Trial Outcomes & Findings for First-time-in-Human (FTIH) Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single (in Both Fed and Fasted States) or Repeat Doses of GSK3358699 (NCT NCT03426995)
NCT ID: NCT03426995
Last Updated: 2020-12-02
Results Overview
An adverse event (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 medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, important medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the outcomes listed before. Safety Population consisted of all randomized participants who took at least 1 dose of study treatment.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
Up to Day 193
Results posted on
2020-12-02
Participant Flow
This was a randomized, double-blind, placebo-controlled, 3-part study. Part A was single ascending dose crossover with 2 interlocking cohorts(1 and 2);Part B was planned to be a single dose, open-label, 2-way crossover in fed, fasted conditions(Cohort3);Part C was repeat dose design in sequential cohorts(4,5) and cohorts 6 to 8 were planned.
A total 48 participants were enrolled in this study. Part B and Part C (Cohorts 6 to 8) were not initiated as the study was terminated early due to strategic reasons following emergence of new data. Hence, no participants were enrolled in Part B and Part C (Cohorts 6 to 8).
Participant milestones
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Part A: Cohort 1- Sequence PCEP
Participants in Part A Cohort 1 were planned to receive a single dose (SD) of placebo (Treatment P) on Day 1 in treatment Period 1. Participants were received a SD of GSK3358699 10 milligram (mg) (Treatment C) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 40 mg (Treatment E) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by intravenous (IV) administration of in vivo lipopolysaccharide (LPS) challenge at a dose of 0.75 nanograms per kilogram (ng/kg) and further treated with 0.2 percent (%) cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
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Part A: Cohort 1- Sequence PCER
Participants in Part A Cohort 1 received a SD of placebo (Treatment P) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 10 mg (Treatment C) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 40 mg (Treatment E) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
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Part A: Cohort 1- Sequence APEP
Participants in Part A Cohort 1 received a SD of GSK3358699 1 mg (Treatment A) on Day 1 in treatment Period 1; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 40 mg (Treatment E) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
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Part A: Cohort 1- Sequence APER
Participants in Part A Cohort 1 received a SD of GSK3358699 1 mg (Treatment A) on Day 1 in treatment Period 1; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 40 mg (Treatment E) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
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Part A: Cohort 1- Sequence ACPP
Participants in Part A Cohort 1 received a SD of GSK3358699 1 mg (Treatment A) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 10 mg (Treatment C) on Day 1 in treatment Period 2; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
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Part A: Cohort 1- Sequence ACPR
Participants in Part A Cohort 1 received a SD of GSK3358699 1 mg (Treatment A) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 10 mg (Treatment C) on Day 1 in treatment Period 2; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
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Part A: Cohort 2- Sequence PDFP
Participants in Part A Cohort 2 received a SD of placebo (Treatment P) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 20 mg (Treatment D) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 30 mg (Treatment F) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by IV administration of in vivo administration of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) at a dose of 60 micrograms per meter square (mcg/m\^2) and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
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Part A: Cohort 2- Sequence PDFR
Participants in Part A Cohort 2 received a SD of placebo (Treatment P) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 20 mg (Treatment D) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 30 mg (Treatment F) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo administration of GM-CSF at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
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Part A: Cohort 2- Sequence BPFP
Participants in Part A Cohort 2 received a SD of GSK3358699 3 mg (Treatment B) on Day 1 in treatment Period 1; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 30 mg (Treatment F) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by IV administration of in vivo administration of GM-CSF at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
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Part A: Cohort 2- Sequence BPFR
Participants in Part A Cohort 2 were planned to receive a SD of GSK3358699 3 mg (Treatment B) on Day 1 in treatment Period 1.Participants were received a SD of placebo (Treatment P) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 30 mg (Treatment F) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo administration of GM-CSF at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
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Part A: Cohort 2- Sequence BDPP
Participants in Part A Cohort 2 received a SD of GSK3358699 3 mg (Treatment B) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 20 mg (Treatment D) on Day 1 in treatment Period 2; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by IV administration of in vivo administration of GM-CSF at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
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Part A: Cohort 2- Sequence BDPR
Participants in Part A Cohort 2 received a SD of GSK3358699 3 mg (Treatment B) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 20 mg (Treatment D) on Day 1 in treatment Period 2; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo administration of GM-CSF at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
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Part B: Cohort 3- GSK3358699 Fed + GSK3358699 Fasted
Participants in Part B Cohort 3 were planned to receive a SD of GSK3358699 under fed conditions on Day 1 in treatment Period 1; followed by a SD of GSK3358699 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 14 days between each treatment period.
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Part B: Cohort 3- GSK3358699 Fasted + GSK3358699 Fed
Participants in Part B Cohort 3 were planned to receive a SD of GSK3358699 under fasted conditions on Day 1 in treatment Period 1; followed by a SD of GSK3358699 under fed conditions on Day 1 in treatment Period 2. There was a planned washout period of 14 days between each treatment period.
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Part C: Cohort 4 and 5- Placebo RD
Participants received once daily repeat dose (RD) of placebo on Days 1 to 14. In Cohort 4, on Day 14, participants were administered an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo at a dose of 60 mcg/m\^2. The administration of LPS or GM-CSF was followed by blister induction on forearm (0.2% cantharidin).
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Part C: Cohort 4 and 5- GSK3358699 10 mg RD
Participants received once daily repeat dose of GSK3358699 10 mg on Days 1 to 14. In Cohort 4, on Day 14, participants were administered an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo at a dose of 60 mcg/m\^2. The administration of LPS or GM-CSF was followed by blister induction on forearm (0.2% cantharidin).
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Part C: Cohort 6- GSK3358699 or Placebo RD
Participants in Part C Cohort 6 were planned to receive once daily repeat dose of GSK3358699 or placebo on Days 1 to 14.
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Part C: Cohort 7- GSK3358699 or Placebo RD
Participants in Part C Cohort 7 were planned to receive once daily repeat dose of GSK3358699 or placebo on Days 1 to 14.
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Part C: Cohort 8- GSK3358699 or Placebo RD
Participants in Part C Cohort 8 were planned to receive once daily repeat dose of GSK3358699 or placebo on Days 1 to 14. On Day 14, participants were planned to receive an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo as 60 mcg/m\^2. The administration of LPS or GM-CSF was planned to be followed by blister induction on forearm (0.2% cantharidin).
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Part A: Cohort 2-Period 1 (Day1)
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|
0
|
0
|
0
|
1
|
2
|
1
|
2
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A: Cohort 2-Period 3 (Day1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
PartA:Cohort2-WashoutPeriod3(Upto Day14)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
1
|
2
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
PartA:Cohort2-WashoutPeriod3(Upto Day14)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
1
|
2
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
PartA:Cohort2-WashoutPeriod3(Upto Day14)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A: Cohort 2-Period 4 (Day1)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
3
|
1
|
2
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A: Cohort 2-Period 4 (Day1)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
1
|
2
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A: Cohort 2-Period 4 (Day1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B: Cohort 3- Period 1 (Day 1)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B: Cohort 3- Period 1 (Day 1)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B: Cohort 3- Period 1 (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
PartB:Cohort3-WashoutPeriod (Upto Day14)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
PartB:Cohort3-WashoutPeriod (Upto Day14)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
PartB:Cohort3-WashoutPeriod (Upto Day14)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B: Cohort 3- Period 2 (Day 1)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B: Cohort 3- Period 2 (Day 1)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B: Cohort 3- Period 2 (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part C: Cohorts 4 to 8 (Days 1 to 14)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
11
|
14
|
0
|
0
|
0
|
|
Part C: Cohorts 4 to 8 (Days 1 to 14)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
0
|
0
|
0
|
|
Part C: Cohorts 4 to 8 (Days 1 to 14)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
12
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part A: Cohort 1- Sequence PCEP
Participants in Part A Cohort 1 were planned to receive a single dose (SD) of placebo (Treatment P) on Day 1 in treatment Period 1. Participants were received a SD of GSK3358699 10 milligram (mg) (Treatment C) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 40 mg (Treatment E) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by intravenous (IV) administration of in vivo lipopolysaccharide (LPS) challenge at a dose of 0.75 nanograms per kilogram (ng/kg) and further treated with 0.2 percent (%) cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
|
Part A: Cohort 1- Sequence PCER
Participants in Part A Cohort 1 received a SD of placebo (Treatment P) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 10 mg (Treatment C) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 40 mg (Treatment E) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
|
Part A: Cohort 1- Sequence APEP
Participants in Part A Cohort 1 received a SD of GSK3358699 1 mg (Treatment A) on Day 1 in treatment Period 1; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 40 mg (Treatment E) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
|
Part A: Cohort 1- Sequence APER
Participants in Part A Cohort 1 received a SD of GSK3358699 1 mg (Treatment A) on Day 1 in treatment Period 1; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 40 mg (Treatment E) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
|
Part A: Cohort 1- Sequence ACPP
Participants in Part A Cohort 1 received a SD of GSK3358699 1 mg (Treatment A) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 10 mg (Treatment C) on Day 1 in treatment Period 2; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
|
Part A: Cohort 1- Sequence ACPR
Participants in Part A Cohort 1 received a SD of GSK3358699 1 mg (Treatment A) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 10 mg (Treatment C) on Day 1 in treatment Period 2; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
|
Part A: Cohort 2- Sequence PDFP
Participants in Part A Cohort 2 received a SD of placebo (Treatment P) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 20 mg (Treatment D) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 30 mg (Treatment F) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by IV administration of in vivo administration of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) at a dose of 60 micrograms per meter square (mcg/m\^2) and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
|
Part A: Cohort 2- Sequence PDFR
Participants in Part A Cohort 2 received a SD of placebo (Treatment P) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 20 mg (Treatment D) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 30 mg (Treatment F) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo administration of GM-CSF at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
|
Part A: Cohort 2- Sequence BPFP
Participants in Part A Cohort 2 received a SD of GSK3358699 3 mg (Treatment B) on Day 1 in treatment Period 1; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 30 mg (Treatment F) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by IV administration of in vivo administration of GM-CSF at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
|
Part A: Cohort 2- Sequence BPFR
Participants in Part A Cohort 2 were planned to receive a SD of GSK3358699 3 mg (Treatment B) on Day 1 in treatment Period 1.Participants were received a SD of placebo (Treatment P) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 30 mg (Treatment F) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo administration of GM-CSF at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
|
Part A: Cohort 2- Sequence BDPP
Participants in Part A Cohort 2 received a SD of GSK3358699 3 mg (Treatment B) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 20 mg (Treatment D) on Day 1 in treatment Period 2; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by IV administration of in vivo administration of GM-CSF at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
|
Part A: Cohort 2- Sequence BDPR
Participants in Part A Cohort 2 received a SD of GSK3358699 3 mg (Treatment B) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 20 mg (Treatment D) on Day 1 in treatment Period 2; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo administration of GM-CSF at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
|
Part B: Cohort 3- GSK3358699 Fed + GSK3358699 Fasted
Participants in Part B Cohort 3 were planned to receive a SD of GSK3358699 under fed conditions on Day 1 in treatment Period 1; followed by a SD of GSK3358699 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 14 days between each treatment period.
|
Part B: Cohort 3- GSK3358699 Fasted + GSK3358699 Fed
Participants in Part B Cohort 3 were planned to receive a SD of GSK3358699 under fasted conditions on Day 1 in treatment Period 1; followed by a SD of GSK3358699 under fed conditions on Day 1 in treatment Period 2. There was a planned washout period of 14 days between each treatment period.
|
Part C: Cohort 4 and 5- Placebo RD
Participants received once daily repeat dose (RD) of placebo on Days 1 to 14. In Cohort 4, on Day 14, participants were administered an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo at a dose of 60 mcg/m\^2. The administration of LPS or GM-CSF was followed by blister induction on forearm (0.2% cantharidin).
|
Part C: Cohort 4 and 5- GSK3358699 10 mg RD
Participants received once daily repeat dose of GSK3358699 10 mg on Days 1 to 14. In Cohort 4, on Day 14, participants were administered an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo at a dose of 60 mcg/m\^2. The administration of LPS or GM-CSF was followed by blister induction on forearm (0.2% cantharidin).
|
Part C: Cohort 6- GSK3358699 or Placebo RD
Participants in Part C Cohort 6 were planned to receive once daily repeat dose of GSK3358699 or placebo on Days 1 to 14.
|
Part C: Cohort 7- GSK3358699 or Placebo RD
Participants in Part C Cohort 7 were planned to receive once daily repeat dose of GSK3358699 or placebo on Days 1 to 14.
|
Part C: Cohort 8- GSK3358699 or Placebo RD
Participants in Part C Cohort 8 were planned to receive once daily repeat dose of GSK3358699 or placebo on Days 1 to 14. On Day 14, participants were planned to receive an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo as 60 mcg/m\^2. The administration of LPS or GM-CSF was planned to be followed by blister induction on forearm (0.2% cantharidin).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Cohort 1-Period 1 (Day1)
Protocol defined stopping criteria
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A: Cohort 1-Period 2 (Day1)
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A: Cohort 1-Period 2 (Day1)
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A: Cohort 2-Period 4 (Day1)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A: Cohort 2-Period 4 (Day1)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part C: Cohorts 4 to 8 (Days 1 to 14)
Study Closed/Terminated
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
9
|
0
|
0
|
0
|
|
Part C: Cohorts 4 to 8 (Days 1 to 14)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
3
|
0
|
0
|
0
|
Baseline Characteristics
First-time-in-Human (FTIH) Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single (in Both Fed and Fasted States) or Repeat Doses of GSK3358699
Baseline characteristics by cohort
| Measure |
Part A: Cohort 1- Sequence PCEP
n=1 Participants
Participants in Part A Cohort 1 were planned to receive a single dose (SD) of placebo (Treatment P) on Day 1 in treatment Period 1. Participants were received a SD of GSK3358699 10 milligram (mg) (Treatment C) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 40 mg (Treatment E) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by intravenous (IV) administration of in vivo lipopolysaccharide (LPS) challenge at a dose of 0.75 nanograms per kilogram (ng/kg) and further treated with 0.2 percent (%) cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
|
Part A: Cohort 1- Sequence PCER
n=2 Participants
Participants in Part A Cohort 1 received a SD of placebo (Treatment P) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 10 mg (Treatment C) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 40 mg (Treatment E) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
|
Part A: Cohort 1- Sequence APEP
n=2 Participants
Participants in Part A Cohort 1 received a SD of GSK3358699 1 mg (Treatment A) on Day 1 in treatment Period 1; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 40 mg (Treatment E) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
|
Part A: Cohort 1- Sequence APER
n=2 Participants
Participants in Part A Cohort 1 received a SD of GSK3358699 1 mg (Treatment A) on Day 1 in treatment Period 1; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 40 mg (Treatment E) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
|
Part A: Cohort 1- Sequence ACPP
n=2 Participants
Participants in Part A Cohort 1 received a SD of GSK3358699 1 mg (Treatment A) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 10 mg (Treatment C) on Day 1 in treatment Period 2; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
|
Part A: Cohort 1- Sequence ACPR
n=4 Participants
Participants in Part A Cohort 1 received a SD of GSK3358699 1 mg (Treatment A) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 10 mg (Treatment C) on Day 1 in treatment Period 2; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
|
Part A: Cohort 2- Sequence PDFP
n=1 Participants
Participants in Part A Cohort 2 received a SD of placebo (Treatment P) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 20 mg (Treatment D) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 30 mg (Treatment F) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by IV administration of in vivo administration of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) at a dose of 60 micrograms per meter square (mcg/m\^2) and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
|
Part A: Cohort 2- Sequence PDFR
n=3 Participants
Participants in Part A Cohort 2 received a SD of placebo (Treatment P) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 20 mg (Treatment D) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 30 mg (Treatment F) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo administration of GM-CSF at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
|
Part A: Cohort 2- Sequence BPFP
n=1 Participants
Participants in Part A Cohort 2 received a SD of GSK3358699 3 mg (Treatment B) on Day 1 in treatment Period 1; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 30 mg (Treatment F) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by IV administration of in vivo administration of GM-CSF at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
|
Part A: Cohort 2- Sequence BPFR
n=2 Participants
Participants in Part A Cohort 2 were planned to receive a SD of GSK3358699 3 mg (Treatment B) on Day 1 in treatment Period 1.Participants were received a SD of placebo (Treatment P) on Day 1 in treatment Period 2; followed by a SD of GSK3358699 30 mg (Treatment F) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo administration of GM-CSF at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
|
Part A: Cohort 2- Sequence BDPP
n=1 Participants
Participants in Part A Cohort 2 received a SD of GSK3358699 3 mg (Treatment B) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 20 mg (Treatment D) on Day 1 in treatment Period 2; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo (Treatment P) followed by IV administration of in vivo administration of GM-CSF at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
|
Part A: Cohort 2- Sequence BDPR
n=2 Participants
Participants in Part A Cohort 2 received a SD of GSK3358699 3 mg (Treatment B) on Day 1 in treatment Period 1; followed by a SD of GSK3358699 20 mg (Treatment D) on Day 1 in treatment Period 2; followed by a SD of placebo (Treatment P) on Day 1 in treatment Period 3. On Day 1 of treatment Period 4, participants were administered a SD of GSK3358699 25 mg (Treatment R) followed by IV administration of in vivo administration of GM-CSF at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 and placebo were administered via the oral route. There was a washout period of 14 days between each treatment period.
|
Part B: Cohort 3- GSK3358699 Fed + GSK3358699 Fasted
Participants in Part B Cohort 3 were planned to receive a SD of GSK3358699 under fed conditions on Day 1 in treatment Period 1; followed by a SD of GSK3358699 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 14 days between each treatment period.
|
Part B: Cohort 3- GSK3358699 Fasted + GSK3358699 Fed
Participants in Part B Cohort 3 were planned to receive a SD of GSK3358699 under fasted conditions on Day 1 in treatment Period 1; followed by a SD of GSK3358699 under fed conditions on Day 1 in treatment Period 2. There was a planned washout period of 14 days between each treatment period.
|
Part C: Cohort 4 and 5- Placebo RD
n=11 Participants
Participants received once daily RD of placebo on Days 1 to 14. In Cohort 4, on Day 14, participants were administered an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo at a dose of 60 mcg/m\^2. The administration of LPS or GM-CSF was followed by blister induction on forearm (0.2% cantharidin).
|
Part C: Cohort 4 and 5- GSK3358699 10 mg RD
n=14 Participants
Participants received once daily repeat dose of GSK3358699 10 mg on Days 1 to 14. In Cohort 4, on Day 14, participants were administered an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo at a dose of 60 mcg/m\^2. The administration of LPS or GM-CSF was followed by blister induction on forearm (0.2% cantharidin).
|
Part C: Cohort 6- GSK3358699 or Placebo RD
Participants in Part C Cohort 6 were planned to receive once daily repeat dose of GSK3358699 or placebo on Days 1 to 14.
|
Part C: Cohort 7- GSK3358699 or Placebo RD
Participants in Part C Cohort 7 were planned to receive once daily repeat dose of GSK3358699 or placebo on Days 1 to 14.
|
Part C: Cohort 8- GSK3358699 or Placebo RD
Participants in Part C Cohort 8 were planned to receive once daily repeat dose of GSK3358699 or placebo on Days 1 to 14. On Day 14, participants were planned to receive an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo as 60 mcg/m\^2. The administration of LPS or GM-CSF was planned to be followed by blister induction on forearm (0.2% cantharidin).
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
<=18 years
|
0 Participants
n=5 Participants
|
1 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
|
—
|
—
|
0 Participants
n=16 Participants
|
0 Participants
n=135 Participants
|
—
|
—
|
—
|
1 Participants
n=7 Participants
|
|
Age, Customized
>18 and <65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=64 Participants
|
1 Participants
n=17 Participants
|
2 Participants
n=21 Participants
|
—
|
—
|
11 Participants
n=16 Participants
|
14 Participants
n=135 Participants
|
—
|
—
|
—
|
47 Participants
n=7 Participants
|
|
Age, Customized
>=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
|
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
|
—
|
—
|
0 Participants
n=16 Participants
|
0 Participants
n=135 Participants
|
—
|
—
|
—
|
0 Participants
n=7 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
|
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
|
—
|
—
|
0 Participants
n=16 Participants
|
0 Participants
n=135 Participants
|
—
|
—
|
—
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=64 Participants
|
1 Participants
n=17 Participants
|
2 Participants
n=21 Participants
|
—
|
—
|
11 Participants
n=16 Participants
|
14 Participants
n=135 Participants
|
—
|
—
|
—
|
48 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 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
|
—
|
—
|
1 Participants
n=16 Participants
|
0 Participants
n=135 Participants
|
—
|
—
|
—
|
2 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White-White/Caucasian/European Heritage
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=64 Participants
|
1 Participants
n=17 Participants
|
1 Participants
n=21 Participants
|
—
|
—
|
10 Participants
n=16 Participants
|
14 Participants
n=135 Participants
|
—
|
—
|
—
|
45 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
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
|
1 Participants
n=21 Participants
|
—
|
—
|
0 Participants
n=16 Participants
|
0 Participants
n=135 Participants
|
—
|
—
|
—
|
1 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Up to Day 193Population: Safety Population.
An adverse event (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 medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, important medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the outcomes listed before. Safety Population consisted of all randomized participants who took at least 1 dose of study treatment.
Outcome measures
| Measure |
Part A: Placebo SD
n=23 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=5 Participants
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
n=3 Participants
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
n=12 Participants
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
8 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
8 Participants
|
4 Participants
|
3 Participants
|
|
Part A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 30Population: Safety Population. Data was not collected as no participants were enrolled in Part B.
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 medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, important medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the outcomes listed before.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Day 49Population: Safety Population. Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
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 medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, important medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the outcomes listed before.
Outcome measures
| Measure |
Part A: Placebo SD
n=11 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=14 Participants
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: Number of Participants With AEs and SAEs
AEs
|
7 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With AEs and SAEs
SAEs
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 193Population: Safety Population.
Blood samples were collected for analysis of clinical chemistry parameters. PCI ranges were \<30 grams per liter (g/L) (albumin), \<2 or \>2.75 millimoles/L (mmol/L) (calcium), \>1.3\* upper limit of normal (ULN) mmol/L (creatinine), \<3 or \>9 mmol/L (glucose), \<3 or \>5.5 mmol/L (potassium), and \<130 or \>150 mmol/L (sodium). Participants were counted in worst case category that their value changes to (low, within range or no change or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, were recorded in To within Range or No Change (NC) category. Participants were counted twice if participant had values that changed To Low and To High, so the percentages may not add to 100%.
Outcome measures
| Measure |
Part A: Placebo SD
n=23 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=5 Participants
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
n=3 Participants
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
n=12 Participants
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Potassium: To within Range or No Change
|
23 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Potassium: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Sodium: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Sodium: To within Range or No Change
|
23 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Sodium: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Albumin: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Albumin: To within Range or No Change
|
23 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Albumin: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Creatinine: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Calcium: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Calcium: To within Range or No Change
|
23 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Calcium: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Creatinine: To within Range or No Change
|
23 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Creatinine: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Glucose: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Glucose: To within Range or No Change
|
22 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Glucose: To High
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Potassium: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 193Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Clinical chemistry parameters assessed were alanine aminotransferase(ALT)(\<10 or \>50 international units per liter\[IU/L\]),alkaline phosphatase(ALP)(\<40 or \>129 IU/L),aspartate aminotransferase(AST)(\<0 or \>37 IU/L),cholesterol(\<2.3 or \>4.9 mmol/L),direct bilirubin(DB)(\<0 or \>5 micromoles\[mcmol\]/L),high density lipoprotein (DL)(\<0.9 or \>1.5 mmol/L),C-reactive protein(CRP)(\<0.0 or \>5.0mg/liter),low DL(\<0 or \>3.0 mmol/L), total bilirubin (\<0 or \>20 mcmol/L),total protein(\<63 or \>83 grams/L),triglycerides(\<0 or \>2.3 mmol/L) and blood urea nitrogen(BUN)(\<4.76 or \>23.24 mg/deciliter).Participants were counted in worst case category that their value changes to (low, normal or high), unless there is NC in their category.Participants whose laboratory value category was unchanged(e.g.,High to High) or whose value became normal, are recorded in "To Normal or NC" category.Participants were counted twice if participant had values that changed To Low and To High, so percentages may not add to 100%.
Outcome measures
| Measure |
Part A: Placebo SD
n=23 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=5 Participants
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
n=3 Participants
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
n=12 Participants
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
ALT: To Low,n=23,5,3,6,6,12,6,6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
ALT: To Normal or NC,n=23,5,3,6,6,12,6,6
|
22 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
ALT: To High,n=23,5,3,6,6,12,6,6
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
ALP: To Low,n=23,5,3,6,6,12,6,6
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
ALP: To Normal or NC,n=23,5,3,6,6,12,6,6
|
23 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
ALP: To High,n=23,5,3,6,6,12,6,6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
AST: To Low,n=23,5,3,6,6,12,6,6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
AST: To Normal or NC,n=23,5,3,6,6,12,6,6
|
22 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
AST: To High,n=23,5,3,6,6,12,6,6
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Cholesterol: To Low,n=23,5,3,6,6,12,6,6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Cholesterol: To Normal or NC,n=23,5,3,6,6,12,6,6
|
22 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
10 Participants
|
5 Participants
|
4 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
DB:To Normal or NC,n=23,5,3,6,6,12,6,6
|
22 Participants
|
5 Participants
|
2 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
High DL: To Low,n=23,5,3,6,6,12,6,6
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
High DL:To Normal or NC,n=23,5,3,6,6,12,6,6
|
22 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
11 Participants
|
6 Participants
|
6 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
High DL: To High,n=23,5,3,6,6,12,6,6
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
CRP: To Normal or NC,n=23,5,3,6,4,12,6,6
|
18 Participants
|
5 Participants
|
2 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
CRP: To High,n=23,5,3,6,4,12,6,6
|
5 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
8 Participants
|
0 Participants
|
1 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Low DL: To Low,n=23,5,3,6,6,12,6,6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Low DL: To Normal or NC,n=23,5,3,6,6,12,6,6
|
21 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
11 Participants
|
5 Participants
|
4 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Low DL: To High,n=23,5,3,6,6,12,6,6
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Total bilirubin: To Low,n=23,5,3,6,6,12,6,6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Total bilirubin:ToNormal or NC,n=23,5,3,6,6,12,6,6
|
22 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
11 Participants
|
6 Participants
|
6 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Total bilirubin: To High,n=23,5,3,6,6,12,6,6
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Total protein: To Low,n=23,5,3,6,6,12,6,6
|
4 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Total protein: To High,n=23,5,3,6,6,12,6,6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Triglycerides: To Low,n=23,5,3,6,6,12,6,6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Triglycerides:To Normal or NC,n=23,5,3,6,6,12,6,6
|
17 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
12 Participants
|
3 Participants
|
4 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Triglycerides: To High,n=23,5,3,6,6,12,6,6
|
6 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
BUN: To Low,n=23,5,3,6,6,12,6,6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
BUN: To Normal or NC,n=23,5,3,6,6,12,6,6
|
23 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
BUN: To High,n=23,5,3,6,6,12,6,6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Cholesterol: To High,n=23,5,3,6,6,12,6,6
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
DB: To Low,n=23,5,3,6,6,12,6,6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
DB: To High,n=23,5,3,6,6,12,6,6
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
CRP: To Low,n=23,5,3,6,4,12,6,6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Total protein:To Normal or NC,n=23,5,3,6,6,12,6,6
|
19 Participants
|
5 Participants
|
2 Participants
|
6 Participants
|
4 Participants
|
9 Participants
|
5 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Up to Day 30Population: Safety Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected to analyze the chemistry parameters.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Day 30Population: Safety Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected to analyze the chemistry parameters.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Day 28Population: Safety Population. Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
Blood samples were collected for analysis of chemistry parameters. PCI ranges were \<30 g/L (albumin), \<2 or \>2.75 mmol/L (calcium), \>1.3\* ULN mmol/L (creatinine), \<3 or \>9 mmol/L (glucose), \<3 or \>5.5 mmol/L (potassium), and \<130 or \>150 mmol/L (sodium). Participants were counted in worst case category that their value changes to (low, within range or no change or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, were recorded in To within Range or No Change category. Participants were counted twice if participant had values that changed To Low and To High, so the percentages may not add to 100%.
Outcome measures
| Measure |
Part A: Placebo SD
n=11 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=14 Participants
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline
Albumin: To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline
Calcium: To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline
Creatinine: To within Range or No Change
|
11 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline
Glucose: To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline
Potassium: To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline
Potassium: To within Range or No Change
|
11 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline
Sodium: To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline
Sodium: To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline
Albumin: To within Range or No Change
|
11 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline
Albumin: To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline
Calcium: To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline
Calcium: To within Range or No Change
|
11 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline
Creatinine: To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline
Creatinine: To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline
Glucose: To within Range or No Change
|
11 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline
Glucose: To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline
Potassium: To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline
Sodium: To within Range or No Change
|
11 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 28Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
Clinical chemistry parameters assessed were ALT (\<10 or \>50 IU/L), ALP (\<40 or \>129 IU/L), AST (\<0 or \>37 IU/L), cholesterol (\<2.3 or \>4.9 mmol/L), DB (\<0 or \>5 mcmol/L), high DL (\<0.9 or \>1.5 mmol/L), CRP (\<0.0 or \>5.0 mg/liter), low DL (\<0 or \>3.0 mmol/L), total bilirubin (\<0 or \>20 mcmol/L), total protein (\<63 or \>83 grams/L), triglycerides (\<0 or \>2.3 mmol/L) and BUN (\<4.76 or \>23.24 mg/deciliter). Participants were counted in worst case category that their value changes to (low, normal or high), unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g., High to High) or whose value became normal, are recorded in "To Normal or NC" category. Participants were counted twice if participant had values that changed To Low and To High, so percentages may not add to 100%.
Outcome measures
| Measure |
Part A: Placebo SD
n=11 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=14 Participants
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
ALT: To Normal or NC,n=11,14,0,0,0
|
11 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
ALP: To Normal or NC,n=11,14,0,0,0
|
11 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
AST: To Low,n=11,14,0,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
DB: To High,n=11,14,0,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
High DL: To High,n=11,14,0,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
CRP: To Normal or NC,n=10,13,0,0,0
|
9 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Total bilirubin: To Low,n=11,14,0,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Total bilirubin: To High,n=11,14,0,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Total protein: To High,n=11,14,0,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
ALT: To Low,n=11,14,0,0,0
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
ALT: To High,n=11,14,0,0,0
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
ALP: To Low,n=11,14,0,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
ALP: To High,n=11,14,0,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
AST: To Normal or NC,n=11,14,0,0,0
|
10 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
AST: To High,n=11,14,0,0,0
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Cholesterol: To Low,n=11,14,0,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Cholesterol: To Normal or NC,n=11,14,0,0,0
|
9 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Cholesterol: To High,n=11,14,0,0,0
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
DB: To Low,n=11,14,0,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
DB:To Normal or NC,n=11,14,0,0,0
|
11 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
High DL: To Low,n=11,14,0,0,0
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Low DL: To High,n=11,14,0,0,0
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
High DL:To Normal or NC,n=11,14,0,0,0
|
10 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
CRP: To Low,n=10,13,0,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
CRP: To High,n=10,13,0,0,0
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Low DL: To Low,n=11,14,0,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Low DL: To Normal or NC,n=11,14,0,0,0
|
8 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Total bilirubin:ToNormal or NC,n=11,14,0,0,0
|
11 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Total protein: To Low,n=11,14,0,0,0
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Total protein:To Normal or NC,n=11,14,0,0,0
|
10 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Triglycerides: To Low,n=11,14,0,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Triglycerides:To Normal or NC,n=11,14,0,0,0
|
10 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Triglycerides: To High,n=11,14,0,0,0
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
BUN: To Low,n=11,14,0,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
BUN: To Normal or NC,n=11,14,0,0,0
|
11 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
BUN: To High,n=11,14,0,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 193Population: Safety Population.
Blood samples collected for analysis of hematology parameters. PCI ranges were \>0.54 proportion of red blood cells in blood (hematocrit), \>180 grams/liter (hemoglobin), \<0.8 \*10\^9 cells/L (lymphocyte count), \<1.5 \*10\^9 cells/L (total absolute neutrophil count \[ANC\]), \<100 or \>550 \*10\^9 cells/L (platelet count), and \<3 or \>20\*10\^9 cells/L (white blood cell \[WBC\] count). Participants were counted in worst case category that their value changes to (low, within range or no change or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, were recorded in To within Range or No Change category. Participants were counted twice if the participant had values that changed To Low and To High, so the percentages may not add to 100%.
Outcome measures
| Measure |
Part A: Placebo SD
n=23 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=5 Participants
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
n=3 Participants
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
n=12 Participants
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
Hematocrit: To within Range or No Change
|
23 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
Hematocrit: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
Hemoglobin: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
Hemoglobin: To within Range or No Change
|
23 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
Lymphocyte count: To Low
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
Lymphocyte count: To within Range or No Change
|
21 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
10 Participants
|
6 Participants
|
6 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
Lymphocyte count: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
Platelet count: To within Range or No Change
|
23 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
Platelet count: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
Total ANC: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
WBC: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
WBC: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
Hematocrit: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
Hemoglobin: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
Platelet count: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
Total ANC: To Low
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
Total ANC: To within Range or No Change
|
23 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
WBC: To within Range or No Change
|
23 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to Day 193Population: Safety Population.
Hematology parameters assessed were activated partial thromboplastin time (APTT) (\<25 or \>37 seconds), basophil count (\<0.0 or \>0.1\*10\^9 cells/L), eosinophil count (\<0.0 or \>0.4\*10\^9 cells/L), fibrinogen (\<1.5 or \>4.0 g/L), mean corpuscle hemoglobin (MCH) (\<26.0 or \>33.5 picogram), mean corpuscle volume (MCV) (\<80 or \>99 femtoliter), monocyte count (\<0.2 or \>1.0\*10\^9 cells/L), prothrombin time (PT) (\<10 or \>12 seconds), red blood cell (RBC) count (\<4.4 or \>5.8\*10\^12 cells/L) and reticulocyte count (\<0.38 or \>2.64 percentage of reticulocytes). Participants were counted in worst case category that their value changes to (low, normal or high), unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g., High to High) or whose value became normal, are recorded in "To Normal or NC" category. Participants were counted twice if participant had values that changed To Low and To High, so percentages may not add to 100%.
Outcome measures
| Measure |
Part A: Placebo SD
n=23 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=5 Participants
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
n=3 Participants
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
n=12 Participants
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
APTT: To Normal or NC
|
21 Participants
|
5 Participants
|
2 Participants
|
6 Participants
|
4 Participants
|
11 Participants
|
6 Participants
|
4 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
APTT: To High
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Basophil count: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Basophil count: To Normal or NC
|
23 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
5 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Basophil count: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Eosinophil count: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Eosinophil count: To High
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Fibrinogen: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Fibrinogen: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
MCH: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Monocyte count: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Monocyte count: To Normal or NC
|
19 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Monocyte count: To High
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
PT: To High
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
RBC: To Normal or NC
|
22 Participants
|
5 Participants
|
2 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
RBC: To High
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Reticulocyte count: To Normal or NC
|
23 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Reticulocyte count: To High
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
APTT: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Eosinophil count: To Normal or NC
|
21 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
5 Participants
|
12 Participants
|
6 Participants
|
5 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Fibrinogen: To Normal or NC
|
23 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
5 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
MCH: To Normal or NC
|
23 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
MCH: To High
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
MCV: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
MCV: To Normal or NC
|
23 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
MCV: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
PT: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
PT: To Normal or NC
|
23 Participants
|
5 Participants
|
2 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
5 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
RBC: To Low
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Reticulocyte count: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 30Population: Safety Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected to analyze hematology parameters.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Day 30Population: Safety Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected to analyze hematology parameters.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Day 28Population: Safety Population. Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
Blood samples were collected for analysis of hematology parameters. PCI ranges were \>0.54 proportion of red blood cells in blood (hematocrit), \>180 grams/liter (hemoglobin), \<0.8\*10\^9 cells/L (lymphocyte count), \<1.5\*10\^9 cells/L (total ANC), \<100 or \>550\*10\^9 cells/L (platelet count), and \<3 or \>20\*10\^9 cells/L (WBC count). Participants were counted in worst case category that their value changes to (low, within range or no change or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, were recorded in To within Range or No Change category. Participants were counted twice if the participant had values that changed To Low and To High, so the percentages may not add to 100%.
Outcome measures
| Measure |
Part A: Placebo SD
n=11 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=14 Participants
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
WBC: To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
WBC: To within Range or No Change
|
10 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
Hemoglobin: To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
Lymphocyte count: To Low
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
Lymphocyte count: To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
Platelet count: To within Range or No Change
|
11 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
Total ANC: To Low
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
Total ANC: To within Range or No Change
|
10 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
Hematocrit: To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
Hematocrit: To within Range or No Change
|
11 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
Hematocrit: To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
Hemoglobin: To within Range or No Change
|
11 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
Hemoglobin: To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
Lymphocyte count: To within Range or No Change
|
10 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
Platelet count: To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
Platelet count: To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
Total ANC: To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline
WBC: To Low
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 28Population: Safety Population. Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
Hematology parameters assessed were APTT (\<25 or \>37 seconds), basophil count (\<0.0 or \>0.1\*10\^9 cells/L), eosinophil count (\<0.0 or \>0.4\*10\^9 cells/L), fibrinogen (\<1.5 or \>4.0 g/L), MCH (\<26.0 or \>33.5 picogram), MCV (\<80 or \>99 femtoliter), monocyte count (\<0.2 or \>1.0\*10\^9 cells/L), PT (\<10 or \>12 seconds), RBC count (\<4.4 or \>5.8\*10\^12 cells/L) and reticulocyte count (\<0.38 or \>2.64 percentage of reticulocytes). Participants were counted in worst case category that their value changes to (low, normal or high), unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g., High to High) or whose value became normal, are recorded in "To Normal or NC" category. Participants were counted twice if participant had values that changed To Low and To High, so percentages may not add to 100%.
Outcome measures
| Measure |
Part A: Placebo SD
n=11 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=14 Participants
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
APTT: To Low
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Eosinophil count: To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Eosinophil count: To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Fibrinogen: To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Fibrinogen: To Normal or NC
|
11 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Fibrinogen: To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Monocyte count: To Normal or NC
|
11 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Monocyte count: To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
RBC: To Low
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
RBC: To Normal or NC
|
11 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
RBC: To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Reticulocyte count: To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Reticulocyte count: To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
PT: To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
PT: To Normal or NC
|
10 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
PT: To High
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Reticulocyte count: To Normal or NC
|
11 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
APTT: To Normal or NC
|
10 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
APTT: To High
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Basophil count: To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Basophil count: To Normal or NC
|
11 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Basophil count: To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Eosinophil count: To Normal or NC
|
11 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
MCH: To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
MCH: To Normal or NC
|
11 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
MCH: To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
MCV: To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
MCV: To Normal or NC
|
11 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
MCV: To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Monocyte count: To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 193Population: Safety Population.
Urine samples were collected from participants for analyzing the following urine parameters: potential of hydrogen (pH) and glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocytes levels by dipstick. Urine samples showing any abnormality were sent for microscopic examination to detect the presence of RBC, WBC, cellular casts, granular casts, hyaline casts, and were counted as cells per high-power field (cells/HPF). Number of participants with abnormal urinalysis result by microscopic examination have been presented.
Outcome measures
| Measure |
Part A: Placebo SD
n=23 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=5 Participants
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
n=3 Participants
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
n=12 Participants
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Abnormal Urinalysis Parameters
RBC
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Abnormal Urinalysis Parameters
WBC
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part A: Number of Participants With Abnormal Urinalysis Parameters
Cellular casts
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Abnormal Urinalysis Parameters
Granular casts
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Abnormal Urinalysis Parameters
Hyaline casts
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 30Population: Safety Population. Data was not collected as no participants were enrolled in Part B.
Urine samples were planned to be collected to analyze urine parameters.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Day 28Population: Safety Population. Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
Urine samples were collected from participants for analyzing the following urine parameters: pH and glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocytes levels by dipstick. Urine samples showing any abnormality were sent for microscopic examination to detect the presence of RBC, WBC, cellular casts, granular casts, hyaline casts, and were counted as cells/HPF. Number of participants with abnormal urinalysis result by microscopic examination have been presented.
Outcome measures
| Measure |
Part A: Placebo SD
n=11 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=14 Participants
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: Number of Participants With Abnormal Urinalysis Parameters
Cellular casts
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Abnormal Urinalysis Parameters
Granular casts
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Abnormal Urinalysis Parameters
RBC
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Abnormal Urinalysis Parameters
WBC
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Abnormal Urinalysis Parameters
Hyaline casts
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 193Population: Safety Population.
Vital signs included systolic blood pressure(SBP), diastolic blood pressure(DBP), heart rate, respiratory rate and body temperature and were measured in a semi-supine position after 5 minutes rest. PCI ranges were, SBP (millimeters of mercury \[mmHg\]): \<85 (low) or \>160 (high), DBP (mmHg): \<45 (low) or \>100 (high), heart rate (beats per minute): \<40 (low) or \>110 (high), respiration rate (breaths per minute): \<11(low) or \>20(high) and body temperature (degrees Celsius) \<35.5 (low) or \>38.0 (high). Participants were counted in the worst case category that their value changes to (low, within range or no change, or high), unless there is no change in their category. Participants whose vital signs value category was unchanged (e.g., High to High), or whose value became within range, were recorded in the "To within Range or No Change" category. Participants were counted twice if the participant had values that changed "To Low" and "To High", so the percentages may not add to 100%.
Outcome measures
| Measure |
Part A: Placebo SD
n=23 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=5 Participants
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
n=3 Participants
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
n=12 Participants
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
SBP: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
SBP: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
DBP: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
DBP: To within Range or No Change
|
23 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
|
Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
Heart rate: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
Heart rate: To within Range or No Change
|
23 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
|
Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
Heart rate: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
Respiratory rate: To Low
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
Respiratory rate: To within Range or No Change
|
22 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
11 Participants
|
6 Participants
|
6 Participants
|
|
Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
Respiratory rate: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
Body temperature: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
Body temperature: To within Range or No Change
|
22 Participants
|
5 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
11 Participants
|
6 Participants
|
6 Participants
|
|
Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
Body temperature: To High
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
SBP: To within Range or No Change
|
23 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
|
Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
DBP: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 30Population: Safety Population. Data was not collected as no participants were enrolled in Part B.
Vital signs were planned to be measured in a semi-supine position after 5 minutes of rest.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Day 49Population: Safety Population. Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
Vital signs included SBP, DBP, heart rate, respiratory rate and body temperature and were measured in a semi-supine position after 5 minutes rest. PCI ranges were, SBP (mmHg): \<85 (low) or \>160 (high), DBP (mmHg): \<45 (low) or \>100 (high), heart rate (beats per minute): \<40 (low) or \>110 (high), respiration rate (breaths per minute): \<11 (low) or \>20 (high) and body temperature (degrees Celsius) \<35.5 (low) or \>38.0 (high). Participants were counted in the worst case category that their value changes to (low, within range or no change, or high), unless there is no change in their category. Participants whose vital signs value category was unchanged (e.g., High to High), or whose value became within range, were recorded in the "To within Range or No Change" category. Participants were counted twice if the participant had values that changed "To Low" and "To High", so the percentages may not add to 100%.
Outcome measures
| Measure |
Part A: Placebo SD
n=11 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=14 Participants
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
SBP: To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
SBP: To within Range or No Change
|
11 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
DBP: To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
Heart rate: To Low
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
Respiratory rate: To High
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
Body temperature: To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
SBP: To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
DBP: To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
DBP: To within Range or No Change
|
11 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
Heart rate: To within Range or No Change
|
10 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
Heart rate: To High
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
Respiratory rate: To Low
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
Respiratory rate: To within Range or No Change
|
9 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
Body temperature: To within Range or No Change
|
11 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
Body temperature: To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 193Population: Safety Population.
Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF) intervals. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with worst case post-Baseline abnormal ECG findings have been presented.
Outcome measures
| Measure |
Part A: Placebo SD
n=23 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=5 Participants
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
n=3 Participants
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
n=12 Participants
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings
Abnormal - not clinically significant
|
6 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Part A: Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings
Abnormal - clinically significant
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 30Population: Safety Population. Data was not collected as no participants were enrolled in Part B.
Twelve lead ECGs were planned to be performed to measure PR interval, QRS duration, QT interval and QTcF.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Day 28Population: Safety Population. Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QTcF intervals. Abnormal findings were categorized as clinically significant and not clinically significant. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with worst case post-Baseline abnormal ECG findings have been presented.
Outcome measures
| Measure |
Part A: Placebo SD
n=11 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=14 Participants
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings
Abnormal - not clinically significant
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings
Abnormal - clinically significant
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment periodPopulation: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. Pharmacokinetic (PK) parameters were calculated using standard non-compartmental analysis. PK Population consisted of all participants in the Safety Population who received an active dose and for whom a PK sample was obtained and analyzed.
Outcome measures
| Measure |
Part A: Placebo SD
n=5 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=3 Participants
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
n=12 Participants
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Plasma Concentrations of GSK3358699
Pre-dose, n=5,3,6,6,12,6,6
|
0.0000 Nanogram per milliliter
Interval 0.0 to 0.0
|
0.0000 Nanogram per milliliter
Interval 0.0 to 0.0
|
0.0000 Nanogram per milliliter
Interval 0.0 to 0.0
|
0.0000 Nanogram per milliliter
Interval 0.0 to 0.0
|
0.0000 Nanogram per milliliter
Interval 0.0 to 0.0
|
0.0000 Nanogram per milliliter
Interval 0.0 to 0.0
|
0.0000 Nanogram per milliliter
Interval 0.0 to 0.0
|
—
|
|
Part A: Plasma Concentrations of GSK3358699
15 minutes, n=5,3,6,6,12,6,6
|
0.4950 Nanogram per milliliter
Interval 0.0 to 1.921
|
0.6470 Nanogram per milliliter
Interval 0.431 to 1.142
|
1.0480 Nanogram per milliliter
Interval 0.0 to 10.565
|
0.5390 Nanogram per milliliter
Interval 0.0 to 16.637
|
0.2620 Nanogram per milliliter
Interval 0.0 to 15.086
|
5.8460 Nanogram per milliliter
Interval 0.189 to 21.54
|
0.9245 Nanogram per milliliter
Interval 0.0 to 3.315
|
—
|
|
Part A: Plasma Concentrations of GSK3358699
30 minutes, n=5,3,6,6,12,6,6
|
0.6840 Nanogram per milliliter
Interval 0.497 to 1.106
|
1.9510 Nanogram per milliliter
Interval 1.094 to 2.411
|
6.4560 Nanogram per milliliter
Interval 3.01 to 10.78
|
5.1050 Nanogram per milliliter
Interval 1.017 to 28.795
|
5.9130 Nanogram per milliliter
Interval 0.726 to 22.813
|
64.4810 Nanogram per milliliter
Interval 8.884 to 99.8
|
33.2120 Nanogram per milliliter
Interval 1.966 to 211.754
|
—
|
|
Part A: Plasma Concentrations of GSK3358699
1 hour, n=5,3,6,6,12,6,6
|
0.4210 Nanogram per milliliter
Interval 0.264 to 0.553
|
0.9960 Nanogram per milliliter
Interval 0.893 to 1.44
|
3.5150 Nanogram per milliliter
Interval 1.234 to 8.072
|
9.1840 Nanogram per milliliter
Interval 4.283 to 18.108
|
11.0785 Nanogram per milliliter
Interval 2.165 to 17.95
|
28.4500 Nanogram per milliliter
Interval 20.421 to 92.656
|
28.8380 Nanogram per milliliter
Interval 15.838 to 39.777
|
—
|
|
Part A: Plasma Concentrations of GSK3358699
2 hours, n=5,3,6,6,12,6,6
|
0.1810 Nanogram per milliliter
Interval 0.119 to 0.215
|
0.4790 Nanogram per milliliter
Interval 0.284 to 0.651
|
1.6930 Nanogram per milliliter
Interval 0.638 to 2.067
|
4.8100 Nanogram per milliliter
Interval 2.093 to 8.048
|
6.9495 Nanogram per milliliter
Interval 3.397 to 26.662
|
10.6550 Nanogram per milliliter
Interval 6.792 to 18.163
|
8.6735 Nanogram per milliliter
Interval 7.895 to 18.906
|
—
|
|
Part A: Plasma Concentrations of GSK3358699
6 hours, n=5,3,6,6,12,6,6
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
0.3160 Nanogram per milliliter
Interval 0.243 to 0.792
|
0.6720 Nanogram per milliliter
Interval 0.385 to 1.327
|
1.1020 Nanogram per milliliter
Interval 0.409 to 2.342
|
1.4305 Nanogram per milliliter
Interval 0.916 to 3.954
|
1.2515 Nanogram per milliliter
Interval 0.98 to 1.748
|
—
|
|
Part A: Plasma Concentrations of GSK3358699
12 hours, n=5,3,2,6,12,6,6
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
0.1390 Nanogram per milliliter
Interval 0.136 to 0.142
|
0.1490 Nanogram per milliliter
Interval 0.1 to 0.159
|
0.2510 Nanogram per milliliter
Interval 0.145 to 0.605
|
0.5195 Nanogram per milliliter
Interval 0.291 to 0.745
|
0.4255 Nanogram per milliliter
Interval 0.145 to 0.939
|
—
|
|
Part A: Plasma Concentrations of GSK3358699
24 hours, n=5,3,6,6,9,4,5
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
0.1510 Nanogram per milliliter
Interval 0.0 to 0.369
|
0.1250 Nanogram per milliliter
Interval 0.0 to 0.485
|
0.2090 Nanogram per milliliter
Interval 0.0 to 0.287
|
—
|
|
Part A: Plasma Concentrations of GSK3358699
4 hours, n=5,2,6,6,12,6,6
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
0.1560 Nanogram per milliliter
Interval 0.151 to 0.161
|
0.5265 Nanogram per milliliter
Interval 0.358 to 0.916
|
1.2865 Nanogram per milliliter
Interval 0.746 to 1.599
|
1.9095 Nanogram per milliliter
Interval 1.158 to 4.344
|
3.6390 Nanogram per milliliter
Interval 1.706 to 4.101
|
2.5920 Nanogram per milliliter
Interval 1.886 to 4.266
|
—
|
|
Part A: Plasma Concentrations of GSK3358699
8 hours, n=5,3,6,6,12,6,6
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
0.2120 Nanogram per milliliter
Interval 0.11 to 0.426
|
0.3775 Nanogram per milliliter
Interval 0.209 to 0.611
|
0.5915 Nanogram per milliliter
Interval 0.23 to 1.131
|
0.8340 Nanogram per milliliter
Interval 0.318 to 1.72
|
0.6665 Nanogram per milliliter
Interval 0.434 to 1.033
|
—
|
|
Part A: Plasma Concentrations of GSK3358699
48 hours, n=5,3,6,6,6,6,6
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
0.0000 Nanogram per milliliter
Interval 0.0 to 0.114
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment periodPopulation: PK Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3358699.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Days 4, 8 and 12: Pre-dose; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dosePopulation: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo SD
n=14 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: Plasma Concentrations of GSK3358699
Day 1:1 hour,n=14,0,0,0
|
3.8955 Nanogram per milliliter
Interval 1.758 to 12.384
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3358699
Day 1:2 hours,n=14,0,0,0
|
1.3365 Nanogram per milliliter
Interval 0.826 to 4.71
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3358699
Day 1:4 hours,n=14,0,0,0
|
0.5730 Nanogram per milliliter
Interval 0.205 to 0.922
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3358699
Day 1:6 hours,n=14,0,0,0
|
0.2940 Nanogram per milliliter
Interval 0.109 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3358699
Day 1:8 hours,n=10,0,0,0
|
0.1690 Nanogram per milliliter
Interval 0.109 to 0.384
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3358699
Day 14:8 hours,n=2,0,0,0
|
0.3920 Nanogram per milliliter
Interval 0.155 to 0.629
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3358699
Day 14:12 hours,n=1,0,0,0
|
0.2730 Nanogram per milliliter
Interval 0.273 to 0.273
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3358699
Day 14:24 hours,n=2,0,0,0
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3358699
Day 14:48 hours,n=2,0,0,0
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3358699
Day 1:Pre-dose,n=14,0,0,0
|
0.0000 Nanogram per milliliter
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3358699
Day 1:15 minutes,n=14,0,0,0
|
0.2825 Nanogram per milliliter
Interval 0.0 to 13.601
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3358699
Day 1:30 minutes,n=14,0,0,0
|
5.7430 Nanogram per milliliter
Interval 0.914 to 16.96
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3358699
Day 1:12 hours,n=3,0,0,0
|
0.1390 Nanogram per milliliter
Interval 0.12 to 0.144
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3358699
Day 1:24 hours,n=14,0,0,0
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3358699
Day 4: Pre-dose,n=1,0,0,0
|
0.0000 Nanogram per milliliter
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3358699
Day 8: Pre-dose,n=2,0,0,0
|
0.0000 Nanogram per milliliter
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3358699
Day 12: Pre-dose,n=4,0,0,0
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3358699
Day 14:Pre-dose,n=2,0,0,0
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3358699
Day 14:15 minutes,n=2,0,0,0
|
4.3390 Nanogram per milliliter
Interval 1.836 to 6.842
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3358699
Day 14:30 minutes,n=2,0,0,0
|
6.0065 Nanogram per milliliter
Interval 4.658 to 7.355
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3358699
Day 14:1 hour,n=2,0,0,0
|
3.0170 Nanogram per milliliter
Interval 2.233 to 3.801
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3358699
Day 14:2 hours,n=2,0,0,0
|
1.4905 Nanogram per milliliter
Interval 0.979 to 2.002
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3358699
Day 14:4 hours,n=2,0,0,0
|
0.8295 Nanogram per milliliter
Interval 0.754 to 0.905
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3358699
Day 14:6 hours,n=2,0,0,0
|
0.6360 Nanogram per milliliter
Interval 0.313 to 0.959
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment periodPopulation: PK Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo SD
n=5 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=3 Participants
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
n=12 Participants
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Area Under the Plasma Concentration Curve From Time Zero to Last Time of Quantifiable Concentration (AUC[0-t]) of GSK3358699
|
0.74 Hours*nanogram per milliliter
Interval 0.6 to 1.3
|
2.33 Hours*nanogram per milliliter
Interval 1.7 to 2.8
|
10.77 Hours*nanogram per milliliter
Interval 5.1 to 16.4
|
23.40 Hours*nanogram per milliliter
Interval 18.1 to 30.5
|
31.88 Hours*nanogram per milliliter
Interval 27.2 to 56.0
|
66.38 Hours*nanogram per milliliter
Interval 54.6 to 128.1
|
58.09 Hours*nanogram per milliliter
Interval 48.1 to 114.3
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment periodPopulation: PK Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3358699.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dosePopulation: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo SD
n=14 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: AUC(0-t) of GSK3358699
Day 1, n=14,0,0,0
|
9.47 Hours*nanogram per milliliter
Interval 4.8 to 20.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: AUC(0-t) of GSK3358699
Day 14, n=2,0,0,0
|
11.70 Hours*nanogram per milliliter
Interval 7.6 to 15.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment periodPopulation: PK Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo SD
n=5 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=3 Participants
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
n=5 Participants
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
n=9 Participants
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
n=4 Participants
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
n=5 Participants
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-infinity]) of GSK3358699
|
NA Hours*nanogram per milliliter
AUC(0-infinity) could not be calculated as we need at least 3 data points in terminal elimination phase within same participant and this criteria could not be fulfilled due to insufficient data above limit of quantification (in all participants).
|
NA Hours*nanogram per milliliter
AUC(0-infinity) could not be calculated as we need at least 3 data points in terminal elimination phase within same participant and this criteria could not be fulfilled due to insufficient data above limit of quantification (in all participants).
|
13.20 Hours*nanogram per milliliter
Interval 5.6 to 17.0
|
23.89 Hours*nanogram per milliliter
Interval 18.6 to 31.0
|
33.22 Hours*nanogram per milliliter
Interval 28.4 to 57.0
|
69.13 Hours*nanogram per milliliter
Interval 56.6 to 129.0
|
59.68 Hours*nanogram per milliliter
Interval 49.2 to 114.7
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment periodPopulation: PK Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3358699.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dosePopulation: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo SD
n=7 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: AUC(0-infinity) of GSK3358699
Day 1, n=7,0,0,0
|
9.07 Hours*nanogram per milliliter
Interval 5.9 to 16.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours post-dose in each treatment periodPopulation: PK Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo SD
n=5 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=3 Participants
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
n=5 Participants
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
n=10 Participants
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
n=5 Participants
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) of GSK3358699
|
NA Hours*nanogram per milliliter
AUC(0-24) could not be calculated as we need at least 3 data points in terminal elimination phase within same participant and this criteria could not be fulfilled due to insufficient data above limit of quantification (in all participants).
|
NA Hours*nanogram per milliliter
AUC(0-24) could not be calculated as we need at least 3 data points in terminal elimination phase within same participant and this criteria could not be fulfilled due to insufficient data above limit of quantification (in all participants).
|
13.17 Hours*nanogram per milliliter
Interval 5.6 to 16.9
|
23.86 Hours*nanogram per milliliter
Interval 18.6 to 31.0
|
32.69 Hours*nanogram per milliliter
Interval 25.4 to 56.0
|
67.38 Hours*nanogram per milliliter
Interval 56.4 to 128.1
|
59.05 Hours*nanogram per milliliter
Interval 48.1 to 114.7
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours post-dose in each treatment periodPopulation: PK Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3358699.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 and 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, and 24 hours post-dosePopulation: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo SD
n=7 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: AUC(0-24) of GSK3358699
Day 1, n=7,0,0,0
|
9.07 Hours*nanogram per milliliter
Interval 5.8 to 16.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: AUC(0-24) of GSK3358699
Day 14, n=1,0,0,0
|
7.99 Hours*nanogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual AUC(0-24) for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment periodPopulation: PK Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo SD
n=5 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=3 Participants
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
n=12 Participants
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Maximum Plasma Concentration (Cmax) of GSK3358699
|
0.68 Nanogram per milliliter
Interval 0.5 to 1.9
|
1.95 Nanogram per milliliter
Interval 1.4 to 2.4
|
6.46 Nanogram per milliliter
Interval 3.0 to 10.8
|
16.10 Nanogram per milliliter
Interval 9.1 to 28.8
|
17.47 Nanogram per milliliter
Interval 7.5 to 26.7
|
64.48 Nanogram per milliliter
Interval 20.4 to 99.8
|
34.58 Nanogram per milliliter
Interval 20.4 to 211.8
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment periodPopulation: PK Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3358699.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dosePopulation: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo SD
n=14 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: Cmax of GSK3358699
Day 1, n=14,0,0,0
|
6.19 Nanogram per milliliter
Interval 2.6 to 17.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Cmax of GSK3358699
Day 14, n=2,0,0,0
|
6.01 Nanogram per milliliter
Interval 4.7 to 7.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment periodPopulation: PK Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo SD
n=5 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=3 Participants
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
n=12 Participants
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Time to Cmax (Tmax) of GSK3358699
|
0.50 Hours
Interval 0.3 to 1.0
|
0.50 Hours
Interval 0.5 to 1.0
|
0.50 Hours
Interval 0.5 to 0.5
|
1.00 Hours
Interval 0.3 to 1.0
|
1.00 Hours
Interval 0.2 to 2.0
|
0.76 Hours
Interval 0.5 to 1.0
|
0.51 Hours
Interval 0.5 to 1.1
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment periodPopulation: PK Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3358699.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dosePopulation: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo SD
n=14 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: Tmax of GSK3358699
Day 1, n=14,0,0,0
|
0.50 Hours
Interval 0.3 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Tmax of GSK3358699
Day 14, n=2,0,0,0
|
0.53 Hours
Interval 0.5 to 0.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment periodPopulation: PK Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo SD
n=5 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=3 Participants
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
n=5 Participants
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
n=9 Participants
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
n=4 Participants
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
n=5 Participants
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Apparent Terminal Phase Half-life (t1/2) of GSK3358699
|
NA Hours
t1/2 could not be calculated as we need at least 3 time points in terminal elimination phase within the same participant and this criteria could not be fulfilled due to insufficient data above limit of quantification (in all participants).
|
NA Hours
t1/2 could not be calculated as we need at least 3 time points in terminal elimination phase within the same participant and this criteria could not be fulfilled due to insufficient data above limit of quantification (in all participants).
|
2.44 Hours
Interval 2.0 to 2.8
|
2.75 Hours
Interval 2.0 to 3.4
|
6.02 Hours
Interval 2.1 to 18.4
|
4.77 Hours
Interval 3.5 to 11.8
|
6.88 Hours
Interval 2.1 to 11.1
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment periodPopulation: PK Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3358699.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dosePopulation: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3358699. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo SD
n=7 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: t1/2 of GSK3358699
Day 1, n=7,0,0,0
|
2.47 Hours
Interval 1.4 to 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: t1/2 of GSK3358699
Day 14, n=1,0,0,0
|
1.57 Hours
Full range is not applicable due to single participant, and the median value presented here is the actual t1/2 for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment periodPopulation: PK Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699.
Outcome measures
| Measure |
Part A: Placebo SD
n=5 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=3 Participants
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
n=12 Participants
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Plasma Concentrations of GSK3206944
Pre-dose
|
0.0000 Nanogram per milliliter
Interval 0.0 to 0.0
|
0.000 Nanogram per milliliter
Interval 0.0 to 0.0
|
0.0000 Nanogram per milliliter
Interval 0.0 to 0.0
|
0.0000 Nanogram per milliliter
Interval 0.0 to 0.0
|
0.0000 Nanogram per milliliter
Interval 0.0 to 0.0
|
0.0000 Nanogram per milliliter
Interval 0.0 to 0.0
|
0.0000 Nanogram per milliliter
Interval 0.0 to 0.0
|
—
|
|
Part A: Plasma Concentrations of GSK3206944
15 minutes
|
0.2050 Nanogram per milliliter
Interval 0.0 to 0.87
|
0.2070 Nanogram per milliliter
Interval 0.107 to 0.247
|
0.0550 Nanogram per milliliter
Interval 0.0 to 0.973
|
0.0000 Nanogram per milliliter
Interval 0.0 to 0.292
|
0.0000 Nanogram per milliliter
Interval 0.0 to 6.579
|
0.0575 Nanogram per milliliter
Interval 0.0 to 1.462
|
0.0000 Nanogram per milliliter
Interval 0.0 to 0.155
|
—
|
|
Part A: Plasma Concentrations of GSK3206944
30 minutes
|
1.2090 Nanogram per milliliter
Interval 0.223 to 3.045
|
1.8410 Nanogram per milliliter
Interval 0.705 to 2.156
|
3.1930 Nanogram per milliliter
Interval 2.03 to 9.85
|
1.8370 Nanogram per milliliter
Interval 0.0 to 10.528
|
4.3810 Nanogram per milliliter
Interval 0.216 to 25.498
|
17.2245 Nanogram per milliliter
Interval 1.546 to 27.299
|
6.3350 Nanogram per milliliter
Interval 0.412 to 46.595
|
—
|
|
Part A: Plasma Concentrations of GSK3206944
1 hour
|
3.0310 Nanogram per milliliter
Interval 1.808 to 4.898
|
4.2200 Nanogram per milliliter
Interval 2.505 to 6.026
|
17.1455 Nanogram per milliliter
Interval 6.453 to 26.263
|
26.1280 Nanogram per milliliter
Interval 18.35 to 43.603
|
33.6145 Nanogram per milliliter
Interval 2.943 to 68.271
|
89.1965 Nanogram per milliliter
Interval 16.207 to 205.963
|
74.5130 Nanogram per milliliter
Interval 26.229 to 205.962
|
—
|
|
Part A: Plasma Concentrations of GSK3206944
2 hours
|
3.2830 Nanogram per milliliter
Interval 2.145 to 4.324
|
5.5640 Nanogram per milliliter
Interval 4.837 to 7.256
|
17.6535 Nanogram per milliliter
Interval 7.569 to 30.51
|
46.4250 Nanogram per milliliter
Interval 27.542 to 82.343
|
70.4010 Nanogram per milliliter
Interval 20.386 to 105.133
|
102.0865 Nanogram per milliliter
Interval 51.492 to 161.313
|
121.2220 Nanogram per milliliter
Interval 88.345 to 231.739
|
—
|
|
Part A: Plasma Concentrations of GSK3206944
4 hours
|
1.9110 Nanogram per milliliter
Interval 1.223 to 2.658
|
3.2490 Nanogram per milliliter
Interval 2.951 to 3.733
|
10.6790 Nanogram per milliliter
Interval 7.4 to 15.516
|
22.6925 Nanogram per milliliter
Interval 13.453 to 50.059
|
46.8165 Nanogram per milliliter
Interval 28.244 to 78.533
|
51.7230 Nanogram per milliliter
Interval 40.674 to 84.834
|
69.2315 Nanogram per milliliter
Interval 46.996 to 132.904
|
—
|
|
Part A: Plasma Concentrations of GSK3206944
12 hours
|
0.2540 Nanogram per milliliter
Interval 0.122 to 0.353
|
0.4670 Nanogram per milliliter
Interval 0.336 to 0.667
|
1.8400 Nanogram per milliliter
Interval 0.785 to 2.418
|
3.4535 Nanogram per milliliter
Interval 2.385 to 4.611
|
5.3830 Nanogram per milliliter
Interval 3.258 to 9.084
|
6.7365 Nanogram per milliliter
Interval 4.811 to 8.739
|
8.7280 Nanogram per milliliter
Interval 5.519 to 19.739
|
—
|
|
Part A: Plasma Concentrations of GSK3206944
48 hours
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
0.0000 Nanogram per milliliter
Interval 0.0 to 0.249
|
0.0000 Nanogram per milliliter
Interval 0.0 to 0.205
|
0.3440 Nanogram per milliliter
Interval 0.0 to 1.447
|
0.1895 Nanogram per milliliter
Interval 0.0 to 0.922
|
0.2565 Nanogram per milliliter
Interval 0.0 to 1.659
|
—
|
|
Part A: Plasma Concentrations of GSK3206944
6 hours
|
0.9490 Nanogram per milliliter
Interval 0.529 to 1.342
|
1.5760 Nanogram per milliliter
Interval 1.532 to 1.877
|
6.7745 Nanogram per milliliter
Interval 4.726 to 9.175
|
13.7955 Nanogram per milliliter
Interval 10.716 to 28.908
|
23.1275 Nanogram per milliliter
Interval 15.32 to 44.082
|
30.4690 Nanogram per milliliter
Interval 23.891 to 34.815
|
36.8305 Nanogram per milliliter
Interval 19.883 to 59.881
|
—
|
|
Part A: Plasma Concentrations of GSK3206944
8 hours
|
0.5840 Nanogram per milliliter
Interval 0.303 to 0.945
|
1.0200 Nanogram per milliliter
Interval 1.019 to 1.096
|
4.6515 Nanogram per milliliter
Interval 2.297 to 5.599
|
8.3535 Nanogram per milliliter
Interval 6.187 to 14.398
|
13.7165 Nanogram per milliliter
Interval 9.459 to 21.878
|
16.5795 Nanogram per milliliter
Interval 10.812 to 21.258
|
18.4825 Nanogram per milliliter
Interval 12.948 to 31.766
|
—
|
|
Part A: Plasma Concentrations of GSK3206944
24 hours
|
0.0000 Nanogram per milliliter
Interval 0.0 to 0.118
|
0.1050 Nanogram per milliliter
Interval 0.0 to 0.113
|
0.2620 Nanogram per milliliter
Interval 0.136 to 0.626
|
0.4790 Nanogram per milliliter
Interval 0.348 to 0.577
|
1.2020 Nanogram per milliliter
Interval 0.598 to 3.96
|
1.1015 Nanogram per milliliter
Interval 0.63 to 2.452
|
1.5040 Nanogram per milliliter
Interval 0.471 to 4.065
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment periodPopulation: PK Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3206944. GSK3206944 is a metabolite of GSK3358699.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Days 4, 8 and 12: Pre-dose; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dosePopulation: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699.
Outcome measures
| Measure |
Part A: Placebo SD
n=14 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: Plasma Concentrations of GSK3206944
Day 1:Pre-dose,n=14,0,0,0
|
0.0000 Nanogram per milliliter
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3206944
Day 1:15 minutes,n=14,0,0,0
|
0.0000 Nanogram per milliliter
Interval 0.0 to 0.459
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3206944
Day 1:30 minutes,n=14,0,0,0
|
3.1310 Nanogram per milliliter
Interval 0.116 to 12.947
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3206944
Day 1:1 hour,n=14,0,0,0
|
19.9335 Nanogram per milliliter
Interval 5.173 to 38.568
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3206944
Day 1:2 hours,n=14,0,0,0
|
22.2250 Nanogram per milliliter
Interval 11.285 to 56.829
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3206944
Day 1:4 hours,n=14,0,0,0
|
12.7730 Nanogram per milliliter
Interval 7.948 to 39.355
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3206944
Day 1:6 hours,n=14,0,0,0
|
7.2920 Nanogram per milliliter
Interval 4.588 to 18.565
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3206944
Day 1:8 hours,n=14,0,0,0
|
4.3750 Nanogram per milliliter
Interval 2.446 to 10.04
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3206944
Day 14:30 minutes,n=2,0,0,0
|
6.4130 Nanogram per milliliter
Interval 4.906 to 7.92
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3206944
Day 14:1 hour,n=2,0,0,0
|
15.3355 Nanogram per milliliter
Interval 14.722 to 15.949
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3206944
Day 14:2 hours,n=2,0,0,0
|
15.0925 Nanogram per milliliter
Interval 14.474 to 15.711
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3206944
Day 14:4 hours,n=2,0,0,0
|
10.4550 Nanogram per milliliter
Interval 9.88 to 11.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3206944
Day 14:6 hours,n=2,0,0,0
|
6.8500 Nanogram per milliliter
Interval 5.834 to 7.866
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3206944
Day 14:8 hours,n=2,0,0,0
|
6.0330 Nanogram per milliliter
Interval 3.779 to 8.287
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3206944
Day 14:12 hours,n=2,0,0,0
|
2.2290 Nanogram per milliliter
Interval 1.424 to 3.034
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3206944
Day 1:12 hours,n=14,0,0,0
|
2.2070 Nanogram per milliliter
Interval 0.883 to 4.176
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3206944
Day 1:24 hours,n=14,0,0,0
|
0.3805 Nanogram per milliliter
Interval 0.309 to 1.062
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3206944
Day 4: Pre-dose,n=14,0,0,0
|
0.5355 Nanogram per milliliter
Interval 0.0 to 0.89
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3206944
Day 8: Pre-dose,n=7,0,0,0
|
0.6640 Nanogram per milliliter
Interval 0.2 to 1.233
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3206944
Day 12: Pre-dose,n=4,0,0,0
|
0.4945 Nanogram per milliliter
Interval 0.382 to 1.217
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3206944
Day 14:Pre-dose,n=2,0,0,0
|
0.5820 Nanogram per milliliter
Interval 0.549 to 0.615
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3206944
Day 14:15 minutes,n=2,0,0,0
|
0.7430 Nanogram per milliliter
Interval 0.582 to 0.904
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3206944
Day 14:24 hours,n=2,0,0,0
|
0.5275 Nanogram per milliliter
Interval 0.445 to 0.61
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Plasma Concentrations of GSK3206944
Day 14:48 hours,n=1,0,0,0
|
0.1110 Nanogram per milliliter
Interval 0.111 to 0.111
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment periodPopulation: PK Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699.
Outcome measures
| Measure |
Part A: Placebo SD
n=5 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=3 Participants
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
n=12 Participants
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: AUC(0-t) of GSK3206944
|
15.16 Hours*nanogram per milliliter
Interval 9.0 to 22.6
|
29.12 Hours*nanogram per milliliter
Interval 25.0 to 31.6
|
106.55 Hours*nanogram per milliliter
Interval 73.3 to 143.0
|
209.98 Hours*nanogram per milliliter
Interval 172.2 to 376.7
|
381.16 Hours*nanogram per milliliter
Interval 289.5 to 431.4
|
470.40 Hours*nanogram per milliliter
Interval 403.1 to 706.8
|
630.63 Hours*nanogram per milliliter
Interval 432.5 to 1030.1
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment periodPopulation: PK Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3206944. GSK3206944 is a metabolite of GSK3358699.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dosePopulation: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699.
Outcome measures
| Measure |
Part A: Placebo SD
n=14 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: AUC(0-t) of GSK3206944
Day 1, n=14,0,0,0
|
115.17 Hours*nanogram per milliliter
Interval 68.7 to 272.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: AUC(0-t) of GSK3206944
Day 14, n=2,0,0,0
|
109.71 Hours*nanogram per milliliter
Interval 94.7 to 124.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment periodPopulation: PK Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699.
Outcome measures
| Measure |
Part A: Placebo SD
n=2 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=2 Participants
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
n=4 Participants
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
n=8 Participants
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
n=4 Participants
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: AUC(0-infinity) of GSK3206944
|
17.08 Hours*nanogram per milliliter
Interval 16.4 to 17.8
|
29.05 Hours*nanogram per milliliter
Interval 25.7 to 32.4
|
108.29 Hours*nanogram per milliliter
Interval 74.7 to 144.3
|
189.02 Hours*nanogram per milliliter
Interval 174.4 to 221.8
|
357.98 Hours*nanogram per milliliter
Interval 291.8 to 419.1
|
492.92 Hours*nanogram per milliliter
Interval 408.6 to 709.6
|
649.74 Hours*nanogram per milliliter
Interval 443.5 to 1030.9
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment periodPopulation: PK Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3206944. GSK3206944 is a metabolite of GSK3358699.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dosePopulation: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699.
Outcome measures
| Measure |
Part A: Placebo SD
n=14 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: AUC(0-infinity) of GSK3206944
Day 1, n=14,0,0,0
|
117.25 Hours*nanogram per milliliter
Interval 71.2 to 274.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours post-dose in each treatment periodPopulation: PK Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699.
Outcome measures
| Measure |
Part A: Placebo SD
n=2 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=2 Participants
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
n=12 Participants
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: AUC(0-24) of GSK3206944
|
16.44 Hours*nanogram per milliliter
Interval 15.2 to 17.7
|
28.27 Hours*nanogram per milliliter
Interval 25.0 to 31.6
|
106.55 Hours*nanogram per milliliter
Interval 65.4 to 143.0
|
209.96 Hours*nanogram per milliliter
Interval 172.2 to 368.7
|
374.49 Hours*nanogram per milliliter
Interval 278.6 to 406.3
|
452.66 Hours*nanogram per milliliter
Interval 377.9 to 692.4
|
586.70 Hours*nanogram per milliliter
Interval 407.2 to 1019.2
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours post-dose in each treatment periodPopulation: PK Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3206944. GSK3206944 is a metabolite of GSK3358699.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 and 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, and 24 hours post-dosePopulation: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699.
Outcome measures
| Measure |
Part A: Placebo SD
n=14 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: AUC(0-24) of GSK3206944
Day 14, n=2,0,0,0
|
106.19 Hours*nanogram per milliliter
Interval 94.7 to 117.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: AUC(0-24) of GSK3206944
Day 1, n=14,0,0,0
|
115.31 Hours*nanogram per milliliter
Interval 68.8 to 272.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment periodPopulation: PK Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699.
Outcome measures
| Measure |
Part A: Placebo SD
n=5 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=3 Participants
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
n=12 Participants
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Cmax of GSK3206944
|
3.28 Nanogram per milliliter
Interval 2.1 to 4.9
|
6.03 Nanogram per milliliter
Interval 4.8 to 7.3
|
19.39 Nanogram per milliliter
Interval 7.6 to 30.5
|
50.13 Nanogram per milliliter
Interval 27.5 to 82.3
|
71.67 Nanogram per milliliter
Interval 44.3 to 105.1
|
102.09 Nanogram per milliliter
Interval 51.5 to 206.0
|
121.22 Nanogram per milliliter
Interval 88.3 to 231.7
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment periodPopulation: PK Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3206944. GSK3206944 is a metabolite of GSK3358699.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dosePopulation: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699.
Outcome measures
| Measure |
Part A: Placebo SD
n=14 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: Cmax of GSK3206944
Day 1, n=14,0,0,0
|
23.02 Nanogram per milliliter
Interval 11.3 to 56.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Cmax of GSK3206944
Day 14, n=2,0,0,0
|
15.34 Nanogram per milliliter
Interval 14.7 to 15.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment periodPopulation: PK Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699.
Outcome measures
| Measure |
Part A: Placebo SD
n=5 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=3 Participants
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
n=12 Participants
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Tmax of GSK3206944
|
1.00 Hours
Interval 1.0 to 2.0
|
2.00 Hours
Interval 1.0 to 2.0
|
2.00 Hours
Interval 1.0 to 2.0
|
2.01 Hours
Interval 1.0 to 2.1
|
2.00 Hours
Interval 2.0 to 4.0
|
2.00 Hours
Interval 1.0 to 2.0
|
2.00 Hours
Interval 1.0 to 2.0
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment periodPopulation: PK Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3206944. GSK3206944 is a metabolite of GSK3358699.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dosePopulation: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699.
Outcome measures
| Measure |
Part A: Placebo SD
n=14 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: Tmax of GSK3206944
Day 1, n=14,0,0,0
|
2.00 Hours
Interval 1.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Tmax of GSK3206944
Day 14, n=2,0,0,0
|
0.99 Hours
Interval 0.98 to 1.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment periodPopulation: PK Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699.
Outcome measures
| Measure |
Part A: Placebo SD
n=2 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=2 Participants
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
n=4 Participants
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
n=8 Participants
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
n=4 Participants
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: t1/2 of GSK3206944
|
4.97 Hours
Interval 2.8 to 7.1
|
4.91 Hours
Interval 4.8 to 5.0
|
4.10 Hours
Interval 3.0 to 14.5
|
3.80 Hours
Interval 3.5 to 4.3
|
7.81 Hours
Interval 3.8 to 11.6
|
6.98 Hours
Interval 4.1 to 8.8
|
6.76 Hours
Interval 3.0 to 15.2
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose in each treatment periodPopulation: PK Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3206944. GSK3206944 is a metabolite of GSK3358699.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12 and 24 hours; Day 14: Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dosePopulation: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3206944. PK parameters were calculated using standard non-compartmental analysis. GSK3206944 is a metabolite of GSK3358699.
Outcome measures
| Measure |
Part A: Placebo SD
n=14 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: t1/2 of GSK3206944
Day 1, n=14,0,0,0
|
5.02 Hours
Interval 3.3 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: t1/2 of GSK3206944
Day 14, n=2,0,0,0
|
6.15 Hours
Interval 5.5 to 6.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: 1, 4, 8, 24 and 48 hours post-dose in each treatment periodPopulation: PK Population.
Blood samples were collected into sodium heparin tubes for the isolation of monocytes and for measurement of GSK3206944 concentrations in monocytes. GSK3206944 is a metabolite of GSK3358699.
Outcome measures
| Measure |
Part A: Placebo SD
n=5 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=3 Participants
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
n=12 Participants
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Monocyte Intracellular Concentration of GSK3206944
Day 1: 1 hour
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
0.177 Nanogram per milliliter
Interval 0.0 to 0.6
|
0.673 Nanogram per milliliter
Interval 0.0 to 1.08
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
1.243 Nanogram per milliliter
Interval 0.63 to 2.13
|
1.410 Nanogram per milliliter
Interval 0.94 to 1.94
|
—
|
|
Part A: Monocyte Intracellular Concentration of GSK3206944
Day 1: 8 hours
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
—
|
|
Part A: Monocyte Intracellular Concentration of GSK3206944
Day 1: 24 hours
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
—
|
|
Part A: Monocyte Intracellular Concentration of GSK3206944
Day 1: 48 hours
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
—
|
|
Part A: Monocyte Intracellular Concentration of GSK3206944
Day 1: 4 hours
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
0.105 Nanogram per milliliter
Interval 0.0 to 0.26
|
0.149 Nanogram per milliliter
Interval 0.0 to 0.84
|
0.277 Nanogram per milliliter
Interval 0.0 to 0.38
|
0.297 Nanogram per milliliter
Interval 0.0 to 0.45
|
—
|
SECONDARY outcome
Timeframe: Day 1: 1, 4, 8, 24 and 48 hours post-dose in each treatment periodPopulation: PK Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected into sodium heparin tubes for the isolation of monocytes and for measurement of GSK3206944 concentrations in monocytes. GSK3206944 is a metabolite of GSK3358699.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 and 13: 1, 4 and 8 hour; Days 4, 8 and 12: Pre-dose; Day 14: 1, 4, 8, 24 and 48 hours post-dosePopulation: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). Data was not collected for Cohorts 6 to 8 as no participants were enrolled.
Blood samples were collected into sodium heparin tubes for the isolation of monocytes and for measurement of GSK3206944 concentrations in monocytes. GSK3206944 is a metabolite of GSK3358699.
Outcome measures
| Measure |
Part A: Placebo SD
n=14 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: Monocyte Intracellular Concentration of GSK3206944
Day 1: 1 hour,n=14,0,0,0
|
0.313 Nanogram per milliliter
Interval 0.0 to 0.56
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Monocyte Intracellular Concentration of GSK3206944
Day 1: 4 hours,n=14,0,0,0
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Monocyte Intracellular Concentration of GSK3206944
Day 1: 8 hours,n=14,0,0,0
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Monocyte Intracellular Concentration of GSK3206944
Day 4: Pre-dose,n=14,0,0,0
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Monocyte Intracellular Concentration of GSK3206944
Day 8: Pre-dose,n=14,0,0,0
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Monocyte Intracellular Concentration of GSK3206944
Day 12: Pre-dose,n=14,0,0,0
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Monocyte Intracellular Concentration of GSK3206944
Day 13: 1 hour,n=1,0,0,0
|
0.317 Nanogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual monocyte intracellular concentration for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Monocyte Intracellular Concentration of GSK3206944
Day 13: 4 hours,n=1,0,0,0
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Monocyte Intracellular Concentration of GSK3206944
Day 13: 8 hours,n=1,0,0,0
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Monocyte Intracellular Concentration of GSK3206944
Day 14: 1 hour,n=1,0,0,0
|
0.256 Nanogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual monocyte intracellular concentration for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Monocyte Intracellular Concentration of GSK3206944
Day 14: 4 hours,n=1,0,0,0
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Monocyte Intracellular Concentration of GSK3206944
Day 14: 8 hours,n=1,0,0,0
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Monocyte Intracellular Concentration of GSK3206944
Day 14: 24 hours,n=1,0,0,0
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Monocyte Intracellular Concentration of GSK3206944
Day 14: 48 hours,n=1,0,0,0
|
NA Nanogram per milliliter
Data could not be calculated as it was below the limit of quantification.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: 1, 4, 8, 12, 24 and 48 hoursPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). Data was not collected for GSK3358699 25 mg SD arm.
Whole blood samples of 1 milliliter (mL) were collected in TruCulture tubes, containing LPS and incubated for 24 hours, post which the inflammatory mediators (MCP-1, IL-6 and TNF alpha) were analyzed.
Outcome measures
| Measure |
Part A: Placebo SD
n=17 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=5 Participants
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
n=3 Participants
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
n=6 Participants
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation
Day 1: IL6, 4 hours, n=17,5,3,6,6,0,6,6
|
13092.01 Picogram per milliliter
Interval 4833.9 to 19117.2
|
13851.61 Picogram per milliliter
Interval 9601.7 to 23110.3
|
19431.61 Picogram per milliliter
Interval 16293.4 to 24387.6
|
15636.75 Picogram per milliliter
Interval 8048.6 to 34008.3
|
12900.07 Picogram per milliliter
Interval 6507.3 to 25108.1
|
—
|
12074.28 Picogram per milliliter
Interval 4669.2 to 21515.6
|
7544.02 Picogram per milliliter
Interval 5345.9 to 26788.0
|
|
Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation
Day 1: IL6, 8 hours, n=17,5,3,6,6,0,6,6
|
12560.83 Picogram per milliliter
Interval 7112.0 to 33941.2
|
13629.60 Picogram per milliliter
Interval 10440.1 to 27946.6
|
28805.81 Picogram per milliliter
Interval 24272.2 to 31362.4
|
16564.79 Picogram per milliliter
Interval 11058.8 to 26785.4
|
17019.48 Picogram per milliliter
Interval 12120.4 to 21106.7
|
—
|
16486.96 Picogram per milliliter
Interval 7413.4 to 21952.6
|
8688.63 Picogram per milliliter
Interval 6758.8 to 20765.0
|
|
Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation
Day 1: MCP-1, 8 hours, n=17,5,3,6,6,0,6,6
|
1300.34 Picogram per milliliter
Interval 713.0 to 3074.7
|
2911.87 Picogram per milliliter
Interval 1297.8 to 4926.4
|
3145.66 Picogram per milliliter
Interval 2964.7 to 3966.5
|
1606.85 Picogram per milliliter
Interval 993.1 to 2784.3
|
1533.33 Picogram per milliliter
Interval 634.0 to 3454.9
|
—
|
2312.12 Picogram per milliliter
Interval 899.7 to 3203.8
|
1863.25 Picogram per milliliter
Interval 1295.9 to 3392.0
|
|
Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation
Day 1: MCP-1, 12 hour, n=17,5,3,6,6,0,6,6
|
1791.07 Picogram per milliliter
Interval 808.9 to 4505.9
|
2738.20 Picogram per milliliter
Interval 2017.5 to 4140.2
|
3048.56 Picogram per milliliter
Interval 3045.4 to 4036.5
|
2003.41 Picogram per milliliter
Interval 832.7 to 4276.2
|
1297.53 Picogram per milliliter
Interval 903.3 to 5483.9
|
—
|
2062.41 Picogram per milliliter
Interval 1546.5 to 3811.4
|
2270.49 Picogram per milliliter
Interval 882.1 to 7042.9
|
|
Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation
Day 1: MCP-1, 24 hours, n=17,5,3,6,6,0,6,6
|
1662.28 Picogram per milliliter
Interval 673.9 to 3360.2
|
2349.62 Picogram per milliliter
Interval 912.1 to 3608.3
|
2216.41 Picogram per milliliter
Interval 1124.8 to 5178.2
|
1691.59 Picogram per milliliter
Interval 661.1 to 2299.7
|
1062.86 Picogram per milliliter
Interval 369.0 to 5821.6
|
—
|
2275.17 Picogram per milliliter
Interval 845.9 to 2731.8
|
1988.64 Picogram per milliliter
Interval 1360.9 to 3313.2
|
|
Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation
Day 1: MCP-1, 48 hours, n=17,5,3,6,6,0,6,6
|
1398.36 Picogram per milliliter
Interval 526.2 to 4408.1
|
2306.83 Picogram per milliliter
Interval 577.0 to 4174.3
|
1621.46 Picogram per milliliter
Interval 1505.3 to 3215.7
|
1729.87 Picogram per milliliter
Interval 958.5 to 2877.5
|
1200.15 Picogram per milliliter
Interval 514.4 to 3554.8
|
—
|
1595.51 Picogram per milliliter
Interval 1082.1 to 2315.4
|
1828.23 Picogram per milliliter
Interval 894.9 to 2434.1
|
|
Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation
Day 1: TNF alpha, 4 hours, n=17,5,3,6,6,0,6,6
|
3189.81 Picogram per milliliter
Interval 1264.1 to 5492.9
|
3452.27 Picogram per milliliter
Interval 3139.9 to 8159.2
|
3381.52 Picogram per milliliter
Interval 3014.8 to 8775.2
|
4493.55 Picogram per milliliter
Interval 1481.7 to 16761.7
|
2672.58 Picogram per milliliter
Interval 1527.3 to 7834.4
|
—
|
3618.72 Picogram per milliliter
Interval 698.0 to 5482.5
|
1876.55 Picogram per milliliter
Interval 1429.5 to 10939.6
|
|
Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation
Day 1: TNF alpha, 8 hours, n=17,5,3,6,6,0,6,6
|
3673.78 Picogram per milliliter
Interval 1891.2 to 8758.2
|
3630.47 Picogram per milliliter
Interval 2520.6 to 8206.4
|
9631.19 Picogram per milliliter
Interval 8462.1 to 9881.2
|
4612.79 Picogram per milliliter
Interval 2513.7 to 10996.7
|
4908.42 Picogram per milliliter
Interval 3867.7 to 7647.1
|
—
|
5233.22 Picogram per milliliter
Interval 1875.8 to 6062.3
|
2934.21 Picogram per milliliter
Interval 2142.3 to 8128.1
|
|
Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation
Day 1: TNF alpha, 12 hour, n=17,5,3,6,6,0,6,6
|
4206.18 Picogram per milliliter
Interval 717.0 to 9209.7
|
3680.34 Picogram per milliliter
Interval 3268.1 to 6257.6
|
8736.93 Picogram per milliliter
Interval 7805.2 to 10949.6
|
5139.53 Picogram per milliliter
Interval 1199.2 to 10251.4
|
3079.37 Picogram per milliliter
Interval 2178.8 to 7014.1
|
—
|
2846.57 Picogram per milliliter
Interval 1964.6 to 7505.2
|
1729.42 Picogram per milliliter
Interval 1203.4 to 2845.9
|
|
Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation
Day 1: TNF alpha, 24 hours, n=17,5,3,5,6,0,6,6
|
3164.79 Picogram per milliliter
Interval 845.9 to 6087.5
|
4528.14 Picogram per milliliter
Interval 3348.7 to 7098.2
|
4694.58 Picogram per milliliter
Interval 3321.5 to 13261.4
|
5576.01 Picogram per milliliter
Interval 1699.4 to 12223.1
|
3543.62 Picogram per milliliter
Interval 2185.0 to 9815.1
|
—
|
3649.08 Picogram per milliliter
Interval 1319.2 to 4891.2
|
2741.96 Picogram per milliliter
Interval 1683.3 to 8477.3
|
|
Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation
Day 1: TNF alpha, 48 hours, n=17,5,3,6,6,0,6,6
|
3445.95 Picogram per milliliter
Interval 2189.6 to 7880.2
|
4077.77 Picogram per milliliter
Interval 2120.7 to 6772.6
|
10364.95 Picogram per milliliter
Interval 3942.4 to 14023.2
|
4186.10 Picogram per milliliter
Interval 2069.1 to 12454.5
|
3963.40 Picogram per milliliter
Interval 1613.3 to 5663.8
|
—
|
3788.04 Picogram per milliliter
Interval 2727.4 to 5746.1
|
2404.11 Picogram per milliliter
Interval 1734.5 to 6985.8
|
|
Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation
Day 1: IL6, 12 hour, n=17,5,3,6,6,0,6,6
|
15125.82 Picogram per milliliter
Interval 2587.2 to 26028.6
|
13890.39 Picogram per milliliter
Interval 11271.0 to 21279.4
|
28948.13 Picogram per milliliter
Interval 24063.6 to 33176.4
|
18712.82 Picogram per milliliter
Interval 6493.7 to 26803.1
|
15622.25 Picogram per milliliter
Interval 10623.8 to 24243.3
|
—
|
12305.88 Picogram per milliliter
Interval 8132.7 to 19539.9
|
6754.46 Picogram per milliliter
Interval 3909.8 to 13207.0
|
|
Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation
Day 1: IL6, 24 hours, n=17,5,3,6,6,0,6,6
|
12876.74 Picogram per milliliter
Interval 5221.8 to 19587.8
|
16961.79 Picogram per milliliter
Interval 10045.9 to 23511.8
|
23634.22 Picogram per milliliter
Interval 17018.1 to 32159.5
|
14387.39 Picogram per milliliter
Interval 9362.7 to 32140.8
|
12593.53 Picogram per milliliter
Interval 8519.9 to 32945.4
|
—
|
12894.02 Picogram per milliliter
Interval 5914.3 to 17523.1
|
8705.59 Picogram per milliliter
Interval 6150.6 to 23530.0
|
|
Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation
Day 1: IL6, 48 hours, n=17,5,3,6,6,0,6,6
|
13204.84 Picogram per milliliter
Interval 6897.8 to 24379.3
|
16209.14 Picogram per milliliter
Interval 8492.7 to 25387.3
|
27160.99 Picogram per milliliter
Interval 17882.7 to 45604.5
|
14786.71 Picogram per milliliter
Interval 10321.9 to 33336.3
|
13685.44 Picogram per milliliter
Interval 7729.6 to 20697.6
|
—
|
14374.44 Picogram per milliliter
Interval 8079.6 to 19835.0
|
8359.81 Picogram per milliliter
Interval 6088.1 to 19757.4
|
|
Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation
Day 1: MCP-1, 4 hours, n=17,5,3,6,6,0,6,6
|
1748.71 Picogram per milliliter
Interval 878.2 to 3917.7
|
2638.95 Picogram per milliliter
Interval 1272.7 to 2942.2
|
3774.02 Picogram per milliliter
Interval 2841.1 to 4578.7
|
1410.01 Picogram per milliliter
Interval 617.5 to 1973.0
|
1648.51 Picogram per milliliter
Interval 559.9 to 4038.0
|
—
|
2604.00 Picogram per milliliter
Interval 918.1 to 3465.2
|
1643.37 Picogram per milliliter
Interval 1067.0 to 3385.4
|
|
Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation
Day 1: MCP-1, 1 hour, n=17,5,2,6,6,0,6,6
|
2107.38 Picogram per milliliter
Interval 692.3 to 4748.1
|
2997.62 Picogram per milliliter
Interval 775.1 to 5062.0
|
2539.15 Picogram per milliliter
Interval 1560.9 to 3517.4
|
1273.19 Picogram per milliliter
Interval 872.5 to 2047.4
|
1278.42 Picogram per milliliter
Interval 640.5 to 2640.6
|
—
|
1604.85 Picogram per milliliter
Interval 863.0 to 3331.4
|
1047.32 Picogram per milliliter
Interval 716.5 to 1933.0
|
|
Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation
Day 1: IL6, 1 hour, n=17,5,3,6,6,0,6,6
|
10352.87 Picogram per milliliter
Interval 6166.6 to 19166.3
|
15208.12 Picogram per milliliter
Interval 7257.3 to 24940.9
|
20385.25 Picogram per milliliter
Interval 13064.2 to 22017.3
|
12820.72 Picogram per milliliter
Interval 9166.6 to 33445.0
|
15596.95 Picogram per milliliter
Interval 3426.4 to 28751.1
|
—
|
10057.64 Picogram per milliliter
Interval 5014.4 to 17359.8
|
5728.17 Picogram per milliliter
Interval 4267.2 to 18422.7
|
|
Part A: Absolute Values of Monocyte Chemotactic Protein (MCP)-1, Interleukin (IL)6, Tumor Necrosis Factor (TNF) Alpha in Blood After Ex-vivo Lipopolysaccharide (LPS) Activation
Day 1: TNF alpha, 1 hour, n=17,5,3,6,6,0,6,6
|
2525.78 Picogram per milliliter
Interval 1073.6 to 4950.0
|
2281.20 Picogram per milliliter
Interval 2214.6 to 5283.6
|
4340.00 Picogram per milliliter
Interval 2395.2 to 6512.0
|
3455.53 Picogram per milliliter
Interval 2172.3 to 12708.3
|
3916.76 Picogram per milliliter
Interval 567.9 to 5873.5
|
—
|
1971.77 Picogram per milliliter
Interval 992.6 to 3554.9
|
1552.10 Picogram per milliliter
Interval 640.6 to 5120.6
|
SECONDARY outcome
Timeframe: Day 1: 1, 4, 8, 12, 24 and 48 hoursPopulation: Safety Population. Data was not collected as no participants were enrolled in Part B.
Whole blood samples were planned to be collected in TruCulture tubes, containing LPS and incubated for 24 hours, post which the inflammatory mediators (MCP-1, IL6 and TNF alpha) were planned to be analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1: 1, 4 and 8 hours; Days 2, 4, 8 and 12: Pre-dose; Day 13: Pre-dose, 1, 4 and 8 hours; Day 14: Pre-dose, Pre-LPS challenge, 1, 4, 8, 24 and 48 hoursPopulation: Safety Population. Data was not collected for Cohorts 6 to 8 as no participants were enrolled. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Whole blood samples of 1 mL were collected in TruCulture tubes, containing LPS and incubated for 24 hours, post which the inflammatory mediators (MCP-1, IL-6 and TNF alpha) were analyzed.
Outcome measures
| Measure |
Part A: Placebo SD
n=11 Participants
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=14 Participants
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
IL6:Day 1,8 hours,n=11,14,0,0,0
|
13079.21 Picogram per milliliter
Interval 5597.2 to 20424.0
|
15475.58 Picogram per milliliter
Interval 1340.7 to 35210.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
IL6:Day 2,Pre-dose,n=11,14,0,0,0
|
9323.67 Picogram per milliliter
Interval 4126.4 to 19011.4
|
12396.71 Picogram per milliliter
Interval 5456.9 to 19819.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
IL6:Day 14,Pre LPS challenge,n=1,1,0,0,0
|
8696.65 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual IL6 for this single participant.
|
11340.79 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual IL6 for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
IL6:Day 14,8 hours,n=1,1,0,0,0
|
10986.16 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual IL6 for this single participant.
|
12544.55 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual IL6 for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
MCP-1:Day 1,1 hour,n=11,14,0,0,0
|
1739.49 Picogram per milliliter
Interval 114.6 to 4212.9
|
2216.06 Picogram per milliliter
Interval 1080.4 to 4084.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
MCP-1:Day 1,4 hours,n=11,14,0,0,0
|
1825.09 Picogram per milliliter
Interval 813.5 to 3719.8
|
2405.11 Picogram per milliliter
Interval 996.0 to 5337.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
MCP-1:Day 13,Pre-dose,n=1,1,0,0,0
|
1839.00 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual MCP-1 for this single participant.
|
513.36 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual MCP-1 for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
MCP-1:Day 14,1 hour,n=1,1,0,0,0
|
3503.11 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual MCP-1 for this single participant.
|
3623.79 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual MCP-1 for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
TNF alpha:Day 1,1 hour,n=11,13,0,0,0
|
1994.72 Picogram per milliliter
Interval 135.2 to 3287.3
|
2078.66 Picogram per milliliter
Interval 962.5 to 4069.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
TNF alpha:Day 1,4 hours,n=11,14,0,0,0
|
1843.08 Picogram per milliliter
Interval 596.4 to 4580.6
|
2297.36 Picogram per milliliter
Interval 1173.8 to 4818.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
TNF alpha:Day 12,Pre-dose,n=5,4,0,0,0
|
2482.03 Picogram per milliliter
Interval 1958.2 to 3588.4
|
2407.60 Picogram per milliliter
Interval 1143.7 to 2971.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
TNF alpha:Day 14,Pre-dose,n=1,1,0,0,0
|
2304.40 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual TNF alpha for this single participant.
|
3327.69 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual TNF alpha for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
TNF alpha:Day 14,8 hours,n=1,1,0,0,0
|
2560.84 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual TNF alpha for this single participant.
|
3481.91 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual TNF alpha for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
IL6:Day 1,1 hour,n=11,13,0,0,0
|
9488.65 Picogram per milliliter
Interval 331.7 to 16540.5
|
9629.75 Picogram per milliliter
Interval 3513.3 to 14975.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
IL6:Day 1,4 hours,n=11,14,0,0,0
|
9121.35 Picogram per milliliter
Interval 3866.4 to 18996.3
|
10686.75 Picogram per milliliter
Interval 3976.0 to 17276.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
IL6:Day 4,Pre-dose,n=11,14,0,0,0
|
11002.47 Picogram per milliliter
Interval 2713.4 to 19232.1
|
12558.78 Picogram per milliliter
Interval 4188.7 to 20344.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
IL6:Day 8,Pre-dose,n=6,7,0,0,0
|
11305.84 Picogram per milliliter
Interval 8590.8 to 31436.0
|
10766.02 Picogram per milliliter
Interval 4511.8 to 13171.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
IL6:Day 12,Pre-dose,n=5,4,0,0,0
|
9329.36 Picogram per milliliter
Interval 7777.5 to 16845.5
|
10539.82 Picogram per milliliter
Interval 7378.2 to 12671.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
IL6:Day 13,Pre-dose,n=1,1,0,0,0
|
9966.64 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual IL6 for this single participant.
|
12743.26 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual IL6 for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
IL6:Day 13,1 hour,n=1,1,0,0,0
|
11718.40 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual IL6 for this single participant.
|
12508.94 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual IL6 for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
IL6:Day 13,4 hours,n=1,1,0,0,0
|
7099.42 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual IL6 for this single participant.
|
11616.53 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual IL6 for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
IL6:Day 13,8 hours,n=1,1,0,0,0
|
10722.24 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual IL6 for this single participant.
|
16723.58 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual IL6 for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
IL6:Day 14,Pre-dose,n=1,1,0,0,0
|
8918.96 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual IL6 for this single participant.
|
14654.83 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual IL6 for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
IL6:Day 14,1 hour,n=1,1,0,0,0
|
10082.23 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual IL6 for this single participant.
|
13244.20 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual IL6 for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
IL6:Day 14,4 hours,n=1,1,0,0,0
|
9122.21 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual IL6 for this single participant.
|
11543.08 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual IL6 for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
IL6:Day 14,24 hours,n=1,1,0,0,0
|
9176.89 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual IL6 for this single participant.
|
9114.15 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual IL6 for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
IL6:Day 14,48 hours,n=1,1,0,0,0
|
8257.88 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual IL6 for this single participant.
|
10304.01 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual IL6 for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
MCP-1:Day 1,8 hours,n=11,14,0,0,0
|
2002.44 Picogram per milliliter
Interval 656.7 to 4982.8
|
2044.64 Picogram per milliliter
Interval 148.3 to 2887.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
MCP-1:Day 2,Pre-dose,n=11,14,0,0,0
|
1939.09 Picogram per milliliter
Interval 511.6 to 4614.3
|
1928.51 Picogram per milliliter
Interval 818.2 to 4090.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
MCP-1:Day 4,Pre-dose,n=11,14,0,0,0
|
1677.88 Picogram per milliliter
Interval 537.9 to 3500.9
|
1939.65 Picogram per milliliter
Interval 747.5 to 3428.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
MCP-1:Day 8,Pre-dose,n=6,7,0,0,0
|
1638.33 Picogram per milliliter
Interval 1129.3 to 6091.9
|
1719.26 Picogram per milliliter
Interval 1336.5 to 3634.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
MCP-1:Day 12,Pre-dose,n=5,4,0,0,0
|
1799.12 Picogram per milliliter
Interval 1262.3 to 4483.2
|
2176.12 Picogram per milliliter
Interval 497.9 to 2954.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
MCP-1:Day 13,1 hour,n=1,1,0,0,0
|
2113.92 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual MCP-1 for this single participant.
|
294.72 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual MCP-1 for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
MCP-1:Day 13,4 hours,n=1,1,0,0,0
|
1872.12 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual MCP-1 for this single participant.
|
890.77 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual MCP-1 for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
MCP-1:Day 13,8 hours,n=1,1,0,0,0
|
1997.87 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual MCP-1 for this single participant.
|
1412.52 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual MCP-1 for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
MCP-1:Day 14,Pre-dose,n=1,1,0,0,0
|
2007.09 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual MCP-1 for this single participant.
|
4935.03 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual MCP-1 for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
MCP-1:Day 14,Pre LPS challenge,n=1,1,0,0,0
|
1876.05 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual MCP-1 for this single participant.
|
1981.15 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual MCP-1 for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
MCP-1:Day 14,4 hours,n=1,1,0,0,0
|
2066.72 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual MCP-1 for this single participant.
|
3293.92 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual MCP-1 for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
MCP-1:Day 14,8 hours,n=1,1,0,0,0
|
2593.90 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual MCP-1 for this single participant.
|
3150.84 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual MCP-1 for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
MCP-1:Day 14,24 hours,n=1,1,0,0,0
|
2082.28 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual MCP-1 for this single participant.
|
3372.94 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual MCP-1 for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
MCP-1:Day 14,48 hours,n=1,1,0,0,0
|
1879.53 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual MCP-1 for this single participant.
|
2715.94 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual MCP-1 for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
TNF alpha:Day 1,8 hours,n=11,14,0,0,0
|
3692.36 Picogram per milliliter
Interval 1094.9 to 6402.9
|
3854.86 Picogram per milliliter
Interval 289.5 to 13254.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
TNF alpha:Day 2,Pre-dose,n=11,14,0,0,0
|
2711.07 Picogram per milliliter
Interval 849.2 to 4558.3
|
3028.33 Picogram per milliliter
Interval 1506.6 to 5961.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
TNF alpha:Day 4,Pre-dose,n=11,14,0,0,0
|
2987.24 Picogram per milliliter
Interval 456.6 to 5033.0
|
3045.05 Picogram per milliliter
Interval 1202.4 to 5443.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
TNF alpha:Day 8,Pre-dose,n=6,7,0,0,0
|
2932.72 Picogram per milliliter
Interval 2616.4 to 7598.9
|
2849.52 Picogram per milliliter
Interval 784.2 to 3366.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
TNF alpha:Day 13,Pre-dose,n=1,1,0,0,0
|
2311.66 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual TNF alpha for this single participant.
|
2995.36 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual TNF alpha for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
TNF alpha:Day 13,1 hour,n=1,1,0,0,0
|
3495.21 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual TNF alpha for this single participant.
|
2648.27 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual TNF alpha for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
TNF alpha:Day 13,4 hours,n=1,1,0,0,0
|
1573.18 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual TNF alpha for this single participant.
|
2815.39 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual TNF alpha for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
TNF alpha:Day 13,8 hours,n=1,1,0,0,0
|
2486.89 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual TNF alpha for this single participant.
|
4472.25 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual TNF alpha for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
TNF alpha:Day 14,Pre LPS challenge,n=1,1,0,0,0
|
2092.07 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual TNF alpha for this single participant.
|
2081.54 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual TNF alpha for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
TNF alpha:Day 14,1 hour,n=1,1,0,0,0
|
2103.62 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual TNF alpha for this single participant.
|
3133.32 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual TNF alpha for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
TNF alpha:Day 14,4 hours,n=1,1,0,0,0
|
1771.69 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual TNF alpha for this single participant.
|
2457.35 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual TNF alpha for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
TNF alpha:Day 14,24 hours,n=1,1,0,0,0
|
1482.94 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual TNF alpha for this single participant.
|
2187.40 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual TNF alpha for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Absolute Values of MCP-1, IL6, TNF Alpha in Blood After Ex-vivo LPS Activation
TNF alpha:Day 14,48 hours,n=1,1,0,0,0
|
1909.65 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual TNF alpha for this single participant.
|
2597.32 Picogram per milliliter
Full range is not applicable due to single participant, and the median value presented here is the actual TNF alpha for this single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part A: Placebo SD
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part A: GSK3358699 1 mg SD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A: GSK3358699 3 mg SD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: GSK3358699 10 mg SD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A: GSK3358699 20 mg SD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: GSK3358699 25 mg SD
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part A: GSK3358699 30 mg SD
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part A: GSK3358699 40 mg SD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part B: Cohort 3- GSK3358699 Fed + GSK3358699 Fasted
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B: Cohort 3- GSK3358699 Fasted + GSK3358699 Fed
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part C: Cohort 4 and 5- Placebo RD
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part C: Cohort 4 and 5- GSK3358699 10 mg RD
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Part C: Cohort 6- GSK3358699 or Placebo RD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part C: Cohort 7- GSK3358699 or Placebo RD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part C: Cohort 8- GSK3358699 or Placebo RD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: Placebo SD
n=23 participants at risk
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=5 participants at risk
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
n=3 participants at risk
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
n=6 participants at risk
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
n=6 participants at risk
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
n=12 participants at risk
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
n=6 participants at risk
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
n=6 participants at risk
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
Part B: Cohort 3- GSK3358699 Fed + GSK3358699 Fasted
Participants in Part B Cohort 3 were planned to receive a SD of GSK3358699 under fed conditions on Day 1 in treatment Period 1; followed by a SD of GSK3358699 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 14 days between each treatment period.
|
Part B: Cohort 3- GSK3358699 Fasted + GSK3358699 Fed
Participants in Part B Cohort 3 were planned to receive a SD of GSK3358699 under fasted conditions on Day 1 in treatment Period 1; followed by a SD of GSK3358699 under fed conditions on Day 1 in treatment Period 2. There was a planned washout period of 14 days between each treatment period.
|
Part C: Cohort 4 and 5- Placebo RD
n=11 participants at risk
Participants received once daily RD of placebo on Days 1 to 14. In Cohort 4, on Day 14, participants were administered an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo at a dose of 60 mcg/m\^2. The administration of LPS or GM-CSF was followed by blister induction on forearm (0.2% cantharidin).
|
Part C: Cohort 4 and 5- GSK3358699 10 mg RD
n=14 participants at risk
Participants received once daily repeat dose of GSK3358699 10 mg on Days 1 to 14. In Cohort 4, on Day 14, participants were administered an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo at a dose of 60 mcg/m\^2. The administration of LPS or GM-CSF was followed by blister induction on forearm (0.2% cantharidin).
|
Part C: Cohort 6- GSK3358699 or Placebo RD
Participants in Part C Cohort 6 were planned to receive once daily repeat dose of GSK3358699 or placebo on Days 1 to 14.
|
Part C: Cohort 7- GSK3358699 or Placebo RD
Participants in Part C Cohort 7 were planned to receive once daily repeat dose of GSK3358699 or placebo on Days 1 to 14.
|
Part C: Cohort 8- GSK3358699 or Placebo RD
Participants in Part C Cohort 8 were planned to receive once daily repeat dose of GSK3358699 or placebo on Days 1 to 14. On Day 14, participants were planned to receive an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo as 60 mcg/m\^2. The administration of LPS or GM-CSF was planned to be followed by blister induction on forearm (0.2% cantharidin).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/23 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/5 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/3 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/12 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/11 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
7.1%
1/14 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
Other adverse events
| Measure |
Part A: Placebo SD
n=23 participants at risk
Participants in Part A received a SD of placebo on Day 1 in either treatment Period 1, 2 and 3. On Day 1 of treatment Period 4, participants were administered a SD of placebo followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. Placebo were administered via the oral route.
|
Part A: GSK3358699 1 mg SD
n=5 participants at risk
Participants in Part A received a SD of GSK3358699 1 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 3 mg SD
n=3 participants at risk
Participants in Part A received a SD of GSK3358699 3 mg on Day 1 in treatment Period 1.
|
Part A: GSK3358699 10 mg SD
n=6 participants at risk
Participants in Part A received a SD of GSK3358699 10 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 20 mg SD
n=6 participants at risk
Participants in Part A received a SD of GSK3358699 20 mg on Day 1 in treatment Period 2.
|
Part A: GSK3358699 25 mg SD
n=12 participants at risk
Participants in Part A received a SD of GSK3358699 25 mg on Day 1 in treatment Period 4. On Day 1, participants were administered a SD of GSK3358699 25 mg followed by IV administration of in vivo LPS challenge at a dose of 0.75 ng/kg for induction of blisters on the forearm in Cohort 1 and in Cohort 2, participants were administered with IV administration of in vivo GM-CSF challenge at a dose of 60 mcg/m\^2 and further treated with 0.2% cantharidin for induction of blisters on the forearm. GSK3358699 were administered via the oral route.
|
Part A: GSK3358699 30 mg SD
n=6 participants at risk
Participants in Part A received a SD of GSK3358699 30 mg on Day 1 in treatment Period 3.
|
Part A: GSK3358699 40 mg SD
n=6 participants at risk
Participants in Part A received a SD of GSK3358699 40 mg on Day 1 in treatment Period 3.
|
Part B: Cohort 3- GSK3358699 Fed + GSK3358699 Fasted
Participants in Part B Cohort 3 were planned to receive a SD of GSK3358699 under fed conditions on Day 1 in treatment Period 1; followed by a SD of GSK3358699 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 14 days between each treatment period.
|
Part B: Cohort 3- GSK3358699 Fasted + GSK3358699 Fed
Participants in Part B Cohort 3 were planned to receive a SD of GSK3358699 under fasted conditions on Day 1 in treatment Period 1; followed by a SD of GSK3358699 under fed conditions on Day 1 in treatment Period 2. There was a planned washout period of 14 days between each treatment period.
|
Part C: Cohort 4 and 5- Placebo RD
n=11 participants at risk
Participants received once daily RD of placebo on Days 1 to 14. In Cohort 4, on Day 14, participants were administered an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo at a dose of 60 mcg/m\^2. The administration of LPS or GM-CSF was followed by blister induction on forearm (0.2% cantharidin).
|
Part C: Cohort 4 and 5- GSK3358699 10 mg RD
n=14 participants at risk
Participants received once daily repeat dose of GSK3358699 10 mg on Days 1 to 14. In Cohort 4, on Day 14, participants were administered an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo at a dose of 60 mcg/m\^2. The administration of LPS or GM-CSF was followed by blister induction on forearm (0.2% cantharidin).
|
Part C: Cohort 6- GSK3358699 or Placebo RD
Participants in Part C Cohort 6 were planned to receive once daily repeat dose of GSK3358699 or placebo on Days 1 to 14.
|
Part C: Cohort 7- GSK3358699 or Placebo RD
Participants in Part C Cohort 7 were planned to receive once daily repeat dose of GSK3358699 or placebo on Days 1 to 14.
|
Part C: Cohort 8- GSK3358699 or Placebo RD
Participants in Part C Cohort 8 were planned to receive once daily repeat dose of GSK3358699 or placebo on Days 1 to 14. On Day 14, participants were planned to receive an IV in vivo LPS challenge at a dose of 0.75 ng/kg or an IV infusion of GM-CSF, in vivo as 60 mcg/m\^2. The administration of LPS or GM-CSF was planned to be followed by blister induction on forearm (0.2% cantharidin).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/23 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/5 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/3 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
8.3%
1/12 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/11 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/14 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/23 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/5 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/3 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
16.7%
1/6 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/12 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
16.7%
1/6 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
9.1%
1/11 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
14.3%
2/14 • Number of events 2 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.3%
1/23 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/5 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/3 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/12 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
16.7%
1/6 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/11 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/14 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/23 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/5 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
33.3%
1/3 • Number of events 2 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/12 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/11 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/14 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/23 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/5 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/3 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/12 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
16.7%
1/6 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/11 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/14 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/23 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/5 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
33.3%
1/3 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/12 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/11 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/14 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
4.3%
1/23 • Number of events 2 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/5 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/3 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/12 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
16.7%
1/6 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/11 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/14 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/23 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/5 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/3 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
8.3%
1/12 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
9.1%
1/11 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/14 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/23 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/5 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/3 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
16.7%
1/6 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/12 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/11 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/14 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/23 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/5 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/3 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
16.7%
1/6 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/12 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
16.7%
1/6 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/11 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/14 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/23 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/5 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
33.3%
1/3 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
16.7%
1/6 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/12 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/11 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/14 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/23 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/5 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/3 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
16.7%
1/6 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/12 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/11 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/14 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/23 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
20.0%
1/5 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/3 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/12 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/11 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/14 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/23 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/5 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
33.3%
1/3 • Number of events 2 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/12 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
9.1%
1/11 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/14 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
|
Nervous system disorders
Headache
|
8.7%
2/23 • Number of events 2 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
20.0%
1/5 • Number of events 3 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
33.3%
1/3 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
16.7%
1/6 • Number of events 3 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
33.3%
2/6 • Number of events 2 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
33.3%
4/12 • Number of events 4 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
16.7%
1/6 • Number of events 2 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
33.3%
2/6 • Number of events 2 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
18.2%
2/11 • Number of events 2 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
14.3%
2/14 • Number of events 2 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/23 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/5 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/3 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/12 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
16.7%
1/6 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/11 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/14 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/23 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/5 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/3 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
8.3%
1/12 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/11 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/14 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/23 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/5 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/3 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
8.3%
1/12 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/11 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/14 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
|
General disorders
Feeling cold
|
4.3%
1/23 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/5 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/3 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
8.3%
1/12 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
9.1%
1/11 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/14 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
|
General disorders
Feeling hot
|
0.00%
0/23 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/5 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/3 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
16.7%
2/12 • Number of events 2 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/11 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/14 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
|
General disorders
Malaise
|
0.00%
0/23 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/5 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
33.3%
1/3 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/12 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/11 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/14 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
|
General disorders
Pain
|
0.00%
0/23 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/5 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/3 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
8.3%
1/12 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/11 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/14 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
|
General disorders
Pyrexia
|
4.3%
1/23 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/5 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/3 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/12 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
16.7%
1/6 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/11 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/14 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/23 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/5 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/3 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
8.3%
1/12 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/11 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/14 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/23 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/5 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/3 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
8.3%
1/12 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/11 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
7.1%
1/14 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/23 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/5 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/3 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/12 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
9.1%
1/11 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/14 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/23 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/5 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/3 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/12 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/11 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
7.1%
1/14 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/23 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/5 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/3 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/12 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/11 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
7.1%
1/14 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/23 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/5 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/3 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/12 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/11 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
7.1%
1/14 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/23 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/5 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/3 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/12 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
9.1%
1/11 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
7.1%
1/14 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
|
Eye disorders
Keratitis
|
0.00%
0/23 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/5 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/3 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/12 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
9.1%
1/11 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/14 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/23 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/5 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/3 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/12 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
9.1%
1/11 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/14 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/23 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/5 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/3 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/12 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
9.1%
1/11 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/14 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
|
Renal and urinary disorders
Renal atrophy
|
0.00%
0/23 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/5 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/3 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/12 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
9.1%
1/11 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/14 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/23 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/5 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/3 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/12 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/6 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
0.00%
0/11 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
7.1%
1/14 • Number of events 1 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
—
0/0 • Up to Day 193 in Part A and up to Day 49 in Part C (Cohorts 4 and 5)
Safety Population.All-cause mortality,non-SAEs and SAEs were not collected in Part B and Part C(Cohorts 6 to 8) as no participants were enrolled.Data is presented for Part A and Part C(Cohorts4 and 5) only as data was not collected in Part B and Part C(Cohorts6 to 8) due to study termination and Part B and Part C(Cohorts 6 to 8) were not initiated.
|
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