Trial Outcomes & Findings for Substance P Challenge in Healthy Participants (NCT NCT04676763)
NCT ID: NCT04676763
Last Updated: 2025-01-20
Results Overview
Wheal response-time AUC during the 2 hours post-challenge period following skin challenge for Substance P (SP) was calculated using the trapezoidal rule. The wheal response was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50, 150 and 500 picomoles (pmol) during the 2 hours post-challenge period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
0, 5, 10, 15, 20, 40, 60, 90 and 120 minutes post-challenge on Day 1 (Visit 1)
Results posted on
2025-01-20
Participant Flow
This was an open label, 2-part, sequential, prospective enabling study of Substance P (SP) intradermal challenge in healthy participants conducted at a single center in the Netherlands.
A total of 32 participants were enrolled (Enrolled population: All participants in the screened population who entered the study) in Part 1 (12 participants) and Part 2 (20 participants) of the study.
Participant milestones
| Measure |
Part 1- Skin Challenges
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
Part 1- No Skin Challenges
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants whose wheal responses did not meet the acceptable saline and histamine response within 20 minutes of each control challenge or who were withdrawn from the study, independent of the wheal response acceptability, were not administered Substance P.
|
Part 2- Skin Challenges
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50 and 150 PMOL) and wheal and flare responses were assessed along with Intradermal microdialysis (IDM) after Challenge Visit 1 (Day 1). At Challenge Visit 2 (Week 2), participants were administered up to 6 Substance P intradermal injections and wheal and flare response, IDM and biopsies were taken (one from each challenged site and one from a non-challenged area of skin.
|
|---|---|---|---|
|
Part 1 (Up to Day 1)
STARTED
|
9
|
3
|
0
|
|
Part 1 (Up to Day 1)
Number of Participants Who Received SP 5 PMOL
|
9
|
0
|
0
|
|
Part 1 (Up to Day 1)
Number of Participants Who Received SP 15 PMOL
|
9
|
0
|
0
|
|
Part 1 (Up to Day 1)
Number of Participants Who Received SP 50 PMOL
|
4
|
0
|
0
|
|
Part 1 (Up to Day 1)
Number of Participants Who Received SP 150 PMOL
|
9
|
0
|
0
|
|
Part 1 (Up to Day 1)
Number of Participants Who Received SP 500 PMOL
|
5
|
0
|
0
|
|
Part 1 (Up to Day 1)
COMPLETED
|
9
|
0
|
0
|
|
Part 1 (Up to Day 1)
NOT COMPLETED
|
0
|
3
|
0
|
|
Part 2 (Up to 3 Weeks)
STARTED
|
0
|
0
|
20
|
|
Part 2 (Up to 3 Weeks)
Number of Participants Who Received SP 5 PMOL
|
0
|
0
|
20
|
|
Part 2 (Up to 3 Weeks)
Number of Participants Who Received SP 15 PMOL
|
0
|
0
|
20
|
|
Part 2 (Up to 3 Weeks)
Number of Participants Who Received SP 50 PMOL
|
0
|
0
|
20
|
|
Part 2 (Up to 3 Weeks)
Number of Participants Who Received SP 150 PMOL
|
0
|
0
|
20
|
|
Part 2 (Up to 3 Weeks)
COMPLETED
|
0
|
0
|
20
|
|
Part 2 (Up to 3 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part 1- Skin Challenges
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
Part 1- No Skin Challenges
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants whose wheal responses did not meet the acceptable saline and histamine response within 20 minutes of each control challenge or who were withdrawn from the study, independent of the wheal response acceptability, were not administered Substance P.
|
Part 2- Skin Challenges
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50 and 150 PMOL) and wheal and flare responses were assessed along with Intradermal microdialysis (IDM) after Challenge Visit 1 (Day 1). At Challenge Visit 2 (Week 2), participants were administered up to 6 Substance P intradermal injections and wheal and flare response, IDM and biopsies were taken (one from each challenged site and one from a non-challenged area of skin.
|
|---|---|---|---|
|
Part 1 (Up to Day 1)
Protocol Violation
|
0
|
1
|
0
|
|
Part 1 (Up to Day 1)
Physician Decision
|
0
|
1
|
0
|
|
Part 1 (Up to Day 1)
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
Substance P Challenge in Healthy Participants
Baseline characteristics by cohort
| Measure |
Part 1- Skin Challenges
n=9 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
Part 1- No Skin Challenges
n=3 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants whose wheal responses did not meet the acceptable saline and histamine response within 20 minutes of each control challenge or who were withdrawn from the study, independent of the wheal response acceptability, were not administered Substance P.
|
Part 2- Skin Challenges
n=20 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50 and 150 PMOL) and wheal and flare responses were assessed along with Intradermal microdialysis (IDM) after Challenge Visit 1 (Day 1). At Challenge Visit 2 (Week 2), participants were administered up to 6 Substance P intradermal injections and wheal and flare response, IDM and biopsies were taken (one from each challenged site and one from a non-challenged area of skin.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
23.0 Years
STANDARD_DEVIATION 3.50 • n=5 Participants
|
22.0 Years
STANDARD_DEVIATION 4.58 • n=7 Participants
|
26.8 Years
STANDARD_DEVIATION 9.34 • n=5 Participants
|
25.3 Years
STANDARD_DEVIATION 7.88 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White- Arabic / North African Heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White- White/ Caucasian/ European Heritage
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 0, 5, 10, 15, 20, 40, 60, 90 and 120 minutes post-challenge on Day 1 (Visit 1)Population: Safety Population consisted of all participants in the enrolled analysis set who received at least one challenge-related study procedure on their (first) challenge day. Only those participants with data available at the specified data points were analyzed.
Wheal response-time AUC during the 2 hours post-challenge period following skin challenge for Substance P (SP) was calculated using the trapezoidal rule. The wheal response was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50, 150 and 500 picomoles (pmol) during the 2 hours post-challenge period.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=9 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 1: Wheal Response-time Area Under the Curve (AUC) Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
Saline
|
155.2379 Millimeter square*minutes
Standard Deviation 97.43852
|
|
Part 1: Wheal Response-time Area Under the Curve (AUC) Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
Histamine
|
2151.2320 Millimeter square*minutes
Standard Deviation 1352.66124
|
|
Part 1: Wheal Response-time Area Under the Curve (AUC) Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 5 pmol
|
2749.0997 Millimeter square*minutes
Standard Deviation 2000.66201
|
|
Part 1: Wheal Response-time Area Under the Curve (AUC) Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 15 pmol
|
5727.2220 Millimeter square*minutes
Standard Deviation 3859.78704
|
|
Part 1: Wheal Response-time Area Under the Curve (AUC) Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 50 pmol
|
7111.5570 Millimeter square*minutes
Standard Deviation 5388.48885
|
|
Part 1: Wheal Response-time Area Under the Curve (AUC) Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 150 pmol
|
8295.6310 Millimeter square*minutes
Standard Deviation 5912.58152
|
|
Part 1: Wheal Response-time Area Under the Curve (AUC) Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 500 pmol
|
12540.9840 Millimeter square*minutes
Standard Deviation 14705.68961
|
PRIMARY outcome
Timeframe: 0, 5, 10, 15, 20, 30, 40, 60, 90 and 120 minutes post-challenge on Day 1 (Visit 1) and on Week 2 (Visit 2)Population: Safety Population
Wheal response-time AUC during the 2 hours post-challenge period following skin challenge for Substance P was calculated using the trapezoidal rule. The wheal response was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50 and 150 pmol during the 2 hours post-challenge period.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=20 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 2: Wheal Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 5 pmol: 2 hours post-challenge at Week 2
|
4563.5113 Millimeter square*minutes
Standard Deviation 2517.52789
|
|
Part 2: Wheal Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Saline: 2 hours post-challenge on Day 1
|
157.9157 Millimeter square*minutes
Standard Deviation 110.11185
|
|
Part 2: Wheal Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Saline: 2 hours post-challenge at Week 2
|
216.5196 Millimeter square*minutes
Standard Deviation 113.81519
|
|
Part 2: Wheal Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Histamine: 2 hours post-challenge on Day 1
|
2617.3622 Millimeter square*minutes
Standard Deviation 1362.88319
|
|
Part 2: Wheal Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Histamine: 2 hours post-challenge at Week 2
|
2486.9477 Millimeter square*minutes
Standard Deviation 1171.55762
|
|
Part 2: Wheal Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 5 pmol: 2 hours post-challenge on Day 1
|
4534.4513 Millimeter square*minutes
Standard Deviation 2153.69897
|
|
Part 2: Wheal Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 15 pmol: 2 hours post-challenge on Day 1
|
6754.7067 Millimeter square*minutes
Standard Deviation 3501.44122
|
|
Part 2: Wheal Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 15 pmol: 2 hours post-challenge at Week 2
|
6506.0915 Millimeter square*minutes
Standard Deviation 3199.02966
|
|
Part 2: Wheal Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 50 pmol: 2 hours post-challenge on Day 1
|
8937.9117 Millimeter square*minutes
Standard Deviation 4089.24955
|
|
Part 2: Wheal Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 50 pmol: 2 hours post-challenge at Week 2
|
9763.2271 Millimeter square*minutes
Standard Deviation 4963.46223
|
|
Part 2: Wheal Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 150 pmol:2 hours post-challenge on Day 1
|
11017.5544 Millimeter square*minutes
Standard Deviation 4779.69981
|
|
Part 2: Wheal Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 150 pmol: 2 hours post-challenge at Week 2
|
9977.7777 Millimeter square*minutes
Standard Deviation 4155.85567
|
SECONDARY outcome
Timeframe: 2 hours post-challenge on Day 1 (Visit 1)Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
Wheal area was calculated using the following formula: 1/4 \* pi \* longest diameter \* orthogonal diameter, for area of an ellipse, using the longest and orthogonal diameters measured by the calliper method. The maximum observed wheal area was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50, 150 and 500 pmol during the 2 hours post-challenge period.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=9 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 1: Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 15 pmol
|
82.7571 Millimeter square
Standard Deviation 41.76154
|
|
Part 1: Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
Saline
|
15.2152 Millimeter square
Standard Deviation 8.97791
|
|
Part 1: Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
Histamine
|
44.5782 Millimeter square
Standard Deviation 16.73404
|
|
Part 1: Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 5 pmol
|
42.4284 Millimeter square
Standard Deviation 20.26132
|
|
Part 1: Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 50 pmol
|
99.8398 Millimeter square
Standard Deviation 48.06381
|
|
Part 1: Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 150 pmol
|
126.1186 Millimeter square
Standard Deviation 55.28040
|
|
Part 1: Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 500 pmol
|
194.0748 Millimeter square
Standard Deviation 178.88175
|
SECONDARY outcome
Timeframe: 2 hours post-challenge on Day 1 (Visit 1) and 2 hours post-challenge at Week 2 (Visit 2)Population: Safety Population
Wheal area was calculated using the following formula: 1/4 \* pi \* longest diameter \* orthogonal diameter, for area of an ellipse, using the longest and orthogonal diameters measured by the calliper method. The maximum observed wheal area was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50 and 150 pmol during the 2 hours post-challenge period.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=20 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 2: Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P Across- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Saline : 2 hours post-challenge on Day 1
|
16.6335 Millimeter square
Standard Deviation 11.36559
|
|
Part 2: Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P Across- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Saline: 2 hours post-challenge at Week 2
|
21.7610 Millimeter square
Standard Deviation 12.79723
|
|
Part 2: Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P Across- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Histamine: 2 hours post-challenge on Day 1
|
53.1929 Millimeter square
Standard Deviation 26.57857
|
|
Part 2: Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P Across- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Histamine: 2 hours post-challenge at Week 2
|
52.8665 Millimeter square
Standard Deviation 16.31003
|
|
Part 2: Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P Across- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 5 pmol: 2 hours post-challenge on Day 1
|
85.8111 Millimeter square
Standard Deviation 23.45193
|
|
Part 2: Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P Across- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 5 pmol: 2 hours post-challenge at Week 2
|
92.1595 Millimeter square
Standard Deviation 24.44909
|
|
Part 2: Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P Across- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 15 pmol: 2 hours post-challenge on Day 1
|
112.9690 Millimeter square
Standard Deviation 30.79242
|
|
Part 2: Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P Across- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 15 pmol: 2 hours post-challenge at Week 2
|
113.0940 Millimeter square
Standard Deviation 26.92327
|
|
Part 2: Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P Across- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 50 pmol: 2 hours post-challenge on Day 1
|
134.6049 Millimeter square
Standard Deviation 39.38378
|
|
Part 2: Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P Across- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 50 pmol: 2 hours post-challenge at Week 2
|
151.1447 Millimeter square
Standard Deviation 39.31424
|
|
Part 2: Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P Across- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 150 pmol:2 hours post-challenge on Day 1
|
148.8571 Millimeter square
Standard Deviation 47.72791
|
|
Part 2: Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P Across- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 150 pmol: 2 hours post-challenge at Week 2
|
153.0084 Millimeter square
Standard Deviation 39.81310
|
SECONDARY outcome
Timeframe: 2 hours post-challenge on Day 1 (Visit 1)Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
Time to maximum observed wheal area was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50, 150 and 500 pmol during the 2 hours post-challenge period.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=9 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 1: Time to Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
Saline
|
5.0 Minutes
Interval 5.0 to 11.0
|
|
Part 1: Time to Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
Histamine
|
20.0 Minutes
Interval 15.0 to 42.0
|
|
Part 1: Time to Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 5 pmol
|
20.0 Minutes
Interval 5.0 to 60.0
|
|
Part 1: Time to Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 15 pmol
|
20.0 Minutes
Interval 10.0 to 40.0
|
|
Part 1: Time to Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 50 pmol
|
17.5 Minutes
Interval 10.0 to 21.0
|
|
Part 1: Time to Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 150 pmol
|
20.0 Minutes
Interval 10.0 to 60.0
|
|
Part 1: Time to Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 500 pmol
|
20.0 Minutes
Interval 5.0 to 20.0
|
SECONDARY outcome
Timeframe: 2 hours post-challenge on Day 1 (Visit 1) and 2 hours post-challenge at Week 2 (Visit 2)Population: Safety Population
Time to maximum observed wheal area was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50 and 150 pmol during the 2 hours post-challenge period.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=20 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 2: Time to Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 15 pmol: 2 hours post-challenge at Week 2
|
18.5 Minutes
Interval 11.0 to 89.0
|
|
Part 2: Time to Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Saline : 2 hours post-challenge on Day 1
|
5.0 Minutes
Interval 4.0 to 10.0
|
|
Part 2: Time to Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Saline: 2 hours post-challenge at Week 2
|
5.0 Minutes
Interval 4.0 to 10.0
|
|
Part 2: Time to Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Histamine: 2 hours post-challenge on Day 1
|
30.0 Minutes
Interval 9.0 to 62.0
|
|
Part 2: Time to Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Histamine: 2 hours post-challenge at Week 2
|
24.5 Minutes
Interval 14.0 to 60.0
|
|
Part 2: Time to Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 5 pmol: 2 hours post-challenge on Day 1
|
18.5 Minutes
Interval 9.0 to 39.0
|
|
Part 2: Time to Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 5 pmol: 2 hours post-challenge at Week 2
|
19.0 Minutes
Interval 9.0 to 39.0
|
|
Part 2: Time to Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 15 pmol: 2 hours post-challenge on Day 1
|
19.5 Minutes
Interval 8.0 to 90.0
|
|
Part 2: Time to Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 50 pmol: 2 hours post-challenge on Day 1
|
23.5 Minutes
Interval 4.0 to 60.0
|
|
Part 2: Time to Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 50 pmol: 2 hours post-challenge at Week 2
|
25.0 Minutes
Interval 15.0 to 59.0
|
|
Part 2: Time to Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 150 pmol:2 hours post-challenge on Day 1
|
28.0 Minutes
Interval 5.0 to 90.0
|
|
Part 2: Time to Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 150 pmol: 2 hours post-challenge at Week 2
|
27.5 Minutes
Interval 15.0 to 41.0
|
SECONDARY outcome
Timeframe: 2 hours post-challenge on Day 1 (Visit 1)Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
Time to complete wheal area disappearance was calculated during the 2 hours post-challenge period. Complete disappearance is defined as a value of 0 for wheal area, longest diameter or orthogonal diameter. Participants who did not have a disappearance within the 2 hours post challenge period were excluded. Time to complete wheal area disappearance was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50, 150 and 500 pmol during the 2 hours post-challenge period.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=9 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 1: Time to Complete Wheal Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
Saline
|
39.0 Minutes
Interval 15.0 to 55.0
|
|
Part 1: Time to Complete Wheal Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
Histamine
|
90.0 Minutes
Interval 56.0 to 93.0
|
|
Part 1: Time to Complete Wheal Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 5 pmol
|
62.0 Minutes
Interval 40.0 to 120.0
|
|
Part 1: Time to Complete Wheal Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 15 pmol
|
120.0 Minutes
Interval 42.0 to 121.0
|
|
Part 1: Time to Complete Wheal Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 50 pmol
|
74.5 Minutes
Interval 59.0 to 90.0
|
|
Part 1: Time to Complete Wheal Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 150 pmol
|
75.5 Minutes
Interval 40.0 to 120.0
|
|
Part 1: Time to Complete Wheal Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 500 pmol
|
104.5 Minutes
Interval 60.0 to 120.0
|
SECONDARY outcome
Timeframe: 2 hours post-challenge on Day 1 (Visit 1) and 2 hours post-challenge at Week 2 (Visit 2)Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
Time to complete wheal area disappearance was calculated during the 2 hours post-challenge period. Complete disappearance is defined as a value of 0 for wheal area, longest diameter or orthogonal diameter. Participants who did not have a disappearance within the 2 hours post challenge period were excluded. Time to complete wheal area disappearance was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50 and 150 pmol during the 2 hours post-challenge period.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=20 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 2: Time to Complete Wheal Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 15 pmol: 2 hours post-challenge on Day 1
|
90.0 Minutes
Interval 38.0 to 121.0
|
|
Part 2: Time to Complete Wheal Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Saline : 2 hours post-challenge on Day 1
|
16.0 Minutes
Interval 11.0 to 30.0
|
|
Part 2: Time to Complete Wheal Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Saline: 2 hours post-challenge at Week 2
|
20.0 Minutes
Interval 11.0 to 27.0
|
|
Part 2: Time to Complete Wheal Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Histamine: 2 hours post-challenge on Day 1
|
90.5 Minutes
Interval 6.0 to 120.0
|
|
Part 2: Time to Complete Wheal Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Histamine: 2 hours post-challenge at Week 2
|
90.0 Minutes
Interval 40.0 to 120.0
|
|
Part 2: Time to Complete Wheal Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 5 pmol: 2 hours post-challenge on Day 1
|
89.0 Minutes
Interval 38.0 to 121.0
|
|
Part 2: Time to Complete Wheal Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 5 pmol: 2 hours post-challenge at Week 2
|
61.0 Minutes
Interval 58.0 to 121.0
|
|
Part 2: Time to Complete Wheal Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 15 pmol: 2 hours post-challenge at Week 2
|
88.0 Minutes
Interval 40.0 to 123.0
|
|
Part 2: Time to Complete Wheal Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 50 pmol: 2 hours post-challenge on Day 1
|
90.0 Minutes
Interval 58.0 to 121.0
|
|
Part 2: Time to Complete Wheal Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 50 pmol: 2 hours post-challenge at Week 2
|
90.0 Minutes
Interval 60.0 to 122.0
|
|
Part 2: Time to Complete Wheal Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 150 pmol:2 hours post-challenge on Day 1
|
104.5 Minutes
Interval 59.0 to 121.0
|
|
Part 2: Time to Complete Wheal Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 150 pmol: 2 hours post-challenge at Week 2
|
90.0 Minutes
Interval 60.0 to 121.0
|
SECONDARY outcome
Timeframe: 0, 5, 10, 15, 20, 40, 60, 90 and 120 minutes post-challenge on Day 1 (Visit 1)Population: Safety Population. Only those participants with data available at the specified data points were analyzed. Zeros reported reflect measured data derived during analysis.
Flare response-time AUC during the 2 hours post-challenge period following skin challenge for Substance P was calculated using the trapezoidal rule. The flare response was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50, 150 and 500 pmol during the 2 hours post-challenge period.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=9 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 1: Flare Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
Saline
|
0.0000 Millimeter square*minutes
Standard Deviation 0.00000
|
|
Part 1: Flare Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
Histamine
|
47977.8047 Millimeter square*minutes
Standard Deviation 35779.56892
|
|
Part 1: Flare Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 5 pmol
|
8232.5351 Millimeter square*minutes
Standard Deviation 10307.53738
|
|
Part 1: Flare Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 15 pmol
|
26562.8609 Millimeter square*minutes
Standard Deviation 22150.49500
|
|
Part 1: Flare Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 50 pmol
|
53505.6580 Millimeter square*minutes
Standard Deviation 31081.10933
|
|
Part 1: Flare Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 150 pmol
|
54407.2697 Millimeter square*minutes
Standard Deviation 34805.98795
|
|
Part 1: Flare Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 500 pmol
|
64978.5132 Millimeter square*minutes
Standard Deviation 67350.94024
|
SECONDARY outcome
Timeframe: 0, 5, 10, 15, 20, 30, 40, 60, 90 and 120 minutes post-challenge on Day 1 (Visit 1) and on Week 2 (Visit 2)Population: Safety Population. Zeros reported reflect measured data derived during analysis.
Flare response-time AUC during the 2 hours post-challenge period following skin challenge for Substance P was calculated using the trapezoidal rule. The flare response variable was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50 and 150 pmol during the 2 hours post-challenge period.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=20 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 2: Flare Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Saline : 2 hours post-challenge on Day 1
|
0.0000 Millimeter square*minutes
Standard Deviation 0.00000
|
|
Part 2: Flare Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Saline: 2 hours post-challenge at Week 2
|
0.0000 Millimeter square*minutes
Standard Deviation 0.00000
|
|
Part 2: Flare Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Histamine: 2 hours post-challenge on Day 1
|
42825.0421 Millimeter square*minutes
Standard Deviation 31599.99246
|
|
Part 2: Flare Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Histamine: 2 hours post-challenge at Week 2
|
50717.6974 Millimeter square*minutes
Standard Deviation 35294.02927
|
|
Part 2: Flare Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 5 pmol: 2 hours post-challenge on Day 1
|
20515.8733 Millimeter square*minutes
Standard Deviation 17779.84450
|
|
Part 2: Flare Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 5 pmol: 2 hours post-challenge at Week 2
|
30689.5773 Millimeter square*minutes
Standard Deviation 29415.10538
|
|
Part 2: Flare Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 15 pmol: 2 hours post-challenge on Day 1
|
48796.3715 Millimeter square*minutes
Standard Deviation 31253.62644
|
|
Part 2: Flare Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 15 pmol: 2 hours post-challenge at Week 2
|
52359.5705 Millimeter square*minutes
Standard Deviation 34531.05693
|
|
Part 2: Flare Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 50 pmol: 2 hours post-challenge on Day 1
|
68798.6958 Millimeter square*minutes
Standard Deviation 36263.19533
|
|
Part 2: Flare Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 50 pmol: 2 hours post-challenge at Week 2
|
81245.6716 Millimeter square*minutes
Standard Deviation 50591.14135
|
|
Part 2: Flare Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 150 pmol:2 hours post-challenge on Day 1
|
76360.0164 Millimeter square*minutes
Standard Deviation 32955.71419
|
|
Part 2: Flare Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 150 pmol: 2 hours post-challenge at Week 2
|
77243.2496 Millimeter square*minutes
Standard Deviation 37747.18154
|
SECONDARY outcome
Timeframe: 2 hours post-challenge on Day 1 (Visit 1)Population: Safety Population. Only those participants with data available at the specified data points were analyzed. Zeros reported reflect measured data derived during analysis.
Flare area was calculated using the following formula: 1/4 \* pi \* longest diameter \* orthogonal diameter, for area of an ellipse, using the longest and orthogonal diameters measured by the calliper method. The maximum observed flare area was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50, 150 and 500 pmol during the 2 hours post-challenge period.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=9 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 1: Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
Saline
|
0.0000 Millimeter square
Standard Deviation 0.00000
|
|
Part 1: Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
Histamine
|
1209.6224 Millimeter square
Standard Deviation 604.47133
|
|
Part 1: Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 5 pmol
|
619.6359 Millimeter square
Standard Deviation 940.26080
|
|
Part 1: Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 15 pmol
|
1422.8103 Millimeter square
Standard Deviation 763.79695
|
|
Part 1: Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 50 pmol
|
2240.1860 Millimeter square
Standard Deviation 971.83781
|
|
Part 1: Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 150 pmol
|
2282.5890 Millimeter square
Standard Deviation 1149.03190
|
|
Part 1: Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 500 pmol
|
2383.3822 Millimeter square
Standard Deviation 1590.27531
|
SECONDARY outcome
Timeframe: 2 hours post-challenge on Day 1 (Visit 1) and 2 hours post-challenge At Week 2 (Visit 2)Population: Safety Population. Zeros reported reflect measured data derived during analysis.
Flare area was calculated using the following formula: 1/4 \* pi \* longest diameter \* orthogonal diameter, for area of an ellipse, using the longest and orthogonal diameters measured by the calliper method. The maximum observed flare area was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50 and 150 pmol during the 2 hours post-challenge period.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=20 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 2: Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P Across- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Saline: 2 hours post-challenge at Week 2
|
0.0000 Millimeter square
Standard Deviation 0.00000
|
|
Part 2: Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P Across- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Saline : 2 hours post-challenge on Day 1
|
0.0000 Millimeter square
Standard Deviation 0.00000
|
|
Part 2: Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P Across- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Histamine: 2 hours post-challenge on Day 1
|
1110.0748 Millimeter square
Standard Deviation 514.76131
|
|
Part 2: Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P Across- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Histamine: 2 hours post-challenge at Week 2
|
1392.6911 Millimeter square
Standard Deviation 671.10955
|
|
Part 2: Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P Across- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 5 pmol: 2 hours post-challenge on Day 1
|
1035.4156 Millimeter square
Standard Deviation 572.41049
|
|
Part 2: Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P Across- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 5 pmol: 2 hours post-challenge at Week 2
|
1398.2891 Millimeter square
Standard Deviation 1007.58015
|
|
Part 2: Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P Across- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 15 pmol: 2 hours post-challenge on Day 1
|
1892.5393 Millimeter square
Standard Deviation 791.10820
|
|
Part 2: Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P Across- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 15 pmol: 2 hours post-challenge at Week 2
|
1956.0858 Millimeter square
Standard Deviation 1018.31529
|
|
Part 2: Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P Across- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 50 pmol: 2 hours post-challenge on Day 1
|
2229.9920 Millimeter square
Standard Deviation 772.48097
|
|
Part 2: Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P Across- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 50 pmol: 2 hours post-challenge at Week 2
|
2575.5958 Millimeter square
Standard Deviation 1627.22854
|
|
Part 2: Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P Across- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 150 pmol:2 hours post-challenge on Day 1
|
2058.1909 Millimeter square
Standard Deviation 660.32625
|
|
Part 2: Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P Across- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 150 pmol: 2 hours post-challenge at Week 2
|
2281.9739 Millimeter square
Standard Deviation 853.10184
|
SECONDARY outcome
Timeframe: 2 hours post-challenge on Day 1 (Visit 1)Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
Time to maximum observed flare area was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50, 150 and 500 pmol during the 2 hours post-challenge period.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=9 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 1: Time to Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
Saline
|
5.0 Minutes
Interval 4.0 to 5.0
|
|
Part 1: Time to Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
Histamine
|
15.0 Minutes
Interval 5.0 to 21.0
|
|
Part 1: Time to Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 5 pmol
|
10.0 Minutes
Interval 5.0 to 11.0
|
|
Part 1: Time to Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 15 pmol
|
5.0 Minutes
Interval 5.0 to 10.0
|
|
Part 1: Time to Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 50 pmol
|
5.0 Minutes
Interval 4.0 to 5.0
|
|
Part 1: Time to Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 150 pmol
|
6.0 Minutes
Interval 5.0 to 15.0
|
|
Part 1: Time to Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 500 pmol
|
5.0 Minutes
Interval 5.0 to 5.0
|
SECONDARY outcome
Timeframe: 2 hours post-challenge on Day 1 (Visit 1) and 2 hours post-challenge At Week 2 (Visit 2)Population: Safety Population
Time to maximum observed flare area was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50 and 150 pmol during the 2 hours post-challenge period.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=20 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 2: Time to Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 5 pmol: 2 hours post-challenge at Week 2
|
5.0 Minutes
Interval 5.0 to 18.0
|
|
Part 2: Time to Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 15 pmol: 2 hours post-challenge on Day 1
|
5.0 Minutes
Interval 4.0 to 15.0
|
|
Part 2: Time to Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Saline : 2 hours post-challenge on Day 1
|
5.0 Minutes
Interval 4.0 to 6.0
|
|
Part 2: Time to Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Saline: 2 hours post-challenge at Week 2
|
5.0 Minutes
Interval 4.0 to 6.0
|
|
Part 2: Time to Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Histamine: 2 hours post-challenge on Day 1
|
11.0 Minutes
Interval 5.0 to 30.0
|
|
Part 2: Time to Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Histamine: 2 hours post-challenge at Week 2
|
6.0 Minutes
Interval 5.0 to 20.0
|
|
Part 2: Time to Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 5 pmol: 2 hours post-challenge on Day 1
|
5.0 Minutes
Interval 4.0 to 14.0
|
|
Part 2: Time to Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 15 pmol: 2 hours post-challenge at Week 2
|
5.0 Minutes
Interval 4.0 to 15.0
|
|
Part 2: Time to Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 50 pmol: 2 hours post-challenge on Day 1
|
5.0 Minutes
Interval 3.0 to 15.0
|
|
Part 2: Time to Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 50 pmol: 2 hours post-challenge at Week 2
|
5.5 Minutes
Interval 4.0 to 20.0
|
|
Part 2: Time to Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 150 pmol:2 hours post-challenge on Day 1
|
5.0 Minutes
Interval 4.0 to 16.0
|
|
Part 2: Time to Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 150 pmol: 2 hours post-challenge at Week 2
|
5.0 Minutes
Interval 4.0 to 19.0
|
SECONDARY outcome
Timeframe: 2 hours post-challenge on Day 1 (Visit 1)Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
Time to complete flare area disappearance was calculated during the 2 hours post-challenge period. Complete disappearance is defined as a value of 0 for flare area, longest diameter or orthogonal diameter. Participants who did not have a disappearance within the 2 hours post challenge period were excluded. Time to complete wheal area disappearance was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50, 150 and 500 pmol during the 2 hours post-challenge period.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=9 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 1: Time to Complete Flare Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
Saline
|
5.0 Minutes
Interval 4.0 to 5.0
|
|
Part 1: Time to Complete Flare Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 150 pmol
|
60.0 Minutes
Interval 40.0 to 90.0
|
|
Part 1: Time to Complete Flare Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
Histamine
|
89.0 Minutes
Interval 56.0 to 93.0
|
|
Part 1: Time to Complete Flare Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 5 pmol
|
20.0 Minutes
Interval 10.0 to 60.0
|
|
Part 1: Time to Complete Flare Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 15 pmol
|
42.0 Minutes
Interval 19.0 to 90.0
|
|
Part 1: Time to Complete Flare Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 50 pmol
|
59.5 Minutes
Interval 41.0 to 90.0
|
|
Part 1: Time to Complete Flare Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1)
SP 500 pmol
|
61.0 Minutes
Interval 20.0 to 90.0
|
SECONDARY outcome
Timeframe: 2 hours post-challenge on Day 1 (Visit 1) and 2 hours post-challenge At Week 2 (Visit 2)Population: Safety Population
Time to complete flare area disappearance was calculated during the 2 hours post-challenge period. Complete disappearance is defined as a value of 0 for wheal area, longest diameter or orthogonal diameter. Participants who did not have a disappearance within the 2 hours post challenge period were excluded. Time to complete wheal area disappearance was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50 and 150 pmol during the 2 hours post-challenge period.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=20 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 2: Time to Complete Flare Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 15 pmol: 2 hours post-challenge at Week 2
|
59.0 Minutes
Interval 15.0 to 88.0
|
|
Part 2: Time to Complete Flare Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 150 pmol: 2 hours post-challenge at Week 2
|
88.0 Minutes
Interval 40.0 to 91.0
|
|
Part 2: Time to Complete Flare Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Saline : 2 hours post-challenge on Day 1
|
5.0 Minutes
Interval 4.0 to 6.0
|
|
Part 2: Time to Complete Flare Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Saline: 2 hours post-challenge at Week 2
|
5.0 Minutes
Interval 4.0 to 6.0
|
|
Part 2: Time to Complete Flare Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Histamine: 2 hours post-challenge on Day 1
|
75.5 Minutes
Interval 39.0 to 119.0
|
|
Part 2: Time to Complete Flare Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Histamine: 2 hours post-challenge at Week 2
|
76.0 Minutes
Interval 39.0 to 94.0
|
|
Part 2: Time to Complete Flare Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 5 pmol: 2 hours post-challenge on Day 1
|
40.0 Minutes
Interval 5.0 to 60.0
|
|
Part 2: Time to Complete Flare Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 5 pmol: 2 hours post-challenge at Week 2
|
39.0 Minutes
Interval 6.0 to 89.0
|
|
Part 2: Time to Complete Flare Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 15 pmol: 2 hours post-challenge on Day 1
|
59.0 Minutes
Interval 13.0 to 89.0
|
|
Part 2: Time to Complete Flare Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 50 pmol: 2 hours post-challenge on Day 1
|
61.0 Minutes
Interval 29.0 to 91.0
|
|
Part 2: Time to Complete Flare Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 50 pmol: 2 hours post-challenge at Week 2
|
60.0 Minutes
Interval 30.0 to 91.0
|
|
Part 2: Time to Complete Flare Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SP 150 pmol:2 hours post-challenge on Day 1
|
90.0 Minutes
Interval 29.0 to 91.0
|
SECONDARY outcome
Timeframe: Up to Day 1Population: Safety Population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of participants with non-serious AEs and SAEs is presented.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=9 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs)- Substance P Only
Non-serious AEs
|
1 Participants
|
|
Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs)- Substance P Only
SAEs
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 3 weeksPopulation: Safety Population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of participants with non-serious AEs and SAEs is presented.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=20 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 2: Number of Participants With Non-serious AEs and SAEs- Substance P Only
SAEs
|
0 Participants
|
|
Part 2: Number of Participants With Non-serious AEs and SAEs- Substance P Only
Non-serious AEs
|
2 Participants
|
SECONDARY outcome
Timeframe: At Day 1 (Visit 1)Population: Safety Population.
Vital signs parameters including Systolic blood pressure (SBP), Diastolic blood pressure (DBP) and heart rate were measured in a semi-supine position after 5 minutes of rest with a completely automated device. PCI ranges were: SBP (Lower: less than \[\<\]85 and Upper: greater than \[\>\]160 millimeters of mercury \[mmHg\]); DBP (Lower: \<45 and Upper: \>100 mmHg); Heart Rate: (Lower: \<40 and Upper: \>110 beats per minute). Baseline value is defined as the latest non-missing pre-first control challenge assessment value at challenge visit 1, including those from unscheduled visits. Participants were counted in the worst case category that their value changes to (low, within range or no change, or high), unless there is no change in their category. Participants were counted twice if the participant had values that changed "To Low" and "To High", so the percentages (%) may not add to 100%.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=9 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1)
SBP: To High
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1)
SBP: To low
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1)
SBP: To within range or no Change
|
9 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1)
DBP: To low
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1)
DBP: To within range or no Change
|
9 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1)
DBP: To High
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1)
Heart rate: To low
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1)
Heart rate: To within range or no Change
|
9 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1)
Heart rate: To High
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 1 (Visit 1) and Week 2 (Visit 2)Population: Safety Population
Vital signs parameters including SBP, DBP and heart rate were measured in a semi-supine position after 5 minutes of rest with a completely automated device. PCI ranges were: SBP (Lower: \<85 and Upper: \>160 mmHg); DBP (Lower: \<45 and Upper: \>100 mmHg); Heart Rate: (Lower: \<40 and Upper: \>110 beats per minute). Baseline value is defined as the latest non-missing pre-first control challenge assessment value at challenge visit 1 and challenge visit 2, including those from unscheduled visits. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Participants were counted in the worst case category that their value changes to (low, within range or no change, or high), unless there is no change in their category. Participants were counted twice if the participant had values that changed "To Low" and "To High", so the % may not add to 100%.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=20 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 2: Number of Participants With Worst Case Vital Signs Parameter Results by Potential Clinical Importance (PCI) Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SBP: To low, Day 1
|
0 Participants
|
|
Part 2: Number of Participants With Worst Case Vital Signs Parameter Results by Potential Clinical Importance (PCI) Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SBP: To within range or no Change, Day 1
|
20 Participants
|
|
Part 2: Number of Participants With Worst Case Vital Signs Parameter Results by Potential Clinical Importance (PCI) Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SBP: To High, Day 1
|
0 Participants
|
|
Part 2: Number of Participants With Worst Case Vital Signs Parameter Results by Potential Clinical Importance (PCI) Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SBP: To low, Week 2
|
0 Participants
|
|
Part 2: Number of Participants With Worst Case Vital Signs Parameter Results by Potential Clinical Importance (PCI) Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SBP: To within range or no Change, Week 2
|
20 Participants
|
|
Part 2: Number of Participants With Worst Case Vital Signs Parameter Results by Potential Clinical Importance (PCI) Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
SBP: To High, Week 2
|
0 Participants
|
|
Part 2: Number of Participants With Worst Case Vital Signs Parameter Results by Potential Clinical Importance (PCI) Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
DBP: To low, Day 1
|
0 Participants
|
|
Part 2: Number of Participants With Worst Case Vital Signs Parameter Results by Potential Clinical Importance (PCI) Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
DBP: To within range or no Change, Day 1
|
20 Participants
|
|
Part 2: Number of Participants With Worst Case Vital Signs Parameter Results by Potential Clinical Importance (PCI) Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
DBP: To High, Day 1
|
0 Participants
|
|
Part 2: Number of Participants With Worst Case Vital Signs Parameter Results by Potential Clinical Importance (PCI) Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
DBP: To low, Week 2
|
0 Participants
|
|
Part 2: Number of Participants With Worst Case Vital Signs Parameter Results by Potential Clinical Importance (PCI) Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
DBP: To within range or no Change, Week 2
|
20 Participants
|
|
Part 2: Number of Participants With Worst Case Vital Signs Parameter Results by Potential Clinical Importance (PCI) Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
DBP: To High, Week 2
|
0 Participants
|
|
Part 2: Number of Participants With Worst Case Vital Signs Parameter Results by Potential Clinical Importance (PCI) Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Heart rate: To low, Day 1
|
0 Participants
|
|
Part 2: Number of Participants With Worst Case Vital Signs Parameter Results by Potential Clinical Importance (PCI) Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Heart rate: To within range or no Change, Day 1
|
20 Participants
|
|
Part 2: Number of Participants With Worst Case Vital Signs Parameter Results by Potential Clinical Importance (PCI) Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Heart rate: To High, Day 1
|
0 Participants
|
|
Part 2: Number of Participants With Worst Case Vital Signs Parameter Results by Potential Clinical Importance (PCI) Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Heart rate: To low, Week 2
|
0 Participants
|
|
Part 2: Number of Participants With Worst Case Vital Signs Parameter Results by Potential Clinical Importance (PCI) Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Heart rate: To within range or no Change,Week 2
|
20 Participants
|
|
Part 2: Number of Participants With Worst Case Vital Signs Parameter Results by Potential Clinical Importance (PCI) Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Heart rate: To High, Week 2
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1: pre-dose) and At Day 1 (Visit 1)Population: Safety Population.
Blood samples were collected for the analysis of hematology parameters: basophils, eosinophils, lymphocytes, monocytes, total neutrophil count, platelet count and white blood cell count. Baseline value is defined as the latest non-missing pre-first control challenge assessment value (Within 1 hour before first control challenge) at challenge visit 1, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=9 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophil Count, Platelet Count and White Blood Cell Count- Substance P Only at Challenge Visit 1 (Day 1)
Basophils
|
0.041 Giga cells per liter
Standard Deviation 0.0215
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophil Count, Platelet Count and White Blood Cell Count- Substance P Only at Challenge Visit 1 (Day 1)
Eosinophils
|
0.112 Giga cells per liter
Standard Deviation 0.1402
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophil Count, Platelet Count and White Blood Cell Count- Substance P Only at Challenge Visit 1 (Day 1)
Lymphocytes
|
1.818 Giga cells per liter
Standard Deviation 0.3138
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophil Count, Platelet Count and White Blood Cell Count- Substance P Only at Challenge Visit 1 (Day 1)
Monocytes
|
0.413 Giga cells per liter
Standard Deviation 0.1055
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophil Count, Platelet Count and White Blood Cell Count- Substance P Only at Challenge Visit 1 (Day 1)
Total neutrophil count
|
3.141 Giga cells per liter
Standard Deviation 1.1766
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophil Count, Platelet Count and White Blood Cell Count- Substance P Only at Challenge Visit 1 (Day 1)
Platelet count
|
256.8 Giga cells per liter
Standard Deviation 56.77
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophil Count, Platelet Count and White Blood Cell Count- Substance P Only at Challenge Visit 1 (Day 1)
White blood cell count
|
5.526 Giga cells per liter
Standard Deviation 1.3657
|
SECONDARY outcome
Timeframe: Baseline (Day 1: pre-dose) and At Week 2 (Visit 2)Population: Safety Population
Blood samples were collected for the analysis of hematology parameters: Basophils, eosinophils, lymphocytes, monocytes, total neutrophil count, platelet count and white blood cell count. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=20 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophil Count, Platelet Count and White Blood Cell Count- Substance P Only at Challenge Visit 2 (Week 2)
Basophils
|
0.045 Giga cells per liter
Standard Deviation 0.0235
|
|
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophil Count, Platelet Count and White Blood Cell Count- Substance P Only at Challenge Visit 2 (Week 2)
Eosinophils
|
0.308 Giga cells per liter
Standard Deviation 0.3889
|
|
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophil Count, Platelet Count and White Blood Cell Count- Substance P Only at Challenge Visit 2 (Week 2)
Lymphocytes
|
2.016 Giga cells per liter
Standard Deviation 0.5291
|
|
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophil Count, Platelet Count and White Blood Cell Count- Substance P Only at Challenge Visit 2 (Week 2)
Monocytes
|
0.490 Giga cells per liter
Standard Deviation 0.1649
|
|
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophil Count, Platelet Count and White Blood Cell Count- Substance P Only at Challenge Visit 2 (Week 2)
Total neutrophil count
|
3.788 Giga cells per liter
Standard Deviation 1.3756
|
|
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophil Count, Platelet Count and White Blood Cell Count- Substance P Only at Challenge Visit 2 (Week 2)
Platelet count
|
244.5 Giga cells per liter
Standard Deviation 54.47
|
|
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophil Count, Platelet Count and White Blood Cell Count- Substance P Only at Challenge Visit 2 (Week 2)
White blood cell count
|
6.646 Giga cells per liter
Standard Deviation 1.7007
|
SECONDARY outcome
Timeframe: Baseline (Day 1: pre-dose) and At Day 1 (Visit 1)Population: Safety Population.
Blood samples were collected for the analysis of hematology parameter: Hemoglobin. Baseline value is defined as the latest non-missing pre-first control challenge assessment value (Within 1 hour before first control challenge) at challenge visit 1, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=9 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 1: Change From Baseline in Hematology Parameter: Hemoglobin- Substance P Only at Challenge Visit 1 (Day 1)
|
140.186580 Grams per liter
Standard Deviation 11.4507222
|
SECONDARY outcome
Timeframe: Baseline (Day 1: pre-dose) and At Week 2 (Visit 2)Population: Safety Population
Blood samples were collected for the analysis of hematology parameter: Hemoglobin. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=20 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 2: Change From Baseline in Hematology Parameter: Hemoglobin- Substance P Only at Challenge Visit 2 (Week 2)
|
133.821787 Grams per liter
Standard Deviation 8.9711806
|
SECONDARY outcome
Timeframe: Baseline (Day 1: pre-dose) and At Day 1 (Visit 1)Population: Safety Population.
Blood samples were collected for the analysis of hematology parameter: Hematocrit. Baseline value is defined as the latest non-missing pre-first control challenge assessment value (Within 1 hour before first control challenge) at challenge visit 1, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=9 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 1: Change From Baseline in Hematology Parameter: Hematocrit- Substance P Only at Challenge Visit 1 (Day 1)
|
0.4117 Proportion of red blood cells in blood
Standard Deviation 0.02807
|
SECONDARY outcome
Timeframe: Baseline (Day 1: pre-dose) and At Week 2 (Visit 2)Population: Safety Population
Blood samples were collected for the analysis of hematology parameter: Hematocrit. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=20 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 2: Change From Baseline in Hematology Parameter: Hematocrit- Substance P Only at Challenge Visit 2 (Week 2)
|
0.3929 Proportion of red blood cells in blood
Standard Deviation 0.02349
|
SECONDARY outcome
Timeframe: Baseline (Day 1: pre-dose) and At Day 1 (Visit 1)Population: Safety Population.
Blood samples were collected for the analysis of hematology parameter: Mean corpuscle hemoglobin. Baseline value is defined as the latest non-missing pre-first control challenge assessment value (Within 1 hour before first control challenge) at challenge visit 1, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=9 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 1: Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin- Substance P Only at Challenge Visit 1 (Day 1)
|
30.203673 Picograms
Standard Deviation 1.0991155
|
SECONDARY outcome
Timeframe: Baseline (Day 1: pre-dose) and At Week 2 (Visit 2)Population: Safety Population
Blood samples were collected for the analysis of hematology parameter: Mean corpuscle hemoglobin. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=20 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 2: Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin- Substance P Only at Challenge Visit 2 (Week 2)
|
30.204568 Picograms
Standard Deviation 1.6675822
|
SECONDARY outcome
Timeframe: Baseline (Day 1: pre-dose) and At Day 1 (Visit 1)Population: Safety Population.
Blood samples were collected for the analysis of hematology parameter: Mean corpuscle volume. Baseline value is defined as the latest non-missing pre-first control challenge assessment value (Within 1 hour before first control challenge) at challenge visit 1, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=9 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 1: Change From Baseline in Hematology Parameter: Mean Corpuscle Volume- Substance P Only at Challenge Visit 1 (Day 1)
|
89.0 Femtoliters
Standard Deviation 4.09
|
SECONDARY outcome
Timeframe: Baseline (Day 1: pre-dose) and At Week 2 (Visit 2)Population: Safety Population
Blood samples were collected for the analysis of hematology parameter: Mean corpuscle volume. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=20 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 2: Change From Baseline in Hematology Parameter: Mean Corpuscle Volume- Substance P Only at Challenge Visit 2 (Week 2)
|
88.7 Femtoliters
Standard Deviation 2.92
|
SECONDARY outcome
Timeframe: Baseline (Day 1: pre-dose) and At Day 1 (Visit 1)Population: Safety Population.
Blood samples were collected for the analysis of hematology parameter: Red blood cell count. Baseline value is defined as the latest non-missing pre-first control challenge assessment value (Within 1 hour before first control challenge) at challenge visit 1, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=9 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 1: Change From Baseline in Hematology Parameter: Red Blood Cell Count- Substance P Only at Challenge Visit 1 (Day 1)
|
4.652 Trillion cells per liter
Standard Deviation 0.5003
|
SECONDARY outcome
Timeframe: Baseline (Day 1: pre-dose) and At Week 2 (Visit 2)Population: Safety Population
Blood samples were collected for the analysis of hematology parameter: Red blood cell count. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=20 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 2: Change From Baseline in Hematology Parameter: Red Blood Cell Count- Substance P Only at Challenge Visit 2 (Week 2)
|
4.440 Trillion cells per liter
Standard Deviation 0.3345
|
SECONDARY outcome
Timeframe: Baseline (Day 1: pre-dose) and At Day 1 (Visit 1)Population: Safety Population. Only those participants with data available at the specified time points were analyzed
Blood samples were collected for the analysis of hematology parameter: Reticulocyte. Baseline value is defined as the latest non-missing pre-first control challenge assessment value (Within 1 hour before first control challenge) at challenge visit 1, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=7 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 1: Change From Baseline in Hematology Parameter: Reticulocyte- Substance P Only at Challenge Visit 1 (Day 1)
|
0.01197 Percentage of reticulocytes
Standard Deviation 0.002160
|
SECONDARY outcome
Timeframe: Baseline (Day 1: pre-dose) and At Week 2 (Visit 2)Population: Safety Population
Blood samples were collected for the analysis of hematology parameter: Reticulocyte. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=20 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 2: Change From Baseline in Hematology Parameter: Reticulocyte- Substance P Only at Challenge Visit 2 (Week 2)
|
0.01482 Percentage of reticulocytes
Standard Deviation 0.004017
|
SECONDARY outcome
Timeframe: Baseline (Day 1: pre-dose) and At Day 1 (Visit 1)Population: Safety Population.
Blood samples were collected for the analysis of clinical chemistry parameters: Alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase. Baseline value is defined as the latest non-missing pre-first control challenge assessment value (Within 1 hour before first control challenge) at challenge visit 1, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=9 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase- Substance P Only at Challenge Visit 1 (Day 1)
Alkaline phosphatase
|
71.1 International units per liter
Standard Deviation 18.38
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase- Substance P Only at Challenge Visit 1 (Day 1)
Alanine aminotransferase
|
19.0 International units per liter
Standard Deviation 8.82
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase- Substance P Only at Challenge Visit 1 (Day 1)
Aspartate aminotransferase
|
18.8 International units per liter
Standard Deviation 3.70
|
SECONDARY outcome
Timeframe: Baseline (Day 1: pre-dose) and At Week 2 (Visit 2)Population: Safety Population
Blood samples were collected for the analysis of clinical chemistry parameters: Alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=20 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase- Substance P Only at Challenge Visit 2 (Week 2)
Alkaline phosphatase
|
72.4 International units per liter
Standard Deviation 30.54
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase- Substance P Only at Challenge Visit 2 (Week 2)
Alanine aminotransferase
|
19.7 International units per liter
Standard Deviation 7.38
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase- Substance P Only at Challenge Visit 2 (Week 2)
Aspartate aminotransferase
|
21.1 International units per liter
Standard Deviation 5.85
|
SECONDARY outcome
Timeframe: Baseline (Day 1: pre-dose) and At Day 1 (Visit 1)Population: Safety Population.
Blood samples were collected for the analysis of clinical chemistry parameters: Total Bilirubin and creatinine. Baseline value is defined as the latest non-missing pre-first control challenge assessment value (Within 1 hour before first control challenge) at challenge visit 1, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=9 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine- Substance P Only at Challenge Visit 1 (Day 1)
Total bilirubin
|
11.6 Micromoles per liter
Standard Deviation 3.50
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine- Substance P Only at Challenge Visit 1 (Day 1)
Creatinine
|
60.3 Micromoles per liter
Standard Deviation 10.54
|
SECONDARY outcome
Timeframe: Baseline (Day 1: pre-dose) and At Week 2 (Visit 2)Population: Safety Population
Blood samples were collected for the analysis of clinical chemistry parameters: Total bilirubin and creatinine. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=20 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine- Substance P Only at Challenge Visit 2 (Week 2)
Total bilirubin
|
6.7 Micromoles per liter
Standard Deviation 2.80
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine- Substance P Only at Challenge Visit 2 (Week 2)
Creatinine
|
66.9 Micromoles per liter
Standard Deviation 13.67
|
SECONDARY outcome
Timeframe: Baseline (Day 1: pre-dose) and At Day 1 (Visit 1)Population: Safety Population.
Blood samples were collected for the analysis of clinical chemistry parameters: Calcium, glucose, potassium, sodium, and urea/BUN. Baseline value is defined as the latest non-missing pre-first control challenge assessment value (Within 1 hour before first control challenge) at challenge visit 1, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=9 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)- Substance P Only at Challenge Visit 1 (Day 1)
Calcium
|
2.350 Millimoles per liter
Standard Deviation 0.0910
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)- Substance P Only at Challenge Visit 1 (Day 1)
Glucose
|
5.09 Millimoles per liter
Standard Deviation 0.457
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)- Substance P Only at Challenge Visit 1 (Day 1)
Potassium
|
4.27 Millimoles per liter
Standard Deviation 0.265
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)- Substance P Only at Challenge Visit 1 (Day 1)
Sodium
|
141.8 Millimoles per liter
Standard Deviation 1.86
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)- Substance P Only at Challenge Visit 1 (Day 1)
Urea/BUN
|
4.04 Millimoles per liter
Standard Deviation 0.979
|
SECONDARY outcome
Timeframe: Baseline (Day 1: pre-dose) and At Week 2 (Visit 2)Population: Safety Population
Blood samples were collected for the analysis of clinical chemistry parameters: Calcium, glucose, potassium, sodium, and urea/BUN. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=20 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, and Urea/BUN- Substance P Only at Challenge Visit 2 (Week 2)
Calcium
|
2.346 Millimoles per liter
Standard Deviation 0.1074
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, and Urea/BUN- Substance P Only at Challenge Visit 2 (Week 2)
Glucose
|
4.89 Millimoles per liter
Standard Deviation 0.713
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, and Urea/BUN- Substance P Only at Challenge Visit 2 (Week 2)
Potassium
|
4.19 Millimoles per liter
Standard Deviation 0.315
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, and Urea/BUN- Substance P Only at Challenge Visit 2 (Week 2)
Sodium
|
141.1 Millimoles per liter
Standard Deviation 2.38
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, and Urea/BUN- Substance P Only at Challenge Visit 2 (Week 2)
Urea/BUN
|
4.38 Millimoles per liter
Standard Deviation 1.614
|
SECONDARY outcome
Timeframe: Baseline (Day 1: pre-dose) and At Day 1 (Visit 1)Population: Safety Population.
Blood samples were collected for the analysis of clinical chemistry parameter: Total protein. Baseline value is defined as the latest non-missing pre-first control challenge assessment value (Within 1 hour before first control challenge) at challenge visit 1, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=9 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 1: Change From Baseline in Clinical Chemistry Parameter: Total Protein- Substance P Only at Challenge Visit 1 (Day 1)
|
69.4 Grams per liter
Standard Deviation 3.97
|
SECONDARY outcome
Timeframe: Baseline (Day 1: pre-dose) and At Week 2 (Visit 2)Population: Safety Population
Blood samples were collected for the analysis of clinical chemistry parameter: Total protein. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=20 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 2: Change From Baseline in Clinical Chemistry Parameter: Total Protein- Substance P Only at Challenge Visit 2 (Week 2)
|
68.8 Grams per liter
Standard Deviation 3.72
|
SECONDARY outcome
Timeframe: At Day 1 (Visit 1)Population: Safety Population.
Urine samples were collected for the analysis of urinalysis parameters: Occult blood, glucose, ketones and protein by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters indicate proportional concentrations in the urine sample. Number of participants with abnormal results were reported as 'Any increase' if there was any increase in their urine concentrations compared to Baseline. Participants whose value was unchanged or whose value was decreased, were recorded in the 'No change/Decreased' category. Baseline value is defined as the latest non-missing pre-first control challenge assessment value at challenge visit 1, including those from unscheduled visits.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=9 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 1: Number of Participants With Worst Case Urinalysis Parameters Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1)
Occult blood: No change/decreased
|
8 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Parameters Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1)
Occult blood: Any increase
|
1 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Parameters Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1)
Glucose: No change/decreased
|
9 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Parameters Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1)
Glucose: Any increase
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Parameters Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1)
Ketones No change/decreased
|
9 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Parameters Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1)
Ketones: Any increase
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Parameters Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1)
Protein: No change/decreased
|
9 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Parameters Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1)
Protein: Any increase
|
0 Participants
|
SECONDARY outcome
Timeframe: At Week 2 (Visit 2)Population: Safety Population
Urine samples were collected for the analysis of urinalysis parameters: Occult blood, glucose, ketones and protein by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters indicate proportional concentrations in the urine sample. Number of participants with abnormal results were reported as 'Any increase' if there was any increase in their urine concentrations compared to Baseline. Participants whose value was unchanged or whose value was decreased, were recorded in the 'No change/Decreased' category. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=20 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 2: Number of Participants With Worst Case Urinalysis Parameters Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 2 (Week 2)
Occult blood: No change/decreased
|
20 Participants
|
|
Part 2: Number of Participants With Worst Case Urinalysis Parameters Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 2 (Week 2)
Occult blood: Any increase
|
0 Participants
|
|
Part 2: Number of Participants With Worst Case Urinalysis Parameters Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 2 (Week 2)
Glucose: No change/decreased
|
20 Participants
|
|
Part 2: Number of Participants With Worst Case Urinalysis Parameters Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 2 (Week 2)
Glucose: Any increase
|
0 Participants
|
|
Part 2: Number of Participants With Worst Case Urinalysis Parameters Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 2 (Week 2)
Ketones No change/decreased
|
20 Participants
|
|
Part 2: Number of Participants With Worst Case Urinalysis Parameters Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 2 (Week 2)
Ketones: Any increase
|
0 Participants
|
|
Part 2: Number of Participants With Worst Case Urinalysis Parameters Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 2 (Week 2)
Protein: No change/decreased
|
20 Participants
|
|
Part 2: Number of Participants With Worst Case Urinalysis Parameters Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 2 (Week 2)
Protein: Any increase
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 1 (Visit 1)Population: Safety Population.
12-lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and corrected QT (QTc) intervals and calculated heart rate. Data for abnormal, clinically significant (CS) ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=9 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 1: Number of Participants With Clinically Significant Abnormal 12-lead Electrocardiogram (ECG) Findings- Substance P Only at Challenge Visit 1 (Day 1)
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 1 (Visit 1) and Week 2 (Visit 2)Population: Safety Population
12-lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and QTc intervals and calculated heart rate. Data for abnormal, CS ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Outcome measures
| Measure |
Part 1- Skin Challenges
n=20 Participants
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
|---|---|
|
Part 2: Number of Participants With Clinically Significant Abnormal 12-lead ECG Findings- Substance P Only at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Day 1
|
0 Participants
|
|
Part 2: Number of Participants With Clinically Significant Abnormal 12-lead ECG Findings- Substance P Only at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2)
Week 2
|
0 Participants
|
Adverse Events
Part 1- Skin Challenges
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2- Skin Challenges
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1- Skin Challenges
n=9 participants at risk
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole \[PMOL\]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1.
|
Part 2- Skin Challenges
n=20 participants at risk
Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50 and 150 PMOL) and wheal and flare responses were assessed along with Intradermal microdialysis (IDM) after Challenge Visit 1 (Day 1). At Challenge Visit 2 (Week 2), participants were administered up to 6 Substance P intradermal injections and wheal and flare response, IDM and biopsies were taken (one from each challenged site and one from a non-challenged area of skin.
|
|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/9 • All-cause mortality, SAEs and non-serious AEs were collected from the start of study treatment up to Day 1 for Part 1 and Up to Week 3 for Part 2.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants in the enrolled analysis set who received at least one challenge-related study procedure on their (first) challenge day. AEs were not collected for "Part 1:No Skin Challenges" arm (N=3), as they did not receive any challenge related study procedure, hence were not included in Safety population.
|
10.0%
2/20 • All-cause mortality, SAEs and non-serious AEs were collected from the start of study treatment up to Day 1 for Part 1 and Up to Week 3 for Part 2.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants in the enrolled analysis set who received at least one challenge-related study procedure on their (first) challenge day. AEs were not collected for "Part 1:No Skin Challenges" arm (N=3), as they did not receive any challenge related study procedure, hence were not included in Safety population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
1/9 • All-cause mortality, SAEs and non-serious AEs were collected from the start of study treatment up to Day 1 for Part 1 and Up to Week 3 for Part 2.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants in the enrolled analysis set who received at least one challenge-related study procedure on their (first) challenge day. AEs were not collected for "Part 1:No Skin Challenges" arm (N=3), as they did not receive any challenge related study procedure, hence were not included in Safety population.
|
0.00%
0/20 • All-cause mortality, SAEs and non-serious AEs were collected from the start of study treatment up to Day 1 for Part 1 and Up to Week 3 for Part 2.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants in the enrolled analysis set who received at least one challenge-related study procedure on their (first) challenge day. AEs were not collected for "Part 1:No Skin Challenges" arm (N=3), as they did not receive any challenge related study procedure, hence were not included in Safety population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER