Trial Outcomes & Findings for Study to Evaluate Safety and Tolerability of sc Immunotherapy With DM-101 in Adults With Birch Pollen Allergy (NCT NCT04266028)
NCT ID: NCT04266028
Last Updated: 2023-03-21
Results Overview
Number of All Treatment Emergent Adverse Events (TEAEs) in Subjects Receiving DM-101 Compared to Placebo
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
From the first dose until 28 days following the last dose.
Results posted on
2023-03-21
Participant Flow
Participants were enrolled at one study site in Finland. The first participant was screened 11 February 2020. The last study visit occurred on 31 Mat 2021.
61 participants were screened.
Participant milestones
| Measure |
DM-101 Single Dose
Participants received a single subcutaneous (SC) dose of DM-101 30 ng on Day 1.
|
Placebo Single Dose
Participants received a single SC injection of placebo on Day 1.
|
DM-101 Low Multiple Ascending Doses (MAD)
Participants received 5 biweekly administered SC doses of DM-101 as follows: 30 ng on Day 1,50 ng on Day 14, 100 ng on Day 28, 42, and 56.
|
Placebo Low MAD
Participants received 5 biweekly administered SC injections of placebo on Day 1,14, 28, 42, and 56.
|
DM-101 High MAD
Participants received 5 biweekly administered SC doses of DM-101 as follows: 30 ng on Day 1,50 ng on Day 14, 100 ng on Day 28, 200 ng (dose divided into two SC injections) on Day 42, and 300 ng (dose divided into three SC injections) on Day 56.
|
Placebo High MAD
Participants received 5 biweekly administered SC injections of placebo as follows: single injection on Day 1, 14 and 28; two injections on Day 42; three injections on Day 56.
|
DM-101 2-Day Ultra-Rush Dose Escalation
Participants received 9 SC doses of DM-101 as follows: 100, 250, 500, 1000, 2500, 5000, 10000 and 25000 ng during Day 1 and Day 2.
|
Placebo 2-Day Ultra-Rush Dose Escalation
Participants received 9 SC injections of placebo during Day 1 and Day 2.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
2
|
6
|
2
|
6
|
2
|
4
|
1
|
|
Overall Study
COMPLETED
|
4
|
2
|
5
|
2
|
4
|
2
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
2
|
0
|
4
|
1
|
Reasons for withdrawal
| Measure |
DM-101 Single Dose
Participants received a single subcutaneous (SC) dose of DM-101 30 ng on Day 1.
|
Placebo Single Dose
Participants received a single SC injection of placebo on Day 1.
|
DM-101 Low Multiple Ascending Doses (MAD)
Participants received 5 biweekly administered SC doses of DM-101 as follows: 30 ng on Day 1,50 ng on Day 14, 100 ng on Day 28, 42, and 56.
|
Placebo Low MAD
Participants received 5 biweekly administered SC injections of placebo on Day 1,14, 28, 42, and 56.
|
DM-101 High MAD
Participants received 5 biweekly administered SC doses of DM-101 as follows: 30 ng on Day 1,50 ng on Day 14, 100 ng on Day 28, 200 ng (dose divided into two SC injections) on Day 42, and 300 ng (dose divided into three SC injections) on Day 56.
|
Placebo High MAD
Participants received 5 biweekly administered SC injections of placebo as follows: single injection on Day 1, 14 and 28; two injections on Day 42; three injections on Day 56.
|
DM-101 2-Day Ultra-Rush Dose Escalation
Participants received 9 SC doses of DM-101 as follows: 100, 250, 500, 1000, 2500, 5000, 10000 and 25000 ng during Day 1 and Day 2.
|
Placebo 2-Day Ultra-Rush Dose Escalation
Participants received 9 SC injections of placebo during Day 1 and Day 2.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
1
|
0
|
2
|
0
|
|
Overall Study
temporary halt of the study
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
|
Overall Study
Onset of birch pollen season
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Study to Evaluate Safety and Tolerability of sc Immunotherapy With DM-101 in Adults With Birch Pollen Allergy
Baseline characteristics by cohort
| Measure |
DM-101 Single Dose
n=4 Participants
Participants received a single subcutaneous (SC) dose of DM-101 30 ng on Day 1.
|
Placebo Single Dose
n=2 Participants
Participants received a single SC injection of placebo on Day 1.
|
DM-101 Low Multiple Ascending Doses (MAD)
n=6 Participants
Participants received 5 biweekly administered SC doses of DM-101 as follows: 30 ng on Day 1,50 ng on Day 14, 100 ng on Day 28, 42, and 56.
|
Placebo Low MAD
n=2 Participants
Participants received 5 biweekly administered SC injections of placebo on Day 1,14, 28, 42, and 56.
|
DM-101 High MAD
n=6 Participants
Participants received 5 biweekly administered SC doses of DM-101 as follows: 30 ng on Day 1,50 ng on Day 14, 100 ng on Day 28, 200 ng (dose divided into two SC injections) on Day 42, and 300 ng (dose divided into three SC injections) on Day 56.
|
Placebo High MAD
n=2 Participants
Participants received 5 biweekly administered SC injections of placebo as follows: single injection on Day 1, 14 and 28; two injections on Day 42; three injections on Day 56.
|
DM-101 2-Day Ultra-Rush Dose Escalation
n=4 Participants
Participants received 9 SC doses of DM-101 as follows: 100, 250, 500, 1000, 2500, 5000, 10000 and 25000 ng during Day 1 and Day 2.
|
Placebo 2-Day Ultra-Rush Dose Escalation
n=1 Participants
Participants received 9 SC injections of placebo during Day 1 and Day 2.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
39.3 years
STANDARD_DEVIATION 10.81 • n=5 Participants
|
27.5 years
STANDARD_DEVIATION 4.95 • n=7 Participants
|
29.8 years
STANDARD_DEVIATION 11.34 • n=5 Participants
|
26.5 years
STANDARD_DEVIATION 4.95 • n=4 Participants
|
37.7 years
STANDARD_DEVIATION 8.43 • n=21 Participants
|
34.5 years
STANDARD_DEVIATION 7.78 • n=8 Participants
|
44.0 years
STANDARD_DEVIATION 5.03 • n=8 Participants
|
33.0 years
STANDARD_DEVIATION 0.0 • n=24 Participants
|
31.11 years
STANDARD_DEVIATION 9.42 • n=42 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
15 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
27 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
27 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
Finland
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
2 participants
n=4 Participants
|
6 participants
n=21 Participants
|
2 participants
n=8 Participants
|
4 participants
n=8 Participants
|
1 participants
n=24 Participants
|
27 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: From the first dose until 28 days following the last dose.Population: The Safety Set included participants who received at least 1 dose of study drug.
Number of All Treatment Emergent Adverse Events (TEAEs) in Subjects Receiving DM-101 Compared to Placebo
Outcome measures
| Measure |
DM-101 Single Dose
n=4 Participants
Participants received a single subcutaneous (SC) dose of DM-101 30 ng on Day 1.
|
Placebo Single Dose
n=2 Participants
Participants received a single SC injection of placebo on Day 1.
|
DM-101 Low Multiple Ascending Doses (MAD)
n=6 Participants
Participants received 5 biweekly administered SC doses of DM-101 as follows: 30 ng on Day 1,50 ng on Day 14, 100 ng on Day 28, 42, and 56.
|
Placebo Low MAD
n=2 Participants
Participants received 5 biweekly administered SC injections of placebo on Day 1,14, 28, 42, and 56.
|
DM-101 High MAD
n=6 Participants
Participants received 5 biweekly administered SC doses of DM-101 as follows: 30 ng on Day 1,50 ng on Day 14, 100 ng on Day 28, 200 ng (dose divided into two SC injections) on Day 42, and 300 ng (dose divided into three SC injections) on Day 56.
|
Placebo High MAD
n=2 Participants
Participants received 5 biweekly administered SC injections of placebo as follows: single injection on Day 1, 14 and 28; two injections on Day 42; three injections on Day 56.
|
DM-101 2-Day Ultra-Rush Dose Escalation
n=4 Participants
Participants received 9 SC doses of DM-101 as follows: 100, 250, 500, 1000, 2500, 5000, 10000 and 25000 ng during Day 1 and Day 2.
|
Placebo 2-Day Ultra-Rush Dose Escalation
n=1 Participants
Participants received 9 SC injections of placebo during Day 1 and Day 2.
|
|---|---|---|---|---|---|---|---|---|
|
Treatment Emergent Adverse Events
|
13 number of adverse events per arm
|
3 number of adverse events per arm
|
81 number of adverse events per arm
|
2 number of adverse events per arm
|
88 number of adverse events per arm
|
7 number of adverse events per arm
|
72 number of adverse events per arm
|
2 number of adverse events per arm
|
SECONDARY outcome
Timeframe: From the first dose until 28 days following the last dose.Population: The Safety Analysis Set included participants who received at least 1 dose of study drug.
Severity of SARs are graded from Grade 1 to 5 (Grade 5 being fatal) as defined by WAO Subcutaneous Immunotherapy Systemic Reaction Grading System.
Outcome measures
| Measure |
DM-101 Single Dose
n=4 Participants
Participants received a single subcutaneous (SC) dose of DM-101 30 ng on Day 1.
|
Placebo Single Dose
n=2 Participants
Participants received a single SC injection of placebo on Day 1.
|
DM-101 Low Multiple Ascending Doses (MAD)
n=6 Participants
Participants received 5 biweekly administered SC doses of DM-101 as follows: 30 ng on Day 1,50 ng on Day 14, 100 ng on Day 28, 42, and 56.
|
Placebo Low MAD
n=2 Participants
Participants received 5 biweekly administered SC injections of placebo on Day 1,14, 28, 42, and 56.
|
DM-101 High MAD
n=6 Participants
Participants received 5 biweekly administered SC doses of DM-101 as follows: 30 ng on Day 1,50 ng on Day 14, 100 ng on Day 28, 200 ng (dose divided into two SC injections) on Day 42, and 300 ng (dose divided into three SC injections) on Day 56.
|
Placebo High MAD
n=2 Participants
Participants received 5 biweekly administered SC injections of placebo as follows: single injection on Day 1, 14 and 28; two injections on Day 42; three injections on Day 56.
|
DM-101 2-Day Ultra-Rush Dose Escalation
n=4 Participants
Participants received 9 SC doses of DM-101 as follows: 100, 250, 500, 1000, 2500, 5000, 10000 and 25000 ng during Day 1 and Day 2.
|
Placebo 2-Day Ultra-Rush Dose Escalation
n=1 Participants
Participants received 9 SC injections of placebo during Day 1 and Day 2.
|
|---|---|---|---|---|---|---|---|---|
|
Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo
Grade 1
|
0 number of systemic reactions per arm
|
0 number of systemic reactions per arm
|
2 number of systemic reactions per arm
|
0 number of systemic reactions per arm
|
0 number of systemic reactions per arm
|
0 number of systemic reactions per arm
|
0 number of systemic reactions per arm
|
0 number of systemic reactions per arm
|
|
Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo
Grade 2
|
0 number of systemic reactions per arm
|
0 number of systemic reactions per arm
|
0 number of systemic reactions per arm
|
0 number of systemic reactions per arm
|
0 number of systemic reactions per arm
|
0 number of systemic reactions per arm
|
2 number of systemic reactions per arm
|
0 number of systemic reactions per arm
|
|
Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo
Grade 3
|
0 number of systemic reactions per arm
|
0 number of systemic reactions per arm
|
0 number of systemic reactions per arm
|
0 number of systemic reactions per arm
|
0 number of systemic reactions per arm
|
0 number of systemic reactions per arm
|
1 number of systemic reactions per arm
|
0 number of systemic reactions per arm
|
|
Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo
Grade 4
|
0 number of systemic reactions per arm
|
0 number of systemic reactions per arm
|
0 number of systemic reactions per arm
|
0 number of systemic reactions per arm
|
0 number of systemic reactions per arm
|
0 number of systemic reactions per arm
|
0 number of systemic reactions per arm
|
0 number of systemic reactions per arm
|
|
Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo
Grade 5
|
0 number of systemic reactions per arm
|
0 number of systemic reactions per arm
|
0 number of systemic reactions per arm
|
0 number of systemic reactions per arm
|
0 number of systemic reactions per arm
|
0 number of systemic reactions per arm
|
0 number of systemic reactions per arm
|
0 number of systemic reactions per arm
|
SECONDARY outcome
Timeframe: From the first dose until 28 days following the last dose.Population: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Pain, tenderness, erythema/redness and induration/swelling at the injection site was assessed after each injection using a 4-point scale (Grade 1 = mild, Grade 4 = severe) as defined in the study protocol.
Outcome measures
| Measure |
DM-101 Single Dose
n=4 Participants
Participants received a single subcutaneous (SC) dose of DM-101 30 ng on Day 1.
|
Placebo Single Dose
n=2 Participants
Participants received a single SC injection of placebo on Day 1.
|
DM-101 Low Multiple Ascending Doses (MAD)
n=6 Participants
Participants received 5 biweekly administered SC doses of DM-101 as follows: 30 ng on Day 1,50 ng on Day 14, 100 ng on Day 28, 42, and 56.
|
Placebo Low MAD
n=2 Participants
Participants received 5 biweekly administered SC injections of placebo on Day 1,14, 28, 42, and 56.
|
DM-101 High MAD
n=6 Participants
Participants received 5 biweekly administered SC doses of DM-101 as follows: 30 ng on Day 1,50 ng on Day 14, 100 ng on Day 28, 200 ng (dose divided into two SC injections) on Day 42, and 300 ng (dose divided into three SC injections) on Day 56.
|
Placebo High MAD
n=2 Participants
Participants received 5 biweekly administered SC injections of placebo as follows: single injection on Day 1, 14 and 28; two injections on Day 42; three injections on Day 56.
|
DM-101 2-Day Ultra-Rush Dose Escalation
n=4 Participants
Participants received 9 SC doses of DM-101 as follows: 100, 250, 500, 1000, 2500, 5000, 10000 and 25000 ng during Day 1 and Day 2.
|
Placebo 2-Day Ultra-Rush Dose Escalation
n=1 Participants
Participants received 9 SC injections of placebo during Day 1 and Day 2.
|
|---|---|---|---|---|---|---|---|---|
|
Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo
Grade 1
|
4 number of LISRs per arm
|
0 number of LISRs per arm
|
26 number of LISRs per arm
|
1 number of LISRs per arm
|
27 number of LISRs per arm
|
0 number of LISRs per arm
|
3 number of LISRs per arm
|
0 number of LISRs per arm
|
|
Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo
Grade 2
|
0 number of LISRs per arm
|
0 number of LISRs per arm
|
0 number of LISRs per arm
|
0 number of LISRs per arm
|
8 number of LISRs per arm
|
0 number of LISRs per arm
|
12 number of LISRs per arm
|
0 number of LISRs per arm
|
|
Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo
Grade 3
|
0 number of LISRs per arm
|
0 number of LISRs per arm
|
0 number of LISRs per arm
|
0 number of LISRs per arm
|
0 number of LISRs per arm
|
0 number of LISRs per arm
|
3 number of LISRs per arm
|
0 number of LISRs per arm
|
|
Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo
Grade 4
|
0 number of LISRs per arm
|
0 number of LISRs per arm
|
0 number of LISRs per arm
|
0 number of LISRs per arm
|
0 number of LISRs per arm
|
0 number of LISRs per arm
|
0 number of LISRs per arm
|
0 number of LISRs per arm
|
SECONDARY outcome
Timeframe: From the first dose until 28 days following the last dose.Population: The Safety Analysis Set included participants who received at least 1 dose of study drug
Proportion of subjects reaching the pre-defined, admissible dose in each DM-101 dosing group
Outcome measures
| Measure |
DM-101 Single Dose
n=4 Participants
Participants received a single subcutaneous (SC) dose of DM-101 30 ng on Day 1.
|
Placebo Single Dose
n=6 Participants
Participants received a single SC injection of placebo on Day 1.
|
DM-101 Low Multiple Ascending Doses (MAD)
n=6 Participants
Participants received 5 biweekly administered SC doses of DM-101 as follows: 30 ng on Day 1,50 ng on Day 14, 100 ng on Day 28, 42, and 56.
|
Placebo Low MAD
n=4 Participants
Participants received 5 biweekly administered SC injections of placebo on Day 1,14, 28, 42, and 56.
|
DM-101 High MAD
Participants received 5 biweekly administered SC doses of DM-101 as follows: 30 ng on Day 1,50 ng on Day 14, 100 ng on Day 28, 200 ng (dose divided into two SC injections) on Day 42, and 300 ng (dose divided into three SC injections) on Day 56.
|
Placebo High MAD
Participants received 5 biweekly administered SC injections of placebo as follows: single injection on Day 1, 14 and 28; two injections on Day 42; three injections on Day 56.
|
DM-101 2-Day Ultra-Rush Dose Escalation
Participants received 9 SC doses of DM-101 as follows: 100, 250, 500, 1000, 2500, 5000, 10000 and 25000 ng during Day 1 and Day 2.
|
Placebo 2-Day Ultra-Rush Dose Escalation
Participants received 9 SC injections of placebo during Day 1 and Day 2.
|
|---|---|---|---|---|---|---|---|---|
|
Subjects Reaching the Pre-defined DM-101 Dose
|
4 Participants
|
5 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
Adverse Events
DM-101 Single Dose
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo Single Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
DM-101 Low Multiple Ascending Doses (MAD)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo Low MAD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
DM-101 High MAD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo High MAD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
DM-101 2-Day Ultra-Rush Dose Escalation
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo 2-Day Ultra-Rush Dose Escalation
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DM-101 Single Dose
n=4 participants at risk
Participants received a single subcutaneous (SC) dose of DM-101 30 ng on Day 1.
|
Placebo Single Dose
n=2 participants at risk
Participants received a single SC injection of placebo on Day 1.
|
DM-101 Low Multiple Ascending Doses (MAD)
n=6 participants at risk
Participants received 5 biweekly administered SC doses of DM-101 as follows: 30 ng on Day 1,50 ng on Day 14, 100 ng on Day 28, 42, and 56.
|
Placebo Low MAD
n=2 participants at risk
Participants received 5 biweekly administered SC injections of placebo on Day 1,14, 28, 42, and 56.
|
DM-101 High MAD
n=6 participants at risk
Participants received 5 biweekly administered SC doses of DM-101 as follows: 30 ng on Day 1,50 ng on Day 14, 100 ng on Day 28, 200 ng (dose divided into two SC injections) on Day 42, and 300 ng (dose divided into three SC injections) on Day 56.
|
Placebo High MAD
n=2 participants at risk
Participants received 5 biweekly administered SC injections of placebo as follows: single injection on Day 1, 14 and 28; two injections on Day 42; three injections on Day 56.
|
DM-101 2-Day Ultra-Rush Dose Escalation
n=4 participants at risk
Participants received 9 SC doses of DM-101 as follows: 100, 250, 500, 1000, 2500, 5000, 10000 and 25000 ng during Day 1 and Day 2.
|
Placebo 2-Day Ultra-Rush Dose Escalation
n=1 participants at risk
Participants received 9 SC injections of placebo during Day 1 and Day 2.
|
|---|---|---|---|---|---|---|---|---|
|
Reproductive system and breast disorders
Ovarian Cyst Ruptured
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
16.7%
1/6 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
Other adverse events
| Measure |
DM-101 Single Dose
n=4 participants at risk
Participants received a single subcutaneous (SC) dose of DM-101 30 ng on Day 1.
|
Placebo Single Dose
n=2 participants at risk
Participants received a single SC injection of placebo on Day 1.
|
DM-101 Low Multiple Ascending Doses (MAD)
n=6 participants at risk
Participants received 5 biweekly administered SC doses of DM-101 as follows: 30 ng on Day 1,50 ng on Day 14, 100 ng on Day 28, 42, and 56.
|
Placebo Low MAD
n=2 participants at risk
Participants received 5 biweekly administered SC injections of placebo on Day 1,14, 28, 42, and 56.
|
DM-101 High MAD
n=6 participants at risk
Participants received 5 biweekly administered SC doses of DM-101 as follows: 30 ng on Day 1,50 ng on Day 14, 100 ng on Day 28, 200 ng (dose divided into two SC injections) on Day 42, and 300 ng (dose divided into three SC injections) on Day 56.
|
Placebo High MAD
n=2 participants at risk
Participants received 5 biweekly administered SC injections of placebo as follows: single injection on Day 1, 14 and 28; two injections on Day 42; three injections on Day 56.
|
DM-101 2-Day Ultra-Rush Dose Escalation
n=4 participants at risk
Participants received 9 SC doses of DM-101 as follows: 100, 250, 500, 1000, 2500, 5000, 10000 and 25000 ng during Day 1 and Day 2.
|
Placebo 2-Day Ultra-Rush Dose Escalation
n=1 participants at risk
Participants received 9 SC injections of placebo during Day 1 and Day 2.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leucocytosis
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
25.0%
1/4 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
16.7%
1/6 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
16.7%
1/6 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Eye disorders
Conjuctival Hyperaemia
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
50.0%
2/4 • Number of events 2 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Eye disorders
Eye Pruritus
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
50.0%
3/6 • Number of events 3 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
25.0%
1/4 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Eye disorders
Nictitating Spasm
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
25.0%
1/4 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
25.0%
1/4 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Gastrointestinal disorders
Hypoaesthesia Oral
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
25.0%
1/4 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Gastrointestinal disorders
Intestinal Ulcer
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
16.7%
1/6 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
16.7%
1/6 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
16.7%
1/6 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
General disorders
Injection Site Erythema
|
100.0%
4/4 • Number of events 4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
100.0%
6/6 • Number of events 6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
100.0%
6/6 • Number of events 6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
100.0%
4/4 • Number of events 4 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
General disorders
Injection Site Pain
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
100.0%
6/6 • Number of events 6 • From the first dose until 28 days following the last dose
|
50.0%
1/2 • Number of events 1 • From the first dose until 28 days following the last dose
|
100.0%
6/6 • Number of events 6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
50.0%
2/4 • Number of events 2 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
General disorders
Pain
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
25.0%
1/4 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
General disorders
Swelling Face
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
25.0%
1/4 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
General disorders
Catheter Site Pruritus
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
100.0%
1/1 • Number of events 1 • From the first dose until 28 days following the last dose
|
|
General disorders
Injection Site Swelling
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
16.7%
1/6 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
33.3%
2/6 • Number of events 2 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
100.0%
4/4 • Number of events 4 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
General disorders
Fatigue
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
16.7%
1/6 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
General disorders
Injection Site Pruritus
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
16.7%
1/6 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
General disorders
Malaise
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
16.7%
1/6 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
General disorders
Pyrexia
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
16.7%
1/6 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
General disorders
Catheter Site Pain
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
16.7%
1/6 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
50.0%
1/2 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
50.0%
1/2 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Injury, poisoning and procedural complications
Vaccination Complication
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
16.7%
1/6 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Investigations
Forced Respiratory Volume Decreased
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
25.0%
1/4 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
16.7%
1/6 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
16.7%
1/6 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
16.7%
1/6 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
16.7%
1/6 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
25.0%
1/4 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
25.0%
1/4 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
16.7%
1/6 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
25.0%
1/4 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
33.3%
2/6 • Number of events 2 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
16.7%
1/6 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Nervous system disorders
Amnesia
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
16.7%
1/6 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
50.0%
3/6 • Number of events 3 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
50.0%
3/6 • Number of events 3 • From the first dose until 28 days following the last dose
|
50.0%
1/2 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
100.0%
1/1 • Number of events 1 • From the first dose until 28 days following the last dose
|
|
Nervous system disorders
Hyperreflexia
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
25.0%
1/4 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
25.0%
1/4 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
33.3%
2/6 • Number of events 2 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
50.0%
1/2 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
50.0%
2/4 • Number of events 2 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
25.0%
1/4 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
25.0%
1/4 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
25.0%
1/4 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
25.0%
1/4 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
25.0%
1/4 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
16.7%
1/6 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
25.0%
1/4 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Respiratory, thoracic and mediastinal disorders
Orypharyngeal Pain
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
25.0%
1/4 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Skin and subcutaneous tissue disorders
Erythema
|
25.0%
1/4 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
16.7%
1/6 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
75.0%
3/4 • Number of events 3 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
16.7%
1/6 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
75.0%
3/4 • Number of events 3 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
25.0%
1/4 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Skin and subcutaneous tissue disorders
Urticaria Papular
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
50.0%
2/4 • Number of events 2 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
16.7%
1/6 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Skin and subcutaneous tissue disorders
Skin Reaction
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
16.7%
1/6 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
25.0%
1/4 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
25.0%
1/4 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
1/4 • Number of events 1 • From the first dose until 28 days following the last dose
|
50.0%
1/2 • Number of events 1 • From the first dose until 28 days following the last dose
|
16.7%
1/6 • Number of events 1 • From the first dose until 28 days following the last dose
|
50.0%
1/2 • Number of events 1 • From the first dose until 28 days following the last dose
|
33.3%
2/6 • Number of events 2 • From the first dose until 28 days following the last dose
|
50.0%
1/2 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
16.7%
1/6 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Infections and infestations
Eye Infection
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
50.0%
1/2 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/6 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
16.7%
1/6 • Number of events 1 • From the first dose until 28 days following the last dose
|
0.00%
0/2 • From the first dose until 28 days following the last dose
|
0.00%
0/4 • From the first dose until 28 days following the last dose
|
0.00%
0/1 • From the first dose until 28 days following the last dose
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place