Trial Outcomes & Findings for A Study of Ramucirumab (LY3009806) in Healthy Participants (NCT NCT04495478)
NCT ID: NCT04495478
Last Updated: 2023-02-14
Results Overview
An SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, risk of death), persistent or significant disability/incapacity, congenital anomaly/birth defect, Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
50 participants
Primary outcome timeframe
Baseline through Day 90
Results posted on
2023-02-14
Participant Flow
Participant milestones
| Measure |
Placebo IV
Participants received single dose of placebo administered Intravenously (IV).
|
350 mg Ramucirumab IV
Participants received single 350 milligram (mg) ramucirumab administered as a 60-minute intravenous infusion at a concentration of 10 milligram per millilitre (mg/mL) as one 35 mL infusion.
|
Placebo SC
Participants received single dose of placebo administered subcutaneously (SC).
|
350 mg Ramucirumab SC (1x2 mL)
Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as one 2 mL injection.
|
350 mg Ramucirumab SC (2x2 mL)
Participants received single 350 mg ramucirumab SC administered at a concentration of 87.5 mg/mL as two 2 mL injections.
|
350 mg Ramucirumab SC (2x1 mL)
Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 1 mL injections.
|
700 mg Ramucirumab SC (2x2 mL)
Participants received single 700 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 2 mL injections.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
7
|
12
|
7
|
7
|
7
|
7
|
|
Overall Study
Received at Least One Dose of Study Drug
|
3
|
7
|
12
|
7
|
7
|
7
|
7
|
|
Overall Study
COMPLETED
|
3
|
6
|
12
|
6
|
6
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo IV
Participants received single dose of placebo administered Intravenously (IV).
|
350 mg Ramucirumab IV
Participants received single 350 milligram (mg) ramucirumab administered as a 60-minute intravenous infusion at a concentration of 10 milligram per millilitre (mg/mL) as one 35 mL infusion.
|
Placebo SC
Participants received single dose of placebo administered subcutaneously (SC).
|
350 mg Ramucirumab SC (1x2 mL)
Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as one 2 mL injection.
|
350 mg Ramucirumab SC (2x2 mL)
Participants received single 350 mg ramucirumab SC administered at a concentration of 87.5 mg/mL as two 2 mL injections.
|
350 mg Ramucirumab SC (2x1 mL)
Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 1 mL injections.
|
700 mg Ramucirumab SC (2x2 mL)
Participants received single 700 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 2 mL injections.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study of Ramucirumab (LY3009806) in Healthy Participants
Baseline characteristics by cohort
| Measure |
Placebo IV
n=3 Participants
Participants received single dose of placebo administered IV.
|
350 mg Ramucirumab IV
n=7 Participants
Participants received single 350 mg ramucirumab administered as a 60-minute intravenous infusion at a concentration of 10 mg/mL as one 35 mL infusion.
|
Placebo SC
n=12 Participants
Participants received single dose of placebo administered SC.
|
350 mg Ramucirumab SC (1x2 mL)
n=7 Participants
Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as one 2 mL injection.
|
350 mg Ramucirumab SC (2x2 mL)
n=7 Participants
Participants received single 350 mg ramucirumab SC administered at a concentration of 87.5 mg/mL as two 2 mL injections.
|
350 mg Ramucirumab SC (2x1 mL)
n=7 Participants
Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 1 mL injections.
|
700 mg Ramucirumab SC (2x2 mL)
n=7 Participants
Participants received single 700 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 2 mL injections.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
34 years
n=5 Participants
|
35 years
n=7 Participants
|
37 years
n=5 Participants
|
51 years
n=4 Participants
|
46 years
n=21 Participants
|
39 years
n=10 Participants
|
41 years
n=115 Participants
|
40 years
n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
9 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
41 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
23 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
27 Participants
n=24 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=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
12 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
35 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
|
Race (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=24 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
50 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline through Day 90Population: All participants who received at least one dose of study drug.
An SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, risk of death), persistent or significant disability/incapacity, congenital anomaly/birth defect, Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Outcome measures
| Measure |
Placebo IV
n=3 Participants
Participants received single dose of placebo administered IV.
|
350 mg Ramucirumab IV
n=7 Participants
Participants received single 350 mg ramucirumab administered as a 60-minute intravenous infusion at a concentration of 10 mg/mL as one 35 mL infusion.
|
Placebo SC
n=12 Participants
Participants received single dose of placebo administered SC.
|
350 mg Ramucirumab SC (1x2 mL)
n=7 Participants
Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as one 2 mL injection.
|
350 mg Ramucirumab SC (2x2 mL)
n=7 Participants
Participants received single 350 mg ramucirumab SC administered at a concentration of 87.5 mg/mL as two 2 mL injections.
|
350 mg Ramucirumab SC (2x1 mL)
n=7 Participants
Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 1 mL injections.
|
700 mg Ramucirumab SC (2x2 mL)
n=7 Participants
Participants received single 700 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 2 mL injections.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 Predose through Day 90Population: All participants who received at least one dose of study drug subcutaneously.
Number of participants showing ISRs when the drug was administered subcutaneously were reported.
Outcome measures
| Measure |
Placebo IV
n=12 Participants
Participants received single dose of placebo administered IV.
|
350 mg Ramucirumab IV
n=7 Participants
Participants received single 350 mg ramucirumab administered as a 60-minute intravenous infusion at a concentration of 10 mg/mL as one 35 mL infusion.
|
Placebo SC
n=7 Participants
Participants received single dose of placebo administered SC.
|
350 mg Ramucirumab SC (1x2 mL)
n=7 Participants
Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as one 2 mL injection.
|
350 mg Ramucirumab SC (2x2 mL)
n=7 Participants
Participants received single 350 mg ramucirumab SC administered at a concentration of 87.5 mg/mL as two 2 mL injections.
|
350 mg Ramucirumab SC (2x1 mL)
Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 1 mL injections.
|
700 mg Ramucirumab SC (2x2 mL)
Participants received single 700 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 2 mL injections.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Injection Site Reactions (ISRs) Following Subcutaneous (SC) Administration of Study Drug
|
3 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 1, 8, 24, 48, 72, 96, 120, 144, 168, 264, 336, 504 hours post-dosePopulation: All participants who received at least one dose of ramucirumab and had sufficient evaluable PK data.
PK: AUC\[0-∞\] of Ramucirumab.
Outcome measures
| Measure |
Placebo IV
n=7 Participants
Participants received single dose of placebo administered IV.
|
350 mg Ramucirumab IV
n=5 Participants
Participants received single 350 mg ramucirumab administered as a 60-minute intravenous infusion at a concentration of 10 mg/mL as one 35 mL infusion.
|
Placebo SC
n=7 Participants
Participants received single dose of placebo administered SC.
|
350 mg Ramucirumab SC (1x2 mL)
n=6 Participants
Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as one 2 mL injection.
|
350 mg Ramucirumab SC (2x2 mL)
n=7 Participants
Participants received single 350 mg ramucirumab SC administered at a concentration of 87.5 mg/mL as two 2 mL injections.
|
350 mg Ramucirumab SC (2x1 mL)
Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 1 mL injections.
|
700 mg Ramucirumab SC (2x2 mL)
Participants received single 700 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 2 mL injections.
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Ramucirumab
|
18700 hour*microgram per milliliter (h*μg/mL)
Geometric Coefficient of Variation 19
|
5250 hour*microgram per milliliter (h*μg/mL)
Geometric Coefficient of Variation 48
|
5140 hour*microgram per milliliter (h*μg/mL)
Geometric Coefficient of Variation 76
|
6350 hour*microgram per milliliter (h*μg/mL)
Geometric Coefficient of Variation 57
|
14200 hour*microgram per milliliter (h*μg/mL)
Geometric Coefficient of Variation 76
|
—
|
—
|
PRIMARY outcome
Timeframe: 1, 8, 24, 48, 72, 96, 120, 144, 168, 264, 336, 504 hours post-dosePopulation: All participants who received at least one dose of ramucirumab and had sufficient evaluable PK data.
PK: Cmax of Ramucirumab
Outcome measures
| Measure |
Placebo IV
n=7 Participants
Participants received single dose of placebo administered IV.
|
350 mg Ramucirumab IV
n=6 Participants
Participants received single 350 mg ramucirumab administered as a 60-minute intravenous infusion at a concentration of 10 mg/mL as one 35 mL infusion.
|
Placebo SC
n=7 Participants
Participants received single dose of placebo administered SC.
|
350 mg Ramucirumab SC (1x2 mL)
n=7 Participants
Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as one 2 mL injection.
|
350 mg Ramucirumab SC (2x2 mL)
n=7 Participants
Participants received single 350 mg ramucirumab SC administered at a concentration of 87.5 mg/mL as two 2 mL injections.
|
350 mg Ramucirumab SC (2x1 mL)
Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 1 mL injections.
|
700 mg Ramucirumab SC (2x2 mL)
Participants received single 700 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 2 mL injections.
|
|---|---|---|---|---|---|---|---|
|
PK: Maximum Concentration (Cmax) of Ramucirumab
|
116 μg/mL
Geometric Coefficient of Variation 11
|
24 μg/mL
Geometric Coefficient of Variation 56
|
20.2 μg/mL
Geometric Coefficient of Variation 63
|
21 μg/mL
Geometric Coefficient of Variation 66
|
46.7 μg/mL
Geometric Coefficient of Variation 44
|
—
|
—
|
Adverse Events
Placebo IV
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
350 mg Ramucirumab IV
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo SC
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
350 mg Ramucirumab SC (1x2 mL)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
350 mg Ramucirumab SC (2x2 mL)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
350 mg Ramucirumab SC (2x1 mL)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
700 mg Ramucirumab SC (2x2 mL)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo IV
n=3 participants at risk
Participants received single dose of placebo administered IV.
|
350 mg Ramucirumab IV
n=7 participants at risk
Participants received single 350 mg Ramucirumab administered as a 60-minute intravenous infusion at a concentration of 10 mg/mL as one 35 mL infusion.
|
Placebo SC
n=12 participants at risk
Participants received single dose of placebo administered SC.
|
350 mg Ramucirumab SC (1x2 mL)
n=7 participants at risk
Participants received single 350 mg Ramucirumab SC administered at a concentration of 175 mg/mL as one 2 mL injection.
|
350 mg Ramucirumab SC (2x2 mL)
n=7 participants at risk
Participants received single 350 mg Ramucirumab SC administered at a concentration of 87.5 mg/mL as two 2 mL injections.
|
350 mg Ramucirumab SC (2x1 mL)
n=7 participants at risk
Participants received single 350 mg Ramucirumab SC administered at a concentration of 175 mg/mL as two 1 mL injections.
|
700 mg Ramucirumab SC (2x2 mL)
n=7 participants at risk
Participants received single 700 mg Ramucirumab SC administered at a concentration of 175 mg/mL as two 2 mL injections.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/3 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/12 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/3 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/12 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/3 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/12 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/3 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Placebo IV
n=3 participants at risk
Participants received single dose of placebo administered IV.
|
350 mg Ramucirumab IV
n=7 participants at risk
Participants received single 350 mg Ramucirumab administered as a 60-minute intravenous infusion at a concentration of 10 mg/mL as one 35 mL infusion.
|
Placebo SC
n=12 participants at risk
Participants received single dose of placebo administered SC.
|
350 mg Ramucirumab SC (1x2 mL)
n=7 participants at risk
Participants received single 350 mg Ramucirumab SC administered at a concentration of 175 mg/mL as one 2 mL injection.
|
350 mg Ramucirumab SC (2x2 mL)
n=7 participants at risk
Participants received single 350 mg Ramucirumab SC administered at a concentration of 87.5 mg/mL as two 2 mL injections.
|
350 mg Ramucirumab SC (2x1 mL)
n=7 participants at risk
Participants received single 350 mg Ramucirumab SC administered at a concentration of 175 mg/mL as two 1 mL injections.
|
700 mg Ramucirumab SC (2x2 mL)
n=7 participants at risk
Participants received single 700 mg Ramucirumab SC administered at a concentration of 175 mg/mL as two 2 mL injections.
|
|---|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Excessive cerumen production
|
0.00%
0/3 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/12 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/3 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/12 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/12 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/12 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/12 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 2 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/12 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
|
General disorders
Feeling hot
|
0.00%
0/3 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/12 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
|
General disorders
Injection site bruising
|
0.00%
0/3 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/12 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/12 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/12 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/12 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/3 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/12 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/12 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/12 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/12 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/12 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
57.1%
4/7 • Number of events 4 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
28.6%
2/7 • Number of events 3 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/12 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/3 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/12 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
33.3%
1/3 • Number of events 1 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/12 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/12 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline up to Day 90
All participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Neither Lilly or Supplier shall publish, discuss, or release data emanating from a study without the other party's express written permission which shall not be unreasonably withheld. Nothing herein shall limit supplier's right to respond to legal inquiries.
- Publication restrictions are in place
Restriction type: OTHER