Trial Outcomes & Findings for A Study of LY3074828 in Healthy Participants (NCT NCT03456713)
NCT ID: NCT03456713
Last Updated: 2024-02-20
Results Overview
Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3074828
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
72 participants
Primary outcome timeframe
Day 1: 0, 2, 6; Day 2: 24; Day 4: 72; Day 8: 168; Day 11: 240; Day 15: 336; Day 22: 504; Day 29: 672; Day 43: 1008; Day 57: 1344; Day 71: 1680; Day 85: 2016 hours
Results posted on
2024-02-20
Participant Flow
This study had a screening period of 28 days and residential period with a parallel 2 day Part A and a crossover 3 day Part B.
Participant milestones
| Measure |
Part A: 250 mg LY3074828 (Reference)
250 mg LY3074828 administered subcutaneous (SC) as solution formulation in two prefilled syringes targeting a 5- to 10-second injection time for each injection on day 1.
|
Part A: 250 mg LY3074828 (Test 1)
250 mg LY3074828 administered SC as solution formulation in a prefilled syringe targeting a 5- to 15-second injection time on day 1.
|
Part B: 250 mg LY3074828 (Test 2 and Test 3)
Test 2: 250 mg LY3074828 administered subcutaneous (SC) as solution formulation in an auto-injector at slow speed targeting an approximately 13-second injection time on day 1.
Test 3: 250 mg LY3074828 administered subcutaneous (SC) as solution formulation in an auto-injector at fast speed targeting an approximately 5-second injection time on day 2.
|
Part B: 125 mg LY3074828 (Test 4 and Test 5)
Test 4: 125 mg LY3074828 administered SC as solution formulation in an auto-injector at slow speed targeting an approximately 7-second injection time on day 1.
Test 5: 125 mg LY3074828 administered SC as solution formulation in an auto-injector at fast speed targeting an approximately 4.5-second injection time on day 2.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
18
|
18
|
|
Overall Study
Received at Least One Dose of Study Drug
|
18
|
18
|
18
|
18
|
|
Overall Study
COMPLETED
|
17
|
18
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part A: 250 mg LY3074828 (Reference)
250 mg LY3074828 administered subcutaneous (SC) as solution formulation in two prefilled syringes targeting a 5- to 10-second injection time for each injection on day 1.
|
Part A: 250 mg LY3074828 (Test 1)
250 mg LY3074828 administered SC as solution formulation in a prefilled syringe targeting a 5- to 15-second injection time on day 1.
|
Part B: 250 mg LY3074828 (Test 2 and Test 3)
Test 2: 250 mg LY3074828 administered subcutaneous (SC) as solution formulation in an auto-injector at slow speed targeting an approximately 13-second injection time on day 1.
Test 3: 250 mg LY3074828 administered subcutaneous (SC) as solution formulation in an auto-injector at fast speed targeting an approximately 5-second injection time on day 2.
|
Part B: 125 mg LY3074828 (Test 4 and Test 5)
Test 4: 125 mg LY3074828 administered SC as solution formulation in an auto-injector at slow speed targeting an approximately 7-second injection time on day 1.
Test 5: 125 mg LY3074828 administered SC as solution formulation in an auto-injector at fast speed targeting an approximately 4.5-second injection time on day 2.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study of LY3074828 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Part A: 250 mg LY3074828 (Reference)
n=18 Participants
250 mg LY3074828 administered subcutaneous (SC) as solution formulation in two prefilled syringes targeting a 5- to 10-second injection time for each injection on day 1.
|
Part A: 250 mg LY3074828 (Test 1)
n=18 Participants
250 mg LY3074828 administered SC as solution formulation in a prefilled syringe targeting a 5- to 15-second injection time on day 1.
|
Part B: 250 mg LY3074828 (Test 2 and Test 3)
n=18 Participants
Test 2: 250 mg LY3074828 administered subcutaneous (SC) as solution formulation in an auto-injector at slow speed targeting an approximately 13-second injection time on day 1
Test 3: 250 mg LY3074828 administered subcutaneous (SC) as solution formulation in an auto-injector at fast speed targeting an approximately 5-second injection time on day 2
|
Part B: 125 mg LY3074828 (Test 4 and Test 5)
n=18 Participants
Test 4: 125 mg LY3074828 administered SC as solution formulation in an auto-injector at slow speed targeting an approximately 7-second injection time on day 1
Test 5: 125 mg LY3074828 administered SC as solution formulation in an auto-injector at fast speed targeting an approximately 4.5-second injection time on day 2.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
Part A
|
37.3 years
STANDARD_DEVIATION 12.7 • n=39 Participants
|
33.9 years
STANDARD_DEVIATION 11.0 • n=41 Participants
|
NA years
STANDARD_DEVIATION NA • n=35 Participants
|
NA years
STANDARD_DEVIATION NA • n=31 Participants
|
35.6 years
STANDARD_DEVIATION 11.8 • n=146 Participants
|
|
Age, Continuous
Part B
|
NA years
STANDARD_DEVIATION NA • n=39 Participants
|
NA years
STANDARD_DEVIATION NA • n=41 Participants
|
42.1 years
STANDARD_DEVIATION 12.3 • n=35 Participants
|
47.2 years
STANDARD_DEVIATION 12.3 • n=31 Participants
|
44.7 years
STANDARD_DEVIATION 12.4 • n=146 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
33 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
12 Participants
n=31 Participants
|
39 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
17 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=39 Participants
|
16 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
12 Participants
n=31 Participants
|
55 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
26 Participants
n=146 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
10 Participants
n=31 Participants
|
40 Participants
n=146 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
18 Participants
n=31 Participants
|
72 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: Day 1: 0, 2, 6; Day 2: 24; Day 4: 72; Day 8: 168; Day 11: 240; Day 15: 336; Day 22: 504; Day 29: 672; Day 43: 1008; Day 57: 1344; Day 71: 1680; Day 85: 2016 hoursPopulation: Part A: All randomized participants who received at least one dose of LY3074828 and have evaluable PK data. Per protocol only Part A data were analyzed for PK.
Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3074828
Outcome measures
| Measure |
Part A: 250 mg LY3074828 (Reference)
n=18 Participants
250 mg LY3074828 administered subcutaneous (SC) as solution formulation in two prefilled syringes targeting a 5- to 10-second injection time for each injection on day 1.
|
Part A: 250 mg LY3074828 (Test 1)
n=18 Participants
250 mg LY3074828 administered SC as solution formulation in a prefilled syringe targeting a 5- to 15-second injection time on day 1.
|
|---|---|---|
|
Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3074828
|
14.4 microgram per milliliters (μg/mL)
Geometric Coefficient of Variation 67
|
21.1 microgram per milliliters (μg/mL)
Geometric Coefficient of Variation 34
|
PRIMARY outcome
Timeframe: Day 1: 0, 2, 6; Day 2: 24; Day 4: 72; Day 8: 168; Day 11: 240; Day 15: 336; Day 22: 504; Day 29: 672; Day 43: 1008; Day 57: 1344; Day 71: 1680; Day 85: 2016 hoursPopulation: All randomized participants who received at least one dose of LY3074828 and have evaluable PK data in Part A. Per protocol only Part A data were analyzed for PK.
Part A PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC\[0-inf\]) of LY3074828
Outcome measures
| Measure |
Part A: 250 mg LY3074828 (Reference)
n=14 Participants
250 mg LY3074828 administered subcutaneous (SC) as solution formulation in two prefilled syringes targeting a 5- to 10-second injection time for each injection on day 1.
|
Part A: 250 mg LY3074828 (Test 1)
n=18 Participants
250 mg LY3074828 administered SC as solution formulation in a prefilled syringe targeting a 5- to 15-second injection time on day 1.
|
|---|---|---|
|
Part A PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY3074828
|
240 Microgram*Day per Milliliters(μg*day/mL)
Geometric Coefficient of Variation 46
|
346 Microgram*Day per Milliliters(μg*day/mL)
Geometric Coefficient of Variation 33
|
PRIMARY outcome
Timeframe: Day 1: 0, 2, 6; Day 2: 24; Day 4: 72; Day 8: 168; Day 11: 240; Day 15: 336; Day 22: 504; Day 29: 672; Day 43: 1008; Day 57: 1344; Day 71: 1680; Day 85: 2016 hoursPopulation: All randomized participants who received at least one dose of LY3074828 and have evaluable PK data in Part A. Per protocol only Part A data were analyzed for PK.
Part A PK: Area Under the Concentration Versus Time Curve From Time Zero to tlast (AUC\[0-tlast\]) of LY3074828
Outcome measures
| Measure |
Part A: 250 mg LY3074828 (Reference)
n=17 Participants
250 mg LY3074828 administered subcutaneous (SC) as solution formulation in two prefilled syringes targeting a 5- to 10-second injection time for each injection on day 1.
|
Part A: 250 mg LY3074828 (Test 1)
n=18 Participants
250 mg LY3074828 administered SC as solution formulation in a prefilled syringe targeting a 5- to 15-second injection time on day 1.
|
|---|---|---|
|
Part A PK: Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC[0-tlast]) of LY3074828
|
205 Microgram*Day per Milliliters(μg*day/mL)
Geometric Coefficient of Variation 54
|
341 Microgram*Day per Milliliters(μg*day/mL)
Geometric Coefficient of Variation 33
|
PRIMARY outcome
Timeframe: Day 1, 0 hourPopulation: All participants who received a dose of LY3074828 whether or not they completed all protocol requirements.
Pain was assessed by the SF-MPQ and quantified using the validated VAS where 0mm represented "no pain" and 100mm represented "worst possible pain". The SF-MPQ total score ranges from 0 to 45 (the higher the total score, the more pain experienced). Least Squares (LS) mean was calculated using linear fixed-effects model with treatment (Reference or Test 1) as a fixed effect. Model: Log (Score+1) = Treatment + Random Error.
Outcome measures
| Measure |
Part A: 250 mg LY3074828 (Reference)
n=18 Participants
250 mg LY3074828 administered subcutaneous (SC) as solution formulation in two prefilled syringes targeting a 5- to 10-second injection time for each injection on day 1.
|
Part A: 250 mg LY3074828 (Test 1)
n=18 Participants
250 mg LY3074828 administered SC as solution formulation in a prefilled syringe targeting a 5- to 15-second injection time on day 1.
|
|---|---|---|
|
Part A: Short Form McGill Pain Questionnaire (SF-MPQ) Total Score (Including Visual Analog Scale (VAS ) Score)
|
4.16 units on a scale
Interval 2.88 to 6.01
|
3.04 units on a scale
Interval 2.1 to 4.39
|
PRIMARY outcome
Timeframe: Day 1, 0 hourPopulation: All participants who received a dose of LY3074828 whether or not they completed all protocol requirements.
Pain was assessed by the SF-MPQ and quantified using the validated VAS where 0mm represented "no pain" and 100mm represented "worst possible pain". The SF-MPQ total score ranges from 0 to 45 (the higher the total score, the more pain experienced). LS mean was calculated using linear fixed-effects model with treatment (Test 2 or Test 3) as a fixed effect. Model: Log (Score+1) = Treatment + Random Error.
Outcome measures
| Measure |
Part A: 250 mg LY3074828 (Reference)
n=9 Participants
250 mg LY3074828 administered subcutaneous (SC) as solution formulation in two prefilled syringes targeting a 5- to 10-second injection time for each injection on day 1.
|
Part A: 250 mg LY3074828 (Test 1)
n=9 Participants
250 mg LY3074828 administered SC as solution formulation in a prefilled syringe targeting a 5- to 15-second injection time on day 1.
|
|---|---|---|
|
Part B: Short Form McGill Pain Questionnaire (SF-MPQ) Total Score (Including VAS Score) For 250 mg LY3074828 Slow Versus Fast
|
5.06 units on a scale
Interval 3.48 to 7.36
|
4.96 units on a scale
Interval 3.41 to 7.22
|
PRIMARY outcome
Timeframe: Day 1, 0 hourPopulation: All participants who received a dose of LY3074828 whether or not they completed all protocol requirements.
Pain was assessed by the SF-MPQ and quantified using the validated VAS where 0mm represented "no pain" and 100mm represented "worst possible pain". The SF-MPQ total score ranges from 0 to 45 (the higher the total score, the more pain experienced). LS mean was calculated using linear fixed-effects model with treatment (Test 4 or Test 5) as a fixed effect. Model: Log (Score+1) = Treatment + Random Error.
Outcome measures
| Measure |
Part A: 250 mg LY3074828 (Reference)
n=9 Participants
250 mg LY3074828 administered subcutaneous (SC) as solution formulation in two prefilled syringes targeting a 5- to 10-second injection time for each injection on day 1.
|
Part A: 250 mg LY3074828 (Test 1)
n=9 Participants
250 mg LY3074828 administered SC as solution formulation in a prefilled syringe targeting a 5- to 15-second injection time on day 1.
|
|---|---|---|
|
Part B: Short Form McGill Pain Questionnaire (SF-MPQ) Total Score (Including VAS Score) For 125 mg LY3074828 Slow Versus Fast
|
4.36 units on a scale
Interval 3.0 to 6.35
|
3.07 units on a scale
Interval 2.11 to 4.47
|
Adverse Events
Part A: 250 mg LY3074828 (Reference)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A: 250 mg LY3074828 (Test 1)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part B: 250 mg LY3074828 (Test 2)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B: 250 mg LY3074828 (Test 3)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part B: 125 mg LY3074828 (Test 4)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B: 125 mg LY3074828 (Test 5)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A: 250 mg LY3074828 (Reference)
n=18 participants at risk
250 mg LY3074828 administered subcutaneous (SC) as solution formulation in two prefilled syringes targeting a 5- to 10-second injection time for each injection on day 1.
|
Part A: 250 mg LY3074828 (Test 1)
n=18 participants at risk
250 mg LY3074828 administered SC as solution formulation in a prefilled syringe targeting a 5- to 15-second injection time on day 1.
|
Part B: 250 mg LY3074828 (Test 2)
n=18 participants at risk
Test 2: 250 mg LY3074828 administered subcutaneous (SC) as solution formulation in an auto-injector at slow speed targeting an approximately 13-second injection time on day 1
|
Part B: 250 mg LY3074828 (Test 3)
n=18 participants at risk
Test 3: 250 mg LY3074828 administered subcutaneous (SC) as solution formulation in an auto-injector at fast speed targeting an approximately 5-second injection time on day 2.
|
Part B: 125 mg LY3074828 (Test 4)
n=18 participants at risk
Test 4: 125 mg LY3074828 administered SC as solution formulation in an auto-injector at slow speed targeting an approximately 7-second injection time on day 1.
|
Part B: 125 mg LY3074828 (Test 5)
n=18 participants at risk
Test 5: 125 mg LY3074828 administered SC as solution formulation in an auto-injector at fast speed targeting an approximately 4.5-second injection time on day 2.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
5.6%
1/18 • Number of events 1 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
|
General disorders
Injection site bruising
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
5.6%
1/18 • Number of events 1 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
|
General disorders
Injection site reaction
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
5.6%
1/18 • Number of events 1 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
11.1%
2/18 • Number of events 2 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
5.6%
1/18 • Number of events 1 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
5.6%
1/18 • Number of events 1 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
5.6%
1/18 • Number of events 1 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
5.6%
1/18 • Number of events 1 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
5.6%
1/18 • Number of events 1 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
11.1%
2/18 • Number of events 2 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
5.6%
1/18 • Number of events 1 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
1/18 • Number of events 1 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
5.6%
1/18 • Number of events 1 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
5.6%
1/18 • Number of events 1 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
5.6%
1/18 • Number of events 1 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
All participants who received at least one dose of study drug.
|
0.00%
0/18 • Baseline Up To Day 88
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