Trial Outcomes & Findings for Safety and Efficacy Study of Different Dose Levels of EXC 001 to Improve the Appearance of Scars in Subjects Undergoing Elective Abdominoplasty (NCT NCT01038297)

Last Updated: 2021-09-20

Results Overview

Scar assessment by an expert panel was done on blinded photographs using 100 millimeter (mm) visual analog scale (VAS) where a score of 0 mm = best possible scar and a score of 100 mm = worst possible scar, where higher scores indicate worse condition. The difference was calculated for scars at Week 13 as EXC 001 score minus placebo score, thus a negative difference would indicate that the EXC 001-treated scars had lower scar severity. The score was defined as the within participant average difference between EXC 001- and Placebo-treated scars at Week 13.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

Week 13 of Part B

Results posted on

2021-09-20

Participant Flow

Participants who had chosen and qualified (had sufficient excess abdominal tissue) for a standard elective abdominoplasty were recruited in this study. The study was conducted in two-parts: Part A (Skin Testing Phase) and Part B (Active Dosing Phase). Participants with negative skin sensitization in Part A entered into Part B .

Part B (incision wounds \[IW\] and abdominoplasty surgery): On Day 1, participants received 20 incisions (2 centimeters \[cm\] each), 10 incisions on either side of the midline (4 vertical columns of 4 incisions each, 2 columns of 2 incisions \[lateral biomarker incisions\]), on the abdominal area to be removed during abdominoplasty.

Participant milestones

Participant milestones
Measure	Cohort 1: EXC 001 and Placebo In Part A participants received single intradermal injections of EXC-001 at a dose of 5 milligram (mg) on Day 1 and 21. Third 5 mg intradermal injection was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to surgery (Day 1 in Part B). The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery. Participants with negative skin sensitization in Part A were assigned to Part B of the study. In Part B Participants received intradermal injections of EXC 001 on 1 side of the abdominal incisions and on the other side received intradermal injections of placebo matched to EXC 001 at Week 2, 4, 6, 8 and 10. On the EXC 001 treated side 1 column received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Out of 2 lateral biomarker incisions 1 incision received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Participants received an abdominoplasty at week 13 with a follow-up post-surgery visit at week 14.	Cohort 2: EXC 001 and Placebo In Part A participants received single intradermal injections of EXC-001 at a dose of 5 milligram (mg) on Day 1 and 21. Third 5 mg intradermal injection was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to surgery (Day 1 in Part B). The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery. Participants with negative skin sensitization in Part A were assigned to Part B of the study. In Part B participants received intradermal injections of EXC 001 on 1 side of the abdominal incisions and on the other side received intradermal injections of placebo matched to EXC 001 at Week 2, 5, 8 and 11. On the EXC 001 treated side 1 column received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Out of 2 lateral biomarker incisions 1 incision received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Participants received an abdominoplasty at week 13 with a follow-up post-surgery visit at week 14.	Cohort 3: EXC 001 and Placebo In Part A participants received single intradermal injections of EXC-001 at a dose of 5 milligram (mg) on Day 1 and 21. Third 5 mg intradermal injection was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to surgery (Day 1 in Part B). The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery. Participants with negative skin sensitization in Part A were assigned to Part B of the study. In Part B participants received intradermal injections of EXC 001 on 1 side of the abdominal incisions and on the other side received intradermal injections of placebo matched to EXC 001 at Week 2, 6 and 10. On the EXC 001 treated side 1 column received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Out of 2 lateral biomarker incisions 1 incision received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Participants received an abdominoplasty at week 13 with a follow-up post-surgery visit at week 14.
Part A: Skin Testing Phase (50 Days) STARTED	10	10	10
Part A: Skin Testing Phase (50 Days) COMPLETED	9	10	10
Part A: Skin Testing Phase (50 Days) NOT COMPLETED	1	0	0
Part B: Active Dosing Phase (13 Weeks) STARTED	9	10	10
Part B: Active Dosing Phase (13 Weeks) COMPLETED	9	10	10
Part B: Active Dosing Phase (13 Weeks) NOT COMPLETED	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: EXC 001 and Placebo In Part A participants received single intradermal injections of EXC-001 at a dose of 5 milligram (mg) on Day 1 and 21. Third 5 mg intradermal injection was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to surgery (Day 1 in Part B). The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery. Participants with negative skin sensitization in Part A were assigned to Part B of the study. In Part B Participants received intradermal injections of EXC 001 on 1 side of the abdominal incisions and on the other side received intradermal injections of placebo matched to EXC 001 at Week 2, 4, 6, 8 and 10. On the EXC 001 treated side 1 column received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Out of 2 lateral biomarker incisions 1 incision received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Participants received an abdominoplasty at week 13 with a follow-up post-surgery visit at week 14.	Cohort 2: EXC 001 and Placebo In Part A participants received single intradermal injections of EXC-001 at a dose of 5 milligram (mg) on Day 1 and 21. Third 5 mg intradermal injection was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to surgery (Day 1 in Part B). The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery. Participants with negative skin sensitization in Part A were assigned to Part B of the study. In Part B participants received intradermal injections of EXC 001 on 1 side of the abdominal incisions and on the other side received intradermal injections of placebo matched to EXC 001 at Week 2, 5, 8 and 11. On the EXC 001 treated side 1 column received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Out of 2 lateral biomarker incisions 1 incision received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Participants received an abdominoplasty at week 13 with a follow-up post-surgery visit at week 14.	Cohort 3: EXC 001 and Placebo In Part A participants received single intradermal injections of EXC-001 at a dose of 5 milligram (mg) on Day 1 and 21. Third 5 mg intradermal injection was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to surgery (Day 1 in Part B). The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery. Participants with negative skin sensitization in Part A were assigned to Part B of the study. In Part B participants received intradermal injections of EXC 001 on 1 side of the abdominal incisions and on the other side received intradermal injections of placebo matched to EXC 001 at Week 2, 6 and 10. On the EXC 001 treated side 1 column received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Out of 2 lateral biomarker incisions 1 incision received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Participants received an abdominoplasty at week 13 with a follow-up post-surgery visit at week 14.
Part A: Skin Testing Phase (50 Days) Withdrawal by Subject	1	0	0

Baseline Characteristics

Safety and Efficacy Study of Different Dose Levels of EXC 001 to Improve the Appearance of Scars in Subjects Undergoing Elective Abdominoplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: EXC 001 and Placebo n=10 Participants In Part A participants received single intradermal injections of EXC-001 at a dose of 5 mg on Day 1 and 21. Third 5 mg intradermal injection was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to surgery (Day 1 in Part B). The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery. Participants with negative skin sensitization in Part A were assigned to Part B of the study. In Part B Participants received intradermal injections of EXC 001 on 1 side of the abdominal incisions and on the other side received intradermal injections of placebo matched to EXC 001 at Week 2, 4, 6, 8 and 10. On the EXC 001 treated side 1 column received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Out of 2 lateral biomarker incisions 1 incision received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Participants received an abdominoplasty at week 13 with a follow-up post-surgery visit at week 14.	Cohort 2: EXC 001 and Placebo n=10 Participants In Part A participants received single intradermal injections of EXC-001 at a dose of 5 milligram (mg) on Day 1 and 21. Third 5 mg intradermal injection was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to surgery (Day 1 in Part B). The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery. Participants with negative skin sensitization in Part A were assigned to Part B of the study. In Part B participants received intradermal injections of EXC 001 on 1 side of the abdominal incisions and on the other side received intradermal injections of placebo matched to EXC 001 at Week 2, 5, 8 and 11. On the EXC 001 treated side 1 column received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Out of 2 lateral biomarker incisions 1 incision received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Participants received an abdominoplasty at week 13 with a follow-up post-surgery visit at week 14.	Cohort 3: EXC 001 and Placebo n=10 Participants In Part A participants received single intradermal injections of EXC-001 at a dose of 5 milligram (mg) on Day 1 and 21. Third 5 mg intradermal injection was administered at the discretion of Investigator based on the event of an equivocal skin sensitization on Day 38 or at least 7 days prior to surgery (Day 1 in Part B). The injection site was evaluated immediately after the injection and on Days 21, 28, 38, 50 until day of surgery. Participants with negative skin sensitization in Part A were assigned to Part B of the study. In Part B participants received intradermal injections of EXC 001 on 1 side of the abdominal incisions and on the other side received intradermal injections of placebo matched to EXC 001 at Week 2, 6 and 10. On the EXC 001 treated side 1 column received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Out of 2 lateral biomarker incisions 1 incision received high dose (5.0 mg/linear cm) and other a low dose (1.0 mg/linear cm). Participants received an abdominoplasty at week 13 with a follow-up post-surgery visit at week 14.	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	30 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	29 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 13 of Part B

Population: Completer population included all participants who missed not more than 1 dose of study drug, had the Week 13 assessment and non-missing data for VAS scar assessment score for at least one dose level.

Outcome measures

Outcome measures
Measure	Part B: Cohort 1: EXC 001 High Dose (5.0 mg/Linear cm) + Placebo n=8 Participants Participants received intradermal injections of EXC 001 high dose (5.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 4, 6, 8 and 10.	Part B: Cohort 1: EXC 001 Low Dose (1.0 mg/Linear cm) + Placebo n=8 Participants Participants received intradermal injections of EXC 001 low dose (1.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 4, 6, 8 and 10.	Part B: Cohort 2: EXC 001 High Dose (5.0 mg/Linear cm) + Placebo n=10 Participants Participants received intradermal injections of EXC 001 high dose (5.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 5, 8 and 11.	Part B: Cohort 2: EXC 001 Low Dose (1.0 mg/Linear cm) + Placebo n=10 Participants Participants received intradermal injections of EXC 001 low dose (1.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 5, 8 and 11.	Part B: Cohort 3: EXC 001 High Dose (5.0 mg/Linear cm) + Placebo n=10 Participants Participants received intradermal injections of EXC 001 high dose (5.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 6 and 10.	Part B: Cohort 3: EXC 001 Low Dose (1.0 mg/Linear cm) + Placebo n=10 Participants Participants received intradermal injections of EXC 001 low dose (1.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 6 and 10.
Part B: Expert Panel Scar Assessment Score	-3.16 millimeters Standard Deviation 7.687	0.18 millimeters Standard Deviation 7.154	1.45 millimeters Standard Deviation 12.450	2.91 millimeters Standard Deviation 9.778	-4.78 millimeters Standard Deviation 11.326	-4.05 millimeters Standard Deviation 8.934

SECONDARY outcome

Timeframe: Week 13 of Part B

Physician observer global assessment of scar score was done using a valid published 10-point rating scale. Physicians rated severity of each scar on a scale of 1 = normal skin to 10 = worst scar imaginable. Each scar was given a single score and the differences in scores between the matched pairs of scars were calculated. There were 4 differences within each dose level that were averaged to create a single score for each participant at each dose level. The score was defined as the within participant average difference between EXC 001 and Placebo.

Outcome measures

Outcome measures
Measure	Part B: Cohort 1: EXC 001 High Dose (5.0 mg/Linear cm) + Placebo n=8 Participants Participants received intradermal injections of EXC 001 high dose (5.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 4, 6, 8 and 10.	Part B: Cohort 1: EXC 001 Low Dose (1.0 mg/Linear cm) + Placebo n=8 Participants Participants received intradermal injections of EXC 001 low dose (1.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 4, 6, 8 and 10.	Part B: Cohort 2: EXC 001 High Dose (5.0 mg/Linear cm) + Placebo n=10 Participants Participants received intradermal injections of EXC 001 high dose (5.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 5, 8 and 11.	Part B: Cohort 2: EXC 001 Low Dose (1.0 mg/Linear cm) + Placebo n=10 Participants Participants received intradermal injections of EXC 001 low dose (1.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 5, 8 and 11.	Part B: Cohort 3: EXC 001 High Dose (5.0 mg/Linear cm) + Placebo n=10 Participants Participants received intradermal injections of EXC 001 high dose (5.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 6 and 10.	Part B: Cohort 3: EXC 001 Low Dose (1.0 mg/Linear cm) + Placebo n=10 Participants Participants received intradermal injections of EXC 001 low dose (1.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 6 and 10.
Part B: Physician Observer Global Assessment Scar Score	-0.84 units on a scale Standard Deviation 1.362	-0.44 units on a scale Standard Deviation 1.193	-0.68 units on a scale Standard Deviation 1.448	-0.05 units on a scale Standard Deviation 0.848	-0.75 units on a scale Standard Deviation 1.965	-0.70 units on a scale Standard Deviation 1.153

SECONDARY outcome

Timeframe: Part B: Day 1 up to Week 14

Population: Safety population included participants who completed Part A Day 1 visit of and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo in Part B. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Following vital sign parameters were assessed: diastolic blood pressure, systolic blood pressure, respiration rate, pulse rate, temperature and weight. Number of participants with clinically significant change in any vital sign parameter compared to Baseline were reported. Criteria for clinically significant change in any vital sign parameter compared to baseline was based on investigator's discretion.

Outcome measures

Outcome measures
Measure	Part B: Cohort 1: EXC 001 High Dose (5.0 mg/Linear cm) + Placebo n=9 Participants Participants received intradermal injections of EXC 001 high dose (5.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 4, 6, 8 and 10.	Part B: Cohort 1: EXC 001 Low Dose (1.0 mg/Linear cm) + Placebo n=10 Participants Participants received intradermal injections of EXC 001 low dose (1.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 4, 6, 8 and 10.	Part B: Cohort 2: EXC 001 High Dose (5.0 mg/Linear cm) + Placebo n=10 Participants Participants received intradermal injections of EXC 001 high dose (5.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 5, 8 and 11.	Part B: Cohort 2: EXC 001 Low Dose (1.0 mg/Linear cm) + Placebo Participants received intradermal injections of EXC 001 low dose (1.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 5, 8 and 11.	Part B: Cohort 3: EXC 001 High Dose (5.0 mg/Linear cm) + Placebo Participants received intradermal injections of EXC 001 high dose (5.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 6 and 10.	Part B: Cohort 3: EXC 001 Low Dose (1.0 mg/Linear cm) + Placebo Participants received intradermal injections of EXC 001 low dose (1.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 6 and 10.
Part B: Number of Participants With Clinically Significant Change From Baseline in Vital Signs	0 Participants	0 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Part B: Day 1 up to Week 14

Population: Safety population included participants who completed Part A Day 1 visit of Part A and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo in Part B. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Physical examination included the assessment of skin; head, ears, eyes, nose, and throat; respiratory; cardiovascular; abdomen; musculoskeletal; neurological; gastrointestinal; genitourinary; endocrine and lymph nodes. Criteria for clinically significant findings in physical examination was based on investigator's discretion.

Outcome measures

Outcome measures
Measure	Part B: Cohort 1: EXC 001 High Dose (5.0 mg/Linear cm) + Placebo n=9 Participants Participants received intradermal injections of EXC 001 high dose (5.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 4, 6, 8 and 10.	Part B: Cohort 1: EXC 001 Low Dose (1.0 mg/Linear cm) + Placebo n=10 Participants Participants received intradermal injections of EXC 001 low dose (1.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 4, 6, 8 and 10.	Part B: Cohort 2: EXC 001 High Dose (5.0 mg/Linear cm) + Placebo n=10 Participants Participants received intradermal injections of EXC 001 high dose (5.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 5, 8 and 11.	Part B: Cohort 2: EXC 001 Low Dose (1.0 mg/Linear cm) + Placebo Participants received intradermal injections of EXC 001 low dose (1.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 5, 8 and 11.	Part B: Cohort 3: EXC 001 High Dose (5.0 mg/Linear cm) + Placebo Participants received intradermal injections of EXC 001 high dose (5.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 6 and 10.	Part B: Cohort 3: EXC 001 Low Dose (1.0 mg/Linear cm) + Placebo Participants received intradermal injections of EXC 001 low dose (1.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 6 and 10.
Part B: Number of Participants With Clinically Significant Changes in Physical Examination Findings	1 Participants	0 Participants	1 Participants	—	—	—

SECONDARY outcome

Timeframe: Week 13 of Part B

Following parameters were analyzed for ECG abnormality: PR interval, QRS interval, QT interval, QT interval corrected using the Fridericia's correction (QTc), heart rate (HR). A standard, single 12-lead ECG was taken and results was classified as normal, having a clinically insignificant abnormality, or having a clinically significant abnormality. Number of participants with clinically significant abnormality in ECG compared to baseline were reported. Criteria for clinically significant abnormality in ECG compared to baseline was based on investigator's discretion.

Outcome measures

Outcome measures
Measure	Part B: Cohort 1: EXC 001 High Dose (5.0 mg/Linear cm) + Placebo n=9 Participants Participants received intradermal injections of EXC 001 high dose (5.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 4, 6, 8 and 10.	Part B: Cohort 1: EXC 001 Low Dose (1.0 mg/Linear cm) + Placebo n=10 Participants Participants received intradermal injections of EXC 001 low dose (1.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 4, 6, 8 and 10.	Part B: Cohort 2: EXC 001 High Dose (5.0 mg/Linear cm) + Placebo n=10 Participants Participants received intradermal injections of EXC 001 high dose (5.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 5, 8 and 11.	Part B: Cohort 2: EXC 001 Low Dose (1.0 mg/Linear cm) + Placebo Participants received intradermal injections of EXC 001 low dose (1.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 5, 8 and 11.	Part B: Cohort 3: EXC 001 High Dose (5.0 mg/Linear cm) + Placebo Participants received intradermal injections of EXC 001 high dose (5.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 6 and 10.	Part B: Cohort 3: EXC 001 Low Dose (1.0 mg/Linear cm) + Placebo Participants received intradermal injections of EXC 001 low dose (1.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 6 and 10.
Part B: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings	0 Participants	0 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Part B: Day 1 up to Week 13

Population: Safety population included participants who completed Part A Day 1 visit and received at least 1 dose of study drug. Safety assessment was not planned separately for EXC 001 and placebo in Part B. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Laboratory analysis included hematology, biochemistry and urinalysis. Hematology range: basophils (bas) 0-0.2, eosinophils (eos) 0-0.4, leukocytes (leu) 4-10.5, lymphocytes (lym) 0.7-4.5, neutrophils (neu) 1.8-7.8, platelet 140-415, monocytes (mon) 0.1-1 in 10\^9 per liter; bas/leu 0-3, eos/leu 0-7, lym/leu 14-46, mon/leu 4-13, neu/leu and neu/leu 40-74 in percentage, erythrocytes 3.8-5.1 10\^12/L, hematocrit 0.34-0.44 L/L, hemoglobin 115-150 gram per liter (g/L). Biochemistry range: creatine kinase 24-173, alkaline phosphatase 25-150, alanine aminotransferase (AT) and aspartate AT 0-40 in International units per liter; creatinine 50-88, urate 89-399, bilirubin 2-21 in micromole per liter, glucose 3.6-5.5, potassium 3.5-5.5, sodium 135-148, blood urea nitrogen 1.8-9.3 in millimole/L, albumin 35-55 g/L. Urinalysis parameters: pH (5-7.5), specific gravity (1.005-1.03). Participants with clinically significant abnormal change in any laboratory parameter compared to baseline were reported.

Outcome measures

Outcome measures
Measure	Part B: Cohort 1: EXC 001 High Dose (5.0 mg/Linear cm) + Placebo n=9 Participants Participants received intradermal injections of EXC 001 high dose (5.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 4, 6, 8 and 10.	Part B: Cohort 1: EXC 001 Low Dose (1.0 mg/Linear cm) + Placebo n=10 Participants Participants received intradermal injections of EXC 001 low dose (1.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 4, 6, 8 and 10.	Part B: Cohort 2: EXC 001 High Dose (5.0 mg/Linear cm) + Placebo n=10 Participants Participants received intradermal injections of EXC 001 high dose (5.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 5, 8 and 11.	Part B: Cohort 2: EXC 001 Low Dose (1.0 mg/Linear cm) + Placebo Participants received intradermal injections of EXC 001 low dose (1.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 5, 8 and 11.	Part B: Cohort 3: EXC 001 High Dose (5.0 mg/Linear cm) + Placebo Participants received intradermal injections of EXC 001 high dose (5.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 6 and 10.	Part B: Cohort 3: EXC 001 Low Dose (1.0 mg/Linear cm) + Placebo Participants received intradermal injections of EXC 001 low dose (1.0 mg/linear cm) in 1 vertical column and 1 lateral biomarker incision on 1 side of the abdominal incisions and intradermal injections of placebo matched to EXC 001 on the other side at Week 2, 6 and 10.
Part B: Number of Participants With Clinically Significant Abnormal Laboratory Findings	0 Participants	0 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: From Day 21 of Part A up to Week 2 of Part B

The skin sensitivity reaction was assessed only at the skin sensitivity reaction testing sites. Erythematous, raised (indurated) and edematous reactions were considered as positive skin sensitivity reactions. The number of participants that experienced any positive skin sensitivity reactions were reported.