Trial Outcomes & Findings for A Study of LY3303560 in Healthy Participants and Participants With Alzheimer's Disease (AD) (NCT NCT02754830)
NCT ID: NCT02754830
Last Updated: 2023-10-13
Results Overview
Number of participants with one or more SAEs considered by the investigator to be related to study drug administration. A summary of other nonserious adverse events (AEs), and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
72 participants
Primary outcome timeframe
Baseline up to 146 days
Results posted on
2023-10-13
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo administered as an intravenous (IV) single dose on Day 1.
|
7 mg LY3303560
7 milligram (mg) LY3303560 single dose administered intravenously (IV) on Day 1.
|
21 mg LY3303560
21 mg LY3303560 single dose administered IV on Day 1.
|
70 mg LY3303560
70 mg LY3303560 single dose administered IV on Day 1.
|
210 mg LY3303560
210 mg LY3303560 single dose administered IV on Day 1.
|
210 mg LY3303560 Subcutaneous
210 mg LY3303560 single dose administered subcutaneously (SC) on Day 1.
|
700 mg LY3303560
700 mg LY3303560 single dose administered IV on Day 1.
|
1400 mg LY3303560
1400 mg LY3303560 single dose administered IV on Day 1.
|
2800 mg LY3303560
2800 mg LY3303560 single dose administered IV on Day 1.
|
5600 mg LY3303560
5600 mg LY3303560 single dose administered IV on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
7
|
6
|
|
Overall Study
COMPLETED
|
17
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of LY3303560 in Healthy Participants and Participants With Alzheimer's Disease (AD)
Baseline characteristics by cohort
| Measure |
Placebo
n=17 Participants
Placebo single dose administered IV.
|
7 mg LY3303560
n=6 Participants
7 mg LY3303560 single dose administered IV.
|
21 mg LY3303560
n=6 Participants
21 mg LY3303560 single dose administered IV.
|
70 mg LY3303560
n=6 Participants
70 mg LY3303560 single dose administered IV.
|
210 mg LY3303560
n=6 Participants
210 LY3303560 single dose administered IV.
|
210 mg LY3303560 SC
n=6 Participants
210 mg LY3303560 single dose administered SC.
|
700 mg LY3303560
n=6 Participants
700 mg LY3303560 single dose administered IV.
|
1400 mg LY3303560
n=6 Participants
1400 mg LY3303560 single dose administered IV.
|
2800 mg LY3303560
n=7 Participants
2800 mg LY3303560 single dose administered IV.
|
5600 mg LY3303560
n=6 Participants
5600 mg LY3303560 single dose administered IV.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
47.2 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
41.8 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
48.5 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
49.8 years
STANDARD_DEVIATION 11.2 • n=4 Participants
|
46.3 years
STANDARD_DEVIATION 10.3 • n=21 Participants
|
46.2 years
STANDARD_DEVIATION 6.7 • n=10 Participants
|
46.3 years
STANDARD_DEVIATION 12.2 • n=115 Participants
|
47.0 years
STANDARD_DEVIATION 13.5 • n=6 Participants
|
51.7 years
STANDARD_DEVIATION 9.6 • n=6 Participants
|
40.7 years
STANDARD_DEVIATION 10.4 • n=64 Participants
|
46.7 years
STANDARD_DEVIATION 9.9 • n=17 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=64 Participants
|
22 Participants
n=17 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
3 Participants
n=64 Participants
|
50 Participants
n=17 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=64 Participants
|
9 Participants
n=17 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
4 Participants
n=64 Participants
|
63 Participants
n=17 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=64 Participants
|
26 Participants
n=17 Participants
|
|
Race/Ethnicity, Customized
Non-Japanese
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=64 Participants
|
46 Participants
n=17 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
7 Participants
n=6 Participants
|
6 Participants
n=64 Participants
|
72 Participants
n=17 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 146 daysPopulation: All enrolled participants.
Number of participants with one or more SAEs considered by the investigator to be related to study drug administration. A summary of other nonserious adverse events (AEs), and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Outcome measures
| Measure |
Placebo
n=17 Participants
Placebo single dose administered IV.
|
7 mg LY3303560
n=6 Participants
7 mg LY3303560 single dose administered IV.
|
21 mg LY3303560
n=6 Participants
21 mg LY3303560 single dose administered IV.
|
70 mg LY3303560
n=6 Participants
70 mg LY3303560 single dose administered IV.
|
210 mg LY3303560
n=6 Participants
210 mg LY3303560 single dose administered IV.
|
210 mg LY3303560 SC
n=6 Participants
210 mg LY3303560 single dose administered SC.
|
700 mg LY3303560
n=6 Participants
700 mg LY3303560 single dose administered IV.
|
1400 mg LY3303560
n=6 Participants
1400 mg LY3303560 single dose administered IV.
|
2800 mg LY3303560
n=7 Participants
2800 mg LY3303560 single dose administered IV.
|
5600 mg LY3303560
n=6 Participants
5600 mg LY3303560 single dose administered IV.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Event(s) (SAEs) to be Related to Study Drug Administration
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1: Predose, 0.5, 2, 4, 12, 24, 48, 72, 96, 120, 144, 360, 528, 696, 1032, 1368, 1704, 2040 hours post-dose; additionally, for 2800 mg and 5600 mg: 2712 and 3384 hours postdosePopulation: All participants who had evaluable PK data.
Serum PK: AUC. Statistical analysis was not pre-specified.
Outcome measures
| Measure |
Placebo
n=6 Participants
Placebo single dose administered IV.
|
7 mg LY3303560
n=6 Participants
7 mg LY3303560 single dose administered IV.
|
21 mg LY3303560
n=6 Participants
21 mg LY3303560 single dose administered IV.
|
70 mg LY3303560
n=6 Participants
70 mg LY3303560 single dose administered IV.
|
210 mg LY3303560
n=6 Participants
210 mg LY3303560 single dose administered IV.
|
210 mg LY3303560 SC
n=6 Participants
210 mg LY3303560 single dose administered SC.
|
700 mg LY3303560
n=6 Participants
700 mg LY3303560 single dose administered IV.
|
1400 mg LY3303560
n=7 Participants
1400 mg LY3303560 single dose administered IV.
|
2800 mg LY3303560
n=6 Participants
2800 mg LY3303560 single dose administered IV.
|
5600 mg LY3303560
5600 mg LY3303560 single dose administered IV.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3303560
|
863 microgram*hour per millliliter(µg*hr/mL)
Geometric Coefficient of Variation 15
|
2570 microgram*hour per millliliter(µg*hr/mL)
Geometric Coefficient of Variation 8
|
11300 microgram*hour per millliliter(µg*hr/mL)
Geometric Coefficient of Variation 16
|
27100 microgram*hour per millliliter(µg*hr/mL)
Geometric Coefficient of Variation 15
|
16700 microgram*hour per millliliter(µg*hr/mL)
Geometric Coefficient of Variation 17
|
98000 microgram*hour per millliliter(µg*hr/mL)
Geometric Coefficient of Variation 34
|
219000 microgram*hour per millliliter(µg*hr/mL)
Geometric Coefficient of Variation 28
|
325000 microgram*hour per millliliter(µg*hr/mL)
Geometric Coefficient of Variation 25
|
788000 microgram*hour per millliliter(µg*hr/mL)
Geometric Coefficient of Variation 21
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose, 0.5, 2, 4, 12, 24, 48, 72, 96, 120, 144, 360, 528, 696, 1032, 1368, 1704, 2040 hours post-dose; additionally, for 2800 mg and 5600 mg: 2712 and 3384 hours postdosePopulation: All participants who had evaluable PK data.
Serum PK: Cmax. Statistical analysis was not pre-specified.
Outcome measures
| Measure |
Placebo
n=6 Participants
Placebo single dose administered IV.
|
7 mg LY3303560
n=6 Participants
7 mg LY3303560 single dose administered IV.
|
21 mg LY3303560
n=6 Participants
21 mg LY3303560 single dose administered IV.
|
70 mg LY3303560
n=6 Participants
70 mg LY3303560 single dose administered IV.
|
210 mg LY3303560
n=6 Participants
210 mg LY3303560 single dose administered IV.
|
210 mg LY3303560 SC
n=6 Participants
210 mg LY3303560 single dose administered SC.
|
700 mg LY3303560
n=6 Participants
700 mg LY3303560 single dose administered IV.
|
1400 mg LY3303560
n=7 Participants
1400 mg LY3303560 single dose administered IV.
|
2800 mg LY3303560
n=6 Participants
2800 mg LY3303560 single dose administered IV.
|
5600 mg LY3303560
5600 mg LY3303560 single dose administered IV.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK: Maximum Drug Concentration (Cmax) of LY3303560
|
2.78 microgram/millliliter (µg/mL)
Geometric Coefficient of Variation 12
|
7.68 microgram/millliliter (µg/mL)
Geometric Coefficient of Variation 24
|
41.5 microgram/millliliter (µg/mL)
Geometric Coefficient of Variation 57
|
75.0 microgram/millliliter (µg/mL)
Geometric Coefficient of Variation 20
|
20.9 microgram/millliliter (µg/mL)
Geometric Coefficient of Variation 18
|
331 microgram/millliliter (µg/mL)
Geometric Coefficient of Variation 18
|
631 microgram/millliliter (µg/mL)
Geometric Coefficient of Variation 25
|
1050 microgram/millliliter (µg/mL)
Geometric Coefficient of Variation 30
|
2440 microgram/millliliter (µg/mL)
Geometric Coefficient of Variation 21
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose, 0, 2, 4, 12, 24, and 36 hours post-dosePopulation: Zero participants were analyzed as no AD and Mild Cognitive Impairment (MCI) participants were enrolled.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1: Predose, 0, 2, 4, 12, 24, and 36 hours post-dosePopulation: Zero participants were analyzed as no AD and MCI participants were enrolled.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 7 days postdosePopulation: All enrolled participants.
Mean change from baseline in QT/QTc intervals using Fridericia's formula \[Fridericia's corrected QT(QTcF)\] from ECG monitoring.
Outcome measures
| Measure |
Placebo
n=17 Participants
Placebo single dose administered IV.
|
7 mg LY3303560
n=6 Participants
7 mg LY3303560 single dose administered IV.
|
21 mg LY3303560
n=6 Participants
21 mg LY3303560 single dose administered IV.
|
70 mg LY3303560
n=6 Participants
70 mg LY3303560 single dose administered IV.
|
210 mg LY3303560
n=6 Participants
210 mg LY3303560 single dose administered IV.
|
210 mg LY3303560 SC
n=6 Participants
210 mg LY3303560 single dose administered SC.
|
700 mg LY3303560
n=6 Participants
700 mg LY3303560 single dose administered IV.
|
1400 mg LY3303560
n=6 Participants
1400 mg LY3303560 single dose administered IV.
|
2800 mg LY3303560
n=7 Participants
2800 mg LY3303560 single dose administered IV.
|
5600 mg LY3303560
n=6 Participants
5600 mg LY3303560 single dose administered IV.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in QT/QT Corrected (QTc) Interval
|
2.5 milliseconds (msec)
Standard Deviation 10.7
|
-0.8 milliseconds (msec)
Standard Deviation 14.8
|
-1.0 milliseconds (msec)
Standard Deviation 8.0
|
-0.9 milliseconds (msec)
Standard Deviation 4.0
|
-0.5 milliseconds (msec)
Standard Deviation 11.8
|
-1.0 milliseconds (msec)
Standard Deviation 14.7
|
-1.4 milliseconds (msec)
Standard Deviation 14.0
|
1.7 milliseconds (msec)
Standard Deviation 15.2
|
5.5 milliseconds (msec)
Standard Deviation 21.3
|
0.8 milliseconds (msec)
Standard Deviation 10.9
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
7 mg LY3303560
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
21 mg LY3303560
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
70 mg LY3303560
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
210 mg LY3303560
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
210 mg LY3303560 SC
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
700 mg LY3303560
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
1400 mg LY3303560
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
2600 mg LY3303560
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
5600 mg LY3303560
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 |
Placebo
n=17 participants at risk
Placebo single dose administered IV.
|
7 mg LY3303560
n=6 participants at risk
7mg LY3303560 single dose administered IV.
|
21 mg LY3303560
n=6 participants at risk
21 mg LY3303560 single dose administered IV.
|
70 mg LY3303560
n=6 participants at risk
70 mg LY3303560 single dose administered IV.
|
210 mg LY3303560
n=6 participants at risk
210 mg LY3303560 single dose administered IV.
|
210 mg LY3303560 SC
n=6 participants at risk
210 mg LY3303560 single dose administered SC.
|
700 mg LY3303560
n=6 participants at risk
700 mg LY3303560 single dose administered IV.
|
1400 mg LY3303560
n=6 participants at risk
1400 mg LY3303560 single dose administered IV.
|
2600 mg LY3303560
n=7 participants at risk
2600 mg LY3303560 single dose administered IV.
|
5600 mg LY3303560
n=6 participants at risk
5600 mg LY3303560 single dose administered IV.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/17 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
16.7%
1/6 • Number of events 1 • Baseline up to 146 days
|
0.00%
0/7 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
1/17 • Number of events 1 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/7 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.00%
0/17 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/7 • Baseline up to 146 days
|
16.7%
1/6 • Number of events 1 • Baseline up to 146 days
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
1/17 • Number of events 1 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
16.7%
1/6 • Number of events 1 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/7 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/17 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
16.7%
1/6 • Number of events 1 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/7 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • Number of events 1 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/7 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
|
General disorders
Chest discomfort
|
0.00%
0/17 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
16.7%
1/6 • Number of events 1 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/7 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
|
General disorders
Chest pain
|
0.00%
0/17 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
16.7%
1/6 • Number of events 1 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/7 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
|
General disorders
Influenza like illness
|
0.00%
0/17 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
16.7%
1/6 • Number of events 1 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
16.7%
1/6 • Number of events 1 • Baseline up to 146 days
|
0.00%
0/7 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
|
General disorders
Swelling
|
0.00%
0/17 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
16.7%
1/6 • Number of events 1 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/7 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/17 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
16.7%
1/6 • Number of events 1 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/7 • Baseline up to 146 days
|
16.7%
1/6 • Number of events 1 • Baseline up to 146 days
|
|
General disorders
Vessel puncture site haemorrhage
|
0.00%
0/17 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
16.7%
1/6 • Number of events 1 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/7 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
|
Infections and infestations
Folliculitis
|
5.9%
1/17 • Number of events 1 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/7 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/17 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
16.7%
1/6 • Number of events 1 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/7 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
|
Infections and infestations
Influenza
|
5.9%
1/17 • Number of events 1 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/7 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/17 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/7 • Baseline up to 146 days
|
16.7%
1/6 • Number of events 1 • Baseline up to 146 days
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/17 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
33.3%
2/6 • Number of events 2 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
16.7%
1/6 • Number of events 1 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/7 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/17 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
16.7%
1/6 • Number of events 1 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/7 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/17 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/7 • Baseline up to 146 days
|
16.7%
1/6 • Number of events 1 • Baseline up to 146 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/17 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
16.7%
1/6 • Number of events 1 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
16.7%
1/6 • Number of events 1 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/7 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/17 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
16.7%
1/6 • Number of events 1 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/7 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/17 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
16.7%
1/6 • Number of events 1 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/7 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/17 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
16.7%
1/6 • Number of events 1 • Baseline up to 146 days
|
0.00%
0/7 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/17 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
16.7%
1/6 • Number of events 1 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/7 • Baseline up to 146 days
|
16.7%
1/6 • Number of events 1 • Baseline up to 146 days
|
|
Nervous system disorders
Headache
|
11.8%
2/17 • Number of events 2 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
33.3%
2/6 • Number of events 2 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/7 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
|
Nervous system disorders
Somnolence
|
5.9%
1/17 • Number of events 1 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/7 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
|
Psychiatric disorders
Bradyphrenia
|
0.00%
0/17 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
16.7%
1/6 • Number of events 1 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/7 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/17 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
16.7%
1/6 • Number of events 1 • Baseline up to 146 days
|
0.00%
0/7 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/17 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
16.7%
1/6 • Number of events 1 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/7 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.9%
1/17 • Number of events 1 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
16.7%
1/6 • Number of events 1 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/7 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/17 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
14.3%
1/7 • Number of events 1 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
|
Vascular disorders
Hot flush
|
0.00%
0/17 • Baseline up to 146 days
|
16.7%
1/6 • Number of events 1 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
0.00%
0/7 • Baseline up to 146 days
|
0.00%
0/6 • Baseline up to 146 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60