Trial Outcomes & Findings for A Safety Study of LY3493269 Given as a Single Injection in Healthy Participants (NCT NCT04178733)
NCT ID: NCT04178733
Last Updated: 2025-01-14
Results Overview
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
33 participants
Primary outcome timeframe
Baseline through final follow-up (Up To Day 43)
Results posted on
2025-01-14
Participant Flow
Participant milestones
| Measure |
Placebo SC
Participants received Placebo subcutaneously (SC).
|
0.15 mg LY3493269 SC
Participants received 0.15 milligrams (mg) LY3493269 SC.
|
0.5 mg LY3493269 SC
Participants received 0.5 mg LY3493269 SC.
|
0.5 mg LY3493269 IV
Participants received 0.5 mg LY3493269 intravenously (IV).
|
1.5 mg LY3493269 SC
Participants received 1.5 mg LY3493269 SC.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
7
|
8
|
|
Overall Study
Received at Least One Dose of Study Drug
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
Placebo SC
Participants received Placebo subcutaneously (SC).
|
0.15 mg LY3493269 SC
Participants received 0.15 milligrams (mg) LY3493269 SC.
|
0.5 mg LY3493269 SC
Participants received 0.5 mg LY3493269 SC.
|
0.5 mg LY3493269 IV
Participants received 0.5 mg LY3493269 intravenously (IV).
|
1.5 mg LY3493269 SC
Participants received 1.5 mg LY3493269 SC.
|
|---|---|---|---|---|---|
|
Overall Study
Investigator Decision
|
0
|
0
|
0
|
1
|
2
|
Baseline Characteristics
A Safety Study of LY3493269 Given as a Single Injection in Healthy Participants
Baseline characteristics by cohort
| Measure |
Placebo SC
n=6 Participants
Participants received Placebo subcutaneously(SC).
|
0.15 mg LY3493269 SC
n=6 Participants
Participants received 0.15 mg LY3493269 SC.
|
0.5 mg LY3493269 SC
n=6 Participants
Participants received 0.5 mg LY3493269 SC.
|
0.5 mg LY3493269 IV
n=6 Participants
Participants received 0.5 mg LY3493269 intravenously (IV).
|
1.5 mg LY3493269 SC
n=6 Participants
Participants received 1.5 mg LY3493269 SC.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
47.0 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
40.8 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
43.5 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
36.5 years
STANDARD_DEVIATION 12.7 • n=4 Participants
|
34.7 years
STANDARD_DEVIATION 9.9 • n=21 Participants
|
40.5 years
STANDARD_DEVIATION 11.2 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
30 Participants
n=8 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=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
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=8 Participants
|
|
Region of Enrollment
Singapore
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline through final follow-up (Up To Day 43)Population: All participants who received at least one dose of study drug.
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 SC
n=6 Participants
Participants received Placebo subcutaneously(SC).
|
0.15 mg LY3493269 SC
n=6 Participants
Participants received 0.15 mg LY3493269 SC.
|
0.5 mg LY3493269 SC
n=6 Participants
Participants received 0.5 mg LY3493269 SC.
|
0.5 mg LY3493269 IV
n=6 Participants
Participants received 0.5 mg LY3493269 intravenously (IV).
|
1.5 mg LY3493269 SC
n=6 Participants
Participants received 1.5 mg LY3493269 SC.
|
|---|---|---|---|---|---|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1: Predose, 6, 12 hours; Day 2: 24 hours; Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6:120 hours; Day 8:168 hours; and any time during the visit on Day 15, Day 29, Day 43 and early terminationPopulation: All participants who received at least one dose of study drug.
Pharmacokinetics (PK): Area Under the Concentration time curve from time zero to infinity (AUC 0-∞) of LY3493269
Outcome measures
| Measure |
Placebo SC
n=6 Participants
Participants received Placebo subcutaneously(SC).
|
0.15 mg LY3493269 SC
n=6 Participants
Participants received 0.15 mg LY3493269 SC.
|
0.5 mg LY3493269 SC
n=6 Participants
Participants received 0.5 mg LY3493269 SC.
|
0.5 mg LY3493269 IV
n=6 Participants
Participants received 0.5 mg LY3493269 intravenously (IV).
|
1.5 mg LY3493269 SC
Participants received 1.5 mg LY3493269 SC.
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Infinity (AUC 0-∞) of LY3493269
|
4990 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 26
|
21800 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 24
|
24600 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 23
|
7300 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 21
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose, 6, 12 hours; Day 2: 24 hours; Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6:120 hours; Day 8:168 hours; and any time during the visit on Day 15, Day 29, Day 43 early terminationPopulation: All participants who received at least one dose of study drug.
PK: Maximum Concentration (Cmax) of LY3493269
Outcome measures
| Measure |
Placebo SC
n=6 Participants
Participants received Placebo subcutaneously(SC).
|
0.15 mg LY3493269 SC
n=6 Participants
Participants received 0.15 mg LY3493269 SC.
|
0.5 mg LY3493269 SC
n=6 Participants
Participants received 0.5 mg LY3493269 SC.
|
0.5 mg LY3493269 IV
n=6 Participants
Participants received 0.5 mg LY3493269 intravenously (IV).
|
1.5 mg LY3493269 SC
Participants received 1.5 mg LY3493269 SC.
|
|---|---|---|---|---|---|
|
PK: Maximum Concentration (Cmax) of LY3493269
|
16.4 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 19
|
68.8 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 40
|
181 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 15
|
247 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 27
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose, 6, 12 hours; Day 2: 24 hours; Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6:120 hours; Day 8:168 hours; and any time during the visit on Day 15, Day 29, Day 43 early terminationPopulation: All participants who received at least one dose of study drug.
PK: Time to Maximum Concentration (Tmax) of LY3493269
Outcome measures
| Measure |
Placebo SC
n=6 Participants
Participants received Placebo subcutaneously(SC).
|
0.15 mg LY3493269 SC
n=6 Participants
Participants received 0.15 mg LY3493269 SC.
|
0.5 mg LY3493269 SC
n=6 Participants
Participants received 0.5 mg LY3493269 SC.
|
0.5 mg LY3493269 IV
n=6 Participants
Participants received 0.5 mg LY3493269 intravenously (IV).
|
1.5 mg LY3493269 SC
Participants received 1.5 mg LY3493269 SC.
|
|---|---|---|---|---|---|
|
PK: Time to Maximum Concentration (Tmax) of LY3493269
|
12.01 hours (hr)
Interval 6.0 to 96.73
|
12.06 hours (hr)
Interval 12.0 to 96.0
|
0.39 hours (hr)
Interval 0.25 to 2.0
|
12.00 hours (hr)
Interval 12.0 to 96.08
|
—
|
Adverse Events
Placebo SC
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
0.15 mg LY3493269 SC
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
0.5 mg LY3493269 SC
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
0.5 mg LY3493269 IV
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
1.5 mg LY3493269 SC
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo SC
n=6 participants at risk
Participants received Placebo SC.
|
0.15 mg LY3493269 SC
n=6 participants at risk
Participants received 0.15 mg LY3493269 SC.
|
0.5 mg LY3493269 SC
n=6 participants at risk
Participants received 0.5 mg LY3493269 SC.
|
0.5 mg LY3493269 IV
n=6 participants at risk
Participants received 0.5 mg LY3493269 IV.
|
1.5 mg LY3493269 SC
n=6 participants at risk
Participants received 1.5 mg LY3493269 SC.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
50.0%
3/6 • Number of events 3 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Eye disorders
Vision blurred
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 3 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
33.3%
2/6 • Number of events 2 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
50.0%
3/6 • Number of events 4 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
83.3%
5/6 • Number of events 6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
50.0%
3/6 • Number of events 5 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 2 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
50.0%
3/6 • Number of events 3 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
50.0%
3/6 • Number of events 3 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
50.0%
3/6 • Number of events 8 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
General disorders
Catheter site bruise
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 3 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
General disorders
Catheter site erythema
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
50.0%
3/6 • Number of events 3 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
General disorders
Catheter site pain
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
General disorders
Catheter site phlebitis
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 2 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
General disorders
Catheter site related reaction
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
General disorders
Chills
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
General disorders
Early satiety
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
General disorders
Medical device site erosion
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
General disorders
Medical device site erythema
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 3 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
50.0%
3/6 • Number of events 5 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Scratch
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 3 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Investigations
Body temperature increased
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Appetite disorder
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 3 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
83.3%
5/6 • Number of events 5 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
83.3%
5/6 • Number of events 6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 2 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 4 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
50.0%
3/6 • Number of events 5 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Migraine
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 2 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 Days
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up To 43 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