Trial Outcomes & Findings for A Study of LY2599666 in Healthy Participants and Participants With Mild Cognitive Impairment or Alzheimer's Disease (AD) (NCT NCT02614131)
NCT ID: NCT02614131
Last Updated: 2020-06-17
Results Overview
Number of participants who experienced one or more treatment-emergent serious adverse events related to study treatment. A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
50 participants
Primary outcome timeframe
Baseline through 4 weeks (Part A) or 16 weeks (Part B )
Results posted on
2020-06-17
Participant Flow
Following the enrollment of 7 participants into Part B Cohort 5, a decision was made to stop the development of LY2599666 based on the lack of efficacy results of another compound directed against the same target. Participants were not enrolled for Part B Cohorts 6 and 7 or Part C Cohorts 8 and 9.
Participant milestones
| Measure |
Placebo (Part A - Healthy Participants)
Placebo matching dose given subcutaneously (SC) once.
|
10 mg LY2599666 (Part A Cohort 1)
10 mg LY2599666 given SC once.
|
25 mg LY2599666 (Part A Cohort 2)
25 mg LY2599666 given SC once.
|
100 mg LY2599666 (Part A Cohort 3)
100 mg LY2599666 given SC once.
|
200 mg LY2599666 (Part A Cohort 4)
200 mg LY2599666 given SC once.
|
Placebo (Part B - Cognitively Impaired)
Placebo matching dose given SC.
|
25 mg LY2599666 (Part B Cohort 5)
25 mg LY2599666 given SC once weekly for 12 weeks (13 doses).
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
8
|
8
|
8
|
8
|
2
|
5
|
|
Overall Study
Received at Least One Dose of Drug
|
11
|
8
|
8
|
8
|
8
|
2
|
5
|
|
Overall Study
COMPLETED
|
10
|
8
|
8
|
8
|
8
|
2
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo (Part A - Healthy Participants)
Placebo matching dose given subcutaneously (SC) once.
|
10 mg LY2599666 (Part A Cohort 1)
10 mg LY2599666 given SC once.
|
25 mg LY2599666 (Part A Cohort 2)
25 mg LY2599666 given SC once.
|
100 mg LY2599666 (Part A Cohort 3)
100 mg LY2599666 given SC once.
|
200 mg LY2599666 (Part A Cohort 4)
200 mg LY2599666 given SC once.
|
Placebo (Part B - Cognitively Impaired)
Placebo matching dose given SC.
|
25 mg LY2599666 (Part B Cohort 5)
25 mg LY2599666 given SC once weekly for 12 weeks (13 doses).
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
All randomized participants in Part A and Part B.
Baseline characteristics by cohort
| Measure |
Placebo (Part A)
n=11 Participants
Placebo matching dose given subcutaneously (SC) once.
|
10 mg LY2599666 (Part A Cohort 1)
n=8 Participants
10 mg LY2599666 given SC once.
|
25 mg LY2599666 (Part A Cohort 2)
n=8 Participants
25 mg LY2599666 given SC once.
|
100 mg LY2599666 (Part A Cohort 3)
n=8 Participants
100 mg LY2599666 given SC once.
|
200 mg LY2599666 (Part A Cohort 4)
n=8 Participants
200 mg LY2599666 given SC once.
|
Placebo (Part B)
n=2 Participants
Placebo matching dose given SC.
|
25 mg LY2599666 (Part B Cohort 5)
n=5 Participants
25 mg LY2599666 given SC once weekly for 12 weeks (13 doses).
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Customized
Part A
|
45.8 years
STANDARD_DEVIATION 10.7 • n=11 Participants • All randomized participants in Part A and Part B.
|
40.0 years
STANDARD_DEVIATION 14.1 • n=8 Participants • All randomized participants in Part A and Part B.
|
41.1 years
STANDARD_DEVIATION 13.5 • n=8 Participants • All randomized participants in Part A and Part B.
|
38.9 years
STANDARD_DEVIATION 12.9 • n=8 Participants • All randomized participants in Part A and Part B.
|
44.4 years
STANDARD_DEVIATION 16.2 • n=8 Participants • All randomized participants in Part A and Part B.
|
—
|
—
|
42.3 years
STANDARD_DEVIATION 13.0 • n=43 Participants • All randomized participants in Part A and Part B.
|
|
Age, Customized
Part B
|
—
|
—
|
—
|
—
|
—
|
67 years
STANDARD_DEVIATION 12.7 • n=2 Participants • All randomized participants in Part A and Part B.
|
69 years
STANDARD_DEVIATION 5.3 • n=5 Participants • All randomized participants in Part A and Part B.
|
68.4 years
STANDARD_DEVIATION 6.9 • n=7 Participants • All randomized participants in Part A and Part B.
|
|
Sex: Female, Male
Female
|
2 Participants
n=11 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=2 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=11 Participants
|
5 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=5 Participants
|
36 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=11 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=11 Participants
|
6 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
2 Participants
n=2 Participants
|
5 Participants
n=5 Participants
|
41 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=11 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=5 Participants
|
20 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=11 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=50 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=11 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=2 Participants
|
3 Participants
n=5 Participants
|
22 Participants
n=50 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=50 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=11 Participants
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
1 Participants
n=2 Participants
|
3 Participants
n=5 Participants
|
47 Participants
n=50 Participants
|
|
Region of Enrollment
Japan
|
0 Participants
n=11 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=50 Participants
|
PRIMARY outcome
Timeframe: Baseline through 4 weeks (Part A) or 16 weeks (Part B )Population: All participants who received at least one dose of study drug.
Number of participants who experienced one or more treatment-emergent serious adverse events related to study treatment. A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Outcome measures
| Measure |
Placebo (Part A)
n=11 Participants
Placebo matching dose given subcutaneously (SC) once.
|
10 mg LY2599666 (Part A Cohort 1)
n=8 Participants
10 mg LY2599666 given SC once.
|
25 mg LY2599666 (Part A Cohort 2)
n=8 Participants
25 mg LY2599666 given SC once.
|
100 mg LY2599666 (Part A Cohort 3)
n=8 Participants
100 mg LY2599666 given SC once.
|
200 mg LY2599666 (Part A Cohort 4)
n=8 Participants
200 mg LY2599666 given SC once.
|
Placebo (Part B)
n=2 Participants
Placebo matching dose given SC.
|
25 mg LY2599666 (Part B Cohort 5)
n=5 Participants
25 mg LY2599666 given SC once weekly for 12 weeks (13 doses).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Event (SAE) Considered by the Investigator to be Related to Study Drug Administration
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose and 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 504, 672 hours post-dose (Part A)Population: All participants who received at least one dose of study drug in Part A and had evaluable Cmax data.
PK: Cmax of LY2599666 after a single dose administered subcutaneously.
Outcome measures
| Measure |
Placebo (Part A)
n=8 Participants
Placebo matching dose given subcutaneously (SC) once.
|
10 mg LY2599666 (Part A Cohort 1)
n=8 Participants
10 mg LY2599666 given SC once.
|
25 mg LY2599666 (Part A Cohort 2)
n=8 Participants
25 mg LY2599666 given SC once.
|
100 mg LY2599666 (Part A Cohort 3)
n=8 Participants
100 mg LY2599666 given SC once.
|
200 mg LY2599666 (Part A Cohort 4)
200 mg LY2599666 given SC once.
|
Placebo (Part B)
Placebo matching dose given SC.
|
25 mg LY2599666 (Part B Cohort 5)
25 mg LY2599666 given SC once weekly for 12 weeks (13 doses).
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2599666 Part A
|
NA nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Majority of samples for 10 mg LY2599666 arm were below the limit of quantification in concentration and Cmax summary was not able to be calculated.
|
780 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 74
|
5310 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 28
|
9810 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 44
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 85: Pre-dose, 2, 4, 8, 12, 24, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 96, 120, 168, 216, 264, 336, 504, 672 hours post-dose (Part B)Population: All participants who received at least one dose of drug in Part B and had evaluable Cmax data.
PK: Cmax of LY2599666 after multiple doses administered subcutaneously.
Outcome measures
| Measure |
Placebo (Part A)
n=4 Participants
Placebo matching dose given subcutaneously (SC) once.
|
10 mg LY2599666 (Part A Cohort 1)
10 mg LY2599666 given SC once.
|
25 mg LY2599666 (Part A Cohort 2)
25 mg LY2599666 given SC once.
|
100 mg LY2599666 (Part A Cohort 3)
100 mg LY2599666 given SC once.
|
200 mg LY2599666 (Part A Cohort 4)
200 mg LY2599666 given SC once.
|
Placebo (Part B)
Placebo matching dose given SC.
|
25 mg LY2599666 (Part B Cohort 5)
25 mg LY2599666 given SC once weekly for 12 weeks (13 doses).
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2599666 Part B
|
636 ng/mL
Geometric Coefficient of Variation 41
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose and 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 504, 672 hours post-dose (Part A)Population: All participants who received at least one dose of drug in Part A and had evaluable AUC data.
Area Under the Concentration versus Time Curve of zero to infinity (0 to ∞) after a single dose of LY2599666 administered subcutaneously.
Outcome measures
| Measure |
Placebo (Part A)
n=8 Participants
Placebo matching dose given subcutaneously (SC) once.
|
10 mg LY2599666 (Part A Cohort 1)
n=8 Participants
10 mg LY2599666 given SC once.
|
25 mg LY2599666 (Part A Cohort 2)
n=8 Participants
25 mg LY2599666 given SC once.
|
100 mg LY2599666 (Part A Cohort 3)
n=8 Participants
100 mg LY2599666 given SC once.
|
200 mg LY2599666 (Part A Cohort 4)
200 mg LY2599666 given SC once.
|
Placebo (Part B)
Placebo matching dose given SC.
|
25 mg LY2599666 (Part B Cohort 5)
25 mg LY2599666 given SC once weekly for 12 weeks (13 doses).
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC 0-∞) of LY2599666 Part A
|
NA nanograms*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation NA
Majority of samples for 10 mg LY2599666 arm were below the limit of quantification in concentration and AUC summary was not able to be calculated.
|
96200 nanograms*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 30
|
691000 nanograms*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 20
|
1590000 nanograms*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 27
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 85: Pre-dose, 2, 4, 8, 12, 24, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 96, 120, 168 hours post-dose (Part B)Population: All participants who received at least one dose of drug in Part B and had evaluable AUC data.
Area Under the Concentration time versus curve from 0-168 hours after weekly dose of LY2599666 administered subcutaneously.
Outcome measures
| Measure |
Placebo (Part A)
n=4 Participants
Placebo matching dose given subcutaneously (SC) once.
|
10 mg LY2599666 (Part A Cohort 1)
10 mg LY2599666 given SC once.
|
25 mg LY2599666 (Part A Cohort 2)
25 mg LY2599666 given SC once.
|
100 mg LY2599666 (Part A Cohort 3)
100 mg LY2599666 given SC once.
|
200 mg LY2599666 (Part A Cohort 4)
200 mg LY2599666 given SC once.
|
Placebo (Part B)
Placebo matching dose given SC.
|
25 mg LY2599666 (Part B Cohort 5)
25 mg LY2599666 given SC once weekly for 12 weeks (13 doses).
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to 168 Hours (AUC 0-168) of LY2599666 Part B
|
76100 ng*hr/mL
Geometric Coefficient of Variation 30
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose and 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 504, 672 hours post-dose (Part A)Population: All participants who received at least one dose of study drug in Part A and had evaluable Aβ1-40 data.
Concentration of plasma amyloid beta 1-40 in healthy participants after single dose of LY2599666 administered subcutaneously.
Outcome measures
| Measure |
Placebo (Part A)
n=8 Participants
Placebo matching dose given subcutaneously (SC) once.
|
10 mg LY2599666 (Part A Cohort 1)
n=8 Participants
10 mg LY2599666 given SC once.
|
25 mg LY2599666 (Part A Cohort 2)
n=8 Participants
25 mg LY2599666 given SC once.
|
100 mg LY2599666 (Part A Cohort 3)
n=8 Participants
100 mg LY2599666 given SC once.
|
200 mg LY2599666 (Part A Cohort 4)
200 mg LY2599666 given SC once.
|
Placebo (Part B)
Placebo matching dose given SC.
|
25 mg LY2599666 (Part B Cohort 5)
25 mg LY2599666 given SC once weekly for 12 weeks (13 doses).
|
|---|---|---|---|---|---|---|---|
|
Plasma Amyloid Beta1-40 (Aβ1-40 ) Concentration Part A
|
18800 picograms per milliliter (pg/mL)
Geometric Coefficient of Variation 29
|
36200 picograms per milliliter (pg/mL)
Geometric Coefficient of Variation 13
|
49500 picograms per milliliter (pg/mL)
Geometric Coefficient of Variation 10
|
67700 picograms per milliliter (pg/mL)
Geometric Coefficient of Variation 20
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 85: Pre-dose, 2, 4, 8, 12, 24, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 96, 120, 168, 216, 264, 336, 504, 672 hours post-dose (Part B)Population: All participants who received at least one dose of study drug in Part B and had evaluable Aβ1-40 or Aβ1-42 data.
Concentration of plasma amyloid beta 1-40 and 1-42, in participants with Mild Cognitive Impairment (MCI) or Alzheimer Disease, after multiple doses of LY2599666 administered subcutaneously.
Outcome measures
| Measure |
Placebo (Part A)
n=4 Participants
Placebo matching dose given subcutaneously (SC) once.
|
10 mg LY2599666 (Part A Cohort 1)
10 mg LY2599666 given SC once.
|
25 mg LY2599666 (Part A Cohort 2)
25 mg LY2599666 given SC once.
|
100 mg LY2599666 (Part A Cohort 3)
100 mg LY2599666 given SC once.
|
200 mg LY2599666 (Part A Cohort 4)
200 mg LY2599666 given SC once.
|
Placebo (Part B)
Placebo matching dose given SC.
|
25 mg LY2599666 (Part B Cohort 5)
25 mg LY2599666 given SC once weekly for 12 weeks (13 doses).
|
|---|---|---|---|---|---|---|---|
|
Plasma Amyloid Beta (Aβ1-40 and Aβ1-42) Concentration Part B
Aβ1-40
|
51400 pg/mL
Geometric Coefficient of Variation 14
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Amyloid Beta (Aβ1-40 and Aβ1-42) Concentration Part B
Aβ1-42
|
5730 pg/mL
Geometric Coefficient of Variation 10
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo (Part A)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
10 mg LY2599666 (Part A Cohort 1)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
25 mg LY2599666 (Part A Cohort 2)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
100 mg LY2599666 (Part A Cohort 3)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
200 mg LY2599666 (Part A Cohort 4)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo (Part B)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
25 mg LY2599666 (Part B Cohort 5)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (Part A)
n=11 participants at risk
Placebo matching dose given subcutaneously (SC) once.
|
10 mg LY2599666 (Part A Cohort 1)
n=8 participants at risk
10 mg LY2599666 given SC once.
|
25 mg LY2599666 (Part A Cohort 2)
n=8 participants at risk
25 mg LY2599666 given SC once.
|
100 mg LY2599666 (Part A Cohort 3)
n=8 participants at risk
100 mg LY2599666 given SC once.
|
200 mg LY2599666 (Part A Cohort 4)
n=8 participants at risk
200 mg LY2599666 given SC once.
|
Placebo (Part B)
n=2 participants at risk
Placebo matching dose given SC.
|
25 mg LY2599666 (Part B Cohort 5)
n=5 participants at risk
25 mg LY2599666 given SC once weekly for 12 weeks (13 doses).
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Syncope
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Placebo (Part A)
n=11 participants at risk
Placebo matching dose given subcutaneously (SC) once.
|
10 mg LY2599666 (Part A Cohort 1)
n=8 participants at risk
10 mg LY2599666 given SC once.
|
25 mg LY2599666 (Part A Cohort 2)
n=8 participants at risk
25 mg LY2599666 given SC once.
|
100 mg LY2599666 (Part A Cohort 3)
n=8 participants at risk
100 mg LY2599666 given SC once.
|
200 mg LY2599666 (Part A Cohort 4)
n=8 participants at risk
200 mg LY2599666 given SC once.
|
Placebo (Part B)
n=2 participants at risk
Placebo matching dose given SC.
|
25 mg LY2599666 (Part B Cohort 5)
n=5 participants at risk
25 mg LY2599666 given SC once weekly for 12 weeks (13 doses).
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Number of events 1 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
40.0%
2/5 • Number of events 4 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
General disorders
Injection site bruising
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
25.0%
2/8 • Number of events 2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
General disorders
Injection site erythema
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
37.5%
3/8 • Number of events 3 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
General disorders
Injection site haemorrhage
|
9.1%
1/11 • Number of events 1 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
General disorders
Injection site pruritus
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
General disorders
Injection site rash
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
40.0%
2/5 • Number of events 6 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
General disorders
Injection site reaction
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
General disorders
Puncture site pain
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
General disorders
Vessel puncture site haemorrhage
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
50.0%
1/2 • Number of events 1 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
50.0%
1/2 • Number of events 1 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
25.0%
2/8 • Number of events 2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 3 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
Investigations
Blood urine present
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
50.0%
1/2 • Number of events 1 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
25.0%
2/8 • Number of events 2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
50.0%
1/2 • Number of events 1 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
50.0%
1/2 • Number of events 1 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Migraine
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptom
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/11 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
0.00%
0/2 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Part A up to 29 days and Part B up to 113 days
All participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60