Trial Outcomes & Findings for A Safety and Pharmacokinetic Study of CVX-096 in Type 2 Diabetics (NCT NCT00886821)
NCT ID: NCT00886821
Last Updated: 2017-04-18
Results Overview
AUClast was defined as area under the concentration-time curve from time zero to the time of last measured concentration and calculated by using linear up/log down trapezoidal method.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
114 participants
Primary outcome timeframe
pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1
Results posted on
2017-04-18
Participant Flow
Study consist of two stages: stage 1 and stage 2. Participants were enrolled and randomized for stage 1 and stage 2 separately.
Participant milestones
| Measure |
Cohort 1: PF-04856883 0.1 Milligram (mg)
Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
|
Cohort 2: PF-04856883 0.3 mg
Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
|
Cohort 3: PF-04856883 1.0 mg
Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
|
Cohort 4: PF-04856883 3.0 mg
Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
|
Cohort 5: PF-04856883 6.0 mg
Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
|
Cohort 6: PF-04856883 12.0 mg
Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
|
Cohort 7: PF-04856883 24.0 mg
Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
|
Cohort 8: PF-04856883 36.0 mg
Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
|
Cohort 9: PF-04856883 18.0 mg
Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
|
Cohort 1-9: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
|
Cohort 10: PF-04856883 15.0 mg
Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
|
Cohort 11: PF-04856883 20.0 mg
Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1
STARTED
|
7
|
6
|
6
|
7
|
6
|
6
|
6
|
6
|
6
|
18
|
0
|
0
|
0
|
0
|
|
Stage 1
COMPLETED
|
7
|
6
|
6
|
7
|
6
|
6
|
6
|
6
|
6
|
18
|
0
|
0
|
0
|
0
|
|
Stage 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
9
|
13
|
9
|
|
Stage 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
8
|
8
|
8
|
|
Stage 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
5
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1: PF-04856883 0.1 Milligram (mg)
Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
|
Cohort 2: PF-04856883 0.3 mg
Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
|
Cohort 3: PF-04856883 1.0 mg
Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
|
Cohort 4: PF-04856883 3.0 mg
Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
|
Cohort 5: PF-04856883 6.0 mg
Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
|
Cohort 6: PF-04856883 12.0 mg
Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
|
Cohort 7: PF-04856883 24.0 mg
Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
|
Cohort 8: PF-04856883 36.0 mg
Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
|
Cohort 9: PF-04856883 18.0 mg
Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
|
Cohort 1-9: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
|
Cohort 10: PF-04856883 15.0 mg
Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
|
Cohort 11: PF-04856883 20.0 mg
Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 2
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
3
|
0
|
|
Stage 2
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
Baseline Characteristics
A Safety and Pharmacokinetic Study of CVX-096 in Type 2 Diabetics
Baseline characteristics by cohort
| Measure |
Cohort 1: PF-04856883 0.1 Milligram (mg)
n=7 Participants
Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
|
Cohort 2: PF-04856883 0.3 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
|
Cohort 3: PF-04856883 1.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
|
Cohort 4: PF-04856883 3.0 mg
n=7 Participants
Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
|
Cohort 5: PF-04856883 6.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
|
Cohort 6: PF-04856883 12.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
|
Cohort 7: PF-04856883 24.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
|
Cohort 8: PF-04856883 36.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
|
Cohort 9: PF-04856883 18.0 mg
n=6 Participants
Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
|
Cohort 9: Placebo
n=18 Participants
Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or two dose on Day 1 and 8 respectively.
|
Cohort 10: PF-04856883 15.0 mg
n=9 Participants
Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
|
Cohort 11: PF-04856883 20.0 mg
n=9 Participants
Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
n=13 Participants
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
n=9 Participants
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
4 Participants
n=40 Participants
|
5 Participants
n=8 Participants
|
13 Participants
n=62 Participants
|
8 Participants
n=95 Participants
|
8 Participants
n=129 Participants
|
13 Participants
n=36 Participants
|
8 Participants
n=36 Participants
|
101 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
1 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
13 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
6 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=62 Participants
|
4 Participants
n=95 Participants
|
4 Participants
n=129 Participants
|
3 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
39 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
6 Participants
n=8 Participants
|
15 Participants
n=62 Participants
|
5 Participants
n=95 Participants
|
5 Participants
n=129 Participants
|
10 Participants
n=36 Participants
|
9 Participants
n=36 Participants
|
75 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1Population: Pharmacokinetic (PK) analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. 'N'(Overall number of participants)=participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed in multiple dosing cohort(Cohort 9),as pre-specified in protocol.
AUClast was defined as area under the concentration-time curve from time zero to the time of last measured concentration and calculated by using linear up/log down trapezoidal method.
Outcome measures
| Measure |
Cohort 1: PF-04856883 0.1 Milligram (mg)
n=4 Participants
Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
|
Cohort 2: PF-04856883 0.3 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
|
Cohort 3: PF-04856883 1.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
|
Cohort 4: PF-04856883 3.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
|
Cohort 5: PF-04856883 6.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
|
Cohort 6: PF-04856883 12.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
|
Cohort 7: PF-04856883 24.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
|
Cohort 8: PF-04856883 36.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
|
Cohort 9: PF-04856883 18.0 mg
Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
|
Cohort 10: PF-04856883 15.0 mg
Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
|
Cohort 11: PF-04856883 20.0 mg
Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04856883 on Day 1
|
865 nanogram*hour per milliliter (ng*hr)/mL
Geometric Coefficient of Variation 625.3
|
4960 nanogram*hour per milliliter (ng*hr)/mL
Geometric Coefficient of Variation 462.0
|
7065 nanogram*hour per milliliter (ng*hr)/mL
Geometric Coefficient of Variation 192.1
|
32552 nanogram*hour per milliliter (ng*hr)/mL
Geometric Coefficient of Variation 127.7
|
105950 nanogram*hour per milliliter (ng*hr)/mL
Geometric Coefficient of Variation 53.4
|
304167 nanogram*hour per milliliter (ng*hr)/mL
Geometric Coefficient of Variation 25.9
|
120521 nanogram*hour per milliliter (ng*hr)/mL
Geometric Coefficient of Variation 5404.6
|
297503 nanogram*hour per milliliter (ng*hr)/mL
Geometric Coefficient of Variation 211.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cohort 1-9: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1; Cohort 10-12: pre-dose, 1 and 6 hours post-dose on Day 1Population: PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Cohort 1: PF-04856883 0.1 Milligram (mg)
n=4 Participants
Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
|
Cohort 2: PF-04856883 0.3 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
|
Cohort 3: PF-04856883 1.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
|
Cohort 4: PF-04856883 3.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
|
Cohort 5: PF-04856883 6.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
|
Cohort 6: PF-04856883 12.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
|
Cohort 7: PF-04856883 24.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
|
Cohort 8: PF-04856883 36.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
|
Cohort 9: PF-04856883 18.0 mg
n=6 Participants
Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
|
Cohort 10: PF-04856883 15.0 mg
n=9 Participants
Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
|
Cohort 11: PF-04856883 20.0 mg
n=9 Participants
Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
n=13 Participants
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 1
|
156 hour
Interval 144.0 to 168.0
|
72.1 hour
Interval 36.0 to 144.0
|
168 hour
Interval 96.0 to 168.0
|
72.0 hour
Interval 48.0 to 168.0
|
144 hour
Interval 72.0 to 168.0
|
120 hour
Interval 72.0 to 168.0
|
108 hour
Interval 36.0 to 168.0
|
96.0 hour
Interval 48.0 to 168.0
|
84.0 hour
Interval 36.0 to 144.0
|
168 hour
Interval 48.0 to 168.0
|
168 hour
Interval 48.0 to 168.0
|
168 hour
Interval 25.1 to 194.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8Population: PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. The outcome was not planned to be analyzed for single dosing cohorts (Cohort 1 to 8), since the dosing was done only on Day 1 in these cohorts.
Outcome measures
| Measure |
Cohort 1: PF-04856883 0.1 Milligram (mg)
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
|
Cohort 2: PF-04856883 0.3 mg
Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
|
Cohort 3: PF-04856883 1.0 mg
Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
|
Cohort 4: PF-04856883 3.0 mg
Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
|
Cohort 5: PF-04856883 6.0 mg
Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
|
Cohort 6: PF-04856883 12.0 mg
Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
|
Cohort 7: PF-04856883 24.0 mg
Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
|
Cohort 8: PF-04856883 36.0 mg
Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
|
Cohort 9: PF-04856883 18.0 mg
Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
|
Cohort 10: PF-04856883 15.0 mg
Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
|
Cohort 11: PF-04856883 20.0 mg
Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 8
|
72.0 hour
Interval 48.0 to 96.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: pre-dose, 1 and 6 hours post-dose on Day 22Population: PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Cohort 1: PF-04856883 0.1 Milligram (mg)
n=9 Participants
Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
|
Cohort 2: PF-04856883 0.3 mg
n=7 Participants
Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
|
Cohort 3: PF-04856883 1.0 mg
n=7 Participants
Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
|
Cohort 4: PF-04856883 3.0 mg
Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
|
Cohort 5: PF-04856883 6.0 mg
Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
|
Cohort 6: PF-04856883 12.0 mg
Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
|
Cohort 7: PF-04856883 24.0 mg
Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
|
Cohort 8: PF-04856883 36.0 mg
Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
|
Cohort 9: PF-04856883 18.0 mg
Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
|
Cohort 10: PF-04856883 15.0 mg
Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
|
Cohort 11: PF-04856883 20.0 mg
Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 22
|
48.0 hour
Interval 6.0 to 168.0
|
46.9 hour
Interval 1.0 to 48.0
|
48.0 hour
Interval 47.2 to 168.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cohort 1-9: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1; Cohort 10-12: pre-dose, 1 and 6 hours post-dose on Day 1Population: PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Cohort 1: PF-04856883 0.1 Milligram (mg)
n=4 Participants
Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
|
Cohort 2: PF-04856883 0.3 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
|
Cohort 3: PF-04856883 1.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
|
Cohort 4: PF-04856883 3.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
|
Cohort 5: PF-04856883 6.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
|
Cohort 6: PF-04856883 12.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
|
Cohort 7: PF-04856883 24.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
|
Cohort 8: PF-04856883 36.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
|
Cohort 9: PF-04856883 18.0 mg
n=6 Participants
Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
|
Cohort 10: PF-04856883 15.0 mg
n=9 Participants
Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
|
Cohort 11: PF-04856883 20.0 mg
n=9 Participants
Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
n=13 Participants
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 1
|
7.05 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 104.9
|
29.0 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 126.3
|
24.8 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 92.3
|
149 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 63.2
|
387 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 52.4
|
900 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 36.2
|
579 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 1314.6
|
1299 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 104.3
|
1082 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 50.0
|
736 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 47.1
|
1554 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 38.3
|
958 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 63.1
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8Population: PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. The outcome was not planned to be analyzed for single dosing cohorts (Cohort 1 to 8), since the dosing was done only on Day 1 in these cohorts.
Outcome measures
| Measure |
Cohort 1: PF-04856883 0.1 Milligram (mg)
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
|
Cohort 2: PF-04856883 0.3 mg
Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
|
Cohort 3: PF-04856883 1.0 mg
Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
|
Cohort 4: PF-04856883 3.0 mg
Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
|
Cohort 5: PF-04856883 6.0 mg
Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
|
Cohort 6: PF-04856883 12.0 mg
Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
|
Cohort 7: PF-04856883 24.0 mg
Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
|
Cohort 8: PF-04856883 36.0 mg
Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
|
Cohort 9: PF-04856883 18.0 mg
Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
|
Cohort 10: PF-04856883 15.0 mg
Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
|
Cohort 11: PF-04856883 20.0 mg
Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 8
|
1536 ng/mL
Geometric Coefficient of Variation 54.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: pre-dose, 1 and 6 hours post-dose on Day 22Population: PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Cohort 1: PF-04856883 0.1 Milligram (mg)
n=9 Participants
Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
|
Cohort 2: PF-04856883 0.3 mg
n=8 Participants
Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
|
Cohort 3: PF-04856883 1.0 mg
n=7 Participants
Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
|
Cohort 4: PF-04856883 3.0 mg
Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
|
Cohort 5: PF-04856883 6.0 mg
Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
|
Cohort 6: PF-04856883 12.0 mg
Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
|
Cohort 7: PF-04856883 24.0 mg
Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
|
Cohort 8: PF-04856883 36.0 mg
Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
|
Cohort 9: PF-04856883 18.0 mg
Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
|
Cohort 10: PF-04856883 15.0 mg
Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
|
Cohort 11: PF-04856883 20.0 mg
Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 2: Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 22
|
1767 ng/mL
Geometric Coefficient of Variation 37.6
|
2193 ng/mL
Geometric Coefficient of Variation 36.9
|
2253 ng/mL
Geometric Coefficient of Variation 31.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1Population: PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed in multiple dosing cohort (Cohort 9), as pre specified in protocol.
Apparent terminal elimination half-life is the time measured for the plasma concentration of PF-04856883 to decrease by one-half of its initial concentration.
Outcome measures
| Measure |
Cohort 1: PF-04856883 0.1 Milligram (mg)
n=4 Participants
Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
|
Cohort 2: PF-04856883 0.3 mg
n=4 Participants
Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
|
Cohort 3: PF-04856883 1.0 mg
n=3 Participants
Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
|
Cohort 4: PF-04856883 3.0 mg
n=5 Participants
Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
|
Cohort 5: PF-04856883 6.0 mg
n=5 Participants
Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
|
Cohort 6: PF-04856883 12.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
|
Cohort 7: PF-04856883 24.0 mg
n=5 Participants
Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
|
Cohort 8: PF-04856883 36.0 mg
n=4 Participants
Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
|
Cohort 9: PF-04856883 18.0 mg
Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
|
Cohort 10: PF-04856883 15.0 mg
Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
|
Cohort 11: PF-04856883 20.0 mg
Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Apparent Terminal Elimination Half-Life (t1/2) of PF-04856883 on Day 1
|
NA hour
Standard Deviation NA
Data was not estimable since PK concentration was below the lower limit of quantification.
|
188 hour
Standard Deviation 42.6
|
151 hour
Standard Deviation 5.14
|
186 hour
Standard Deviation 53.3
|
144 hour
Standard Deviation 12.0
|
163 hour
Standard Deviation 52.0
|
156 hour
Standard Deviation 45.6
|
159 hour
Standard Deviation 37.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8Population: PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. The outcome was not planned to be analyzed for single dosing cohorts (Cohort 1 to 8), since the dosing was done only on Day 1 in these cohorts.
Apparent terminal elimination half-life is the time measured for the plasma concentration of PF-04856883 to decrease by one-half of its initial concentration.
Outcome measures
| Measure |
Cohort 1: PF-04856883 0.1 Milligram (mg)
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
|
Cohort 2: PF-04856883 0.3 mg
Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
|
Cohort 3: PF-04856883 1.0 mg
Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
|
Cohort 4: PF-04856883 3.0 mg
Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
|
Cohort 5: PF-04856883 6.0 mg
Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
|
Cohort 6: PF-04856883 12.0 mg
Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
|
Cohort 7: PF-04856883 24.0 mg
Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
|
Cohort 8: PF-04856883 36.0 mg
Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
|
Cohort 9: PF-04856883 18.0 mg
Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
|
Cohort 10: PF-04856883 15.0 mg
Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
|
Cohort 11: PF-04856883 20.0 mg
Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Apparent Terminal Half-Life (t1/2) of PF-04856883 on Day 8
|
156 hour
Standard Deviation 23.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 1 and 6 hours post-dose on Day 22Population: PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure.
Apparent terminal elimination half-life is the time measured for the plasma concentration of PF-04856883 to decrease by one-half of its initial concentration.
Outcome measures
| Measure |
Cohort 1: PF-04856883 0.1 Milligram (mg)
n=8 Participants
Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
|
Cohort 2: PF-04856883 0.3 mg
n=8 Participants
Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
|
Cohort 3: PF-04856883 1.0 mg
n=5 Participants
Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
|
Cohort 4: PF-04856883 3.0 mg
Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
|
Cohort 5: PF-04856883 6.0 mg
Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
|
Cohort 6: PF-04856883 12.0 mg
Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
|
Cohort 7: PF-04856883 24.0 mg
Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
|
Cohort 8: PF-04856883 36.0 mg
Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
|
Cohort 9: PF-04856883 18.0 mg
Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
|
Cohort 10: PF-04856883 15.0 mg
Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
|
Cohort 11: PF-04856883 20.0 mg
Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 2: Apparent Terminal Elimination Half-Life (t1/2) of PF-04856883 on Day 22
|
156 hour
Standard Deviation 32.7
|
102 hour
Standard Deviation 44.9
|
149 hour
Standard Deviation 29.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1Population: PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed in multiple dosing cohort (Cohort 9), as pre specified in protocol.
MRT is defined as AUMC(0 - inf) divided by AUC(0 - inf), where AUMC(0 - inf) is the area under the first moment curve from time 0 extrapolated to infinite time, calculated using the linear/log trapezoidal method and AUC(0 - inf) is the area under the concentration-time curve extrapolated to infinity.
Outcome measures
| Measure |
Cohort 1: PF-04856883 0.1 Milligram (mg)
n=4 Participants
Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
|
Cohort 2: PF-04856883 0.3 mg
n=4 Participants
Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
|
Cohort 3: PF-04856883 1.0 mg
n=3 Participants
Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
|
Cohort 4: PF-04856883 3.0 mg
n=5 Participants
Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
|
Cohort 5: PF-04856883 6.0 mg
n=5 Participants
Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
|
Cohort 6: PF-04856883 12.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
|
Cohort 7: PF-04856883 24.0 mg
n=5 Participants
Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
|
Cohort 8: PF-04856883 36.0 mg
n=4 Participants
Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
|
Cohort 9: PF-04856883 18.0 mg
Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
|
Cohort 10: PF-04856883 15.0 mg
Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
|
Cohort 11: PF-04856883 20.0 mg
Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Mean Residence Time (MRT) of PF-04856883 on Day 1
|
NA hour
Data was not estimable since PK concentration was below the lower limit of quantification.
|
310 hour
Full Range 69.4 • Interval 205.0 to 373.0
|
316 hour
Full Range 20.3 • Interval 286.0 to 325.0
|
350 hour
Full Range 70.5 • Interval 227.0 to 399.0
|
281 hour
Full Range 31.6 • Interval 217.0 to 295.0
|
319 hour
Full Range 77.8 • Interval 176.0 to 390.0
|
239 hour
Full Range 89.7 • Interval 189.0 to 414.0
|
312 hour
Full Range 70.7 • Interval 216.0 to 378.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1Population: PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed in multiple dosing cohort (Cohort 9), as pre specified in protocol.
Apparent oral clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug apparent oral clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Outcome measures
| Measure |
Cohort 1: PF-04856883 0.1 Milligram (mg)
n=4 Participants
Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
|
Cohort 2: PF-04856883 0.3 mg
n=4 Participants
Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
|
Cohort 3: PF-04856883 1.0 mg
n=3 Participants
Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
|
Cohort 4: PF-04856883 3.0 mg
n=5 Participants
Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
|
Cohort 5: PF-04856883 6.0 mg
n=5 Participants
Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
|
Cohort 6: PF-04856883 12.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
|
Cohort 7: PF-04856883 24.0 mg
n=5 Participants
Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
|
Cohort 8: PF-04856883 36.0 mg
n=4 Participants
Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
|
Cohort 9: PF-04856883 18.0 mg
Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
|
Cohort 10: PF-04856883 15.0 mg
Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
|
Cohort 11: PF-04856883 20.0 mg
Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Apparent Oral Clearance (CL/F) of PF-04856883 on Day 1
|
NA Liter per hour (L/hr)
Geometric Coefficient of Variation NA
Data was not estimable since PK concentration was below the lower limit of quantification.
|
0.0176 Liter per hour (L/hr)
Geometric Coefficient of Variation 20.4
|
0.0643 Liter per hour (L/hr)
Geometric Coefficient of Variation 27.4
|
0.0562 Liter per hour (L/hr)
Geometric Coefficient of Variation 36.5
|
0.0487 Liter per hour (L/hr)
Geometric Coefficient of Variation 53.5
|
0.0354 Liter per hour (L/hr)
Geometric Coefficient of Variation 25.6
|
0.0530 Liter per hour (L/hr)
Geometric Coefficient of Variation 47.5
|
0.0527 Liter per hour (L/hr)
Geometric Coefficient of Variation 28.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1Population: PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed in multiple dosing cohort (Cohort 9), as pre specified in protocol.
AUC(0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It was calculated as AUC (0-t) plus (last measurable concentration divided by apparent terminal elimination rate constant).
Outcome measures
| Measure |
Cohort 1: PF-04856883 0.1 Milligram (mg)
n=4 Participants
Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
|
Cohort 2: PF-04856883 0.3 mg
n=4 Participants
Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
|
Cohort 3: PF-04856883 1.0 mg
n=3 Participants
Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
|
Cohort 4: PF-04856883 3.0 mg
n=5 Participants
Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
|
Cohort 5: PF-04856883 6.0 mg
n=5 Participants
Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
|
Cohort 6: PF-04856883 12.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
|
Cohort 7: PF-04856883 24.0 mg
n=5 Participants
Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
|
Cohort 8: PF-04856883 36.0 mg
n=4 Participants
Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
|
Cohort 9: PF-04856883 18.0 mg
Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
|
Cohort 10: PF-04856883 15.0 mg
Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
|
Cohort 11: PF-04856883 20.0 mg
Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC[0 - Inf]) of PF-04856883 on Day 1
|
NA L/hr
Geometric Coefficient of Variation NA
Data was not estimable since PK concentration was below the lower limit of quantification.
|
17013 L/hr
Geometric Coefficient of Variation 20.4
|
15550 L/hr
Geometric Coefficient of Variation 27.4
|
53420 L/hr
Geometric Coefficient of Variation 36.5
|
123081 L/hr
Geometric Coefficient of Variation 53.5
|
339062 L/hr
Geometric Coefficient of Variation 25.6
|
452842 L/hr
Geometric Coefficient of Variation 47.5
|
682543 L/hr
Geometric Coefficient of Variation 28.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cohort 1-8: Baseline up to Day 29; Cohort 9: Baseline up to Day 36; Cohort 10-12: Baseline up to Day 50Population: Safety population included all randomized participants who received at least 1 dose of study medication.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
Cohort 1: PF-04856883 0.1 Milligram (mg)
n=7 Participants
Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
|
Cohort 2: PF-04856883 0.3 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
|
Cohort 3: PF-04856883 1.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
|
Cohort 4: PF-04856883 3.0 mg
n=7 Participants
Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
|
Cohort 5: PF-04856883 6.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
|
Cohort 6: PF-04856883 12.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
|
Cohort 7: PF-04856883 24.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
|
Cohort 8: PF-04856883 36.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
|
Cohort 9: PF-04856883 18.0 mg
n=6 Participants
Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
|
Cohort 10: PF-04856883 15.0 mg
n=18 Participants
Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
|
Cohort 11: PF-04856883 20.0 mg
n=9 Participants
Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
n=9 Participants
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
n=13 Participants
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
n=9 Participants
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
2 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
8 Participants
|
4 Participants
|
—
|
|
Number of Participants With Treatment-emergent 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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 3 and 7Population: Pharmacodynamic analysis population included all randomized participants who had received at least 1 dose of study medication and had PD data. Here, number analyzed signifies those participants who were evaluable at specified time points.
Area under the glucose concentration-time curve from 0 minute (approximately 20 minutes prior to the meal) to 180 minutes post initiation of meal.
Outcome measures
| Measure |
Cohort 1: PF-04856883 0.1 Milligram (mg)
n=7 Participants
Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
|
Cohort 2: PF-04856883 0.3 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
|
Cohort 3: PF-04856883 1.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
|
Cohort 4: PF-04856883 3.0 mg
n=7 Participants
Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
|
Cohort 5: PF-04856883 6.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
|
Cohort 6: PF-04856883 12.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
|
Cohort 7: PF-04856883 24.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
|
Cohort 8: PF-04856883 36.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
|
Cohort 9: PF-04856883 18.0 mg
n=6 Participants
Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
|
Cohort 10: PF-04856883 15.0 mg
n=16 Participants
Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
|
Cohort 11: PF-04856883 20.0 mg
n=2 Participants
Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Change From Baseline in Post-Prandial Area Under the Curve (AUC) of Glucose at Day 3 and 7
Change at Day 3
|
1.44 milligram*hour per deciliter (mg*hr)/dL
Standard Deviation 102
|
44.9 milligram*hour per deciliter (mg*hr)/dL
Standard Deviation 76.8
|
-92.3 milligram*hour per deciliter (mg*hr)/dL
Standard Deviation 78.2
|
-54.0 milligram*hour per deciliter (mg*hr)/dL
Standard Deviation 60.0
|
46.7 milligram*hour per deciliter (mg*hr)/dL
Standard Deviation 70.9
|
-74.5 milligram*hour per deciliter (mg*hr)/dL
Standard Deviation 59.7
|
-140 milligram*hour per deciliter (mg*hr)/dL
Standard Deviation 124
|
-80.1 milligram*hour per deciliter (mg*hr)/dL
Standard Deviation 70.6
|
—
|
-10.6 milligram*hour per deciliter (mg*hr)/dL
Standard Deviation 95.3
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Change From Baseline in Post-Prandial Area Under the Curve (AUC) of Glucose at Day 3 and 7
Change at Day 7
|
-38.8 milligram*hour per deciliter (mg*hr)/dL
Standard Deviation 95.5
|
29.3 milligram*hour per deciliter (mg*hr)/dL
Standard Deviation 161
|
-147 milligram*hour per deciliter (mg*hr)/dL
Standard Deviation 93.4
|
-23.0 milligram*hour per deciliter (mg*hr)/dL
Standard Deviation 125
|
65.1 milligram*hour per deciliter (mg*hr)/dL
Standard Deviation 85.1
|
-39.6 milligram*hour per deciliter (mg*hr)/dL
Standard Deviation 52.6
|
-108 milligram*hour per deciliter (mg*hr)/dL
Standard Deviation 139
|
-38.4 milligram*hour per deciliter (mg*hr)/dL
Standard Deviation 66.7
|
-119 milligram*hour per deciliter (mg*hr)/dL
Standard Deviation 81.7
|
-9.04 milligram*hour per deciliter (mg*hr)/dL
Standard Deviation 119
|
-46.1 milligram*hour per deciliter (mg*hr)/dL
Standard Deviation 6.98
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 3 and 7Population: Pharmacodynamic analysis population included all randomized participants who had received at least 1 dose of study medication and had PD data.
It was assessed by 7-point glucose measurements via the glucose oxidase method.
Outcome measures
| Measure |
Cohort 1: PF-04856883 0.1 Milligram (mg)
n=7 Participants
Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
|
Cohort 2: PF-04856883 0.3 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
|
Cohort 3: PF-04856883 1.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
|
Cohort 4: PF-04856883 3.0 mg
n=7 Participants
Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
|
Cohort 5: PF-04856883 6.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
|
Cohort 6: PF-04856883 12.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
|
Cohort 7: PF-04856883 24.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
|
Cohort 8: PF-04856883 36.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
|
Cohort 9: PF-04856883 18.0 mg
n=6 Participants
Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
|
Cohort 10: PF-04856883 15.0 mg
n=16 Participants
Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
|
Cohort 11: PF-04856883 20.0 mg
n=2 Participants
Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Change From Baseline in 7-point Weighted Mean Glucose at Day 3 and Day 7
Change at Day 7
|
-15.6 milligram per deciliter(mg/dL)
Standard Deviation 23.0
|
7.44 milligram per deciliter(mg/dL)
Standard Deviation 42.1
|
-28.7 milligram per deciliter(mg/dL)
Standard Deviation 26.9
|
-8.45 milligram per deciliter(mg/dL)
Standard Deviation 33.6
|
7.05 milligram per deciliter(mg/dL)
Standard Deviation 53.2
|
-20.5 milligram per deciliter(mg/dL)
Standard Deviation 10.2
|
-33.9 milligram per deciliter(mg/dL)
Standard Deviation 42.1
|
-24.4 milligram per deciliter(mg/dL)
Standard Deviation 29.4
|
-12.8 milligram per deciliter(mg/dL)
Standard Deviation 29.8
|
-5.22 milligram per deciliter(mg/dL)
Standard Deviation 25.9
|
-23.0 milligram per deciliter(mg/dL)
Standard Deviation 11.0
|
—
|
—
|
—
|
—
|
|
Stage 1: Change From Baseline in 7-point Weighted Mean Glucose at Day 3 and Day 7
Change at Day 3
|
3.27 milligram per deciliter(mg/dL)
Standard Deviation 24.1
|
-0.0252 milligram per deciliter(mg/dL)
Standard Deviation 16.3
|
-17.9 milligram per deciliter(mg/dL)
Standard Deviation 21.7
|
1.04 milligram per deciliter(mg/dL)
Standard Deviation 18.2
|
20.2 milligram per deciliter(mg/dL)
Standard Deviation 18.4
|
-15.7 milligram per deciliter(mg/dL)
Standard Deviation 12.4
|
-31.7 milligram per deciliter(mg/dL)
Standard Deviation 30.5
|
-26.4 milligram per deciliter(mg/dL)
Standard Deviation 22.9
|
-23.9 milligram per deciliter(mg/dL)
Standard Deviation 10.6
|
0.506 milligram per deciliter(mg/dL)
Standard Deviation 25.0
|
-16.6 milligram per deciliter(mg/dL)
Standard Deviation 12.0
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50Population: Safety population included all randomized participants who received at least 1 dose of study medication.
Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit: less than (\<) 0.8\*lower limit of normal (LLN), platelet: \<75 or greater than (\>) 700\*10\^3/millimeter (mm)\^3\*upper limit of normal (ULN), leukocyte: \<2.5 or \>17.5\*10\^3/mm\^3\*ULN; total bilirubin 1.5\*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma-glutamyl transferase: \>3.0\*ULN, total protein, albumin: \<0.8\*LLN or \>1.2\*ULN ;blood urea nitrogen, creatinine: \>1.3\*ULN, uric acid \>1.2\*ULN; sodium \<0.95\*LLN or \>1.05\*ULN, potassium, calcium: \<0.9\*LLN or \>1.1\*ULN, albumin, total protein \<0.8\*LLN or \>1.2\*ULN; glucose \<0.6\*LLN or \>1.5\*ULN, creatine kinase \>2.0\*ULN; urine (red blood cell, white blood cell \>6/high power field).
Outcome measures
| Measure |
Cohort 1: PF-04856883 0.1 Milligram (mg)
n=7 Participants
Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
|
Cohort 2: PF-04856883 0.3 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
|
Cohort 3: PF-04856883 1.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
|
Cohort 4: PF-04856883 3.0 mg
n=7 Participants
Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
|
Cohort 5: PF-04856883 6.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
|
Cohort 6: PF-04856883 12.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
|
Cohort 7: PF-04856883 24.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
|
Cohort 8: PF-04856883 36.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
|
Cohort 9: PF-04856883 18.0 mg
n=6 Participants
Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
|
Cohort 10: PF-04856883 15.0 mg
n=16 Participants
Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
|
Cohort 11: PF-04856883 20.0 mg
n=2 Participants
Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
n=9 Participants
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
n=9 Participants
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
n=13 Participants
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
n=9 Participants
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50Population: Safety population included all randomized participants who received at least 1 dose of study medication.
Criteria for vital signs: pulse rate \<40 beats per minute (bpm), supine, sitting and erect pulse rate \<40 bpm, supine pulse rate \>120 bpm, sitting pulse rate \>120 bpm, and erect pulse rate \>120 bpm; systolic blood pressure: SBP \<90 millimeters of mercury (mmHg), change from baseline in SBP greater than or equal to (\>=) 30 mmHg; diastolic blood pressure: DBP \<50 mmHg, change from baseline in DBP \>=20 mmHg.
Outcome measures
| Measure |
Cohort 1: PF-04856883 0.1 Milligram (mg)
n=7 Participants
Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
|
Cohort 2: PF-04856883 0.3 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
|
Cohort 3: PF-04856883 1.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
|
Cohort 4: PF-04856883 3.0 mg
n=7 Participants
Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
|
Cohort 5: PF-04856883 6.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
|
Cohort 6: PF-04856883 12.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
|
Cohort 7: PF-04856883 24.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
|
Cohort 8: PF-04856883 36.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
|
Cohort 9: PF-04856883 18.0 mg
n=6 Participants
Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
|
Cohort 10: PF-04856883 15.0 mg
n=16 Participants
Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
|
Cohort 11: PF-04856883 20.0 mg
n=2 Participants
Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
n=9 Participants
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
n=9 Participants
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
n=13 Participants
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
n=9 Participants
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50Population: Safety population included all randomized participants who received at least 1 dose of study medication.
Criteria for ECG findings: PR interval \>=300 millisecond (msec), \>=25 percent increase when baseline \>200 msec, and \>=50 percent increase when baseline less than or equal to (\<=) 200 msec; QRS interval \>=200 msec, \>=25 percent increase when baseline \>=100 msec, and \>=50 percent increase when baseline \<=100 msec; QT/QTc interval (corrected QT interval) \>=500 msec.
Outcome measures
| Measure |
Cohort 1: PF-04856883 0.1 Milligram (mg)
n=7 Participants
Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
|
Cohort 2: PF-04856883 0.3 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
|
Cohort 3: PF-04856883 1.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
|
Cohort 4: PF-04856883 3.0 mg
n=7 Participants
Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
|
Cohort 5: PF-04856883 6.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
|
Cohort 6: PF-04856883 12.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
|
Cohort 7: PF-04856883 24.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
|
Cohort 8: PF-04856883 36.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
|
Cohort 9: PF-04856883 18.0 mg
n=6 Participants
Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
|
Cohort 10: PF-04856883 15.0 mg
n=16 Participants
Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
|
Cohort 11: PF-04856883 20.0 mg
n=2 Participants
Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
n=9 Participants
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
n=9 Participants
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
n=13 Participants
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
n=9 Participants
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50Population: Safety population included all randomized participants who received at least 1 dose of study medication.
Full physical examination included examination of the skin, eyes, ears, throat, neck, and cardiac, respiratory, gastrointestinal and musculoskeletal systems. The examination assessed the participants for any clinically significant changes in physical status, as determined by the investigator.
Outcome measures
| Measure |
Cohort 1: PF-04856883 0.1 Milligram (mg)
n=7 Participants
Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
|
Cohort 2: PF-04856883 0.3 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
|
Cohort 3: PF-04856883 1.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
|
Cohort 4: PF-04856883 3.0 mg
n=7 Participants
Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
|
Cohort 5: PF-04856883 6.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
|
Cohort 6: PF-04856883 12.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
|
Cohort 7: PF-04856883 24.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
|
Cohort 8: PF-04856883 36.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
|
Cohort 9: PF-04856883 18.0 mg
n=6 Participants
Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
|
Cohort 10: PF-04856883 15.0 mg
n=16 Participants
Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
|
Cohort 11: PF-04856883 20.0 mg
n=2 Participants
Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
n=9 Participants
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
n=9 Participants
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
n=13 Participants
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
n=9 Participants
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Physical Examinations
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1: 0 hour (pre-dose) up to 48 hours post dosePopulation: Safety population included all randomized participants who received at least 1 dose of study medication.
Blood glucose level was checked for hypoglycemia by glucometer. Criteria for hypoglycemia: blood glucose level \<60 mg/dL if accompanied by symptoms, blood glucose level \<=50 mg/dL regardless of symptoms.
Outcome measures
| Measure |
Cohort 1: PF-04856883 0.1 Milligram (mg)
n=7 Participants
Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
|
Cohort 2: PF-04856883 0.3 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
|
Cohort 3: PF-04856883 1.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
|
Cohort 4: PF-04856883 3.0 mg
n=7 Participants
Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
|
Cohort 5: PF-04856883 6.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
|
Cohort 6: PF-04856883 12.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
|
Cohort 7: PF-04856883 24.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
|
Cohort 8: PF-04856883 36.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
|
Cohort 9: PF-04856883 18.0 mg
n=6 Participants
Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
|
Cohort 10: PF-04856883 15.0 mg
n=16 Participants
Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
|
Cohort 11: PF-04856883 20.0 mg
n=2 Participants
Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Number of Participants With Hypoglycemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cohort 1- 8: Day 1 up to Day 3; Cohort 9: Day 1 up to Day 10Population: Safety population will consist of all randomized patients who received at least 1 dose of study medication.
Criteria for abnormal rhythms: asymptomatic marked sinus bradycardia rate \<35 bpm; asymptomatic supraventricular couplets, atrial bigeminy lasting \>30 seconds; asymptomatic ventricular couplets, ventricular bigeminy lasting \>30 seconds; asymptomatic type I second degree (wenckebach) atrioventricular block of \>30 seconds duration; asymptomatic frequent premature ventricular complexes (=\>200/24 hours); asymptomatic frequent premature atrial complexes (=\>240/24 hours).
Outcome measures
| Measure |
Cohort 1: PF-04856883 0.1 Milligram (mg)
n=7 Participants
Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
|
Cohort 2: PF-04856883 0.3 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
|
Cohort 3: PF-04856883 1.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
|
Cohort 4: PF-04856883 3.0 mg
n=7 Participants
Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
|
Cohort 5: PF-04856883 6.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
|
Cohort 6: PF-04856883 12.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
|
Cohort 7: PF-04856883 24.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
|
Cohort 8: PF-04856883 36.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
|
Cohort 9: PF-04856883 18.0 mg
n=6 Participants
Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
|
Cohort 10: PF-04856883 15.0 mg
n=16 Participants
Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
|
Cohort 11: PF-04856883 20.0 mg
n=2 Participants
Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Number of Participants With Clinically Significant Abnormal Rhythms
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0, 8, 14, 15, 21, 28 and 35Population: Safety population included all randomized participants who received at least 1 dose of study medication. Here, number analyzed signifies those participants who were evaluable at specified time points.
Outcome measures
| Measure |
Cohort 1: PF-04856883 0.1 Milligram (mg)
n=7 Participants
Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
|
Cohort 2: PF-04856883 0.3 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
|
Cohort 3: PF-04856883 1.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
|
Cohort 4: PF-04856883 3.0 mg
n=7 Participants
Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
|
Cohort 5: PF-04856883 6.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
|
Cohort 6: PF-04856883 12.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
|
Cohort 7: PF-04856883 24.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
|
Cohort 8: PF-04856883 36.0 mg
n=6 Participants
Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
|
Cohort 9: PF-04856883 18.0 mg
n=6 Participants
Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
|
Cohort 10: PF-04856883 15.0 mg
n=16 Participants
Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
|
Cohort 11: PF-04856883 20.0 mg
n=2 Participants
Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Number of Participants With Anti-Drug Antibodies
Day 28
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Number of Participants With Anti-Drug Antibodies
Day 0
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Stage 1: Number of Participants With Anti-Drug Antibodies
Day 8
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Stage 1: Number of Participants With Anti-Drug Antibodies
Day 14
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Stage 1: Number of Participants With Anti-Drug Antibodies
Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Stage 1: Number of Participants With Anti-Drug Antibodies
Day 21
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Stage 1: Number of Participants With Anti-Drug Antibodies
Day 35
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0, 29 and 50Population: Safety population included all randomized participants who received at least 1 dose of study medication. Here, number analyzed signifies those participants who were evaluable at specified time points.
Outcome measures
| Measure |
Cohort 1: PF-04856883 0.1 Milligram (mg)
n=9 Participants
Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
|
Cohort 2: PF-04856883 0.3 mg
n=9 Participants
Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
|
Cohort 3: PF-04856883 1.0 mg
n=13 Participants
Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
|
Cohort 4: PF-04856883 3.0 mg
n=9 Participants
Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
|
Cohort 5: PF-04856883 6.0 mg
Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
|
Cohort 6: PF-04856883 12.0 mg
Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
|
Cohort 7: PF-04856883 24.0 mg
Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
|
Cohort 8: PF-04856883 36.0 mg
Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
|
Cohort 9: PF-04856883 18.0 mg
Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
|
Cohort 10: PF-04856883 15.0 mg
Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
|
Cohort 11: PF-04856883 20.0 mg
Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 2: Number of Participants With Anti-Drug Antibodies
Day 0 (n= 9, 9, 13 ,9)
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Anti-Drug Antibodies
Day 29 (n= 9, 8, 7, 8)
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Anti-Drug Antibodies
Day 50 (n= 9, 8, 8, 8)
|
0 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort 1: PF-04856883 0.1 Milligram (mg)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2: PF-04856883 0.3 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 3: PF-04856883 1.0 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 4: PF-04856883 3.0 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 5: PF-04856883 6.0 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 6: PF-04856883 12.0 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 7: PF-04856883 24.0 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 8: PF-04856883 36.0 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 9: PF-04856883 18.0 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 1-9: Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 10: PF-04856883 15.0 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 11: PF-04856883 20.0 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 12: PF-04856883 25.0 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 10-12: Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: PF-04856883 0.1 Milligram (mg)
n=7 participants at risk
Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
|
Cohort 2: PF-04856883 0.3 mg
n=6 participants at risk
Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
|
Cohort 3: PF-04856883 1.0 mg
n=6 participants at risk
Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
|
Cohort 4: PF-04856883 3.0 mg
n=7 participants at risk
Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
|
Cohort 5: PF-04856883 6.0 mg
n=6 participants at risk
Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
|
Cohort 6: PF-04856883 12.0 mg
n=6 participants at risk
Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
|
Cohort 7: PF-04856883 24.0 mg
n=6 participants at risk
Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
|
Cohort 8: PF-04856883 36.0 mg
n=6 participants at risk
Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
|
Cohort 9: PF-04856883 18.0 mg
n=6 participants at risk
Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
|
Cohort 1-9: Placebo
n=18 participants at risk
Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
|
Cohort 10: PF-04856883 15.0 mg
n=9 participants at risk
Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
|
Cohort 11: PF-04856883 20.0 mg
n=9 participants at risk
Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
|
Cohort 12: PF-04856883 25.0 mg
n=13 participants at risk
Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
|
Cohort 10-12: Placebo
n=9 participants at risk
Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/7
|
16.7%
1/6
|
16.7%
1/6
|
33.3%
2/6
|
83.3%
5/6
|
16.7%
1/6
|
0.00%
0/18
|
22.2%
2/9
|
22.2%
2/9
|
53.8%
7/13
|
0.00%
0/9
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/6
|
50.0%
3/6
|
0.00%
0/6
|
33.3%
2/6
|
0.00%
0/6
|
0.00%
0/18
|
11.1%
1/9
|
11.1%
1/9
|
23.1%
3/13
|
0.00%
0/9
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7
|
0.00%
0/6
|
50.0%
3/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
33.3%
2/6
|
0.00%
0/6
|
0.00%
0/18
|
33.3%
3/9
|
11.1%
1/9
|
38.5%
5/13
|
0.00%
0/9
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
16.7%
1/6
|
16.7%
1/6
|
16.7%
1/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/13
|
0.00%
0/9
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
16.7%
1/6
|
5.6%
1/18
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/13
|
0.00%
0/9
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.3%
1/7
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/13
|
0.00%
0/9
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
23.1%
3/13
|
0.00%
0/9
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/13
|
0.00%
0/9
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
33.3%
3/9
|
0.00%
0/13
|
0.00%
0/9
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
23.1%
3/13
|
0.00%
0/9
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
11.1%
1/9
|
0.00%
0/13
|
0.00%
0/9
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
7.7%
1/13
|
0.00%
0/9
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
7.7%
1/13
|
0.00%
0/9
|
|
Gastrointestinal disorders
Hematochezia
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
7.7%
1/13
|
0.00%
0/9
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
7.7%
1/13
|
0.00%
0/9
|
|
Nervous system disorders
Headache
|
14.3%
1/7
|
16.7%
1/6
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
16.7%
1/6
|
16.7%
1/6
|
0.00%
0/18
|
11.1%
1/9
|
33.3%
3/9
|
46.2%
6/13
|
11.1%
1/9
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
11.1%
1/9
|
11.1%
1/9
|
7.7%
1/13
|
22.2%
2/9
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/7
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/13
|
0.00%
0/9
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
7.7%
1/13
|
0.00%
0/9
|
|
Nervous system disorders
Somnolence
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
7.7%
1/13
|
0.00%
0/9
|
|
General disorders
Application site rash
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
2/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/13
|
0.00%
0/9
|
|
General disorders
Application site erythema
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/13
|
0.00%
0/9
|
|
General disorders
Application site pruritus
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/13
|
0.00%
0/9
|
|
General disorders
Asthenia
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/18
|
11.1%
1/9
|
0.00%
0/9
|
0.00%
0/13
|
0.00%
0/9
|
|
General disorders
Injection site rash
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/13
|
0.00%
0/9
|
|
General disorders
Swelling
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/13
|
0.00%
0/9
|
|
General disorders
Chest discomfort
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
7.7%
1/13
|
0.00%
0/9
|
|
General disorders
Chills
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
7.7%
1/13
|
0.00%
0/9
|
|
General disorders
Injection site erythema
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
11.1%
1/9
|
0.00%
0/13
|
0.00%
0/9
|
|
General disorders
Injection site pruritus
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
7.7%
1/13
|
0.00%
0/9
|
|
General disorders
Pyrexia
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
11.1%
1/9
|
0.00%
0/13
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/7
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/18
|
11.1%
1/9
|
11.1%
1/9
|
0.00%
0/13
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal hypoaesthesia
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/13
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/7
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/13
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
5.6%
1/18
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/13
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/13
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/7
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/13
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/7
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/13
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/13
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
5.6%
1/18
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/13
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
5.6%
1/18
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/13
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
11.1%
1/9
|
0.00%
0/13
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Milia
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
5.6%
1/18
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/13
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
7.7%
1/13
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
11.1%
1/9
|
0.00%
0/13
|
0.00%
0/9
|
|
Infections and infestations
Rhinitis
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/13
|
0.00%
0/9
|
|
Infections and infestations
Viral infection
|
0.00%
0/7
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/13
|
0.00%
0/9
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
5.6%
1/18
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/13
|
0.00%
0/9
|
|
Infections and infestations
Otitis externa
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
11.1%
1/9
|
0.00%
0/13
|
0.00%
0/9
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
11.1%
1/9
|
0.00%
0/9
|
0.00%
0/13
|
0.00%
0/9
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
7.7%
1/13
|
0.00%
0/9
|
|
Infections and infestations
Tinea infection
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/13
|
11.1%
1/9
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/13
|
11.1%
1/9
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/13
|
0.00%
0/9
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/13
|
0.00%
0/9
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
0.00%
0/9
|
7.7%
1/13
|
0.00%
0/9
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
11.1%
1/9
|
33.3%
3/9
|
15.4%
2/13
|
0.00%
0/9
|
|
Vascular disorders
Hot flush
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/18
|
0.00%
0/9
|
11.1%
1/9
|
0.00%
0/13
|
0.00%
0/9
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER