Trial Outcomes & Findings for A First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Intravenous (IV) Dose of GSK2831781 in Healthy Volunteers and Patients With Plaque Psoriasis (NCT NCT02195349)
NCT ID: NCT02195349
Last Updated: 2021-03-25
Results Overview
Hematology parameters with PCI ranges: hematocrit (high: \>0.54 percentage of red blood cells), hemoglobin (high: \>180 grams per liter \[g/L\]), lymphocytes (low: \<0.8\*giga cells per liter \[10\^9/L\]), neutrophil count (low: \<1.5\*10\^9/L), platelet count (low: \<100\*10\^9/L and high: \>550\*10\^9/L), and while blood cell count (low: \<3\*10\^9/L and high: \>20\*10\^9/L) for healthy volunteers and psoriasis participants. Safety population consisted of all randomized participants who received at least one dose of study treatment. Only those participants for which at least one value of PCI was reported are summarized.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
67 participants
Primary outcome timeframe
Up to 307 days
Results posted on
2021-03-25
Participant Flow
This is a single ascending dose study conducted in healthy volunteers and participants with plaque psoriasis. Participants were enrolled in Germany and the United Kingdom from 30 July 2014 to 07 March 2018.
A total of 330 participants were screened in healthy volunteer cohorts and 197 participants in psoriasis cohorts of which 290 were screen failures in healthy volunteer cohorts and 170 in psoriasis cohorts. A total of 40 participants were enrolled in healthy cohorts and 27 in psoriasis cohorts.
Participant milestones
| Measure |
Placebo for Healthy Volunteer Combined
Healthy volunteers with no delayed type hypersensitivity (DTH) and with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0003 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing anti-drug antibodies negative (ADA-ve) status received a single dose of GSK2831781 0.0003 milligram per kilogram (mg/kg) saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 milliliter (mL) of 2 tuberculin unit (TU) or 10 TU purified protein derivative (PPD) (0.04 microgram \[mcg\]/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
1
|
1
|
6
|
6
|
6
|
6
|
9
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
14
|
1
|
1
|
6
|
6
|
6
|
6
|
9
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Intravenous (IV) Dose of GSK2831781 in Healthy Volunteers and Patients With Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Placebo for Healthy Volunteer Combined
n=14 Participants
Healthy volunteers with no DTH and with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0003 mg/kg (ADA-ve)
n=1 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0003 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
n=1 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
n=9 Participants
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
n=6 Participants
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
n=6 Participants
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
n=6 Participants
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
8 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=64 Participants
|
6 Participants
n=17 Participants
|
66 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
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
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=21 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=10 Participants
|
0 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=64 Participants
|
1 Participants
n=17 Participants
|
6 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=64 Participants
|
5 Participants
n=17 Participants
|
61 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
6 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European heritage
|
12 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
9 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=64 Participants
|
6 Participants
n=17 Participants
|
61 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 307 daysPopulation: Safety population.
Hematology parameters with PCI ranges: hematocrit (high: \>0.54 percentage of red blood cells), hemoglobin (high: \>180 grams per liter \[g/L\]), lymphocytes (low: \<0.8\*giga cells per liter \[10\^9/L\]), neutrophil count (low: \<1.5\*10\^9/L), platelet count (low: \<100\*10\^9/L and high: \>550\*10\^9/L), and while blood cell count (low: \<3\*10\^9/L and high: \>20\*10\^9/L) for healthy volunteers and psoriasis participants. Safety population consisted of all randomized participants who received at least one dose of study treatment. Only those participants for which at least one value of PCI was reported are summarized.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
n=1 Participants
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=14 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
n=1 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
n=9 Participants
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
n=6 Participants
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
n=6 Participants
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
n=6 Participants
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI)
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 307 daysPopulation: Safety population.
Clinical chemistry parameters and their potential clinical concern values: albumin (low: \<30 millimoles per liter \[mmol/L\]), calcium (low: \<2 mmol/L, high: \>2.75 mmol/L), creatinine (high: \>44.2 mmol/L), glucose (low: \<3 mmol/L, high: \>9 mmol/L), magnesium (low: \<0.5 mmol/L, high: \>1.23 mmol/L), phosphorus (low: \<0.8 mmol/L, high: \>1.6 mmol/L), potassium (low: \<3 mmol/L, high: \>5.5 mmol/L), sodium (low: \<130 mmol/L, high: \>150 mmol/L), and total carbon dioxide (CO2) (low: \<18 mmol/L, high: \>32 mmol/L). Number of participants with clinical chemistry of PCI are presented.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
n=1 Participants
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=14 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
n=1 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
n=9 Participants
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
n=6 Participants
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
n=6 Participants
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
n=6 Participants
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinical Chemistry Abnormalities of PCI
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Up to 307 daysPopulation: Safety population.
Vital signs included heart rate, systolic and diastolic blood pressure and body temperature were performed with the participant in a semi-supine position after the participant had rested for at least 5 minutes. The PCI range for heart rate (low: \<40 beats per minute \[BPM\] and high: \>110 BPM), systolic blood pressure (low: \<85 and high: \>160 millimeter of mercury \[mmHg\]), diastolic blood pressure (low: \<45 mmHg and high: \>100 mmHg) and body temperature (low: \<35 degree Celsius and high: \>37.5 degree Celsius). Number of participants with vital signs of PCI are presented.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
n=1 Participants
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=14 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
n=1 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
n=9 Participants
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
n=6 Participants
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
n=6 Participants
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
n=6 Participants
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Signs of PCI
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 307 daysPopulation: Safety population.
Triplicate ECG was measured in a semi-supine position after 5 minutes rest. A single 12-lead ECG was obtained by using an ECG machine that automatically calculates heart rate and measured PR, QRS, QT, and Fridericia's formula (QTcF) intervals. The PCI ranges for QTc Interval (high: \>450 millisecond \[msec\]), PR Interval (low: \<110 msec and high: \>220 msec) and QRS Interval (low: \<75 msec and high: \>110 msec). Number of participants with ECG values of PCI are presented.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
n=1 Participants
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=14 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
n=1 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
n=9 Participants
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
n=6 Participants
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
n=6 Participants
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
n=6 Participants
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) of PCI
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 307 daysPopulation: Safety population.
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect and other important medical events judged by the investigator that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
n=1 Participants
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=14 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
n=1 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
n=9 Participants
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
n=6 Participants
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
n=6 Participants
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
n=6 Participants
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AEs
|
0 Participants
|
8 Participants
|
0 Participants
|
5 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
9 Participants
|
4 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6, 12, 24 and 48 hours post-dosePopulation: Safety population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
IL-6, IL-8, interferon-gamma and TNF alpha were assessed at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day 1, pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
n=1 Participants
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=14 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
n=1 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
n=9 Participants
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
n=6 Participants
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
n=6 Participants
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
n=6 Participants
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha
TNF alpha: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6)
|
-1.030 Picogram per milliliter (pg/mL)
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
-0.201 Picogram per milliliter (pg/mL)
Standard Deviation 1.3961
|
0.700 Picogram per milliliter (pg/mL)
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
5.075 Picogram per milliliter (pg/mL)
Standard Deviation 2.8043
|
6.735 Picogram per milliliter (pg/mL)
Standard Deviation 3.9483
|
6.768 Picogram per milliliter (pg/mL)
Standard Deviation 5.9501
|
2.272 Picogram per milliliter (pg/mL)
Standard Deviation 1.5898
|
-0.301 Picogram per milliliter (pg/mL)
Standard Deviation 0.5766
|
2.100 Picogram per milliliter (pg/mL)
Standard Deviation 1.9397
|
4.265 Picogram per milliliter (pg/mL)
Standard Deviation 2.6663
|
2.753 Picogram per milliliter (pg/mL)
Standard Deviation 1.1083
|
|
Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha
TNF alpha:6hours (n=14,1,1,6,6,6,6,9,6,6,6)
|
0.050 Picogram per milliliter (pg/mL)
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.166 Picogram per milliliter (pg/mL)
Standard Deviation 1.1347
|
1.940 Picogram per milliliter (pg/mL)
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
4.958 Picogram per milliliter (pg/mL)
Standard Deviation 3.8080
|
3.047 Picogram per milliliter (pg/mL)
Standard Deviation 5.0083
|
5.162 Picogram per milliliter (pg/mL)
Standard Deviation 4.6045
|
1.512 Picogram per milliliter (pg/mL)
Standard Deviation 1.3042
|
-0.402 Picogram per milliliter (pg/mL)
Standard Deviation 1.4406
|
2.658 Picogram per milliliter (pg/mL)
Standard Deviation 1.7619
|
2.678 Picogram per milliliter (pg/mL)
Standard Deviation 1.6019
|
3.455 Picogram per milliliter (pg/mL)
Standard Deviation 1.7634
|
|
Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha
IL-6: 6 hours (n=14,1,1,6,6,6,6,9,6,6,6)
|
1.430 Picogram per milliliter (pg/mL)
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
2.889 Picogram per milliliter (pg/mL)
Standard Deviation 5.5511
|
0.000 Picogram per milliliter (pg/mL)
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.258 Picogram per milliliter (pg/mL)
Standard Deviation 1.8234
|
1.025 Picogram per milliliter (pg/mL)
Standard Deviation 1.6945
|
4.305 Picogram per milliliter (pg/mL)
Standard Deviation 5.0046
|
1.142 Picogram per milliliter (pg/mL)
Standard Deviation 1.9865
|
15.003 Picogram per milliliter (pg/mL)
Standard Deviation 29.0749
|
1.445 Picogram per milliliter (pg/mL)
Standard Deviation 1.9297
|
2.062 Picogram per milliliter (pg/mL)
Standard Deviation 1.5145
|
3.837 Picogram per milliliter (pg/mL)
Standard Deviation 6.7895
|
|
Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha
IL-6: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6)
|
7.140 Picogram per milliliter (pg/mL)
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
3.748 Picogram per milliliter (pg/mL)
Standard Deviation 5.0647
|
0.000 Picogram per milliliter (pg/mL)
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.127 Picogram per milliliter (pg/mL)
Standard Deviation 3.2387
|
6.408 Picogram per milliliter (pg/mL)
Standard Deviation 11.0052
|
12.302 Picogram per milliliter (pg/mL)
Standard Deviation 10.2985
|
34.603 Picogram per milliliter (pg/mL)
Standard Deviation 42.6294
|
21.447 Picogram per milliliter (pg/mL)
Standard Deviation 26.3310
|
18.943 Picogram per milliliter (pg/mL)
Standard Deviation 26.2127
|
3.150 Picogram per milliliter (pg/mL)
Standard Deviation 2.0492
|
11.893 Picogram per milliliter (pg/mL)
Standard Deviation 16.0968
|
|
Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha
IL-6: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6)
|
1.720 Picogram per milliliter (pg/mL)
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.727 Picogram per milliliter (pg/mL)
Standard Deviation 1.5514
|
0.000 Picogram per milliliter (pg/mL)
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
-1.272 Picogram per milliliter (pg/mL)
Standard Deviation 3.1149
|
0.522 Picogram per milliliter (pg/mL)
Standard Deviation 1.2778
|
16.748 Picogram per milliliter (pg/mL)
Standard Deviation 28.4330
|
2.710 Picogram per milliliter (pg/mL)
Standard Deviation 5.1169
|
4.284 Picogram per milliliter (pg/mL)
Standard Deviation 9.7552
|
5.825 Picogram per milliliter (pg/mL)
Standard Deviation 9.9881
|
2.737 Picogram per milliliter (pg/mL)
Standard Deviation 1.8897
|
1.987 Picogram per milliliter (pg/mL)
Standard Deviation 5.9878
|
|
Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha
IL-6: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6)
|
7.630 Picogram per milliliter (pg/mL)
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
1.887 Picogram per milliliter (pg/mL)
Standard Deviation 4.1642
|
0.000 Picogram per milliliter (pg/mL)
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
-1.493 Picogram per milliliter (pg/mL)
Standard Deviation 3.6579
|
0.000 Picogram per milliliter (pg/mL)
Standard Deviation 0.0000
|
2.193 Picogram per milliliter (pg/mL)
Standard Deviation 3.8186
|
-0.657 Picogram per milliliter (pg/mL)
Standard Deviation 1.1306
|
-1.091 Picogram per milliliter (pg/mL)
Standard Deviation 1.6867
|
-0.460 Picogram per milliliter (pg/mL)
Standard Deviation 1.8092
|
0.163 Picogram per milliliter (pg/mL)
Standard Deviation 0.6664
|
-1.145 Picogram per milliliter (pg/mL)
Standard Deviation 2.8564
|
|
Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha
IL-8: 6 hours (n=14,1,1,6,6,6,6,9,6,6,6)
|
-0.100 Picogram per milliliter (pg/mL)
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
1.284 Picogram per milliliter (pg/mL)
Standard Deviation 2.7802
|
-0.210 Picogram per milliliter (pg/mL)
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
4.302 Picogram per milliliter (pg/mL)
Standard Deviation 2.7723
|
1.752 Picogram per milliliter (pg/mL)
Standard Deviation 3.0055
|
3.657 Picogram per milliliter (pg/mL)
Standard Deviation 4.9829
|
1.847 Picogram per milliliter (pg/mL)
Standard Deviation 2.1026
|
1.518 Picogram per milliliter (pg/mL)
Standard Deviation 3.5960
|
1.522 Picogram per milliliter (pg/mL)
Standard Deviation 2.6497
|
3.157 Picogram per milliliter (pg/mL)
Standard Deviation 3.7276
|
4.063 Picogram per milliliter (pg/mL)
Standard Deviation 3.7411
|
|
Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha
IL-8: 12 hours (n=14,1,1,6,6,6,6,9,6,6,6)
|
1.800 Picogram per milliliter (pg/mL)
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
4.344 Picogram per milliliter (pg/mL)
Standard Deviation 5.4602
|
2.760 Picogram per milliliter (pg/mL)
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
5.487 Picogram per milliliter (pg/mL)
Standard Deviation 5.5182
|
5.107 Picogram per milliliter (pg/mL)
Standard Deviation 3.1582
|
15.155 Picogram per milliliter (pg/mL)
Standard Deviation 21.9139
|
8.110 Picogram per milliliter (pg/mL)
Standard Deviation 10.8187
|
21.774 Picogram per milliliter (pg/mL)
Standard Deviation 55.5319
|
7.425 Picogram per milliliter (pg/mL)
Standard Deviation 13.5089
|
10.667 Picogram per milliliter (pg/mL)
Standard Deviation 6.9406
|
11.120 Picogram per milliliter (pg/mL)
Standard Deviation 6.7124
|
|
Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha
IL-8: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6)
|
2.100 Picogram per milliliter (pg/mL)
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
6.402 Picogram per milliliter (pg/mL)
Standard Deviation 21.1483
|
-0.260 Picogram per milliliter (pg/mL)
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.560 Picogram per milliliter (pg/mL)
Standard Deviation 2.2738
|
4.780 Picogram per milliliter (pg/mL)
Standard Deviation 10.3055
|
39.248 Picogram per milliliter (pg/mL)
Standard Deviation 50.1491
|
1.710 Picogram per milliliter (pg/mL)
Standard Deviation 1.9256
|
3.321 Picogram per milliliter (pg/mL)
Standard Deviation 8.3425
|
5.993 Picogram per milliliter (pg/mL)
Standard Deviation 14.0442
|
18.330 Picogram per milliliter (pg/mL)
Standard Deviation 22.5892
|
9.208 Picogram per milliliter (pg/mL)
Standard Deviation 13.2078
|
|
Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha
IL-8: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6)
|
47.900 Picogram per milliliter (pg/mL)
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
1.337 Picogram per milliliter (pg/mL)
Standard Deviation 9.4965
|
-0.740 Picogram per milliliter (pg/mL)
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.028 Picogram per milliliter (pg/mL)
Standard Deviation 0.0694
|
-0.212 Picogram per milliliter (pg/mL)
Standard Deviation 2.1383
|
-0.425 Picogram per milliliter (pg/mL)
Standard Deviation 2.7328
|
0.382 Picogram per milliliter (pg/mL)
Standard Deviation 1.0779
|
-1.901 Picogram per milliliter (pg/mL)
Standard Deviation 1.8197
|
-1.140 Picogram per milliliter (pg/mL)
Standard Deviation 2.4624
|
1.047 Picogram per milliliter (pg/mL)
Standard Deviation 2.7193
|
0.300 Picogram per milliliter (pg/mL)
Standard Deviation 3.0864
|
|
Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha
Interferon-gamma:6hours(n=14, 1,1,6,6,6,6,9,6,6,6)
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
|
Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha
Interferon-gamma:12hours(n=13,1,1,6,6,6,6,9,6,6,6)
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
|
Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha
Interferon-gamma:24hours(n=14,1,1,6,6,6,6,9,6,6,6)
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
|
Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha
Interferon-gamma:48hours(n=12,1,1,6,6,6,5,9,6,6,6)
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
0.00 Picogram per milliliter (pg/mL)
Standard Deviation 0.000
|
|
Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha
TNF alpha: 24 hours (n=14,1,1,6,6,6,6,9,6,6,6)
|
-0.450 Picogram per milliliter (pg/mL)
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
-0.244 Picogram per milliliter (pg/mL)
Standard Deviation 1.4101
|
0.310 Picogram per milliliter (pg/mL)
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
2.650 Picogram per milliliter (pg/mL)
Standard Deviation 1.2128
|
5.935 Picogram per milliliter (pg/mL)
Standard Deviation 3.4483
|
5.372 Picogram per milliliter (pg/mL)
Standard Deviation 4.2010
|
0.883 Picogram per milliliter (pg/mL)
Standard Deviation 2.1105
|
-0.029 Picogram per milliliter (pg/mL)
Standard Deviation 1.0534
|
2.775 Picogram per milliliter (pg/mL)
Standard Deviation 1.2677
|
2.942 Picogram per milliliter (pg/mL)
Standard Deviation 2.4473
|
2.502 Picogram per milliliter (pg/mL)
Standard Deviation 1.7958
|
|
Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha
TNF alpha: 48 hours (n=14,1,1,6,6,6,6,9,6,6,6)
|
0.420 Picogram per milliliter (pg/mL)
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
-0.366 Picogram per milliliter (pg/mL)
Standard Deviation 1.2390
|
-0.480 Picogram per milliliter (pg/mL)
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.810 Picogram per milliliter (pg/mL)
Standard Deviation 1.5676
|
0.878 Picogram per milliliter (pg/mL)
Standard Deviation 0.8027
|
1.825 Picogram per milliliter (pg/mL)
Standard Deviation 1.5788
|
-0.007 Picogram per milliliter (pg/mL)
Standard Deviation 1.7897
|
0.286 Picogram per milliliter (pg/mL)
Standard Deviation 1.1455
|
0.752 Picogram per milliliter (pg/mL)
Standard Deviation 0.9434
|
1.712 Picogram per milliliter (pg/mL)
Standard Deviation 1.1398
|
1.083 Picogram per milliliter (pg/mL)
Standard Deviation 0.8472
|
PRIMARY outcome
Timeframe: 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 191Population: Safety population. Only those participants with data available at the specified time points were analyzed.
Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=14 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: 6 hours, 1+
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: 6 hours, 10
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: 6 hours, 7
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: 12 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: 12 hours, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: 72 hours, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: 72 hours, 1+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: 72 hours, 10
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: 72 hours, 50
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: 168 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: 168 hours, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: 168 hours, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: Day 15, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: Day 22, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: Day 22, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: Day 22, 2+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: Day 29, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: Day 29, 1+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: Day 29, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: Day 29, 2+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: Day 29, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: Day 43, 1+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: Day 43, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: Day 43, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: Day 57, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: Day 57, 1+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: Day 57, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: Day 85, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: Day 85, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: Day 121, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: Day 121, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: Day 121, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: Day 191, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: Day 191, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: Day 191, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Glucose: 6 hours, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Glucose: 6 hours, 17
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Glucose: 6 hours, 7
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Glucose: 12 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Glucose: 72 hours, 0
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Glucose: 72 hours, 3
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Glucose: 168 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Glucose: Day 29, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Glucose: Day 43, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Glucose: Day 57, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Glucose: Day 85, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Glucose: Day 121, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Glucose: Day 191, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Ketones: 6 hours, 7
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Ketones: 12 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Ketones: 12 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Ketones: 72 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Ketones: 72 hours, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Ketones: 168 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Ketones: 168 hours, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Ketones: 168 hours, 4+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Ketones: Day 15, 0
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Ketones: Day 15, 0.5
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Ketones: Day 29, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Ketones: Day 29, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Ketones: Day 43, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Ketones: Day 43, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Ketones: Day 85, 0
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Ketones: Day 121, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Ketones: Day 121, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Ketones: Day 121, 2+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Ketones: Day 191, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Nitrite: Day 15, positive
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Nitrite: Day 121, positive
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Protein: 6 hours, 0
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Protein: 6 hours, 7
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Protein: 12 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Protein: 12 hours, 2+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Protein: 72 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Protein: 72 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Protein: 168 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Protein: 168 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Protein: Day 15, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Protein: Day 15, 1+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Protein: Day 22, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Protein: Day 22, 1+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Protein: Day 29, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Protein: Day 29, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Protein: Day 43, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Protein: Day 43, 1+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Protein: Day 57, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Protein: Day 57, 1+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Protein: Day 85, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Protein: Day 121, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Protein: Day 191, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Protein: Day 191, 1+
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: 6 hours, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: 12 hours, 2+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: 168 hours, 1+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Occult blood: Day 43, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Glucose: Day 15, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Glucose: Day 22, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Ketones: 6 hours, 0
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Ketones: Day 22, 0
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Ketones: Day 22, 0.5
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Ketones: Day 43, 1.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Ketones: Day 57, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Ketones: Day 85, 0.5
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Ketones: Day 191, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Ketones: Day 191, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Nitrite: Day 85, positive
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Protein: 168 hours, 2+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Protein: 168 hours, 3+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers
Protein: Day 85, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 6, 12, 72, 168 hours, Day 15 and 29Population: Safety population.
Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=1 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Occult blood: 6 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Occult blood: 72 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Occult blood: 72 hours, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Occult blood: 72 hours, 50
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Occult blood: 168 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Glucose: 6 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Glucose: 72 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Glucose: 72 hours, 3
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Glucose: 168 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Glucose: Day 15, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Glucose: Day 29, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Ketones: 6 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Ketones: 12 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Ketones: 12 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Ketones: 72 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Ketones: 168 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Ketones: 168 hours, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Ketones: Day 15, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Ketones: Day 15, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Ketones: Day 29, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Ketones: Day 29, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Ketones: Day 29, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Nitrite: Day 15, positive
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Protein: 6 hours, 7
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Protein: 12 hours, 2+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Protein: 72 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Protein: 168 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Protein: 168 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Protein: 168 hours, 2+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Protein: Day 15, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Protein: Day 15, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Protein: Day 29, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Protein: Day 29, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Occult blood: 6 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Occult blood: 6 hours, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Occult blood: 6 hours, 7
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Occult blood: 12 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Occult blood: 12 hours, 2+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Occult blood: 12 hours, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Occult blood: 72 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Occult blood: 168 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Occult blood: 168 hours, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Occult blood: 168 hours, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Occult blood: Day 15, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Occult blood: Day 29, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Occult blood: Day 29, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Occult blood: Day 29, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Glucose: 6 hours, 17
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Glucose: 6 hours, 7
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Glucose: 12 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Ketones: 6 hours, 7
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Ketones: 72 hours, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Ketones: 168 hours, 4+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Protein: 6 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Protein: 12 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Protein: 72 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)
Protein: 168 hours, 3+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 6, 12, 72, 168 hours, Days 15, 29 and 43Population: Safety population.
Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=1 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Occult blood: 6 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Occult blood: 6 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Occult blood: 6 hours, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Occult blood: 6 hours, 7
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Occult blood: 12 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Occult blood: 12 hours, 2+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Occult blood: 12 hours, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Occult blood: 72 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Occult blood: 72 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Occult blood: 72 hours, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Occult blood: 72 hours, 50
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Occult blood: 168 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Occult blood: 168 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Occult blood: 168 hours, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Occult blood: 168 hours, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Occult blood: Day 15, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Occult blood: Day 29, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Occult blood: Day 29, 2+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Occult blood: Day 29, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Glucose: 6 hours, 7
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Glucose: 72 hours, 3
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Glucose: Day 29, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Ketones: 72 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Ketones: 72 hours, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Ketones: 168 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Ketones: 168 hours, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Protein: 168 hours, 2+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Protein: Day 15, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Occult blood: Day 29, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Occult blood: Day 43, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Occult blood: Day 43, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Occult blood: Day 43, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Glucose: 6 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Glucose: 6 hours, 17
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Glucose: 12 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Glucose: 72 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Glucose: 168 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Glucose: Day 15, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Glucose: Day 43, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Ketones: 6 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Ketones: 6 hours, 7
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Ketones: 12 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Ketones: 12 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Ketones: 168 hours, 4+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Ketones: Day 15, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Ketones: Day 15, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Ketones: Day 29, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Ketones: Day 29, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Ketones: Day 43, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Ketones: Day 43, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Ketones: Day 43, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Nitrite: Day 15, positive
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Protein: 6 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Protein: 6 hours, 7
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Protein: 12 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Protein: 12 hours, 2+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Protein: 72 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Protein: 72 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Protein: 168 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Protein: 168 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Protein: 168 hours, 3+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Protein: Day 15, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Protein: Day 29, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Protein: Day 29, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Protein: Day 43, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)
Protein: Day 43, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57 and 85Population: Safety population.
Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Occult blood: 6 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Occult blood: Day 22, 2+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Occult blood: Day 29, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Occult blood: Day 43, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Ketones: Day 85, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Ketones: Day 85, 1+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Protein: Day 22, 1+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Occult blood: 6 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Occult blood: 6 hours, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Occult blood: 6 hours, 7
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Occult blood: 12 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Occult blood: 12 hours, 2+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Occult blood: 12 hours, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Occult blood: 72 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Occult blood: 72 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Occult blood: 72 hours, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Occult blood: 72 hours, 50
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Occult blood: 168 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Occult blood: 168 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Occult blood: 168 hours, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Occult blood: 168 hours, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Occult blood: Day 15, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Occult blood: Day 22, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Occult blood: Day 22, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Occult blood: Day 29, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Occult blood: Day 29, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Occult blood: Day 29, 2+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Occult blood: Day 29, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Occult blood: Day 43, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Occult blood: Day 43, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Occult blood: Day 43, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Occult blood: Day 57, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Occult blood: Day 57, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Occult blood: Day 57, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Occult blood: Day 85, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Occult blood: Day 85, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Occult blood: Day 85, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Glucose: 6 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Glucose: 6 hours, 17
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Glucose: 6 hours, 7
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Glucose: 12 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Glucose: 72 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Glucose: 72 hours, 3
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Glucose: 168 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Glucose: Day 15, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Glucose: Day 22, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Glucose: Day 29, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Glucose: Day 43, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Glucose: Day 57, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Glucose: Day 85, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Ketones: 6 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Ketones: 6 hours, 7
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Ketones: 12 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Ketones: 12 hours, 1+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Ketones: 72 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Ketones: 72 hours, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Ketones: 168 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Ketones: 168 hours, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Ketones: 168 hours, 4+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Ketones: Day 15, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Ketones: Day 15, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Ketones: Day 22, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Ketones: Day 22, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Ketones: Day 29, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Ketones: Day 29, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Ketones: Day 43, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Ketones: Day 43, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Ketones: Day 43, 1.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Ketones: Day 57, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Ketones: Day 85, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Nitrite: Day 15, positive
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Protein: 6 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Protein: 6 hours, 7
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Protein: 12 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Protein: 12 hours, 2+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Protein: 72 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Protein: 72 hours, 1+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Protein: 168 hours, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Protein: 168 hours, 1+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Protein: 168 hours, 2+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Protein: 168 hours, 3+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Protein: Day 15, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Protein: Day 15, 1+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Protein: Day 22, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Protein: Day 29, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Protein: Day 29, 1+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Protein: Day 43, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Protein: Day 43, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Protein: Day 57, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Protein: Day 57, 1+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Protein: Day 85, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)
Protein: Day 85, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 147Population: Safety population.
Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: Day 43, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: Day 43, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: Day 43, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: Day 85, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: Day 121, 10
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: Day 147, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: Day 147, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Glucose: 6 hours, 17
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Glucose: 72 hours, 3
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Glucose: 168 hours, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Glucose: Day 15, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Glucose: Day 22, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Glucose: Day 29, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Glucose: Day 121, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Glucose: Day 147, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Ketones: 6 hours, 7
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Ketones: 12 hours, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Ketones: 168 hours, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Ketones: 168 hours, 4+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Ketones: Day 15, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Ketones: Day 22, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Ketones: Day 29, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Ketones: Day 43, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Ketones: Day 43, 1.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Ketones: Day 57, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Ketones: Day 85, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Ketones: Day 121, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Ketones: Day 121, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Ketones: Day 121, 2+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Ketones: Day 147, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Ketones: Day 147, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Ketones: Day 147, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Nitrite: Day 15, positive
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Nitrite: Day 85, positive
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Nitrite: Day 121, positive
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Protein: 6 hours, 7
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Protein: 12 hours, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Protein: 12 hours, 2+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Protein: 72 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Protein: 168 hours, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Protein: 168 hours, 3+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Protein: Day 22, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Protein: Day 57, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Protein: Day 147, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Glucose: Day 43, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Glucose: Day 57, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Glucose: Day 85, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Ketones: 6 hours, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Ketones: 12 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Ketones: 72 hours, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Ketones: 72 hours, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Ketones: 168 hours, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Ketones: Day 15, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Ketones: Day 22, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Ketones: Day 29, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Ketones: Day 43, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Ketones: Day 85, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Protein: 6 hours, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Protein: 72 hours, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: 6 hours, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: 6 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: 6 hours, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: 6 hours, 7
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: 12 hours, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: 12 hours, 2+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: 12 hours, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: 72 hours, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: 72 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: 72 hours, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: 72 hours, 50
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: 168 hours, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: 168 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: 168 hours, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: 168 hours, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: Day 15, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: Day 22, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: Day 22, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: Day 22, 2+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: Day 29, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: Day 29, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: Day 29, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: Day 29, 2+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: Day 29, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: Day 43, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: Day 57, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: Day 57, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: Day 57, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: Day 85, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: Day 121, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: Day 121, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Occult blood: Day 147, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Glucose: 6 hours, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Glucose: 6 hours, 7
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Glucose: 12 hours, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Glucose: 72 hours, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Protein: 168 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Protein: 168 hours, 2+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Protein: Day 15, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Protein: Day 15, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Protein: Day 22, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Protein: Day 29, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Protein: Day 29, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Protein: Day 43, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Protein: Day 43, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Protein: Day 57, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Protein: Day 85, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Protein: Day 85, 1+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Protein: Day 121, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)
Protein: Day 147, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 219Population: Safety population.
Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: 6 hours, 7
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: 72 hours, 1+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: 168 hours, 25
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: Day 22, 10
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: Day 22, 2+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: Day 29, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: Day 57, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: Day 57, 10
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: Day 219, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Glucose: Day 43, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Glucose: Day 57, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Glucose: Day 219, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Ketones: 12 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Ketones: Day 29, 0
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Ketones: Day 43, 1.5
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Ketones: Day 85, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Ketones: Day 121, 2+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Ketones: Day 219, 0
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Nitrite: Day 121, positive
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Protein: 12 hours, 2+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Protein: 168 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Protein: 168 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Protein: Day 15, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Protein: Day 43, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Protein: Day 219, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: 6 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: 6 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: 6 hours, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: 12 hours, 0
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: 12 hours, 2+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: 12 hours, 25
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: 72 hours, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: 72 hours, 10
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: 72 hours, 50
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: 168 hours, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: 168 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: 168 hours, 10
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: Day 15, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: Day 22, 0
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: Day 29, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: Day 29, 10
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: Day 29, 2+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: Day 29, 25
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: Day 43, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: Day 43, 1+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: Day 43, 10
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: Day 43, 25
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: Day 57, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: Day 85, 0
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: Day 85, 10
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: Day 121, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: Day 121, 1+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: Day 121, 10
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: Day 219, 10
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Occult blood: Day 219, 25
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Glucose: 6 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Glucose: 6 hours, 17
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Glucose: 6 hours, 7
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Glucose: 12 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Glucose: 72 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Glucose: 72 hours, 3
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Glucose: 168 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Glucose: Day 15, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Glucose: Day 22, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Glucose: Day 29, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Glucose: Day 85, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Glucose: Day 121, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Ketones: 6 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Ketones: 6 hours, 7
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Ketones: 12 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Ketones: 72 hours, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Ketones: 72 hours, 0.5
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Ketones: 168 hours, 0
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Ketones: 168 hours, 0.5
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Ketones: 168 hours, 4+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Ketones: Day 15, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Ketones: Day 15, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Ketones: Day 22, 0
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Ketones: Day 22, 0.5
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Ketones: Day 29, 0.5
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Ketones: Day 43, 0
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Ketones: Day 43, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Ketones: Day 57, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Ketones: Day 85, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Ketones: Day 121, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Ketones: Day 121, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Ketones: Day 219, 0.5
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Ketones: Day 219, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Nitrite: Day 15, positive
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Nitrite: Day 85, positive
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Protein: 6 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Protein: 6 hours, 7
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Protein: 12 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Protein: 72 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Protein: 72 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Protein: 168 hours, 2+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Protein: 168 hours, 3+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Protein: Day 15, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Protein: Day 22, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Protein: Day 22, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Protein: Day 29, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Protein: Day 29, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Protein: Day 43, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Protein: Day 57, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Protein: Day 57, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Protein: Day 85, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Protein: Day 85, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Protein: Day 121, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)
Protein: Day 219, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 191Population: Safety population.
Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: 6 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: Day 43, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: Day 57, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: Day 191, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Glucose: 12 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Glucose: Day 22, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Glucose: Day 121, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Glucose: Day 191, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Ketones: Day 43, 1.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Ketones: Day 57, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Ketones: Day 85, 0
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Nitrite: Day 85, positive
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Nitrite: Day 121, positive
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Protein: 12 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Protein: Day 29, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: 6 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: 6 hours, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: 6 hours, 7
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: 12 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: 12 hours, 2+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: 12 hours, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: 72 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: 72 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: 72 hours, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: 72 hours, 50
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: 168 hours, 0
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: 168 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: 168 hours, 10
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: 168 hours, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: Day 15, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: Day 22, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: Day 22, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: Day 22, 2+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: Day 29, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: Day 29, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: Day 29, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: Day 29, 2+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: Day 29, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: Day 43, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: Day 43, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: Day 43, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: Day 57, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: Day 57, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: Day 85, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: Day 85, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: Day 121, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: Day 121, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: Day 121, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: Day 191, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Occult blood: Day 191, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Glucose: 6 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Glucose: 6 hours, 17
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Glucose: 6 hours, 7
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Glucose: 72 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Glucose: 72 hours, 3
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Glucose: 168 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Glucose: Day 15, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Glucose: Day 29, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Glucose: Day 43, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Glucose: Day 57, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Glucose: Day 85, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Ketones: 6 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Ketones: 6 hours, 7
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Ketones: 12 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Ketones: 12 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Ketones: 72 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Ketones: 72 hours, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Ketones: 168 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Ketones: 168 hours, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Ketones: 168 hours, 4+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Ketones: Day 15, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Ketones: Day 15, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Ketones: Day 22, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Ketones: Day 22, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Ketones: Day 29, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Ketones: Day 29, 0.5
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Ketones: Day 43, 0
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Ketones: Day 43, 0.5
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Ketones: Day 85, 0.5
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Ketones: Day 121, 0
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Ketones: Day 121, 0.5
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Ketones: Day 121, 2+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Ketones: Day 191, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Ketones: Day 191, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Ketones: Day 191, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Nitrite: Day 15, positive
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Protein: 6 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Protein: 6 hours, 7
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Protein: 12 hours, 2+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Protein: 72 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Protein: 72 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Protein: 168 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Protein: 168 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Protein: 168 hours, 2+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Protein: 168 hours, 3+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Protein: Day 15, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Protein: Day 15, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Protein: Day 22, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Protein: Day 22, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Protein: Day 29, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Protein: Day 43, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Protein: Day 43, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Protein: Day 57, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Protein: Day 57, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Protein: Day 85, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Protein: Day 85, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Protein: Day 121, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Protein: Day 191, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)
Protein: Day 191, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 307Population: Safety population.
Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=9 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: 6 hours, 10
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: 6 hours, 50
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: 12 hours, +
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: 12 hours, 0
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: 12 hours, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: 12 hours, 150
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: 12 hours, 2+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: 12 hours, 25
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: 12 hours, 50
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: 72 hours, +
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: 72 hours, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: 72 hours, 150
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: 72 hours, 25
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: 168 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: 168 hours, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: 168 hours, 150
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: 168 hours, 25
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: 168 hours, 250
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 15, 0
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 15, 10
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 15, 25
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 15, 250
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 15, 50
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 22, 0
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 22, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 22, 10
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 22, 150
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 22, 25
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 22, 50
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 29, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 29, 10
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 29, 150
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 29, 50
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 43, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 43, 10
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 43, 150
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 43, 25
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 43, 3+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 43, 50
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 57, 0
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 57, 10
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 57, 150
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 57, 50
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 85, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 85, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 85, 25
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 85, 50
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 121, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 121, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 121, 150
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 121, 25
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 307, 0
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 307, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 307, 25
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 307, 50
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Glucose: 12 hours, 9
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Glucose: 72 hours, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Glucose: 168 hours, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Glucose: Day 15, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Glucose: Day 22, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Glucose: Day 29, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Glucose: Day 43, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Glucose: Day 85, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Glucose: Day 121, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Glucose: Day 307, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Ketones: 6 hours, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Ketones: 12 hours, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Ketones: 12 hours, 0.5
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Ketones: 72 hours, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Ketones: 168 hours, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Ketones: Day 29, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Ketones: Day 29, 0.5
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Ketones: Day 57, 0.5
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Ketones: Day 85, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Ketones: Day 85, 0.5
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Ketones: Day 121, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Ketones: Day 121, 0.5
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Ketones: Day 307, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Ketones: Day 307, 0.5
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Protein: 6 hours, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Protein: 12 hours, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Protein: 72 hours, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Protein: 168 hours, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Protein: 168 hours, 0.25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Protein: 168 hours, 1+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Protein: Day 15, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Protein: Day 15, 0.25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Protein: Day 22, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Protein: Day 29, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 57, 25
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 121, +
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: Day 121, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: 6 hours, +
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: 6 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: 6 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Occult blood: 72 hours, 10
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Protein: Day 43, 0.25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Glucose: 6 hours, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Glucose: 12 hours, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Protein: Day 57, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Protein: Day 85, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Glucose: Day 22, 5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Glucose: Day 57, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Protein: Day 85, 0.25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Protein: Day 85, 1+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Protein: Day 121, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Protein: Day 307, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Protein: Day 307, 0.25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Ketones: 72 hours, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Ketones: 168 hours, 0.5
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Ketones: Day 15, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Ketones: Day 15, 0.5
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Ketones: Day 22, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Ketones: Day 22, 0.5
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Ketones: Day 43, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Ketones: Day 43, 0.5
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Ketones: Day 43, 1.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Ketones: Day 57, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Nitrite: Day 15, positive
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Protein: Day 22, 0.25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Protein: Day 29, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Protein: Day 29, 0.25
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo
Protein: Day 43, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 237Population: Safety population.
Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: 6 hours, 1+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: 12 hours, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: 12 hours, 2+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: 12 hours, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: 12 hours, 50
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: 168 hours, 250
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 15, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 15, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 15, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 15, 50
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 22, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 22, 150
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 43, 3+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 57, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 57, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 121, +
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Glucose: 12 hours, 9
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Glucose: Day 121, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Ketones: 168 hours, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Ketones: Day 57, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Ketones: Day 85, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Ketones: Day 121, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Ketones: Day 237, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Ketones: Day 237, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Protein: 168 hours, 0.25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Protein: 168 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: 6 hours, +
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: 6 hours, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: 6 hours, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: 6 hours, 50
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: 12 hours, +
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: 12 hours, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: 12 hours, 150
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: 72 hours, +
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: 72 hours, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: 72 hours, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: 72 hours, 150
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: 72 hours, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: 168 hours, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: 168 hours, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: 168 hours, 150
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: 168 hours, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 15, 250
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 22, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 22, 1+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 22, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 22, 50
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 29, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 29, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 29, 150
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 29, 50
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 43, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 43, 10
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 43, 150
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 43, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 43, 50
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 57, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 57, 150
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 57, 50
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 85, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 85, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 85, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 85, 50
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 121, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 121, 1+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 121, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 121, 150
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 121, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 237, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 237, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 237, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Occult blood: Day 237, 50
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Glucose: 6 hours, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Glucose: 12 hours, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Glucose: 72 hours, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Glucose: 168 hours, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Glucose: Day 15, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Glucose: Day 22, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Glucose: Day 22, 5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Glucose: Day 29, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Glucose: Day 43, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Glucose: Day 57, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Glucose: Day 85, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Glucose: Day 237, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Ketones: 6 hours, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Ketones: 12 hours, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Ketones: 12 hours, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Ketones: 72 hours, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Ketones: 72 hours, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Ketones: 168 hours, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Ketones: Day 15, 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Ketones: Day 15, 0.5
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Ketones: Day 22, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Ketones: Day 22, 0.5
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Ketones: Day 29, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Ketones: Day 29, 0.5
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Ketones: Day 43, 0
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Ketones: Day 43, 0.5
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Ketones: Day 43, 1.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Ketones: Day 57, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Ketones: Day 85, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Ketones: Day 121, 0.5
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Nitrite: Day 15, positive
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Protein: 6 hours, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Protein: 12 hours, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Protein: 72 hours, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Protein: 168 hours, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Protein: Day 15, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Protein: Day 15, 0.25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Protein: Day 22, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Protein: Day 22, 0.25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Protein: Day 29, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Protein: Day 29, 0.25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Protein: Day 29, 1+
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Protein: Day 43, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Protein: Day 43, 0.25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Protein: Day 57, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Protein: Day 85, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Protein: Day 85, 0.25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Protein: Day 85, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Protein: Day 121, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Protein: Day 237, 0
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg
Protein: Day 237, 0.25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 277Population: Safety population.
Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 277, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 277, 25
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Ketones: Day 15, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Protein: Day 85, 0.25
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: 6 hours, +
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: 6 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: 6 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: 6 hours, 10
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: 6 hours, 50
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: 12 hours, +
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: 12 hours, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: 12 hours, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: 12 hours, 150
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: 12 hours, 2+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: 12 hours, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: 12 hours, 50
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: 72 hours, +
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: 72 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: 72 hours, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: 72 hours, 150
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: 72 hours, 25
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: 168 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: 168 hours, 10
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: 168 hours, 150
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: 168 hours, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: 168 hours, 250
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 15, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 15, 10
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 15, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 15, 250
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 15, 50
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 22, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 22, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 22, 10
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 22, 150
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 22, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 22, 50
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 29, 0
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 29, 10
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 29, 150
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 29, 50
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 43, 0
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 43, 10
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 43, 150
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 43, 25
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 43, 3+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 43, 50
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 57, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 57, 10
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 57, 150
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 57, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 57, 50
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 85, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 85, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 85, 25
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 85, 50
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 121, +
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 121, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 121, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 121, 10
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 121, 150
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 121, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 277, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Occult blood: Day 277, 50
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Glucose: 6 hours, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Glucose: 12 hours, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Glucose: 12 hours, 9
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Glucose: 72 hours, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Glucose: 168 hours, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Glucose: Day 15, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Glucose: Day 22, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Glucose: Day 22, 5
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Glucose: Day 29, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Glucose: Day 43, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Glucose: Day 57, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Glucose: Day 85, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Glucose: Day 121, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Glucose: Day 277, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Ketones: 6 hours, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Ketones: 12 hours, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Ketones: 12 hours, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Ketones: 72 hours, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Ketones: 72 hours, 0.5
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Ketones: 168 hours, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Ketones: 168 hours, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Ketones: Day 15, 0.5
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Ketones: Day 22, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Ketones: Day 22, 0.5
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Ketones: Day 29, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Ketones: Day 29, 0.5
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Ketones: Day 43, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Ketones: Day 43, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Ketones: Day 43, 1.5
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Ketones: Day 57, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Ketones: Day 57, 0.5
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Ketones: Day 85, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Ketones: Day 85, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Ketones: Day 121, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Ketones: Day 121, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Ketones: Day 277, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Ketones: Day 277, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Nitrite: Day 15, positive
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Protein: 6 hours, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Protein: 12 hours, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Protein: 72 hours, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Protein: 168 hours, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Protein: 168 hours, 0.25
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Protein: 168 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Protein: Day 15, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Protein: Day 15, 0.25
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Protein: Day 22, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Protein: Day 22, 0.25
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Protein: Day 29, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Protein: Day 29, 0.25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Protein: Day 29, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Protein: Day 43, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Protein: Day 43, 0.25
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Protein: Day 57, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Protein: Day 85, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Protein: Day 85, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Protein: Day 121, 0
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Protein: Day 277, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg
Protein: Day 277, 0.25
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 307Population: Safety population. Only those participants with data available at the specified time points were analyzed.
Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: 72 hours, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 22, 50
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 43, 50
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 57, 50
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 307, 10
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Glucose: 12 hours, 9
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Glucose: Day 43, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Glucose: Day 307, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Ketones: Day 85, 0.5
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Protein: Day 29, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Protein: Day 43, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Protein: Day 43, 0.25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Glucose: Day 22, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: 6 hours, +
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: 6 hours, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: 6 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: 6 hours, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: 6 hours, 50
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: 12 hours, +
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: 12 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: 12 hours, 10
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: 12 hours, 150
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: 12 hours, 2+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: 12 hours, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: 12 hours, 50
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: 72 hours, +
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: 72 hours, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: 72 hours, 150
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: 72 hours, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: 168 hours, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: 168 hours, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: 168 hours, 150
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: 168 hours, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: 168 hours, 250
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 15, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 15, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 15, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 15, 250
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 15, 50
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 22, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 22, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 22, 10
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 22, 150
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 22, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 29, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 29, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 29, 150
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 29, 50
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 43, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 43, 10
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 43, 150
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 43, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 43, 3+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 57, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 57, 10
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 57, 150
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 57, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 85, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 85, 10
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 85, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 85, 50
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 121, +
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 121, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 121, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 121, 10
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 121, 150
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 121, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 307, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 307, 25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Occult blood: Day 307, 50
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Glucose: 6 hours, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Glucose: 12 hours, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Glucose: 72 hours, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Glucose: 168 hours, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Glucose: Day 15, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Glucose: Day 22, 5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Glucose: Day 29, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Glucose: Day 57, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Glucose: Day 85, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Glucose: Day 121, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Ketones: 6 hours, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Ketones: 12 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Ketones: 12 hours, 0.5
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Ketones: 72 hours, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Ketones: 72 hours, 0.5
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Ketones: 168 hours, 0
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Ketones: 168 hours, 0.5
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Ketones: Day 15, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Ketones: Day 15, 0.5
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Ketones: Day 22, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Ketones: Day 22, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Ketones: Day 29, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Ketones: Day 29, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Ketones: Day 43, 0
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Ketones: Day 43, 0.5
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Ketones: Day 43, 1.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Ketones: Day 57, 0
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Ketones: Day 57, 0.5
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Ketones: Day 85, 0
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Ketones: Day 121, 0
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Ketones: Day 121, 0.5
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Ketones: Day 307, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Ketones: Day 307, 0.5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Nitrite: Day 15, positive
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Protein: 6 hours, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Protein: 12 hours, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Protein: 72 hours, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Protein: 168 hours, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Protein: 168 hours, 0.25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Protein: 168 hours, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Protein: Day 15, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Protein: Day 15, 0.25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Protein: Day 22, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Protein: Day 22, 0.25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Protein: Day 29, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Protein: Day 29, 0.25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Protein: Day 57, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Protein: Day 85, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Protein: Day 85, 0.25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Protein: Day 85, 1+
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Protein: Day 121, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Protein: Day 307, 0
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg
Protein: Day 307, 0.25
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Days 4, 8, 15 and 22 post-dosePopulation: Safety population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
The induration diameter by challenge site is defined as the average of the two skin response test values (vertical and horizontal) at each challenge site. A challenge site is defined by skin response (SR) directionality (upper/lower) and SR laterality (left/right). Four categories considered were as follows: left upper, right upper, left lower and right lower. Baseline was considered as Day -26. Change from Baseline was calculated as post-Baseline value minus Baseline value. Data is presented for DTH participants.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline (PPD First Challenge) of Induration Diameter From Re-challenge at 3 Days Post-dose
Day 4: Right upper average (n=6,6)
|
6.500 Millimeter (mm)
Standard Deviation 4.3359
|
2.000 Millimeter (mm)
Standard Deviation 4.2426
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline (PPD First Challenge) of Induration Diameter From Re-challenge at 3 Days Post-dose
Day 4: Left upper average (n=6,6)
|
6.500 Millimeter (mm)
Standard Deviation 4.5497
|
3.167 Millimeter (mm)
Standard Deviation 1.8886
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline (PPD First Challenge) of Induration Diameter From Re-challenge at 3 Days Post-dose
Day 8: Left upper average (n=5,3)
|
2.167 Millimeter (mm)
Standard Deviation 5.0083
|
0.300 Millimeter (mm)
Standard Deviation 4.4805
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline (PPD First Challenge) of Induration Diameter From Re-challenge at 3 Days Post-dose
Day 8: Right upper average (n=6,5)
|
-0.700 Millimeter (mm)
Standard Deviation 4.2367
|
-0.917 Millimeter (mm)
Standard Deviation 7.8065
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline (PPD First Challenge) of Induration Diameter From Re-challenge at 3 Days Post-dose
Day 15: Left upper average (n=5,3)
|
-3.333 Millimeter (mm)
Standard Deviation 7.2342
|
-7.500 Millimeter (mm)
Standard Deviation 10.9430
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline (PPD First Challenge) of Induration Diameter From Re-challenge at 3 Days Post-dose
Day 15: Right upper average (n=6,5)
|
-5.800 Millimeter (mm)
Standard Deviation 2.9283
|
-9.000 Millimeter (mm)
Standard Deviation 9.8894
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline (PPD First Challenge) of Induration Diameter From Re-challenge at 3 Days Post-dose
Day 22: Left upper average (n=5,3)
|
-11.833 Millimeter (mm)
Standard Deviation 7.1122
|
-11.600 Millimeter (mm)
Standard Deviation 8.9121
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline (PPD First Challenge) of Induration Diameter From Re-challenge at 3 Days Post-dose
Day 22: Right upper average (n=6,5)
|
-8.900 Millimeter (mm)
Standard Deviation 9.7877
|
-14.083 Millimeter (mm)
Standard Deviation 10.4231
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 28 days post-dosePopulation: Safety population.
The duration of induration was the time (in days) to achieve an overall induration less than 6 mm from the time of the PPD re-challenge post-dose. Duration of induration was calculated as: PPD re-challenge post-dose up to the last available induration measurement. Data is presented for DTH participants.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Induration in the Re-challenge for DTH
|
20.0 Days
Interval 13.0 to 21.0
|
20.0 Days
Interval 13.0 to 22.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 72 hours post-dosePopulation: Safety population.
A punch biopsy was taken from one of the challenge sites. Cells in biopsies of re-challenged skin were measured by immunohistochemistry (IHC) and the LAG-3+ cells characterized and counted. Baseline was considered as Day -26 for this outcome measure. Change from Baseline was calculated as post-Baseline value minus Baseline value. Data is presented for DTH participants.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline (PPD First Challenge) of Lymphocyte Activation Gene-3 (LAG-3)+ Cells in Biopsies of Re-challenged Skin at 3 Days Post-dose
|
19.7 LAG3+ cells
Standard Deviation 18.10
|
15.3 LAG3+ cells
Standard Deviation 24.90
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 29Population: Safety population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
A punch biopsy was taken from active leading edge of the lesion. Cells in lesional biopsies of skin were measured by IHC and count the LAG-3+ cells. The regions of interest for LAG3+ were located in epidermis and dermis. Baseline was considered as the latest pre-dose assessment with a non-missing value for Day -1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=9 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in LAG-3+ Cells in Lesional Biopsies in Psoriasis Participants at Day 29
Skin: Dermis (n=6,4,3,4)
|
-2.5 LAG3+ cells
Standard Deviation 3.70
|
2.7 LAG3+ cells
Standard Deviation 6.09
|
0.3 LAG3+ cells
Standard Deviation 2.08
|
-2.5 LAG3+ cells
Standard Deviation 2.38
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in LAG-3+ Cells in Lesional Biopsies in Psoriasis Participants at Day 29
Skin: Epidermis (n=6,4,4,5)
|
-9.8 LAG3+ cells
Standard Deviation 15.11
|
-1.2 LAG3+ cells
Standard Deviation 12.86
|
-6.5 LAG3+ cells
Standard Deviation 6.45
|
-5.0 LAG3+ cells
Standard Deviation 6.89
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dosePopulation: PK population. Data were not analyzed for AUC(0-infinity) as there were not enough data points collected for a terminal slope required to calculate AUC(0-infinity).
Blood samples were collected at specified time points for GSK2831781 in plasma. Pharmacokinetic (PK) population consisted of all participants in the Safety Population who had at least 1 non-missing PK assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dosePopulation: PK population. Data were not analyzed for AUC(0-infinity) as there were not enough data points collected for a terminal slope required to calculate AUC(0-infinity).
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dosePopulation: PK population. Data were not analyzed for AUC(0-infinity) as there were not enough data points collected for a terminal slope required to calculate AUC(0-infinity).
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dosePopulation: PK population. Data were not analyzed for AUC(0-infinity) as there were not enough data points collected for a terminal slope required to calculate AUC(0-infinity).
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dosePopulation: PK population. Data were not analyzed for AUC(0-infinity) as there were not enough data points collected for a terminal slope required to calculate AUC(0-infinity).
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dosePopulation: PK population. Data were not analyzed for AUC(0-infinity) as there were not enough data points collected for a terminal slope required to calculate AUC(0-infinity).
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dosePopulation: PK population. Data were not analyzed for AUC(0-infinity) as there were not enough data points collected for a terminal slope required to calculate AUC(0-infinity).
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dosePopulation: PK population. Data were not analyzed for AUC(0-infinity) as there were not enough data points collected for a terminal slope required to calculate AUC(0-infinity).
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dosePopulation: PK population. Data was not collected because none of the participants had data evaluable for this measure.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=1 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC(0-t) for GSK2831781 0.0015 mg/kg (ADA-ve)
|
—
|
0.0060 h*mcg/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for one participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC(0-t) for GSK2831781 0.0075 mg/kg (ADA-ve)
|
—
|
1.3497 h*mcg/mL
Geometric Coefficient of Variation 31.95218
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC(0-t) for GSK2831781 0.04 mg/kg (ADA-ve)
|
—
|
23.6008 h*mcg/mL
Geometric Coefficient of Variation 27.26266
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC(0-t) for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)
|
238.1434 h*mcg/mL
Geometric Coefficient of Variation 43.68332
|
168.3458 h*mcg/mL
Geometric Coefficient of Variation 18.00654
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC(0-t) for GSK2831781 0.5 mg/kg
|
—
|
1187.8496 h*mcg/mL
Geometric Coefficient of Variation 34.15549
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC(0-t) for GSK2831781 1.5 mg/kg
|
—
|
8493.7344 h*mcg/mL
Geometric Coefficient of Variation 13.62279
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC(0-t) for GSK2831781 5 mg/kg
|
—
|
40599.8938 h*mcg/mL
Geometric Coefficient of Variation 23.74167
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24 and 696 (Week 4) hours post-dosePopulation: PK population. Data was not collected because none of the participants had data evaluable for this measure.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 696 (Week 4) hours post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=1 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC(0-Week 4) for GSK2831781 0.0015 mg/kg (ADA-ve)
|
—
|
NA h*mcg/mL
Geometric Coefficient of Variation NA
As per predefined analysis plan,AUC(0-Week4) was not derived:concentrations dropped below limit of quantification before Week4, extrapolation was not possible as half-life could not be derived.Instead,AUC(0-t) describe total exposure in terms of AUC.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15 and 29 (Week 4) post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC(0-Week 4) for GSK2831781 0.0075 mg/kg (ADA-ve)
|
—
|
NA h*mcg/mL
Geometric Coefficient of Variation NA
As per predefined analysis plan,AUC(0-Week4) was not derived:concentrations dropped below limit of quantification before Week4, extrapolation was not possible as half-life could not be derived.Instead,AUC(0-t) describe total exposure in terms of AUC.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22 and 29 (Week 4) post-dosePopulation: PK population.
Blood samples were collected at specified time point for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC(0-Week 4) for GSK2831781 0.04 mg/kg (ADA-ve)
|
—
|
NA h*mcg/mL
Geometric Coefficient of Variation NA
As per predefined analysis plan,AUC(0-Week4) was not derived:concentrations dropped below limit of quantification before Week4, extrapolation was not possible as half-life could not be derived.Instead,AUC(0-t) describe total exposure in terms of AUC.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22 and 29 (Week 4) post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC(0-Week 4) for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)
|
NA h*mcg/mL
Geometric Coefficient of Variation NA
As per predefined analysis plan,AUC(0-Week4) was not derived:concentrations dropped below limit of quantification before Week4, extrapolation was not possible as half-life could not be derived.Instead,AUC(0-t) describe total exposure in terms of AUC.
|
NA h*mcg/mL
Geometric Coefficient of Variation NA
As per predefined analysis plan,AUC(0-Week4) was not derived:concentrations dropped below limit of quantification before Week4, extrapolation was not possible as half-life could not be derived.Instead,AUC(0-t) describe total exposure in terms of AUC.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22 and 29 (Week 4) post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC(0-Week 4) for GSK2831781 0.5 mg/kg
|
—
|
NA h*mcg/mL
Geometric Coefficient of Variation NA
As per predefined analysis plan,AUC(0-Week4) was not derived:concentrations dropped below limit of quantification before Week4, extrapolation was not possible as half-life could not be derived.Instead,AUC(0-t) describe total exposure in terms of AUC.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22 and 29 (Week 4) post-dosePopulation: PK population.
Blood samples were collected at specified time point for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC(0-Week 4) for GSK2831781 1.5 mg/kg
|
—
|
NA h*mcg/mL
Geometric Coefficient of Variation NA
As per predefined analysis plan,AUC(0-Week4) was not derived:concentrations dropped below limit of quantification before Week4, extrapolation was not possible as half-life could not be derived.Instead,AUC(0-t) describe total exposure in terms of AUC.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22 and 29 (Week 4) post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC(0-Week 4) for GSK2831781 5 mg/kg
|
—
|
NA h*mcg/mL
Geometric Coefficient of Variation NA
As per predefined analysis plan,AUC(0-Week4) was not derived:concentrations dropped below limit of quantification before Week4, extrapolation was not possible as half-life could not be derived.Instead,AUC(0-t) describe total exposure in terms of AUC.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dosePopulation: PK population. Data were not analyzed for %AUCex as there were not enough data points collected for a terminal slope required to calculate %AUCex.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dosePopulation: PK population. Data were not analyzed for %AUCex as there were not enough data points collected for a terminal slope required to calculate %AUCex.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dosePopulation: PK population. Data were not analyzed for %AUCex as there were not enough data points collected for a terminal slope required to calculate %AUCex.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dosePopulation: PK population. Data were not analyzed for %AUCex as there were not enough data points collected for a terminal slope required to calculate %AUCex.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dosePopulation: PK population. Data were not analyzed for %AUCex as there were not enough data points collected for a terminal slope required to calculate %AUCex.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dosePopulation: PK population. Data were not analyzed for %AUCex as there were not enough data points collected for a terminal slope required to calculate %AUCex.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dosePopulation: PK population. Data were not analyzed for %AUCex as there were not enough data points collected for a terminal slope required to calculate %AUCex.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dosePopulation: PK population. Data were not analyzed for %AUCex as there were not enough data points collected for a terminal slope required to calculate %AUCex.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=1 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) for GSK2831781 0.0003 mg/kg (ADA-ve)
|
—
|
NA mcg/mL
Geometric Coefficient of Variation NA
Data could not be analyzed because data was below the limit of quantitation.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=1 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax for GSK2831781 0.0015 mg/kg (ADA-ve)
|
—
|
0.0127 mcg/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for one participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax for GSK2831781 0.0075 mg/kg (ADA-ve)
|
—
|
0.1523 mcg/mL
Geometric Coefficient of Variation 19.07315
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax for GSK2831781 0.04 mg/kg (ADA-ve)
|
—
|
0.8196 mcg/mL
Geometric Coefficient of Variation 25.57947
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)
|
3.4255 mcg/mL
Geometric Coefficient of Variation 18.07808
|
3.0047 mcg/mL
Geometric Coefficient of Variation 17.41022
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax for GSK2831781 0.5 mg/kg
|
—
|
8.4810 mcg/mL
Geometric Coefficient of Variation 23.51712
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax for GSK2831781 1.5 mg/kg
|
—
|
41.1481 mcg/mL
Geometric Coefficient of Variation 15.53659
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax for GSK2831781 5 mg/kg
|
—
|
158.8243 mcg/mL
Geometric Coefficient of Variation 22.22170
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=1 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time of Occurrence of Cmax (Tmax) for GSK2831781 0.0003 mg/kg (ADA-ve)
|
—
|
NA Hours
Data could not be analyzed because data was below the limit of quantitation.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=1 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax for GSK2831781 0.0015 mg/kg (ADA-ve)
|
—
|
1.950 Hours
Interval 1.95 to 1.95
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax for GSK2831781 0.0075 mg/kg (ADA-ve)
|
—
|
1.950 Hours
Interval 1.87 to 3.98
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax for GSK2831781 0.04 mg/kg (ADA-ve)
|
—
|
4.025 Hours
Interval 1.9 to 11.98
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)
|
4.990 Hours
Interval 1.95 to 8.07
|
1.980 Hours
Interval 1.87 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax for GSK2831781 0.5 mg/kg
|
—
|
3.930 Hours
Interval 1.95 to 8.02
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax for GSK2831781 1.5 mg/kg
|
—
|
1.990 Hours
Interval 1.93 to 4.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax for GSK2831781 5 mg/kg
|
—
|
2.975 Hours
Interval 1.95 to 71.82
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dosePopulation: PK population. Data was not collected because none of the participants had data evaluable for this measure.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=1 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tlast for GSK2831781 0.0015 mg/kg (ADA-ve)
|
—
|
1.950 Hours
Interval 1.95 to 1.95
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tlast for GSK2831781 0.0075 mg/kg (ADA-ve)
|
—
|
18.005 Hours
Interval 12.02 to 24.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tlast for GSK2831781 0.04 mg/kg (ADA-ve)
|
—
|
72.065 Hours
Interval 47.92 to 72.38
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tlast for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)
|
288.235 Hours
Interval 144.1 to 407.68
|
238.750 Hours
Interval 165.0 to 241.02
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tlast for GSK2831781 0.5 mg/kg
|
—
|
468.655 Hours
Interval 314.0 to 507.07
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tlast for GSK2831781 1.5 mg/kg
|
—
|
1343.930 Hours
Interval 1003.55 to 1345.02
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dosePopulation: PK population.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tlast for GSK2831781 5 mg/kg
|
—
|
2016.050 Hours
Interval 1677.67 to 2042.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dosePopulation: PK population. Data were not analyzed for CL as there were not enough data points collected for a terminal slope required to calculate CL.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dosePopulation: PK population. Data were not analyzed for CL as there were not enough data points collected for a terminal slope required to calculate CL.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dosePopulation: PK population. Data were not analyzed for CL as there were not enough data points collected for a terminal slope required to calculate CL.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dosePopulation: PK population. Data were not analyzed for CL as there were not enough data points collected for a terminal slope required to calculate CL.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dosePopulation: PK population. Data were not analyzed for CL as there were not enough data points collected for a terminal slope required to calculate CL.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dosePopulation: PK population. Data were not analyzed for CL as there were not enough data points collected for a terminal slope required to calculate CL.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dosePopulation: PK population. Data were not analyzed for CL as there were not enough data points collected for a terminal slope required to calculate CL.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dosePopulation: PK population. Data were not analyzed for CL as there were not enough data points collected for a terminal slope required to calculate CL.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dosePopulation: PK population. Data were not analyzed for Vss as there were not enough data points collected for a terminal slope required to calculate Vss.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dosePopulation: PK population. Data were not analyzed for Vss as there were not enough data points collected for a terminal slope required to calculate Vss.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dosePopulation: PK population. Data were not analyzed for Vss as there were not enough data points collected for a terminal slope required to calculate Vss.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dosePopulation: PK population. Data were not analyzed for Vss as there were not enough data points collected for a terminal slope required to calculate Vss.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dosePopulation: PK population. Data were not analyzed for Vss as there were not enough data points collected for a terminal slope required to calculate Vss.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dosePopulation: PK population. Data were not analyzed for Vss as there were not enough data points collected for a terminal slope required to calculate Vss.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dosePopulation: PK population. Data were not analyzed for Vss as there were not enough data points collected for a terminal slope required to calculate Vss.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dosePopulation: PK population. Data were not analyzed for Vss as there were not enough data points collected for a terminal slope required to calculate Vss.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dosePopulation: PK population. Data were not analyzed for MRT as there were not enough data points collected for a terminal slope required to calculate MRT.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dosePopulation: PK population. Data were not analyzed for MRT as there were not enough data points collected for a terminal slope required to calculate MRT.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dosePopulation: PK population. Data were not analyzed for MRT as there were not enough data points collected for a terminal slope required to calculate MRT.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dosePopulation: PK population. Data were not analyzed for MRT as there were not enough data points collected for a terminal slope required to calculate MRT.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dosePopulation: PK population. Data were not analyzed for MRT as there were not enough data points collected for a terminal slope required to calculate MRT.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dosePopulation: PK population. Data were not analyzed for MRT as there were not enough data points collected for a terminal slope required to calculate MRT.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dosePopulation: PK population. Data were not analyzed for MRT as there were not enough data points collected for a terminal slope required to calculate MRT.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dosePopulation: PK population. Data were not analyzed for MRT as there were not enough data points collected for a terminal slope required to calculate MRT.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dosePopulation: PK population. Data were not analyzed for lambda z as there were not enough data points collected for a terminal slope required to calculate lambda z.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dosePopulation: PK population. Data were not analyzed for lambda z as there were not enough data points collected for a terminal slope required to calculate lambda z.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dosePopulation: PK population. Data were not analyzed for lambda z as there were not enough data points collected for a terminal slope required to calculate lambda z.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dosePopulation: PK population. Data were not analyzed for lambda z as there were not enough data points collected for a terminal slope required to calculate lambda z.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dosePopulation: PK population. Data were not analyzed for lambda z as there were not enough data points collected for a terminal slope required to calculate lambda z.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dosePopulation: PK population. Data were not analyzed for lambda z as there were not enough data points collected for a terminal slope required to calculate lambda z.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dosePopulation: PK population. Data were not analyzed for lambda z as there were not enough data points collected for a terminal slope required to calculate lambda z.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dosePopulation: PK population. Data were not analyzed for lambda z as there were not enough data points collected for a terminal slope required to calculate lambda z.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dosePopulation: PK population. Data were not analyzed for t1/2 as there were not enough data points collected for a terminal slope required to calculate t1/2.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dosePopulation: PK population. Data were not analyzed for t1/2 as there were not enough data points collected for a terminal slope required to calculate t1/2.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dosePopulation: PK population. Data were not analyzed for t1/2 as there were not enough data points collected for a terminal slope required to calculate t1/2.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dosePopulation: PK population. Data were not analyzed for t1/2 as there were not enough data points collected for a terminal slope required to calculate t1/2.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dosePopulation: PK population. Data were not analyzed for t1/2 as there were not enough data points collected for a terminal slope required to calculate t1/2.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dosePopulation: PK population. Data were not analyzed for t1/2 as there were not enough data points collected for a terminal slope required to calculate t1/2.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dosePopulation: PK population. Data were not analyzed for t1/2 as there were not enough data points collected for a terminal slope required to calculate t1/2.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dosePopulation: PK population. Data were not analyzed for t1/2 as there were not enough data points collected for a terminal slope required to calculate t1/2.
Blood samples were collected at specified time points for GSK2831781 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 191)Population: Safety population.
Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=14 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive ADAs to GSK2831781 in Healthy Volunteer Placebo
Pre-dose
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 in Healthy Volunteer Placebo
168 hours
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 in Healthy Volunteer Placebo
Day 29
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 in Healthy Volunteer Placebo
Day 85
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 in Healthy Volunteer Placebo
Follow-up (Day 191)
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1), 168 hours, and follow-up (Day 29)Population: Safety population.
Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=1 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive ADAs to GSK2831781 0.0003 mg/kg (ADA-ve)
Pre-dose
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 0.0003 mg/kg (ADA-ve)
168 hours
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 0.0003 mg/kg (ADA-ve)
Follow-up (Day 29)
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1), 168 hours, Days 29 and follow-up (Day 43)Population: Safety population.
Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=1 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive ADAs to GSK2831781 0.0015 mg/kg (ADA-ve)
Pre-dose
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 0.0015 mg/kg (ADA-ve)
168 hours
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 0.0015 mg/kg (ADA-ve)
Day 29
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 0.0015 mg/kg (ADA-ve)
Follow-up (Day 43)
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1), 168 hours, Days 29 and follow-up (Day 85)Population: Safety population.
Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive ADAs to GSK2831781 0.0075 mg/kg (ADA-ve)
Pre-dose
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 0.0075 mg/kg (ADA-ve)
168 hours
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 0.0075 mg/kg (ADA-ve)
Day 29
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 0.0075 mg/kg (ADA-ve)
Follow-up (Day 85)
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 147)Population: Safety population.
Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive ADAs to GSK2831781 0.04 mg/kg (ADA-ve)
Pre-dose
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 0.04 mg/kg (ADA-ve)
168 hours
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 0.04 mg/kg (ADA-ve)
Day 29
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 0.04 mg/kg (ADA-ve)
Day 85
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 0.04 mg/kg (ADA-ve)
Follow-up (Day 147)
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 219)Population: Safety population.
Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive ADAs to GSK2831781 0.15 mg/kg (ADA-ve)
Pre-dose
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 0.15 mg/kg (ADA-ve)
168 hours
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 0.15 mg/kg (ADA-ve)
Day 29
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 0.15 mg/kg (ADA-ve)
Day 85
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 0.15 mg/kg (ADA-ve)
Follow-up (Day 219)
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 191)Population: Safety population.
Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive ADAs to GSK2831781 0.15 mg/kg (ADA+ve)
Pre-dose
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 0.15 mg/kg (ADA+ve)
168 hours
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 0.15 mg/kg (ADA+ve)
Day 29
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 0.15 mg/kg (ADA+ve)
Day 85
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 0.15 mg/kg (ADA+ve)
Follow-up (Day 191)
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 307)Population: Safety population.
Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=9 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive ADAs to GSK2831781 Placebo in Psoriasis Participants
Pre-dose
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 Placebo in Psoriasis Participants
168 hours
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 Placebo in Psoriasis Participants
Day 29
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 Placebo in Psoriasis Participants
Day 85
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 Placebo in Psoriasis Participants
Follow-up (Day 307)
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 237)Population: Safety population.
Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive ADAs to GSK2831781 0.5 mg/kg
Pre-dose
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 0.5 mg/kg
168 hours
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 0.5 mg/kg
Day 29
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 0.5 mg/kg
Day 85
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 0.5 mg/kg
Follow-up (Day 237)
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 277)Population: Safety population.
Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive ADAs to GSK2831781 1.5 mg/kg
Pre-dose
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 1.5 mg/kg
168 hours
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 1.5 mg/kg
Day 29
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 1.5 mg/kg
Day 85
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 1.5 mg/kg
Follow-up (Day 277)
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 307)Population: Safety population.
Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=6 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive ADAs to GSK2831781 5 mg/kg
Pre-dose
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 5 mg/kg
168 hours
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 5 mg/kg
Day 29
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 5 mg/kg
Day 85
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADAs to GSK2831781 5 mg/kg
Follow-up (Day 307)
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Days 15, 29, 43, 85 and 121Population: Safety population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
PASI score was determined by evaluation of body surface area (BSA) covered by plaque psoriasis in 4 areas (head, upper extremities, trunk and lower extremities with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged from 0=No symptoms, 1=slight, 2=moderate, 3=marked and 4=very marked) of erythema, induration and scaling in each of the 4 areas. PASI score ranges from 0 (no psoriasis) to 72 (worse psoriasis). Final PASI=(sum of severity score for each area) \* (% body area affected score \* area score). Baseline was considered as the latest pre-dose assessment with a non-missing value for Day -1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=9 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Psoriasis Area Severity Index (PASI) Scores
Day 85 (n=6,0,6,6)
|
—
|
-1.0 Scores on a scale
Standard Deviation 6.09
|
1.2 Scores on a scale
Standard Deviation 3.75
|
-3.3 Scores on a scale
Standard Deviation 2.55
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Psoriasis Area Severity Index (PASI) Scores
Day 15 (n=9,6,6,6)
|
-1.7 Scores on a scale
Standard Deviation 2.43
|
-0.7 Scores on a scale
Standard Deviation 2.66
|
-2.4 Scores on a scale
Standard Deviation 2.56
|
-2.7 Scores on a scale
Standard Deviation 2.54
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Psoriasis Area Severity Index (PASI) Scores
Day 29 (n=9,6,6,6)
|
-1.8 Scores on a scale
Standard Deviation 2.25
|
-0.5 Scores on a scale
Standard Deviation 3.09
|
-3.3 Scores on a scale
Standard Deviation 4.53
|
-3.5 Scores on a scale
Standard Deviation 2.93
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Psoriasis Area Severity Index (PASI) Scores
Day 43 (n=9,6,6,6)
|
-1.6 Scores on a scale
Standard Deviation 2.40
|
-1.7 Scores on a scale
Standard Deviation 4.12
|
-3.8 Scores on a scale
Standard Deviation 4.36
|
-3.7 Scores on a scale
Standard Deviation 2.66
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Psoriasis Area Severity Index (PASI) Scores
Day 121 (n=9,6,6,6)
|
-0.5 Scores on a scale
Standard Deviation 2.44
|
-0.6 Scores on a scale
Standard Deviation 3.03
|
1.2 Scores on a scale
Standard Deviation 5.83
|
-2.7 Scores on a scale
Standard Deviation 2.21
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Days 15, 29, 43, 85 and 121Population: Safety population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head, upper extremities, trunk and lower extremities with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged from 0=No symptoms, 1=slight, 2=moderate, 3=marked and 4=very marked) of erythema, induration and scaling in each of the 4 areas. PASI score ranges from 0 (no psoriasis) to 72 (worse psoriasis). Final PASI=(sum of severity score for each area) \* (% body area affected score \* area score).
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=9 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Actual PASI Scores
Day 29 (n=9,6,6,6)
|
5.0 Scores on a scale
Standard Deviation 2.82
|
9.8 Scores on a scale
Standard Deviation 4.17
|
10.8 Scores on a scale
Standard Deviation 4.14
|
5.7 Scores on a scale
Standard Deviation 2.54
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Actual PASI Scores
Day 43 (n=9,6,6,6)
|
5.2 Scores on a scale
Standard Deviation 2.71
|
8.6 Scores on a scale
Standard Deviation 3.79
|
10.4 Scores on a scale
Standard Deviation 4.06
|
5.5 Scores on a scale
Standard Deviation 2.20
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Actual PASI Scores
Day 121 (n=9,6,6,6)
|
6.3 Scores on a scale
Standard Deviation 3.00
|
9.8 Scores on a scale
Standard Deviation 5.20
|
15.4 Scores on a scale
Standard Deviation 8.59
|
6.5 Scores on a scale
Standard Deviation 3.76
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Actual PASI Scores
Baseline (n=9,6,6,6)
|
6.8 Scores on a scale
Standard Deviation 2.40
|
10.3 Scores on a scale
Standard Deviation 4.52
|
14.1 Scores on a scale
Standard Deviation 6.55
|
9.2 Scores on a scale
Standard Deviation 4.09
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Actual PASI Scores
Day 15 (n=9,6,6,6)
|
5.1 Scores on a scale
Standard Deviation 2.84
|
9.6 Scores on a scale
Standard Deviation 3.92
|
11.7 Scores on a scale
Standard Deviation 5.67
|
6.5 Scores on a scale
Standard Deviation 2.98
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Actual PASI Scores
Day 85 (n=6,0,6,6)
|
—
|
9.4 Scores on a scale
Standard Deviation 5.94
|
15.4 Scores on a scale
Standard Deviation 6.73
|
5.9 Scores on a scale
Standard Deviation 2.39
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Days 15, 29, 43, 85 and 121Population: Safety population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head, upper extremities, trunk and lower extremities with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged from 0=No symptoms, 1=slight, 2=moderate, 3=marked and 4=very marked) of erythema, induration and scaling in each of the 4 areas. PASI score ranges from 0 (no psoriasis) to 72 (worse psoriasis). Final PASI=(sum of severity score for each area) \* (% body area affected score \* area score). Baseline was considered as the latest pre-dose assessment with a non-missing value for Day -1.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=9 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score
PASI 50: Day 29 (n=9,6,6,6)
|
33 Percentage of participants
|
0 Percentage of participants
|
17 Percentage of participants
|
17 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score
PASI 75: Day 85 (n=6,0,6,6)
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score
PASI 50: Day 15 (n=9,6,6,6)
|
17 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
17 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score
PASI 50: Day 43 (n=9,6,6,6)
|
33 Percentage of participants
|
11 Percentage of participants
|
17 Percentage of participants
|
33 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score
PASI 50: Day 85 (n=6,0,6,6)
|
—
|
17 Percentage of participants
|
0 Percentage of participants
|
17 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score
PASI 50: Day 121 (n=9,6,6,6)
|
17 Percentage of participants
|
11 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score
PASI 75: Day 15 (n=9,6,6,6)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score
PASI 75: Day 29 (n=9,6,6,6)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score
PASI 75: Day 43 (n=9,6,6,6)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score
PASI 75: Day 121 (n=9,6,6,6)
|
17 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Days 15, 29, 43, 85 and 121Population: Safety population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
PLSS is a 0 to 12 point rating scale for lesions, calculated as the sum of the scores (ranging from 0 = no symptoms to 4 = very marked) for 3 symptoms: induration, erythema and scaling, measured by a qualified dermatologist. The PLSS score for the Index Plaque ranged from 0 to 12. The score 0 indicated no symptoms and 12 is the worst score. Baseline was considered as the latest pre-dose assessment with a non-missing value for Day -1. Change from Baseline was calculated as post-Baseline value minus Baseline value. A negative change from Baseline is an improvement in symptoms.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=9 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plaque Lesional Severity Score (PLSS) Scores for the Index Plaque
Day 15 (n=9,6,6,6)
|
-1.3 Scores on a scale
Standard Deviation 1.03
|
-0.6 Scores on a scale
Standard Deviation 1.24
|
-1.8 Scores on a scale
Standard Deviation 1.47
|
-1.7 Scores on a scale
Standard Deviation 1.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Plaque Lesional Severity Score (PLSS) Scores for the Index Plaque
Day 29 (n=9,6,6,6)
|
-2.2 Scores on a scale
Standard Deviation 1.33
|
-0.2 Scores on a scale
Standard Deviation 1.79
|
-1.8 Scores on a scale
Standard Deviation 1.47
|
-2.0 Scores on a scale
Standard Deviation 0.89
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Plaque Lesional Severity Score (PLSS) Scores for the Index Plaque
Day 43 (n=9,6,6,6)
|
-1.8 Scores on a scale
Standard Deviation 1.17
|
-0.7 Scores on a scale
Standard Deviation 2.00
|
-1.8 Scores on a scale
Standard Deviation 1.47
|
-1.8 Scores on a scale
Standard Deviation 1.17
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Plaque Lesional Severity Score (PLSS) Scores for the Index Plaque
Day 85 (n=6,0,6,6)
|
—
|
-1.7 Scores on a scale
Standard Deviation 2.42
|
-1.2 Scores on a scale
Standard Deviation 2.04
|
-1.5 Scores on a scale
Standard Deviation 1.64
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Plaque Lesional Severity Score (PLSS) Scores for the Index Plaque
Day 121 (n=9,6,6,6)
|
-0.5 Scores on a scale
Standard Deviation 1.38
|
-0.9 Scores on a scale
Standard Deviation 2.42
|
-1.2 Scores on a scale
Standard Deviation 2.64
|
-0.7 Scores on a scale
Standard Deviation 1.63
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Days 15, 29, 43, 85 and 121Population: Safety population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
PLSS is a 0 to 12 point rating scale for lesions, calculated as the sum of the scores (ranging from 0 = no symptoms to 4 = very marked) for 3 symptoms: induration, erythema and scaling, measured by a qualified dermatologist. The PLSS score for the Index Plaque ranged from 0 to 12. The score 0 indicated no symptoms and 12 is the worst score.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=9 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Absolute PLSS Scores for the Index Plaque
Baseline (n=9,6,6,6)
|
6.5 Scores on a scale
Standard Deviation 1.38
|
7.1 Scores on a scale
Standard Deviation 1.05
|
7.7 Scores on a scale
Standard Deviation 1.37
|
6.5 Scores on a scale
Standard Deviation 0.84
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Absolute PLSS Scores for the Index Plaque
Day 15 (n=9,6,6,6)
|
5.2 Scores on a scale
Standard Deviation 1.94
|
6.6 Scores on a scale
Standard Deviation 1.24
|
5.8 Scores on a scale
Standard Deviation 1.72
|
4.8 Scores on a scale
Standard Deviation 1.33
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Absolute PLSS Scores for the Index Plaque
Day 29 (n=9,6,6,6)
|
4.3 Scores on a scale
Standard Deviation 1.75
|
6.9 Scores on a scale
Standard Deviation 14.62
|
5.8 Scores on a scale
Standard Deviation 1.72
|
4.5 Scores on a scale
Standard Deviation 1.05
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Absolute PLSS Scores for the Index Plaque
Day 43 (n=9,6,6,6)
|
4.7 Scores on a scale
Standard Deviation 1.97
|
6.4 Scores on a scale
Standard Deviation 2.19
|
5.8 Scores on a scale
Standard Deviation 1.72
|
4.7 Scores on a scale
Standard Deviation 1.21
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Absolute PLSS Scores for the Index Plaque
Day 85 (n=6,0,6,6)
|
—
|
5.7 Scores on a scale
Standard Deviation 3.39
|
6.5 Scores on a scale
Standard Deviation 1.05
|
5.0 Scores on a scale
Standard Deviation 1.67
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Absolute PLSS Scores for the Index Plaque
Day 121 (n=9,6,6,6)
|
6.0 Scores on a scale
Standard Deviation 1.41
|
6.2 Scores on a scale
Standard Deviation 2.54
|
6.5 Scores on a scale
Standard Deviation 1.76
|
5.8 Scores on a scale
Standard Deviation 1.17
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Days 15, 29, 43, 85 and 121Population: Safety population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
A 7-point scoring system was used to measure the severity of psoriatic lesions over the whole body. The score 0 indicated as clear: no signs of psoriasis and 6 indicated as severe: very marked plaque elevation, scaling and erythema. Baseline was considered as the latest pre-dose assessment with a non-missing value for Day -1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=9 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Physicians Global Assessment (PGA) Scores in Psoriasis Participants
Day 29 (n=9,6,6,6)
|
-0.5 Scores on a scale
Standard Deviation 0.84
|
-0.3 Scores on a scale
Standard Deviation 1.58
|
-0.5 Scores on a scale
Standard Deviation 1.05
|
-1.3 Scores on a scale
Standard Deviation 1.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Physicians Global Assessment (PGA) Scores in Psoriasis Participants
Day 43 (n=9,6,6,6)
|
0.0 Scores on a scale
Standard Deviation 0.89
|
-0.4 Scores on a scale
Standard Deviation 1.59
|
-0.8 Scores on a scale
Standard Deviation 0.98
|
-1.5 Scores on a scale
Standard Deviation 0.55
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Physicians Global Assessment (PGA) Scores in Psoriasis Participants
Day 15 (n=9,6,6,6)
|
-0.7 Scores on a scale
Standard Deviation 0.82
|
-0.1 Scores on a scale
Standard Deviation 1.05
|
-0.3 Scores on a scale
Standard Deviation 0.82
|
-1.0 Scores on a scale
Standard Deviation 0.63
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Physicians Global Assessment (PGA) Scores in Psoriasis Participants
Day 85 (n=6,0,6,6)
|
—
|
-0.7 Scores on a scale
Standard Deviation 2.07
|
0.0 Scores on a scale
Standard Deviation 0.89
|
-1.5 Scores on a scale
Standard Deviation 0.55
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Physicians Global Assessment (PGA) Scores in Psoriasis Participants
Day 121 (n=9,6,6,6)
|
0.7 Scores on a scale
Standard Deviation 1.75
|
-0.3 Scores on a scale
Standard Deviation 1.50
|
-0.3 Scores on a scale
Standard Deviation 1.21
|
-1.0 Scores on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Days 15, 29, 43, 85 and 121Population: Safety population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
A 7-point scoring system was used to measure the severity of psoriatic lesions over the whole body. The score 0 indicated as clear: no signs of psoriasis and 6 indicated as severe: very marked plaque elevation, scaling and erythema.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=9 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Absolute PGA Scores in Psoriasis Participants
Baseline (n=9,6,6,6)
|
3.2 Scores on a scale
Standard Deviation 0.75
|
4.4 Scores on a scale
Standard Deviation 0.88
|
4.8 Scores on a scale
Standard Deviation 0.75
|
4.2 Scores on a scale
Standard Deviation 0.98
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Absolute PGA Scores in Psoriasis Participants
Day 15 (n=9,6,6,6)
|
2.5 Scores on a scale
Standard Deviation 1.05
|
4.3 Scores on a scale
Standard Deviation 0.71
|
4.5 Scores on a scale
Standard Deviation 1.05
|
3.2 Scores on a scale
Standard Deviation 1.17
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Absolute PGA Scores in Psoriasis Participants
Day 29 (n=9,6,6,6)
|
2.7 Scores on a scale
Standard Deviation 0.82
|
4.1 Scores on a scale
Standard Deviation 1.05
|
4.3 Scores on a scale
Standard Deviation 1.21
|
2.8 Scores on a scale
Standard Deviation 0.75
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Absolute PGA Scores in Psoriasis Participants
Day 43 (n=9,6,6,6)
|
3.2 Scores on a scale
Standard Deviation 0.75
|
4.0 Scores on a scale
Standard Deviation 1.12
|
4.0 Scores on a scale
Standard Deviation 0.89
|
2.7 Scores on a scale
Standard Deviation 0.52
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Absolute PGA Scores in Psoriasis Participants
Day 85 (n=6,0,6,6)
|
—
|
4.0 Scores on a scale
Standard Deviation 1.79
|
4.8 Scores on a scale
Standard Deviation 0.98
|
2.7 Scores on a scale
Standard Deviation 0.52
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Absolute PGA Scores in Psoriasis Participants
Day 121 (n=9,6,6,6)
|
3.8 Scores on a scale
Standard Deviation 1.47
|
4.1 Scores on a scale
Standard Deviation 1.36
|
4.5 Scores on a scale
Standard Deviation 1.38
|
3.2 Scores on a scale
Standard Deviation 0.98
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Days 15, 29, 43, 85 and 121Population: Safety population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
A 7-point scoring system was used to measure the severity of psoriatic lesions over the whole body. The score 0=clear, 1=almost clear, 2=mild, 3=mild to moderate, 4=moderate, 5=moderate to severe and 6=severe.
Outcome measures
| Measure |
GSK2831781 0.15 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
Placebo for Healthy Volunteer
n=9 Participants
Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
n=6 Participants
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants in Each PGA Score Category
Baseline:Almost clear(n=9,6,6,6)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Baseline:Mild (n=9,6,6,6)
|
17 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Baseline:Mild to moderate(n=9,6,6,6)
|
50 Percentage of participants
|
11 Percentage of participants
|
0 Percentage of participants
|
33 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Baseline:Severe (n=9,6,6,6)
|
0 Percentage of participants
|
11 Percentage of participants
|
17 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Day15:Almost clear(n=9,6,6,6)
|
17 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Day15:Mild to moderate(n=9,6,6,6)
|
33 Percentage of participants
|
11 Percentage of participants
|
17 Percentage of participants
|
33 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Day15:Moderate (n=9,6,6,6)
|
17 Percentage of participants
|
44 Percentage of participants
|
33 Percentage of participants
|
17 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Day15:Moderate to severe(n=9,6,6,6)
|
0 Percentage of participants
|
44 Percentage of participants
|
33 Percentage of participants
|
17 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Day29:Mild (n=9,6,6,6)
|
50 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
33 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Day29:Mild to moderate(n=9,6,6,6)
|
33 Percentage of participants
|
33 Percentage of participants
|
33 Percentage of participants
|
50 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Day29:Moderate (n=9,6,6,6)
|
17 Percentage of participants
|
33 Percentage of participants
|
17 Percentage of participants
|
17 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Day43:Almost clear(n=9,6,6,6)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Day43:Mild (n=9,6,6,6)
|
17 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
33 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Day121:Moderate to severe(n=9,6,6,6)
|
33 Percentage of participants
|
56 Percentage of participants
|
17 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Day121:Severe (n=9,6,6,6)
|
0 Percentage of participants
|
0 Percentage of participants
|
33 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Day43:Mild to moderate(n=9,6,6,6)
|
50 Percentage of participants
|
44 Percentage of participants
|
33 Percentage of participants
|
67 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Day43:Moderate (n=9,6,6,6)
|
33 Percentage of participants
|
22 Percentage of participants
|
33 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Day43:Moderate to severe(n=9,6,6,6)
|
0 Percentage of participants
|
22 Percentage of participants
|
33 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Day43:Severe (n=9,6,6,6)
|
0 Percentage of participants
|
11 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Day85:Almost clear(n=6,0,6,6)
|
—
|
17 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Day85:Mild (n=6,0,6,6)
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
33 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Day85:Mild to moderate(n=6,0,6,6)
|
—
|
17 Percentage of participants
|
0 Percentage of participants
|
67 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Day85:Moderate (n=6,0,6,6)
|
—
|
17 Percentage of participants
|
50 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Baseline:Moderate (n=9,6,6,6)
|
33 Percentage of participants
|
44 Percentage of participants
|
33 Percentage of participants
|
17 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Baseline:Moderate to sever(n=9,6,6,6)
|
0 Percentage of participants
|
33 Percentage of participants
|
50 Percentage of participants
|
50 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Day15:Mild (n=9,6,6,6)
|
33 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
33 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Day15:Severe (n=9,6,6,6)
|
0 Percentage of participants
|
0 Percentage of participants
|
17 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Day29:Almost clear(n=9,6,6,6)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Day29:Moderate to severe(n=9,6,6,6)
|
0 Percentage of participants
|
22 Percentage of participants
|
33 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Day29:Severe (n=9,6,6,6)
|
0 Percentage of participants
|
11 Percentage of participants
|
17 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Day85:Moderate to severe(n=6,0,6,6)
|
—
|
33 Percentage of participants
|
17 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Day85:Severe (n=6,0,6,6)
|
—
|
17 Percentage of participants
|
33 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Day121:Almost clear(n=9,6,6,6)
|
17 Percentage of participants
|
11 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Day121:Mild (n=9,6,6,6)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
33 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Day121:Mild to moderate(n=9,6,6,6)
|
0 Percentage of participants
|
11 Percentage of participants
|
33 Percentage of participants
|
17 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants in Each PGA Score Category
Day121:Moderate (n=9,6,6,6)
|
50 Percentage of participants
|
22 Percentage of participants
|
17 Percentage of participants
|
50 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo for Healthy Volunteer Combined
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
GSK2831781 0.0003 mg/kg (ADA-ve)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
GSK2831781 0.0015 mg/kg (ADA-ve)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
GSK2831781 0.0075 mg/kg (ADA-ve)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
GSK2831781 0.04 mg/kg (ADA-ve)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
GSK2831781 0.15 mg/kg (ADA-ve)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
GSK2831781 0.15 mg/kg (ADA+ve)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo for Psoriasis
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
GSK2831781 0.5 mg/kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
GSK2831781 1.5 mg/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
GSK2831781 5 mg/kg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo for Healthy Volunteer Combined
n=14 participants at risk
Healthy volunteers with no DTH and with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0003 mg/kg (ADA-ve)
n=1 participants at risk
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0003 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
n=1 participants at risk
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
n=6 participants at risk
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
n=6 participants at risk
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
n=6 participants at risk
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
n=6 participants at risk
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
n=9 participants at risk
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
n=6 participants at risk
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
n=6 participants at risk
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
n=6 participants at risk
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
Other adverse events
| Measure |
Placebo for Healthy Volunteer Combined
n=14 participants at risk
Healthy volunteers with no DTH and with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0003 mg/kg (ADA-ve)
n=1 participants at risk
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0003 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0015 mg/kg (ADA-ve)
n=1 participants at risk
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.0075 mg/kg (ADA-ve)
n=6 participants at risk
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.04 mg/kg (ADA-ve)
n=6 participants at risk
Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.15 mg/kg (ADA-ve)
n=6 participants at risk
Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
|
GSK2831781 0.15 mg/kg (ADA+ve)
n=6 participants at risk
Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
Placebo for Psoriasis
n=9 participants at risk
Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
|
GSK2831781 0.5 mg/kg
n=6 participants at risk
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 1.5 mg/kg
n=6 participants at risk
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
GSK2831781 5 mg/kg
n=6 participants at risk
Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
11.1%
1/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
11.1%
1/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
14.3%
2/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
50.0%
3/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
44.4%
4/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
50.0%
3/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
33.3%
2/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
2/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
33.3%
2/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
33.3%
2/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
50.0%
3/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.1%
1/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
7.1%
1/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
11.1%
1/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
11.1%
1/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
11.1%
1/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
14.3%
2/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
33.3%
2/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
33.3%
3/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
33.3%
2/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
33.3%
2/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
33.3%
2/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Influenza
|
7.1%
1/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Balanitis candida
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Gastroenteritis
|
7.1%
1/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
11.1%
1/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
33.3%
2/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Ear infection
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
11.1%
1/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
11.1%
1/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
11.1%
1/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
11.1%
1/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
50.0%
3/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
1/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
11.1%
1/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
33.3%
2/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
7.1%
1/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
11.1%
1/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
11.1%
1/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
11.1%
1/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
11.1%
1/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
33.3%
2/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
33.3%
2/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
1/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
11.1%
1/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
11.1%
1/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Feeling hot
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Catheter site pain
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Chest discomfort
|
7.1%
1/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Injury associated with device
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
1/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
7.1%
1/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pityriasis rosea
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
11.1%
1/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
7.1%
1/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Post procedural inflammation
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
33.3%
2/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Immune system disorders
Type IV hypersensitivity reaction
|
7.1%
1/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
7.1%
1/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
11.1%
1/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Eye disorders
Vision blurred
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Eye disorders
Conjunctival irritation
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
11.1%
1/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Reticulocyte count increased
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
11.1%
1/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Surgical and medical procedures
Dental care
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
11.1%
1/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
11.1%
1/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
11.1%
1/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
11.1%
1/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/14 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/1 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/9 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
16.7%
1/6 • On treatment AEs and SAEs were collected Up to 307 days
Safety population consisted of all randomized participants who received at least one dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER