Trial Outcomes & Findings for Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars in Subjects Undergoing Elective Abdominoplasty (NCT NCT01037985)
NCT ID: NCT01037985
Last Updated: 2021-08-02
Results Overview
Scar assessment by an expert panel was done on blinded photographs using 100 millimeter (mm) visual analog scale (VAS) where a score of 0 = best possible scar and a score of 100 = worst possible scar. A pair of photographs for each participant were presented and evaluated 3 times by an expert panel.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
Week 12
Results posted on
2021-08-02
Participant Flow
Participants who had chosen and qualified (sufficient excess abdominal tissue) for a standard elective abdominoplasty were recruited in this study. Study had 2 parts- Part A and B. Participants with negative skin sensitization in Part A (skin testing) were assigned to Part B (abdominoplasty surgery) of the study.
Participant milestones
| Measure |
EXC 001 (PF-0647387) During Part A
In Part A participants received 2 intradermal injections on lower back of EXC 001 at a dose of 5 milligram (mg) on Day 1 and 21. Third 5 mg intradermal injection of EXC 001 was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to surgery. The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery in Part B.
|
EXC 001 (PF-0647387) + Placebo During Part B
Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent abdominoplasty surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear centimeter (cm) to a 6 cm section of both sides of abdominoplasty incision on one side of the midline and 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of abdominoplasty incision on another side of the midline, at Week 2, 5, 8, and 11 after the surgical incision was closed.
|
|---|---|---|
|
Part A: Skin Testing (50 Days)
STARTED
|
41
|
0
|
|
Part A: Skin Testing (50 Days)
COMPLETED
|
37
|
0
|
|
Part A: Skin Testing (50 Days)
NOT COMPLETED
|
4
|
0
|
|
Part B:Abdominoplasty Surgery (24 Weeks)
STARTED
|
0
|
37
|
|
Part B:Abdominoplasty Surgery (24 Weeks)
Treated
|
0
|
33
|
|
Part B:Abdominoplasty Surgery (24 Weeks)
COMPLETED
|
0
|
32
|
|
Part B:Abdominoplasty Surgery (24 Weeks)
NOT COMPLETED
|
0
|
5
|
Reasons for withdrawal
| Measure |
EXC 001 (PF-0647387) During Part A
In Part A participants received 2 intradermal injections on lower back of EXC 001 at a dose of 5 milligram (mg) on Day 1 and 21. Third 5 mg intradermal injection of EXC 001 was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to surgery. The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery in Part B.
|
EXC 001 (PF-0647387) + Placebo During Part B
Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent abdominoplasty surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear centimeter (cm) to a 6 cm section of both sides of abdominoplasty incision on one side of the midline and 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of abdominoplasty incision on another side of the midline, at Week 2, 5, 8, and 11 after the surgical incision was closed.
|
|---|---|---|
|
Part A: Skin Testing (50 Days)
Withdrawal by Subject
|
3
|
0
|
|
Part A: Skin Testing (50 Days)
Physician Decision
|
1
|
0
|
|
Part B:Abdominoplasty Surgery (24 Weeks)
Lost to Follow-up
|
0
|
1
|
|
Part B:Abdominoplasty Surgery (24 Weeks)
Positive Skin Sensitization
|
0
|
4
|
Baseline Characteristics
Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars in Subjects Undergoing Elective Abdominoplasty
Baseline characteristics by cohort
| Measure |
All Enrolled Participants
n=41 Participants
All participants who were enrolled in the study.
|
|---|---|
|
Age, Continuous
|
34.7 years
STANDARD_DEVIATION 4.68 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Completer population included all participants who had missed not more than 1 dose of study drug, had the Week 12 assessment and non-missing data for VAS scar assessment score.
Scar assessment by an expert panel was done on blinded photographs using 100 millimeter (mm) visual analog scale (VAS) where a score of 0 = best possible scar and a score of 100 = worst possible scar. A pair of photographs for each participant were presented and evaluated 3 times by an expert panel.
Outcome measures
| Measure |
EXC 001 (PF-0647387) During Part B
n=32 Participants
Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent abdominoplasty surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear cm to a 6 cm section of both sides of abdominoplasty incision on one side of the midline at Week 2, 5, 8, and 11 after the surgical incision was closed.
|
Placebo During Part B
n=32 Participants
Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent abdominoplasty surgery on Day 1 and then received 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of abdominoplasty incision on another side of the midline, at Week 2, 5, 8, and 11 after the surgical incision was closed.
|
|---|---|---|
|
Expert Panel Scar Assessment Score at Week 12: Part B
|
37.8 millimeter
Standard Deviation 12.96
|
42.1 millimeter
Standard Deviation 12.52
|
SECONDARY outcome
Timeframe: Week 24Population: Completer population included all participants who had missed not more than 1 dose of study drug, had the Week 12 assessment and non-missing data for VAS scar assessment score. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Scar assessment by an expert panel was done on blinded photographs using 100 mm VAS where a score of 0 = best possible scar and a score of 100 = worst possible scar. A pair of photographs for each participant was presented and evaluated 3 times by an expert panel.
Outcome measures
| Measure |
EXC 001 (PF-0647387) During Part B
n=31 Participants
Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent abdominoplasty surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear cm to a 6 cm section of both sides of abdominoplasty incision on one side of the midline at Week 2, 5, 8, and 11 after the surgical incision was closed.
|
Placebo During Part B
n=31 Participants
Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent abdominoplasty surgery on Day 1 and then received 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of abdominoplasty incision on another side of the midline, at Week 2, 5, 8, and 11 after the surgical incision was closed.
|
|---|---|---|
|
Expert Panel Scar Assessment Score at Week 24: Part B
|
37.9 millimeter
Standard Deviation 9.29
|
37.6 millimeter
Standard Deviation 10.73
|
SECONDARY outcome
Timeframe: Week 12 and 24Population: Completer population included all participants who had missed not more than 1 dose of study drug, had the Week 12 assessment and non-missing data for VAS scar assessment score. Here 'n' signifies those participants who were evaluable at specified time-point.
Physician assessment of scar was done using a valid published 10-point rating scale. Physician rated vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion for a scar on a score of 1 = normal skin to 10 = worst scar imaginable. Composite score was the sum of all the scores except the overall opinion score and range from 6 (best score) to 60 (worst score).
Outcome measures
| Measure |
EXC 001 (PF-0647387) During Part B
n=32 Participants
Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent abdominoplasty surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear cm to a 6 cm section of both sides of abdominoplasty incision on one side of the midline at Week 2, 5, 8, and 11 after the surgical incision was closed.
|
Placebo During Part B
n=32 Participants
Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent abdominoplasty surgery on Day 1 and then received 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of abdominoplasty incision on another side of the midline, at Week 2, 5, 8, and 11 after the surgical incision was closed.
|
|---|---|---|
|
Physician Observer Scar Assessment Score at Week 12 and 24: Part B
Week 12: Vascularity
|
3.7 units on a scale
Standard Deviation 1.49
|
4.7 units on a scale
Standard Deviation 1.69
|
|
Physician Observer Scar Assessment Score at Week 12 and 24: Part B
Week 12: Pigmentation
|
3.2 units on a scale
Standard Deviation 1.40
|
3.7 units on a scale
Standard Deviation 1.63
|
|
Physician Observer Scar Assessment Score at Week 12 and 24: Part B
Week 12: Thickness
|
3.2 units on a scale
Standard Deviation 1.52
|
4.6 units on a scale
Standard Deviation 1.95
|
|
Physician Observer Scar Assessment Score at Week 12 and 24: Part B
Week 12: Relief
|
2.8 units on a scale
Standard Deviation 1.36
|
3.7 units on a scale
Standard Deviation 1.84
|
|
Physician Observer Scar Assessment Score at Week 12 and 24: Part B
Week 12: Pliability
|
2.9 units on a scale
Standard Deviation 1.50
|
3.7 units on a scale
Standard Deviation 1.68
|
|
Physician Observer Scar Assessment Score at Week 12 and 24: Part B
Week 12: Surface Area
|
3.7 units on a scale
Standard Deviation 1.77
|
4.1 units on a scale
Standard Deviation 1.62
|
|
Physician Observer Scar Assessment Score at Week 12 and 24: Part B
Week 12: Overall Opinion
|
3.5 units on a scale
Standard Deviation 1.59
|
4.4 units on a scale
Standard Deviation 1.56
|
|
Physician Observer Scar Assessment Score at Week 12 and 24: Part B
Week 12: Composite Score
|
19.5 units on a scale
Standard Deviation 7.10
|
24.5 units on a scale
Standard Deviation 8.10
|
|
Physician Observer Scar Assessment Score at Week 12 and 24: Part B
Week 24: Vascularity
|
3.3 units on a scale
Standard Deviation 1.27
|
3.2 units on a scale
Standard Deviation 1.34
|
|
Physician Observer Scar Assessment Score at Week 12 and 24: Part B
Week 24: Pigmentation
|
3.6 units on a scale
Standard Deviation 1.58
|
3.2 units on a scale
Standard Deviation 1.45
|
|
Physician Observer Scar Assessment Score at Week 12 and 24: Part B
Week 24: Thickness
|
3.3 units on a scale
Standard Deviation 1.47
|
3.5 units on a scale
Standard Deviation 1.48
|
|
Physician Observer Scar Assessment Score at Week 12 and 24: Part B
Week 24: Relief
|
2.6 units on a scale
Standard Deviation 1.48
|
2.6 units on a scale
Standard Deviation 1.43
|
|
Physician Observer Scar Assessment Score at Week 12 and 24: Part B
Week 24: Pliability
|
2.7 units on a scale
Standard Deviation 1.67
|
2.7 units on a scale
Standard Deviation 1.60
|
|
Physician Observer Scar Assessment Score at Week 12 and 24: Part B
Week 24: Surface Area
|
3.4 units on a scale
Standard Deviation 1.50
|
3.4 units on a scale
Standard Deviation 1.56
|
|
Physician Observer Scar Assessment Score at Week 12 and 24: Part B
Week 24: Overall Opinion
|
3.3 units on a scale
Standard Deviation 1.16
|
3.3 units on a scale
Standard Deviation 1.37
|
|
Physician Observer Scar Assessment Score at Week 12 and 24: Part B
Week 24: Composite Score
|
19.0 units on a scale
Standard Deviation 8.01
|
18.5 units on a scale
Standard Deviation 7.88
|
SECONDARY outcome
Timeframe: Week 12 and 24Population: Completer population included all participants who had missed not more than 1 dose of study drug, had the Week 12 assessment and non-missing data for VAS scar assessment score. Here 'n' signifies those participants who were evaluable at specified time-point.
Participants rated pain, itching, color, stiffness, thickness, irregularity, and overall opinion of scar on 10-point scale. For pain and itching associated with scar: range = 1 (no, not at all) to 10 (yes, worst imaginable) and for other parameters associated with scar compared to normal skin: range = 1 (no, same as normal skin) to 10 (yes, very different). Composite score = sum of all scores except overall opinion, range 6 (best) to 60 (worst). Scar appearance composite score = sum of all scores except overall opinion, pain and itching, range 4 (best) to 40 (worst).
Outcome measures
| Measure |
EXC 001 (PF-0647387) During Part B
n=32 Participants
Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent abdominoplasty surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear cm to a 6 cm section of both sides of abdominoplasty incision on one side of the midline at Week 2, 5, 8, and 11 after the surgical incision was closed.
|
Placebo During Part B
n=32 Participants
Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent abdominoplasty surgery on Day 1 and then received 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of abdominoplasty incision on another side of the midline, at Week 2, 5, 8, and 11 after the surgical incision was closed.
|
|---|---|---|
|
Participants Observer Scar Assessment Score at Week 12 and 24: Part B
Week 12: Pain
|
2.0 units on a scale
Standard Deviation 1.50
|
1.9 units on a scale
Standard Deviation 1.68
|
|
Participants Observer Scar Assessment Score at Week 12 and 24: Part B
Week 12: Itching
|
1.8 units on a scale
Standard Deviation 1.35
|
1.8 units on a scale
Standard Deviation 1.32
|
|
Participants Observer Scar Assessment Score at Week 12 and 24: Part B
Week 12: Color
|
5.8 units on a scale
Standard Deviation 2.42
|
6.5 units on a scale
Standard Deviation 2.49
|
|
Participants Observer Scar Assessment Score at Week 12 and 24: Part B
Week 12: Stiffness
|
4.3 units on a scale
Standard Deviation 2.21
|
4.4 units on a scale
Standard Deviation 2.00
|
|
Participants Observer Scar Assessment Score at Week 12 and 24: Part B
Week 12: Thickness
|
4.3 units on a scale
Standard Deviation 2.37
|
4.7 units on a scale
Standard Deviation 2.54
|
|
Participants Observer Scar Assessment Score at Week 12 and 24: Part B
Week 12: Irregular
|
4.7 units on a scale
Standard Deviation 2.46
|
5.3 units on a scale
Standard Deviation 2.44
|
|
Participants Observer Scar Assessment Score at Week 12 and 24: Part B
Week 12: Overall Opinion
|
4.3 units on a scale
Standard Deviation 1.97
|
5.0 units on a scale
Standard Deviation 2.18
|
|
Participants Observer Scar Assessment Score at Week 12 and 24: Part B
Week 12: Composite Score
|
22.9 units on a scale
Standard Deviation 7.34
|
24.7 units on a scale
Standard Deviation 7.44
|
|
Participants Observer Scar Assessment Score at Week 12 and 24: Part B
Week 12: Scar Appearance Composite Score
|
19.1 units on a scale
Standard Deviation 6.87
|
20.9 units on a scale
Standard Deviation 7.27
|
|
Participants Observer Scar Assessment Score at Week 12 and 24: Part B
Week 24: Pain
|
1.4 units on a scale
Standard Deviation 1.05
|
1.1 units on a scale
Standard Deviation 0.34
|
|
Participants Observer Scar Assessment Score at Week 12 and 24: Part B
Week 24: Itching
|
1.7 units on a scale
Standard Deviation 1.60
|
1.5 units on a scale
Standard Deviation 1.46
|
|
Participants Observer Scar Assessment Score at Week 12 and 24: Part B
Week 24: Color
|
6.3 units on a scale
Standard Deviation 2.44
|
5.8 units on a scale
Standard Deviation 2.70
|
|
Participants Observer Scar Assessment Score at Week 12 and 24: Part B
Week 24: Stiffness
|
3.8 units on a scale
Standard Deviation 1.80
|
4.3 units on a scale
Standard Deviation 2.52
|
|
Participants Observer Scar Assessment Score at Week 12 and 24: Part B
Week 24: Thickness
|
4.1 units on a scale
Standard Deviation 2.33
|
4.1 units on a scale
Standard Deviation 2.35
|
|
Participants Observer Scar Assessment Score at Week 12 and 24: Part B
Week 24: Irregular
|
4.9 units on a scale
Standard Deviation 2.57
|
4.9 units on a scale
Standard Deviation 2.78
|
|
Participants Observer Scar Assessment Score at Week 12 and 24: Part B
Week 24: Overall Opinion
|
4.7 units on a scale
Standard Deviation 2.14
|
4.8 units on a scale
Standard Deviation 2.50
|
|
Participants Observer Scar Assessment Score at Week 12 and 24: Part B
Week 24: Composite Score
|
22.1 units on a scale
Standard Deviation 8.61
|
21.8 units on a scale
Standard Deviation 9.65
|
|
Participants Observer Scar Assessment Score at Week 12 and 24: Part B
Week 24: Scar Appearance Composite Score
|
19.1 units on a scale
Standard Deviation 8.06
|
19.2 units on a scale
Standard Deviation 8.97
|
SECONDARY outcome
Timeframe: Day 1 of Part A up to Week 24 of Part BPopulation: Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug.
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. AEs included SAEs and all non-SAEs that occurred during the study.
Outcome measures
| Measure |
EXC 001 (PF-0647387) During Part B
n=41 Participants
Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent abdominoplasty surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear cm to a 6 cm section of both sides of abdominoplasty incision on one side of the midline at Week 2, 5, 8, and 11 after the surgical incision was closed.
|
Placebo During Part B
n=33 Participants
Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent abdominoplasty surgery on Day 1 and then received 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of abdominoplasty incision on another side of the midline, at Week 2, 5, 8, and 11 after the surgical incision was closed.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
7 Participants
|
21 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 of Part A up to Week 12 of Part BPopulation: Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug.
Physical examination included the assessment of skin; head, ears, eyes, nose, and throat; respiratory; cardiovascular; abdomen; musculoskeletal; neurological; gastrointestinal; genitourinary; endocrine and lymph nodes. Abnormal physical examinations findings was based on investigator's discretion.
Outcome measures
| Measure |
EXC 001 (PF-0647387) During Part B
n=41 Participants
Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent abdominoplasty surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear cm to a 6 cm section of both sides of abdominoplasty incision on one side of the midline at Week 2, 5, 8, and 11 after the surgical incision was closed.
|
Placebo During Part B
n=33 Participants
Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent abdominoplasty surgery on Day 1 and then received 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of abdominoplasty incision on another side of the midline, at Week 2, 5, 8, and 11 after the surgical incision was closed.
|
|---|---|---|
|
Number of Participants With Abnormal Physical Examinations Findings: Part A and Part B
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 1 of Part A up to Week 12 of Part BPopulation: Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug.
Number of participants with clinically significant abnormality in ECG were reported. Clinical significance was based on investigator's discretion.
Outcome measures
| Measure |
EXC 001 (PF-0647387) During Part B
n=41 Participants
Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent abdominoplasty surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear cm to a 6 cm section of both sides of abdominoplasty incision on one side of the midline at Week 2, 5, 8, and 11 after the surgical incision was closed.
|
Placebo During Part B
n=33 Participants
Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent abdominoplasty surgery on Day 1 and then received 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of abdominoplasty incision on another side of the midline, at Week 2, 5, 8, and 11 after the surgical incision was closed.
|
|---|---|---|
|
Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG): Part A and Part B
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 of Part A up to Week 12 of Part BPopulation: Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug.
Laboratory analysis included hematology, biochemistry and urinalysis. Hematology range: basophils (bas) 0-0.2, eosinophils (eos) 0-0.4, leukocytes (leu) 4-10.5, lymphocytes (lym) 0.7-4.5, neutrophils (neu) 1.8-7.8, platelet 140-415, monocytes (mon) 0.1-1 in 10\^9 per liter; bas/leu 0-3, eos/leu 0-7, lym/leu 14-46, mon/leu 4-13, neu/leu and neu/leu 40-74 in percentage, erythrocytes 3.8-5.1 10\^12/L, hematocrit 0.34-0.44 L/L, hemoglobin 115-150 gram per liter (g/L). Biochemistry range: creatine kinase 24-173, alkaline phosphatase 25-150, alanine aminotransferase (AT) and aspartate AT 0-40 in International units per liter; creatinine 50-88, urate 89-399, bilirubin 2-21 in micromole per liter, glucose 3.6-5.5, potassium 3.5-5.5, sodium 135-148, blood urea nitrogen 1.8-9.3 in millimole/L, albumin 35-55 g/L. Urinalysis parameters: pH (5-7.5), specific gravity (1.005-1.03). Participants with clinically significant findings were reported.
Outcome measures
| Measure |
EXC 001 (PF-0647387) During Part B
n=41 Participants
Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent abdominoplasty surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear cm to a 6 cm section of both sides of abdominoplasty incision on one side of the midline at Week 2, 5, 8, and 11 after the surgical incision was closed.
|
Placebo During Part B
n=33 Participants
Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent abdominoplasty surgery on Day 1 and then received 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of abdominoplasty incision on another side of the midline, at Week 2, 5, 8, and 11 after the surgical incision was closed.
|
|---|---|---|
|
Number of Participants With Clinically Significant Findings in Laboratory Examinations: Part A and Part B
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1 of Part A up to Week 12 of Part BPopulation: Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug.
Following vital sign parameters were assessed: diastolic blood pressure, systolic blood pressure, respiration rate, pulse rate, and temperature. Number of participants with clinically significant change in any vital sign parameter and weight compared to baseline were reported. Clinical significance was based on investigator's discretion.
Outcome measures
| Measure |
EXC 001 (PF-0647387) During Part B
n=41 Participants
Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent abdominoplasty surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear cm to a 6 cm section of both sides of abdominoplasty incision on one side of the midline at Week 2, 5, 8, and 11 after the surgical incision was closed.
|
Placebo During Part B
n=33 Participants
Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent abdominoplasty surgery on Day 1 and then received 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of abdominoplasty incision on another side of the midline, at Week 2, 5, 8, and 11 after the surgical incision was closed.
|
|---|---|---|
|
Number of Participants With Clinically Significant Findings in Vital Signs and Weight: Part A and Part B
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 21 of Part A up to Day 14 of Part BPopulation: Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug.
Participants were instructed to inform the investigator in case of any itching, redness, pain or any other symptom that appears to be a rash at the injection sites. Erythematous, raised (indurated) and edematous reactions were considered as positive skin sensitivity reactions.
Outcome measures
| Measure |
EXC 001 (PF-0647387) During Part B
n=41 Participants
Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent abdominoplasty surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear cm to a 6 cm section of both sides of abdominoplasty incision on one side of the midline at Week 2, 5, 8, and 11 after the surgical incision was closed.
|
Placebo During Part B
n=33 Participants
Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent abdominoplasty surgery on Day 1 and then received 4 intradermal injections of placebo matched to EXC 001 to a 6 cm section of both sides of abdominoplasty incision on another side of the midline, at Week 2, 5, 8, and 11 after the surgical incision was closed.
|
|---|---|---|
|
Number of Participants With Positive Skin Sensitivity Reaction: Part A and Part B
|
0 Participants
|
4 Participants
|
Adverse Events
EXC 001 (PF-0647387) During Part A
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Active Dosing Phase During Part B
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Post Dosing Phase During Part B
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
EXC 001 (PF-0647387) During Part A
n=41 participants at risk
In Part A participants received 2 intradermal injections on lower back of EXC 001 at a dose of 5 mg on Day 1 and 21. Third 5 mg intradermal injection of EXC 001 was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to surgery (Day 1 in Part B). The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery in Part B.
|
Active Dosing Phase During Part B
n=33 participants at risk
Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants underwent abdominoplasty surgery on Day 1 and then received 4 intradermal injections of EXC 001 at dose of 5 mg per linear cm to a 6 cm section of both sides of abdominoplasty incision on one side of the midline at Week 2, 5, 8, and 11 after the surgical incision was closed. Active dosing phase was from Week 2 to Week 13.
|
Post Dosing Phase During Part B
n=32 participants at risk
Participants who tested negative for skin sensitization in Part A were eligible for Part B. In Part B, participants who received treatment in active dosing phase were followed up from Week 13 until end of the study in post dosing phase.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
6.1%
2/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
3.1%
1/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
Infections and infestations
Sinusitis
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
3.0%
1/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
3.0%
1/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
3.0%
1/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
Infections and infestations
Bronchitis
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
Infections and infestations
Influenza
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
3.0%
1/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
Infections and infestations
Kidney infection
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
3.0%
1/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
Infections and infestations
Vaginal infection
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
Infections and infestations
Vaginitis bacterial
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
3.0%
1/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
Infections and infestations
Viral upper respiratory tract
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
3.0%
1/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
Injury, poisoning and procedural complications
Incision site pruritus
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
9.1%
3/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
3.0%
1/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
Injury, poisoning and procedural complications
Incision site complication
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
3.0%
1/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
Injury, poisoning and procedural complications
Incision site erythema
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
3.0%
1/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
3.0%
1/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
3.0%
1/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
3.0%
1/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
Injury, poisoning and procedural complications
Suture rupture
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
3.0%
1/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
3.0%
1/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
3.1%
1/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
6.1%
2/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
3.0%
1/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
3.0%
1/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
3.0%
1/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
General disorders
Injection site erythema
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
6.1%
2/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
General disorders
Cyst
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
3.0%
1/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
General disorders
Infusion site rash
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
3.0%
1/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
General disorders
Injection site pruritus
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
3.0%
1/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
General disorders
Injection site swelling
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
3.0%
1/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
Nervous system disorders
Headache
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
3.0%
1/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
3.1%
1/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
Nervous system disorders
Migraine
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
Psychiatric disorders
Depression
|
2.4%
1/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
3.0%
1/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
3.1%
1/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/41
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
3.0%
1/33
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
0.00%
0/32
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included participants who completed Day 1 of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo.
|
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