants
In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days
|
Panel D - Placebo
n=2 Participants
In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
|
Panel E and Extension - MK-0873 200 mg
n=7 Participants
In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
|
Panel E and Extension - Placebo
n=2 Participants
In Part III, participants with mild psoriasis received skin application of placebo cream twice daily for up to 28 days.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
42.71 Years
FULL_RANGE 12.19 • n=5 Participants
|
30.50 Years
FULL_RANGE 17.68 • n=7 Participants
|
40.00 Years
FULL_RANGE 11.78 • n=5 Participants
|
45.50 Years
FULL_RANGE 14.85 • n=4 Participants
|
45.67 Years
FULL_RANGE 12.79 • n=21 Participants
|
34.00 Years
FULL_RANGE 7.07 • n=8 Participants
|
30.33 Years
FULL_RANGE 6.77 • n=8 Participants
|
35.50 Years
FULL_RANGE 2.12 • n=24 Participants
|
42.86 Years
FULL_RANGE 11.33 • n=42 Participants
|
40.00 Years
FULL_RANGE 15.56 • n=42 Participants
|
39.67 Years
FULL_RANGE 11.49 • n=42 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
22 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
20 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Up to Day 22 in Part 1Population: The population consisted of all enrolled participants who received at least one dose of study medication in Part I of the study.
Following topical administration of MK-0873 or matching placebo patches once daily for 21 days, the number of participants with an adverse event of erythema was recorded. An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Outcome measures
| Measure |
Panel A - MK-0873 5.1 mg
n=7 Participants
In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
|
Panel A - Placebo
n=2 Participants
In Part I, healthy participants received skin patches containing nothing (plain patch) and placebo once daily for 21 days.
|
Panel C - MK-0873 100 mg
In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
|
Panel D - MK-0873 200 mg
In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
|
Panel E and Extension - MK-0873 200 mg
In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
|
Placebo - Pooled
In Parts I, II, and III, participants who received skin application of cream or patches containing placebo (and no patches containing MK-0873) were pooled for analysis.
|
|---|---|---|---|---|---|---|
|
Number of Participants With an Adverse Event of Erythema in Part I of the Study
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 11Population: The population consisted of all enrolled participants who received MK-0873 and for whom blood samples were collected and evaluable to determine Cmax.
Participant blood samples were collected on Day 11 to determine the Cmax of MK-0873 following topical administration in healthy participants and participants with psoriasis
Outcome measures
| Measure |
Panel A - MK-0873 5.1 mg
n=6 Participants
In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
|
Panel A - Placebo
n=6 Participants
In Part I, healthy participants received skin patches containing nothing (plain patch) and placebo once daily for 21 days.
|
Panel C - MK-0873 100 mg
n=6 Participants
In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
|
Panel D - MK-0873 200 mg
n=6 Participants
In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
|
Panel E and Extension - MK-0873 200 mg
n=6 Participants
In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
|
Placebo - Pooled
In Parts I, II, and III, participants who received skin application of cream or patches containing placebo (and no patches containing MK-0873) were pooled for analysis.
|
|---|---|---|---|---|---|---|
|
Mean Maximum Plasma Concentration (Cmax) of MK-0873 Following Topical Administration for 10 Days
|
NA nM
Standard Deviation NA
The value was below the lower limit of quantification.
|
9.10 nM
Standard Deviation 1.52
|
5.22 nM
Standard Deviation 2.97
|
12.0 nM
Standard Deviation 3.41
|
9.76 nM
Standard Deviation 6.42
|
—
|
PRIMARY outcome
Timeframe: Up to 14 days after last dose of study drug (up to Day 42)Population: The population consisted of all enrolled participants who received at least one dose of study medication for whom safety data were available.
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Outcome measures
| Measure |
Panel A - MK-0873 5.1 mg
n=7 Participants
In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
|
Panel A - Placebo
n=6 Participants
In Part I, healthy participants received skin patches containing nothing (plain patch) and placebo once daily for 21 days.
|
Panel C - MK-0873 100 mg
n=6 Participants
In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
|
Panel D - MK-0873 200 mg
n=6 Participants
In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
|
Panel E and Extension - MK-0873 200 mg
n=7 Participants
In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
|
Placebo - Pooled
n=10 Participants
In Parts I, II, and III, participants who received skin application of cream or patches containing placebo (and no patches containing MK-0873) were pooled for analysis.
|
|---|---|---|---|---|---|---|
|
Number of Participants With an Adverse Event
|
3 Participants
|
3 Participants
|
4 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to Day 28Population: The population consisted of all enrolled participants who received at least one dose of study medication.
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Outcome measures
| Measure |
Panel A - MK-0873 5.1 mg
n=7 Participants
In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
|
Panel A - Placebo
n=6 Participants
In Part I, healthy participants received skin patches containing nothing (plain patch) and placebo once daily for 21 days.
|
Panel C - MK-0873 100 mg
n=6 Participants
In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
|
Panel D - MK-0873 200 mg
n=6 Participants
In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
|
Panel E and Extension - MK-0873 200 mg
n=7 Participants
In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
|
Placebo - Pooled
n=10 Participants
In Parts I, II, and III, participants who received skin application of cream or patches containing placebo (and no patches containing MK-0873) were pooled for analysis.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Medication Due to an Adverse Event
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Panel A - MK-0873 5.1 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Panel B - MK-0873 25 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Panel C - MK-0873 100 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Panel D - MK-0873 200 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Panel E and Extension - MK-0873 200 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo - Pooled
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Panel A - MK-0873 5.1 mg
n=7 participants at risk
In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
|
Panel B - MK-0873 25 mg
n=6 participants at risk
In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
|
Panel C - MK-0873 100 mg
n=6 participants at risk
In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
|
Panel D - MK-0873 200 mg
n=6 participants at risk
In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
|
Panel E and Extension - MK-0873 200 mg
n=7 participants at risk
In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
|
Placebo - Pooled
n=10 participants at risk
In Parts I, II, and III, participants who received skin application of cream or patches containing placebo (and no patches containing MK-0873) were pooled for analysis.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
16.7%
1/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
16.7%
1/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/10 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
16.7%
1/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/10 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
16.7%
1/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/10 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
|
Nervous system disorders
Burning Sensation
|
0.00%
0/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
16.7%
1/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
10.0%
1/10 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
16.7%
1/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
16.7%
1/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
28.6%
2/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/10 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
16.7%
1/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/10 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
|
Renal and urinary disorders
Pyuria
|
0.00%
0/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
16.7%
1/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/10 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
14.3%
1/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/10 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
16.7%
1/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
50.0%
3/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
50.0%
3/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
28.6%
2/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
30.0%
3/10 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
1/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/10 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
|
Vascular disorders
Flushing
|
0.00%
0/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
16.7%
1/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/10 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
14.3%
1/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/10 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
14.3%
1/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/10 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
14.3%
1/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/10 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
|
General disorders
Injection-site reaction
|
0.00%
0/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
14.3%
1/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/10 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
14.3%
1/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/10 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
14.3%
1/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/10 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
14.3%
1/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/10 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
14.3%
1/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/10 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
14.3%
1/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/10 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
14.3%
1/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/10 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
14.3%
1/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/10 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
14.3%
1/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/10 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
14.3%
1/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/10 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/6 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
14.3%
1/7 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
0.00%
0/10 • Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.
- Publication restrictions are in place
Restriction type: OTHER