Trial Outcomes & Findings for Injection Techniques of Collagenase Clostridium Histolyticum (CCH) for the Treatment of EFP (Cellulite) (NCT NCT03632993)

Last Updated: 2023-09-07

Results Overview

Aesthetic appearance improvement for each treatment area (buttocks or thighs) was assessed by a blinded central assessment, using a 5-point Likert scale with scores ranging from -1 to 3. Aesthetic improvement was scored as worse (-1), stayed the same (0), improved (1), much improved (2) and very much improved (3). The assessor evaluated the image at Day 22 in comparison with baseline and recorded the Likert score. Aesthetic appearance Likert scale scores were analyzed using linear mixed model with treatment arm, study visit, interaction of treatment arm and study visit as fixed effects. This model was fitted using the response for the average of left and right of treatment area (that is, average of left buttock and right buttock or average of left thigh and right thigh).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

64 participants

Primary outcome timeframe

Day 22

Results posted on

2023-09-07

Participant Flow

Participants in each treatment region (buttocks or thighs) were assigned to 1 of 5 injection technique treatment arms. No participants were treated in both the buttocks and the thighs.

Unit of analysis: buttocks or thighs

Participant milestones

Participant milestones
Measure	Treatment I: CCH Shallow Injection, 3 Aliquots (Buttocks) In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 milliliters (mL) aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment I: CCH Shallow Injection, 3 Aliquots (Thighs) In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 mL aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment II: CCH Shallow Injection, 1 Aliquot (Buttocks) In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment II: CCH Shallow Injection, 1 Aliquot (Thighs) In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment III: CCH Deep Injection, 1 Aliquot (Buttocks) In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment III: CCH Deep Injection, 1 Aliquot (Thighs) In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit	Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Buttocks) In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Thighs) In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment V: CCH Shallow Injections, 4 Aliquots (Buttocks) In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment V: CCH Shallow Injections, 4 Aliquots (Thighs) In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.
Overall Study STARTED	7 14	6 12	6 12	7 14	6 12	6 12	6 12	7 14	7 14	6 12
Overall Study COMPLETED	6 12	5 10	6 12	7 14	6 12	4 8	6 12	5 10	7 14	5 10
Overall Study NOT COMPLETED	1 2	1 2	0 0	0 0	0 0	2 4	0 0	2 4	0 0	1 2

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment I: CCH Shallow Injection, 3 Aliquots (Buttocks) In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 milliliters (mL) aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment I: CCH Shallow Injection, 3 Aliquots (Thighs) In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 mL aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment III: CCH Deep Injection, 1 Aliquot (Thighs) In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit	Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Thighs) In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment V: CCH Shallow Injections, 4 Aliquots (Thighs) In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.
Overall Study Withdrawal by Subject	1	0	0	0	1
Overall Study Protocol Non-compliance	0	1	0	0	0
Overall Study Lost to Follow-up	0	0	1	1	0
Overall Study Adverse Event	0	0	1	1	0

Baseline Characteristics

One participant did not have data collected for height.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment I: CCH Shallow Injection, 3 Aliquots (Buttocks) n=6 Participants In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 mL aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment I: CCH Shallow Injection, 3 Aliquots (Thighs) n=6 Participants In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 mL aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment II: CCH Shallow Injection, 1 Aliquot (Buttocks) n=6 Participants In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment II: CCH Shallow Injection, 1 Aliquot (Thighs) n=7 Participants In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment III: CCH Deep Injection, 1 Aliquot (Buttocks) n=6 Participants In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment III: CCH Deep Injection, 1 Aliquot (Thighs) n=6 Participants In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Buttocks) n=6 Participants In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Thighs) n=7 Participants In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment V: CCH Shallow Injections, 4 Aliquots (Buttocks) n=7 Participants In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment V: CCH Shallow Injections, 4 Aliquots (Thighs) n=6 Participants In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Total n=63 Participants Total of all reporting groups
Age, Continuous	50.2 years STANDARD_DEVIATION 9.85 • n=6 Participants	44.7 years STANDARD_DEVIATION 8.19 • n=6 Participants	43.3 years STANDARD_DEVIATION 10.95 • n=6 Participants	45.6 years STANDARD_DEVIATION 9.55 • n=7 Participants	48.7 years STANDARD_DEVIATION 15.95 • n=6 Participants	52.2 years STANDARD_DEVIATION 13.04 • n=6 Participants	51.5 years STANDARD_DEVIATION 11.93 • n=6 Participants	49.0 years STANDARD_DEVIATION 12.75 • n=7 Participants	48.4 years STANDARD_DEVIATION 10.00 • n=7 Participants	39.8 years STANDARD_DEVIATION 10.26 • n=6 Participants	47.3 years STANDARD_DEVIATION 11.17 • n=63 Participants
Sex: Female, Male Female	6 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	7 Participants n=7 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	7 Participants n=7 Participants	7 Participants n=7 Participants	6 Participants n=6 Participants	63 Participants n=63 Participants
Sex: Female, Male Male	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	0 Participants n=63 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=6 Participants	4 Participants n=6 Participants	3 Participants n=6 Participants	6 Participants n=7 Participants	3 Participants n=6 Participants	1 Participants n=6 Participants	1 Participants n=6 Participants	2 Participants n=7 Participants	5 Participants n=7 Participants	3 Participants n=6 Participants	32 Participants n=63 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=6 Participants	2 Participants n=6 Participants	3 Participants n=6 Participants	1 Participants n=7 Participants	3 Participants n=6 Participants	5 Participants n=6 Participants	5 Participants n=6 Participants	5 Participants n=7 Participants	2 Participants n=7 Participants	3 Participants n=6 Participants	31 Participants n=63 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	0 Participants n=63 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	0 Participants n=63 Participants
Race (NIH/OMB) Asian	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	1 Participants n=63 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	0 Participants n=63 Participants
Race (NIH/OMB) Black or African American	3 Participants n=6 Participants	0 Participants n=6 Participants	2 Participants n=6 Participants	1 Participants n=7 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	3 Participants n=7 Participants	1 Participants n=7 Participants	3 Participants n=6 Participants	14 Participants n=63 Participants
Race (NIH/OMB) White	3 Participants n=6 Participants	6 Participants n=6 Participants	4 Participants n=6 Participants	6 Participants n=7 Participants	6 Participants n=6 Participants	5 Participants n=6 Participants	5 Participants n=6 Participants	4 Participants n=7 Participants	6 Participants n=7 Participants	3 Participants n=6 Participants	48 Participants n=63 Participants
Race (NIH/OMB) More than one race	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	0 Participants n=63 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	0 Participants n=63 Participants
Weight	90.258 kg STANDARD_DEVIATION 30.2437 • n=6 Participants	75.660 kg STANDARD_DEVIATION 15.2730 • n=6 Participants	87.843 kg STANDARD_DEVIATION 23.6933 • n=6 Participants	84.407 kg STANDARD_DEVIATION 20.2152 • n=7 Participants	76.687 kg STANDARD_DEVIATION 13.3870 • n=6 Participants	74.117 kg STANDARD_DEVIATION 13.9682 • n=6 Participants	65.038 kg STANDARD_DEVIATION 17.0083 • n=6 Participants	72.396 kg STANDARD_DEVIATION 15.6629 • n=7 Participants	78.497 kg STANDARD_DEVIATION 12.0413 • n=7 Participants	96.008 kg STANDARD_DEVIATION 14.9791 • n=6 Participants	80.012 kg STANDARD_DEVIATION 19.0943 • n=63 Participants
Height	158.7 cm STANDARD_DEVIATION 3.67 • n=6 Participants • One participant did not have data collected for height.	162.2 cm STANDARD_DEVIATION 3.03 • n=5 Participants • One participant did not have data collected for height.	161.8 cm STANDARD_DEVIATION 2.14 • n=6 Participants • One participant did not have data collected for height.	164.4 cm STANDARD_DEVIATION 10.01 • n=7 Participants • One participant did not have data collected for height.	163.0 cm STANDARD_DEVIATION 6.90 • n=6 Participants • One participant did not have data collected for height.	162.3 cm STANDARD_DEVIATION 3.88 • n=6 Participants • One participant did not have data collected for height.	161.5 cm STANDARD_DEVIATION 8.96 • n=6 Participants • One participant did not have data collected for height.	167.4 cm STANDARD_DEVIATION 10.55 • n=7 Participants • One participant did not have data collected for height.	164.4 cm STANDARD_DEVIATION 8.96 • n=7 Participants • One participant did not have data collected for height.	165.2 cm STANDARD_DEVIATION 6.65 • n=6 Participants • One participant did not have data collected for height.	163.2 cm STANDARD_DEVIATION 7.18 • n=62 Participants • One participant did not have data collected for height.
Body Mass Index (BMI)	35.92 kg/m^2 STANDARD_DEVIATION 12.643 • n=6 Participants • One participant did not have data collected for BMI.	30.30 kg/m^2 STANDARD_DEVIATION 6.387 • n=5 Participants • One participant did not have data collected for BMI.	33.65 kg/m^2 STANDARD_DEVIATION 9.415 • n=6 Participants • One participant did not have data collected for BMI.	31.11 kg/m^2 STANDARD_DEVIATION 6.277 • n=7 Participants • One participant did not have data collected for BMI.	29.13 kg/m^2 STANDARD_DEVIATION 6.239 • n=6 Participants • One participant did not have data collected for BMI.	28.05 kg/m^2 STANDARD_DEVIATION 4.669 • n=6 Participants • One participant did not have data collected for BMI.	24.78 kg/m^2 STANDARD_DEVIATION 5.202 • n=6 Participants • One participant did not have data collected for BMI.	26.40 kg/m^2 STANDARD_DEVIATION 7.330 • n=7 Participants • One participant did not have data collected for BMI.	29.01 kg/m^2 STANDARD_DEVIATION 4.123 • n=7 Participants • One participant did not have data collected for BMI.	35.10 kg/m^2 STANDARD_DEVIATION 3.929 • n=6 Participants • One participant did not have data collected for BMI.	30.27 kg/m^2 STANDARD_DEVIATION 7.379 • n=62 Participants • One participant did not have data collected for BMI.
Skin Category (Fitzpatrick Scale) I (Pale White)	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=7 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	1 Participants n=63 Participants
Skin Category (Fitzpatrick Scale) II (Fair)	1 Participants n=6 Participants	2 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=7 Participants	2 Participants n=6 Participants	1 Participants n=6 Participants	1 Participants n=6 Participants	2 Participants n=7 Participants	2 Participants n=7 Participants	0 Participants n=6 Participants	12 Participants n=63 Participants
Skin Category (Fitzpatrick Scale) III (Darker White)	0 Participants n=6 Participants	2 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	2 Participants n=6 Participants	3 Participants n=6 Participants	3 Participants n=6 Participants	0 Participants n=7 Participants	1 Participants n=7 Participants	0 Participants n=6 Participants	11 Participants n=63 Participants
Skin Category (Fitzpatrick Scale) IV (Light Brown)	2 Participants n=6 Participants	2 Participants n=6 Participants	3 Participants n=6 Participants	6 Participants n=7 Participants	2 Participants n=6 Participants	1 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=7 Participants	3 Participants n=7 Participants	3 Participants n=6 Participants	23 Participants n=63 Participants
Skin Category (Fitzpatrick Scale) V (Brown)	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	1 Participants n=7 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	1 Participants n=7 Participants	0 Participants n=7 Participants	3 Participants n=6 Participants	7 Participants n=63 Participants
Skin Category (Fitzpatrick Scale) VI (Dark Brown or Black)	3 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	3 Participants n=7 Participants	1 Participants n=7 Participants	0 Participants n=6 Participants	9 Participants n=63 Participants

PRIMARY outcome

Timeframe: Day 22

Population: Evaluable Population includes all participants in the Safety Population who had completed screening procedures and at least 1 baseline assessment of aesthetic appearance improvement Likert scale rating at specified timepoint. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for the assessment.

Outcome measures

Outcome measures
Measure	Treatment I: CCH Shallow Injection, 3 Aliquots (Buttocks) n=6 Participants In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 milliliters (mL) aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment I: CCH Shallow Injection, 3 Aliquots (Thighs) n=5 Participants In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 mL aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment II: CCH Shallow Injection, 1 Aliquot (Buttocks) n=6 Participants In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment II: CCH Shallow Injection, 1 Aliquot (Thighs) n=7 Participants In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment III: CCH Deep Injection, 1 Aliquot (Buttocks) n=6 Participants In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment III: CCH Deep Injection, 1 Aliquot (Thighs) n=5 Participants In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit	Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Buttocks) n=6 Participants In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Thighs) n=6 Participants In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment V: CCH Shallow Injections, 4 Aliquots (Buttocks) n=7 Participants In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment V: CCH Shallow Injections, 4 Aliquots (Thighs) n=5 Participants In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.
Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 22	1.08 score on a scale Interval 0.51 to 1.65	1.10 score on a scale Interval 0.46 to 1.74	0.75 score on a scale Interval 0.18 to 1.32	0.50 score on a scale Interval -0.04 to 1.04	0.67 score on a scale Interval 0.1 to 1.24	0.20 score on a scale Interval -0.44 to 0.84	0.83 score on a scale Interval 0.26 to 1.4	0.67 score on a scale Interval 0.09 to 1.25	1.00 score on a scale Interval 0.47 to 1.53	1.10 score on a scale Interval 0.46 to 1.74

PRIMARY outcome

Timeframe: Day 43

Aesthetic appearance improvement for each treatment area (buttocks or thighs) was assessed by a blinded central assessment, using a 5-point Likert scale with scores ranging from -1 to 3. Aesthetic improvement was scored as worse (-1), stayed the same (0), improved (1), much improved (2) and very much improved (3). The assessor evaluated the image at Day 43 in comparison with baseline and recorded the Likert score. Aesthetic appearance Likert scale scores were analyzed using linear mixed model with treatment arm, study visit, interaction of treatment arm and study visit as fixed effects. This model was fitted using the response for the average of left and right of treatment area (that is, average of left buttock and right buttock or average of left thigh and right thigh).

Outcome measures

Outcome measures
Measure	Treatment I: CCH Shallow Injection, 3 Aliquots (Buttocks) n=6 Participants In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 milliliters (mL) aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment I: CCH Shallow Injection, 3 Aliquots (Thighs) n=5 Participants In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 mL aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment II: CCH Shallow Injection, 1 Aliquot (Buttocks) n=5 Participants In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment II: CCH Shallow Injection, 1 Aliquot (Thighs) n=7 Participants In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment III: CCH Deep Injection, 1 Aliquot (Buttocks) n=6 Participants In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment III: CCH Deep Injection, 1 Aliquot (Thighs) n=5 Participants In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit	Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Buttocks) n=6 Participants In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Thighs) n=6 Participants In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment V: CCH Shallow Injections, 4 Aliquots (Buttocks) n=7 Participants In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment V: CCH Shallow Injections, 4 Aliquots (Thighs) n=5 Participants In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.
Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 43	0.75 score on a scale Interval 0.18 to 1.32	1.40 score on a scale Interval 0.76 to 2.04	1.10 score on a scale Interval 0.47 to 1.73	0.57 score on a scale Interval 0.03 to 1.11	1.00 score on a scale Interval 0.43 to 1.57	-0.01 score on a scale Interval -0.64 to 0.64	1.17 score on a scale Interval 0.6 to 1.74	0.42 score on a scale Interval -0.16 to 1.0	1.21 score on a scale Interval 0.69 to 1.74	0.70 score on a scale Interval 0.06 to 1.34

PRIMARY outcome

Timeframe: Day 71

Aesthetic appearance improvement for each treatment area (buttocks or thighs) was assessed by a blinded central assessment, using a 5-point Likert scale with scores ranging from -1 to 3. Aesthetic improvement was scored as worse (-1), stayed the same (0), improved (1), much improved (2) and very much improved (3). The assessor evaluated the image at Day 71 in comparison with baseline and recorded the Likert score. Aesthetic appearance Likert scale scores were analyzed using linear mixed model with treatment arm, study visit, interaction of treatment arm and study visit as fixed effects. This model was fitted using the response for the average of left and right of treatment area (that is, average of left buttock and right buttock or average of left thigh and right thigh).

Outcome measures

Outcome measures
Measure	Treatment I: CCH Shallow Injection, 3 Aliquots (Buttocks) n=6 Participants In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 milliliters (mL) aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment I: CCH Shallow Injection, 3 Aliquots (Thighs) n=6 Participants In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 mL aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment II: CCH Shallow Injection, 1 Aliquot (Buttocks) n=6 Participants In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment II: CCH Shallow Injection, 1 Aliquot (Thighs) n=7 Participants In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment III: CCH Deep Injection, 1 Aliquot (Buttocks) n=6 Participants In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment III: CCH Deep Injection, 1 Aliquot (Thighs) n=4 Participants In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit	Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Buttocks) n=6 Participants In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Thighs) n=5 Participants In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment V: CCH Shallow Injections, 4 Aliquots (Buttocks) n=7 Participants In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment V: CCH Shallow Injections, 4 Aliquots (Thighs) n=5 Participants In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.
Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 71	1.08 score on a scale Interval 0.51 to 1.65	0.92 score on a scale Interval 0.34 to 1.5	1.08 score on a scale Interval 0.51 to 1.65	0.43 score on a scale Interval -0.11 to 0.97	1.00 score on a scale Interval 0.43 to 1.57	0.12 score on a scale Interval -0.59 to 0.84	0.50 score on a scale Interval -0.07 to 1.07	0.30 score on a scale Interval -0.34 to 0.94	1.29 score on a scale Interval 0.76 to 1.81	0.60 score on a scale Interval -0.04 to 1.24

PRIMARY outcome

Timeframe: Baseline, Day 22

Population: Evaluable Population includes all participants in the Safety Population who had completed screening procedures and at least 1 baseline assessment of aesthetic appearance Likert scale rating at specified timepoint. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for the assessment.

Dimple depth depression for each treatment area was assessed by the Investigator using the Hexsel Cellulite Severity Scale (B). Dimple Depth Depression of Hexsel Cellulite Severity Scale (B) was assessed and graded as: no depression (0), superficial depressions (1), medium depth depressions (2) and deep depressions (3). A negative change in Hexsel CSS (B) from baseline indicated an improvement in depression depth. Change from Baseline in dimple depth depression of Hexsel Cellulite Severity Scale (B) was analyzed using linear mixed model with treatment arm, study visits, interaction of treatment arm and study visit as fixed effect. This model was fitted using the response for the average of left and right of treatment areas (that is, average of left buttock and right buttock; average of left thigh and right thigh)

Outcome measures

Outcome measures
Measure	Treatment I: CCH Shallow Injection, 3 Aliquots (Buttocks) n=6 Participants In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 milliliters (mL) aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment I: CCH Shallow Injection, 3 Aliquots (Thighs) n=5 Participants In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 mL aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment II: CCH Shallow Injection, 1 Aliquot (Buttocks) n=6 Participants In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment II: CCH Shallow Injection, 1 Aliquot (Thighs) n=7 Participants In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment III: CCH Deep Injection, 1 Aliquot (Buttocks) n=6 Participants In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment III: CCH Deep Injection, 1 Aliquot (Thighs) n=5 Participants In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit	Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Buttocks) n=6 Participants In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Thighs) n=6 Participants In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment V: CCH Shallow Injections, 4 Aliquots (Buttocks) n=7 Participants In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment V: CCH Shallow Injections, 4 Aliquots (Thighs) n=5 Participants In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.
Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 22	-0.83 score on a scale Interval -1.28 to -0.39	-0.30 score on a scale Interval -0.84 to 0.24	-0.17 score on a scale Interval -0.61 to 0.28	-0.43 score on a scale Interval -0.89 to 0.03	-0.17 score on a scale Interval -0.61 to 0.28	-0.20 score on a scale Interval -0.74 to 0.34	-0.83 score on a scale Interval -1.28 to -0.39	-0.67 score on a scale Interval -1.16 to -0.17	-0.14 score on a scale Interval -0.56 to 0.27	-0.20 score on a scale Interval -0.74 to 0.34

PRIMARY outcome

Timeframe: Baseline, Day 43

Population: Evaluable Population includes all participants in the Safety Population who had completed screening procedures and at least 1 baseline assessment of aesthetic appearance Likert scale rating at specified timepoint. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for the assessment.

Outcome measures

Outcome measures
Measure	Treatment I: CCH Shallow Injection, 3 Aliquots (Buttocks) n=6 Participants In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 milliliters (mL) aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment I: CCH Shallow Injection, 3 Aliquots (Thighs) n=5 Participants In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 mL aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment II: CCH Shallow Injection, 1 Aliquot (Buttocks) n=5 Participants In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment II: CCH Shallow Injection, 1 Aliquot (Thighs) n=7 Participants In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment III: CCH Deep Injection, 1 Aliquot (Buttocks) n=6 Participants In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment III: CCH Deep Injection, 1 Aliquot (Thighs) n=5 Participants In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit	Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Buttocks) n=6 Participants In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Thighs) n=6 Participants In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment V: CCH Shallow Injections, 4 Aliquots (Buttocks) n=7 Participants In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment V: CCH Shallow Injections, 4 Aliquots (Thighs) n=5 Participants In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.
Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 43	-0.92 score on a scale Interval -1.36 to -0.47	-0.40 score on a scale Interval -0.94 to 0.14	-0.40 score on a scale Interval -0.89 to 0.09	-0.43 score on a scale Interval -0.89 to 0.03	-0.50 score on a scale Interval -0.95 to -0.05	-0.40 score on a scale Interval -0.94 to 0.14	-0.83 score on a scale Interval -1.28 to -0.39	-0.67 score on a scale Interval -1.16 to -0.17	-0.36 score on a scale Interval -0.77 to 0.06	-0.60 score on a scale Interval -1.14 to -0.06

PRIMARY outcome

Timeframe: Baseline, Day 71

Population: Evaluable Population includes all participants in the Safety Population who had completed screening procedures and at least 1 baseline assessment of aesthetic appearance Likert scale rating at specified timepoint. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for the assessment.

Outcome measures

Outcome measures
Measure	Treatment I: CCH Shallow Injection, 3 Aliquots (Buttocks) n=6 Participants In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 milliliters (mL) aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment I: CCH Shallow Injection, 3 Aliquots (Thighs) n=6 Participants In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 mL aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment II: CCH Shallow Injection, 1 Aliquot (Buttocks) n=6 Participants In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment II: CCH Shallow Injection, 1 Aliquot (Thighs) n=7 Participants In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment III: CCH Deep Injection, 1 Aliquot (Buttocks) n=6 Participants In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment III: CCH Deep Injection, 1 Aliquot (Thighs) n=4 Participants In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit	Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Buttocks) n=6 Participants In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Thighs) n=5 Participants In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment V: CCH Shallow Injections, 4 Aliquots (Buttocks) n=7 Participants In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment V: CCH Shallow Injections, 4 Aliquots (Thighs) n=5 Participants In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.
Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 71	-1.17 score on a scale Interval -1.61 to -0.72	-0.33 score on a scale Interval -0.83 to 0.16	-0.08 score on a scale Interval -0.53 to 0.36	-0.29 score on a scale Interval -0.74 to 0.17	-0.67 score on a scale Interval -1.11 to -0.22	-0.75 score on a scale Interval -1.36 to -0.14	-0.83 score on a scale Interval -1.28 to -0.39	-1.40 score on a scale Interval -1.94 to -0.86	-0.36 score on a scale Interval -0.77 to 0.06	-0.80 score on a scale Interval -1.34 to -0.26

SECONDARY outcome

Timeframe: Baseline, Day 22, Day 43, and Day 71

Population: Evaluable Population includes all participants in the Safety Population who had completed screening procedures and at least 1 baseline assessment of aesthetic appearance Likert scale rating at specified timepoint. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for the assessment.

For each treated buttock and thigh, 4 dimple parameters including the maximum length (largest straight line distance across the dimple), maximum width (largest straight line distance perpendicular to the maximum length measurement), surface are, and volume (between the base of the dimple and an interpolated surface) of the target dimple were assessed. A negative change from Day 1 indicated an improvement. Volume of Dimple from Day 1 pre-marking was analyzed using linear mixed model with treatment arm, study visit, interaction of treatment arm and study visit as fixed effects. This model was fitted using the measurement for the average of left and right of treatment areas (that is, average of left buttock posterior and right buttock posterior; average of left thigh lateral, left thigh oblique, left thigh posterior, right thigh lateral, right thigh oblique, and right thigh posterior).

Outcome measures

Outcome measures
Measure	Treatment I: CCH Shallow Injection, 3 Aliquots (Buttocks) n=6 Participants In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 milliliters (mL) aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment I: CCH Shallow Injection, 3 Aliquots (Thighs) n=6 Participants In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 mL aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment II: CCH Shallow Injection, 1 Aliquot (Buttocks) n=6 Participants In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment II: CCH Shallow Injection, 1 Aliquot (Thighs) n=7 Participants In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment III: CCH Deep Injection, 1 Aliquot (Buttocks) n=6 Participants In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment III: CCH Deep Injection, 1 Aliquot (Thighs) n=5 Participants In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit	Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Buttocks) n=6 Participants In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Thighs) n=6 Participants In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment V: CCH Shallow Injections, 4 Aliquots (Buttocks) n=7 Participants In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment V: CCH Shallow Injections, 4 Aliquots (Thighs) n=5 Participants In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.
Change From Baseline of Dimple Volume by Treatment Region Day 22	-0.01 mm^3 Interval -0.04 to 0.01	-0.02 mm^3 Interval -0.07 to 0.02	-0.001 mm^3 Interval -0.03 to 0.02	-0.04 mm^3 Interval -0.08 to -0.0001	-0.01 mm^3 Interval -0.04 to 0.01	0.00 mm^3 Interval -0.05 to 0.05	-0.01 mm^3 Interval -0.04 to 0.01	-0.01 mm^3 Interval -0.06 to 0.03	-0.04 mm^3 Interval -0.06 to -0.01	-0.04 mm^3 Interval -0.09 to 0.01
Change From Baseline of Dimple Volume by Treatment Region Day 43	-0.02 mm^3 Interval -0.05 to 0.0	-0.03 mm^3 Interval -0.08 to 0.02	-0.02 mm^3 Interval -0.05 to 0.0	-0.04 mm^3 Interval -0.08 to 0.0	-0.01 mm^3 Interval -0.04 to 0.01	0.01 mm^3 Interval -0.04 to 0.06	-0.01 mm^3 Interval -0.04 to 0.01	-0.02 mm^3 Interval -0.07 to 0.02	-0.04 mm^3 Interval -0.07 to -0.02	-0.06 mm^3 Interval -0.11 to -0.01
Change From Baseline of Dimple Volume by Treatment Region Day 71	-0.02 mm^3 Interval -0.05 to 0.0	-0.02 mm^3 Interval -0.07 to 0.02	-0.04 mm^3 Interval -0.06 to -0.01	-0.02 mm^3 Interval -0.07 to 0.02	-0.01 mm^3 Interval -0.04 to 0.02	0.04 mm^3 Interval -0.02 to 0.09	-0.02 mm^3 Interval -0.05 to 0.01	-0.02 mm^3 Interval -0.07 to 0.03	-0.05 mm^3 Interval -0.07 to -0.02	-0.05 mm^3 Interval -0.09 to 0.0

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment I: CCH Shallow Injection, 3 Aliquots (Buttocks) n=6 participants at risk In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 mL aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment I: CCH Shallow Injection, 3 Aliquots (Thighs) n=6 participants at risk In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 mL aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment II: CCH Shallow Injection, 1 Aliquot (Buttocks) n=6 participants at risk In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment II: CCH Shallow Injection, 1 Aliquot (Thighs) n=7 participants at risk In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment III: CCH Deep Injection, 1 Aliquot (Buttocks) n=6 participants at risk In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment III: CCH Deep Injection, 1 Aliquot (Thighs) n=6 participants at risk In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Buttocks) n=6 participants at risk In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Thighs) n=7 participants at risk In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment V: CCH Shallow Injections, 4 Aliquots (Buttocks) n=7 participants at risk In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment V: CCH Shallow Injections, 4 Aliquots (Thighs) n=6 participants at risk In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	14.3% 1/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	14.3% 1/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.
Surgical and medical procedures Hospitalization	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	14.3% 1/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.

Other adverse events

Other adverse events
Measure	Treatment I: CCH Shallow Injection, 3 Aliquots (Buttocks) n=6 participants at risk In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 mL aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment I: CCH Shallow Injection, 3 Aliquots (Thighs) n=6 participants at risk In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 mL aliquots (for a total injection volume of 0.3 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment II: CCH Shallow Injection, 1 Aliquot (Buttocks) n=6 participants at risk In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment II: CCH Shallow Injection, 1 Aliquot (Thighs) n=7 participants at risk In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment III: CCH Deep Injection, 1 Aliquot (Buttocks) n=6 participants at risk In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment III: CCH Deep Injection, 1 Aliquot (Thighs) n=6 participants at risk In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot. Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Buttocks) n=6 participants at risk In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Thighs) n=7 participants at risk In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment V: CCH Shallow Injections, 4 Aliquots (Buttocks) n=7 participants at risk In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.	Treatment V: CCH Shallow Injections, 4 Aliquots (Thighs) n=6 participants at risk In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL). Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit.
General disorders Injection site pain	100.0% 6/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	100.0% 6/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	50.0% 3/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	85.7% 6/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	100.0% 6/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	100.0% 6/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	100.0% 6/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	100.0% 7/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	85.7% 6/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	50.0% 3/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.
General disorders Injection site bruising	83.3% 5/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	66.7% 4/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	66.7% 4/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	100.0% 7/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	100.0% 6/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	100.0% 6/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	50.0% 3/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	42.9% 3/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	71.4% 5/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	100.0% 6/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.
General disorders Injection site nodule	50.0% 3/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	33.3% 2/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	66.7% 4/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	85.7% 6/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	83.3% 5/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	83.3% 5/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	42.9% 3/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	42.9% 3/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	83.3% 5/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.
General disorders Injection site warmth	33.3% 2/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	66.7% 4/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	33.3% 2/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	42.9% 3/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	33.3% 2/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	16.7% 1/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	14.3% 1/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	28.6% 2/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	33.3% 2/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.
General disorders Injection site pruritus	50.0% 3/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	50.0% 3/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	16.7% 1/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	42.9% 3/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	33.3% 2/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	33.3% 2/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	14.3% 1/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	28.6% 2/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.
General disorders Injection site haemorrhage	16.7% 1/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	33.3% 2/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	16.7% 1/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	50.0% 3/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	57.1% 4/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	28.6% 2/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.
General disorders Injection site discolouration	16.7% 1/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	16.7% 1/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	33.3% 2/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	57.1% 4/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	16.7% 1/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	16.7% 1/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.
General disorders Injection site swelling	16.7% 1/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	14.3% 1/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	16.7% 1/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	16.7% 1/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	28.6% 2/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	14.3% 1/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	16.7% 1/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.
General disorders Injection site induration	16.7% 1/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	16.7% 1/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	14.3% 1/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	16.7% 1/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	28.6% 2/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	16.7% 1/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.
General disorders Chills	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	14.3% 1/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.
General disorders Influenza-like illness	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	16.7% 1/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.
General disorders Injection site mass	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	16.7% 1/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	16.7% 1/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.
General disorders Pyrexia	16.7% 1/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.
Investigations Gamma-glutamyltransferase increased	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	16.7% 1/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	14.3% 1/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	16.7% 1/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.
Investigations Crystal urine present	16.7% 1/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.
Investigations White blood cells urine positive	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	16.7% 1/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.
Infections and infestations Upper respiratory tract infection	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	16.7% 1/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	16.7% 1/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.
Infections and infestations Pharyngitis streptococcal	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	14.3% 1/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.
Vascular disorders Hypertension	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	16.7% 1/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	16.7% 1/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	14.3% 1/7 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.	0.00% 0/6 • Day 1 (after dosing) through Day 71 All (serious and nonserious) treatment-emergent adverse events, whether elicited or observed during study visits or spontaneously reported by the participant. Safety Population: All enrolled participants who received at least 1 injection of CCH.

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