Trial Outcomes & Findings for A Study of Ixekizumab in Healthy Participants (NCT NCT03848416)
NCT ID: NCT03848416
Last Updated: 2020-06-24
Results Overview
Pharmacokinetics (PK): Maximum Concentration (Cmax) of a single dose of Ixekizumab
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
99 participants
Primary outcome timeframe
Predose, Day 3, Day 5, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 57, Day 71 and Day 85 Post Dose
Results posted on
2020-06-24
Participant Flow
Participants were randomized to 1 of 3 treatments, Reference, Test Formulation 1 or Test Formulation 2.
Participant milestones
| Measure |
Ixekizumab (Reference)
Reference formulation ixekizumab 80 milligram (mg) administered as a subcutaneous (SC) injection in a prefilled syringe.
|
Ixekizumab (Test 1)
Test 1 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe.
|
Ixekizumab (Test 2)
Test 2 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe.
|
|---|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
33
|
|
Overall Study
Received at Least One Dose of Study Drug
|
33
|
33
|
33
|
|
Overall Study
COMPLETED
|
32
|
33
|
32
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Ixekizumab (Reference)
Reference formulation ixekizumab 80 milligram (mg) administered as a subcutaneous (SC) injection in a prefilled syringe.
|
Ixekizumab (Test 1)
Test 1 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe.
|
Ixekizumab (Test 2)
Test 2 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
1
|
Baseline Characteristics
A Study of Ixekizumab in Healthy Participants
Baseline characteristics by cohort
| Measure |
Ixekizumab (Reference)
n=33 Participants
Reference formulation ixekizumab 80 mg administered as a subcutaneous (SC) injection in a prefilled syringe.
|
Ixekizumab (Test 1)
n=33 Participants
Test 1 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe.
|
Ixekizumab (Test 2)
n=33 Participants
Test 2 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.5 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
41.9 years
STANDARD_DEVIATION 15.9 • n=7 Participants
|
49.2 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
44.5 years
STANDARD_DEVIATION 15.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
63 Participants
n=4 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
|
|
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
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 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
|
|
Region of Enrollment
United States
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Predose, Day 3, Day 5, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 57, Day 71 and Day 85 Post DosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of a single dose of Ixekizumab
Outcome measures
| Measure |
Ixekizumab (Reference)
n=33 Participants
Reference formulation ixekizumab 80 mg administered as a subcutaneous (SC) injection in a prefilled syringe.
|
Ixekizumab (Test 1)
n=33 Participants
Test 1 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe.
|
Ixekizumab (Test 2)
n=33 Participants
Test 2 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ixekizumab
|
6.31 microgram/milliliter (ug/mL)
Geometric Coefficient of Variation 48
|
6.29 microgram/milliliter (ug/mL)
Geometric Coefficient of Variation 33
|
6.50 microgram/milliliter (ug/mL)
Geometric Coefficient of Variation 33
|
PRIMARY outcome
Timeframe: Predose, Day 3, Day 5, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 57, Day 71 and Day 85 Post DosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
Area under the plasma concentration versus time curve from time zero to the last measured concentration value (AUC\[0-tlast\]). AUC 0-tlast is equal to AUC (0-85) days where the last time point was 85 Days ± 3 Days.
Outcome measures
| Measure |
Ixekizumab (Reference)
n=32 Participants
Reference formulation ixekizumab 80 mg administered as a subcutaneous (SC) injection in a prefilled syringe.
|
Ixekizumab (Test 1)
n=33 Participants
Test 1 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe.
|
Ixekizumab (Test 2)
n=32 Participants
Test 2 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe.
|
|---|---|---|---|
|
PK: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Ixekizumab
|
146 microgram*day/milliliter (ug*day/mL)
Geometric Coefficient of Variation 43
|
153 microgram*day/milliliter (ug*day/mL)
Geometric Coefficient of Variation 37
|
163 microgram*day/milliliter (ug*day/mL)
Geometric Coefficient of Variation 33
|
PRIMARY outcome
Timeframe: Predose, Day 3, Day 5, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 57, Day 71 and Day 85 Post DosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
Area under the plasma concentration versus time curve from zero to infinity (AUC\[0-∞\]) of a single dose of Ixekizumab.
Outcome measures
| Measure |
Ixekizumab (Reference)
n=32 Participants
Reference formulation ixekizumab 80 mg administered as a subcutaneous (SC) injection in a prefilled syringe.
|
Ixekizumab (Test 1)
n=33 Participants
Test 1 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe.
|
Ixekizumab (Test 2)
n=32 Participants
Test 2 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe.
|
|---|---|---|---|
|
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Ixekizumab.
|
152 ug*day/mL
Geometric Coefficient of Variation 45
|
159 ug*day/mL
Geometric Coefficient of Variation 38
|
170 ug*day/mL
Geometric Coefficient of Variation 34
|
Adverse Events
Ixekizumab (Reference)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Ixekizumab (Test 1)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Ixekizumab (Test 2)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Ixekizumab (Reference)
n=33 participants at risk
Reference formulation ixekizumab 80 mg administered as a subcutaneous (SC) injection in a prefilled syringe.
|
Ixekizumab (Test 1)
n=33 participants at risk
Test 1 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe.
|
Ixekizumab (Test 2)
n=33 participants at risk
Test 2 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe.
|
|---|---|---|---|
|
Infections and infestations
Periorbital abscess
|
0.00%
0/33 • Up to 12 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/33 • Up to 12 Weeks
All randomized participants who received at least one dose of study drug.
|
3.0%
1/33 • Number of events 1 • Up to 12 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Phaeohyphomycotic brain abscess
|
0.00%
0/33 • Up to 12 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/33 • Up to 12 Weeks
All randomized participants who received at least one dose of study drug.
|
3.0%
1/33 • Number of events 1 • Up to 12 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/33 • Up to 12 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/33 • Up to 12 Weeks
All randomized participants who received at least one dose of study drug.
|
3.0%
1/33 • Number of events 1 • Up to 12 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebral venous thrombosis
|
0.00%
0/33 • Up to 12 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/33 • Up to 12 Weeks
All randomized participants who received at least one dose of study drug.
|
3.0%
1/33 • Number of events 1 • Up to 12 Weeks
All randomized participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Ixekizumab (Reference)
n=33 participants at risk
Reference formulation ixekizumab 80 mg administered as a subcutaneous (SC) injection in a prefilled syringe.
|
Ixekizumab (Test 1)
n=33 participants at risk
Test 1 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe.
|
Ixekizumab (Test 2)
n=33 participants at risk
Test 2 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe.
|
|---|---|---|---|
|
General disorders
Injection site reaction
|
3.0%
1/33 • Number of events 1 • Up to 12 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
2/33 • Number of events 2 • Up to 12 Weeks
All randomized participants who received at least one dose of study drug.
|
3.0%
1/33 • Number of events 2 • Up to 12 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/33 • Up to 12 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/33 • Up to 12 Weeks
All randomized participants who received at least one dose of study drug.
|
9.1%
3/33 • Number of events 3 • Up to 12 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.1%
2/33 • Number of events 2 • Up to 12 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/33 • Up to 12 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/33 • Up to 12 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.0%
1/33 • Number of events 1 • Up to 12 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/33 • Up to 12 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
2/33 • Number of events 2 • Up to 12 Weeks
All randomized 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