Trial Outcomes & Findings for Pharmacokinetic and Pharmacodynamic Study of FX006 in Patients With Osteoarthritis of the Knee (NCT NCT01487200)

Last Updated: 2024-01-24

Results Overview

The primary pharmacodynamic endpoint was change from baseline (pre-dose) to Day 1-2, Day 14-15 (Week 2) and Day 42-43 (Week 6) in 24-hour weighted mean serum cortisol. This is defined as AUC over the 0-24 hour measurement period divided by 24

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

Days 1-2, Days 14-15 (Week 2) and Days 42-43 (Week 6)

Results posted on

2024-01-24

Participant Flow

This study took place at 2 centers, both located in Australia. Enrollment for this study took approximately 1.5 months.

Subjects were screened for eligibility within 14 days of being randomized

Participant milestones

Participant milestones
Measure	FX006 10mg 5 subjects received FX006 10 mg as a single 3 mL IA injection.	FX006 40mg 7 subjects received FX006 40 mg as a single 3 mL IA injection.	FX006 60 mg 7 subjects received FX006 60 mg as a single 3 mL IA injection.	TCA IR 40 mg 5 subjects received commercially available triamcinolone acetonide (40 mg) as a single 1 mL IA injection.
Overall Study STARTED	5	7	7	5
Overall Study COMPLETED	5	6	7	5
Overall Study NOT COMPLETED	0	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	FX006 10mg 5 subjects received FX006 10 mg as a single 3 mL IA injection.	FX006 40mg 7 subjects received FX006 40 mg as a single 3 mL IA injection.	FX006 60 mg 7 subjects received FX006 60 mg as a single 3 mL IA injection.	TCA IR 40 mg 5 subjects received commercially available triamcinolone acetonide (40 mg) as a single 1 mL IA injection.
Overall Study Withdrawal by Subject	0	1	0	0

Baseline Characteristics

Pharmacokinetic and Pharmacodynamic Study of FX006 in Patients With Osteoarthritis of the Knee

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FX006 10mg n=5 Participants Single 3 mL IA injection	FX006 40mg n=7 Participants Single 3 mL IA injection	FX006 60 mg n=7 Participants Single 3 mL IA injection	TCA IR (40 mg) n=5 Participants Single 1 mL IA injection	Total n=24 Participants Total of all reporting groups
Age, Continuous	63.2 years n=99 Participants	59.3 years n=107 Participants	64.9 years n=206 Participants	63 years n=7 Participants	62.5 years n=31 Participants
Sex: Female, Male Female	4 Participants n=99 Participants	6 Participants n=107 Participants	3 Participants n=206 Participants	3 Participants n=7 Participants	16 Participants n=31 Participants
Sex: Female, Male Male	1 Participants n=99 Participants	1 Participants n=107 Participants	4 Participants n=206 Participants	2 Participants n=7 Participants	8 Participants n=31 Participants

PRIMARY outcome

Timeframe: Days 1-2, Days 14-15 (Week 2) and Days 42-43 (Week 6)

Outcome measures

Outcome measures
Measure	FX006 10mg n=5 Participants Single 3 mL IA injection	FX006 40mg n=7 Participants Single 3 mL IA injection	FX006 60 mg n=7 Participants Single 3 mL IA injection	TCA IR 40 mg n=5 Participants Single 1 mL IA injection
Change From Baseline in 24-hour Weighted Mean Serum Cortisol Change from BL to Days 1 to 2	-7.7 weighted mean serum cortisol (nmol/L) Interval -38.4 to 38.3	-42.7 weighted mean serum cortisol (nmol/L) Interval -59.2 to -19.4	-62.2 weighted mean serum cortisol (nmol/L) Interval -73.2 to -46.8	-59.0 weighted mean serum cortisol (nmol/L) Interval -72.6 to -38.6
Change From Baseline in 24-hour Weighted Mean Serum Cortisol Change from BL to Days 14 to 15	-11.1 weighted mean serum cortisol (nmol/L) Interval -37.0 to 25.5	-33.4 weighted mean serum cortisol (nmol/L) Interval -50.2 to -10.9	-49.5 weighted mean serum cortisol (nmol/L) Interval -62.3 to -32.4	-19.7 weighted mean serum cortisol (nmol/L) Interval -43.0 to 13.3
Change From Baseline in 24-hour Weighted Mean Serum Cortisol Change in BL to Days 42 to 43	-9.0 weighted mean serum cortisol (nmol/L) Interval -26.2 to 12.3	-18.0 weighted mean serum cortisol (nmol/L) Interval -32.2 to -0.7	-11.8 weighted mean serum cortisol (nmol/L) Interval -26.1 to 5.4	-4.8 weighted mean serum cortisol (nmol/L) Interval -22.7 to 17.4

PRIMARY outcome

Timeframe: Day 1 (1, 2, 4, 6, 8, 12 and 24 hours post dose) and Days 3, 4, 5, 8, 15, 22, 29, 36 and 43

Population: PK population was to include all patients who received study drug and had at least one measurable concentration

Concentrations below the limit of quantification of 50 pg/mL were treated as 0.

Outcome measures

Outcome measures
Measure	FX006 10mg n=5 Participants Single 3 mL IA injection	FX006 40mg n=7 Participants Single 3 mL IA injection	FX006 60 mg n=7 Participants Single 3 mL IA injection	TCA IR 40 mg n=5 Participants Single 1 mL IA injection
Characterize the Pharmacokinetic Profile of FX006 and TCA IR 1 hour postdose	140.941 pg/mL Standard Deviation 0.4767	638.447 pg/mL Standard Deviation 0.6312	862.574 pg/mL Standard Deviation 0.6823	12268.835 pg/mL Standard Deviation 1.4681
Characterize the Pharmacokinetic Profile of FX006 and TCA IR 2 hours postdose	226.058 pg/mL Standard Deviation 0.2204	779.819 pg/mL Standard Deviation 0.6778	1164.013 pg/mL Standard Deviation 0.6772	14243.604 pg/mL Standard Deviation 1.5643
Characterize the Pharmacokinetic Profile of FX006 and TCA IR 4 hours postdose	280.406 pg/mL Standard Deviation 0.3637	860.476 pg/mL Standard Deviation 0.7088	1251.776 pg/mL Standard Deviation 0.7030	16282.659 pg/mL Standard Deviation 1.7765
Characterize the Pharmacokinetic Profile of FX006 and TCA IR 6 hours postdose	261.231 pg/mL Standard Deviation 0.4108	814.647 pg/mL Standard Deviation 0.7131	1182.925 pg/mL Standard Deviation 0.6952	14560.886 pg/mL Standard Deviation 1.7754
Characterize the Pharmacokinetic Profile of FX006 and TCA IR 8 hours postdose	249.298 pg/mL Standard Deviation 0.4640	748.962 pg/mL Standard Deviation 0.7898	1227.658 pg/mL Standard Deviation 0.6245	13543.427 pg/mL Standard Deviation 1.7347
Characterize the Pharmacokinetic Profile of FX006 and TCA IR 12 hours postdose	230.506 pg/mL Standard Deviation 0.5331	691.962 pg/mL Standard Deviation 0.7456	1127.476 pg/mL Standard Deviation 0.7841	10112.863 pg/mL Standard Deviation 1.6684
Characterize the Pharmacokinetic Profile of FX006 and TCA IR Day 2 (24 hrs post dose)	242.764 pg/mL Standard Deviation 0.4037	763.568 pg/mL Standard Deviation 0.7423	1309.260 pg/mL Standard Deviation 0.5869	5421.894 pg/mL Standard Deviation 1.5196
Characterize the Pharmacokinetic Profile of FX006 and TCA IR Day 3 (48 hrs post dose)	233.138 pg/mL Standard Deviation 0.3999	743.344 pg/mL Standard Deviation 0.7583	1294.042 pg/mL Standard Deviation 0.7645	2371.778 pg/mL Standard Deviation 1.1844
Characterize the Pharmacokinetic Profile of FX006 and TCA IR Day 4 (72 hrs post dose)	224.987 pg/mL Standard Deviation 0.4904	675.086 pg/mL Standard Deviation 0.6930	1270.953 pg/mL Standard Deviation 0.7088	1310.061 pg/mL Standard Deviation 0.8301
Characterize the Pharmacokinetic Profile of FX006 and TCA IR Day 5 (96 hrs post dose)	242.533 pg/mL Standard Deviation 0.3787	690.857 pg/mL Standard Deviation 0.7292	1252.021 pg/mL Standard Deviation 0.7097	822.243 pg/mL Standard Deviation 0.6002
Characterize the Pharmacokinetic Profile of FX006 and TCA IR Day 8 (168 hrs post dose)	185.257 pg/mL Standard Deviation 0.5638	586.977 pg/mL Standard Deviation 0.7574	1070.823 pg/mL Standard Deviation 0.6322	235.938 pg/mL Standard Deviation 1.0814
Characterize the Pharmacokinetic Profile of FX006 and TCA IR Day 15 (336 hrs post dose)	113.002 pg/mL Standard Deviation 0.5244	365.970 pg/mL Standard Deviation 0.7325	718.787 pg/mL Standard Deviation 0.5587	0.000 pg/mL Standard Deviation 0.000
Characterize the Pharmacokinetic Profile of FX006 and TCA IR Day 22 (504 hrs post dose)	0.000 pg/mL Standard Deviation 0.000	238.529 pg/mL Standard Deviation 0.7026	521.843 pg/mL Standard Deviation 0.4563	0.000 pg/mL Standard Deviation 0.000
Characterize the Pharmacokinetic Profile of FX006 and TCA IR Day 29 (672 hrs post dose)	0.000 pg/mL Standard Deviation 0.000	189.422 pg/mL Standard Deviation 0.6089	369.683 pg/mL Standard Deviation 0.4589	0.000 pg/mL Standard Deviation 0.000
Characterize the Pharmacokinetic Profile of FX006 and TCA IR Day 36 (840 hrs post dose)	0.000 pg/mL Standard Deviation 0.000	0.000 pg/mL Standard Deviation 0.000	246.176 pg/mL Standard Deviation 0.3844	0.000 pg/mL Standard Deviation 0.000
Characterize the Pharmacokinetic Profile of FX006 and TCA IR Day 43 (1008 hrs post dose)	0.000 pg/mL Standard Deviation 0.000	138.660 pg/mL Standard Deviation 0.6253	187.435 pg/mL Standard Deviation 0.3924	0.000 pg/mL Standard Deviation 0.000

SECONDARY outcome

Timeframe: Baseline to Days 1-2, Baseline to Days 14-15 (Week 2) and Baseline to Days 42-43 (Week 6)

Population: Full Analysis Set (FAS) includes all observations from all patients who received a dose of study drug and provided a baseline observation and at least one post baseline observation.

Outcome measures

Outcome measures
Measure	FX006 10mg n=5 Participants Single 3 mL IA injection	FX006 40mg n=7 Participants Single 3 mL IA injection	FX006 60 mg n=7 Participants Single 3 mL IA injection	TCA IR 40 mg n=5 Participants Single 1 mL IA injection
Change From Baseline in 24-hour Urinary Free Cortisol Excretion Day 1 to 2	47.9 nmol/24h Interval -11.1 to 146.2	-43.8 nmol/24h Interval -63.5 to -13.6	-50.1 nmol/24h Interval -67.7 to -23.0	-58.5 nmol/24h Interval -75.2 to -30.5
Change From Baseline in 24-hour Urinary Free Cortisol Excretion Day 14 to 15	13.0 nmol/24h Interval -25.3 to 70.8	-42.4 nmol/24h Interval -59.3 to -18.3	-59.0 nmol/24h Interval -72.0 to -40.0	-14.7 nmol/24h Interval -43.9 to 29.6
Change From Baseline in 24-hour Urinary Free Cortisol Excretion Day 42 to 43	7.7 nmol/24h Interval -25.8 to 56.3	-38.3 nmol/24h Interval -56.1 to -13.3	-13.1 nmol/24h Interval -36.7 to 19.3	-21.3 nmol/24h Interval -46.0 to 14.8

SECONDARY outcome

Timeframe: Days 1-2, Days 14-15 (Week 2) and Days 42-43 (Week 6)

Population: FAS includes all observations from all patients who received a dose of study drug and provided a baseline observation and at least one post baseline observation.

Outcome measures

Outcome measures
Measure	FX006 10mg n=5 Participants Single 3 mL IA injection	FX006 40mg n=7 Participants Single 3 mL IA injection	FX006 60 mg n=7 Participants Single 3 mL IA injection	TCA IR 40 mg n=5 Participants Single 1 mL IA injection
Total 24-hour Urinary Free Cortisol Excretion Day 1 to 2	75.66 nmol/24h Standard Deviation 1.112	29.94 nmol/24h Standard Deviation 0.770	29.36 nmol/24h Standard Deviation 0.490	18.77 nmol/24h Standard Deviation 0.289
Total 24-hour Urinary Free Cortisol Excretion Day 14 to 15	57.14 nmol/24h Standard Deviation 0.842	30.91 nmol/24h Standard Deviation 0.590	26.46 nmol/24h Standard Deviation 0.925	36.22 nmol/24h Standard Deviation 0.962
Total 24-hour Urinary Free Cortisol Excretion Day 42 to 43	55.74 nmol/24h Standard Deviation 0.715	34.62 nmol/24h Standard Deviation 0.557	51.16 nmol/24h Standard Deviation 0.499	36.38 nmol/24h Standard Deviation 0.626

SECONDARY outcome

Timeframe: Baseline to Days 2, 3, 4, 5, 8, 14, 15, 22, 29, 36, 42 and 43

Population: The full analysis set will include all observations from all patients who received any dose of FX006 and provide a baseline observation and at least one post baseline observation.

Least square mean difference against TCA IR 40 mg

Outcome measures

Outcome measures
Measure	FX006 10mg n=5 Participants Single 3 mL IA injection	FX006 40mg n=7 Participants Single 3 mL IA injection	FX006 60 mg n=7 Participants Single 3 mL IA injection	TCA IR 40 mg n=5 Participants Single 1 mL IA injection
Change From Baseline to Each Measured Time Point Post-dose in Morning Serum Cortisol Day 2	-30.2 nmol/L Interval -68.9 to 57.1	-42.3 nmol/L Interval -71.1 to 15.1	-78.2 nmol/L Interval -89.1 to -56.4	-85.4 nmol/L Interval -93.5 to -67.1
Change From Baseline to Each Measured Time Point Post-dose in Morning Serum Cortisol Day 3	-24.9 nmol/L Interval -61.7 to 47.5	-40.8 nmol/L Interval -66.7 to 5.2	-80.2 nmol/L Interval -88.9 to -64.8	-86.2 nmol/L Interval -93.0 to -72.9
Change From Baseline to Each Measured Time Point Post-dose in Morning Serum Cortisol Day 4	-13.9 nmol/L Interval -58.1 to 77.3	-37.1 nmol/L Interval -66.0 to 16.4	-77.2 nmol/L Interval -87.7 to -57.8	-73.1 nmol/L Interval -86.9 to -44.6
Change From Baseline to Each Measured Time Point Post-dose in Morning Serum Cortisol Day 5	-12.4 nmol/L Interval -50.7 to 55.6	-35.1 nmol/L Interval -60.3 to 5.9	-73.0 nmol/L Interval -83.5 to -55.9	-49.8 nmol/L Interval -71.7 to -10.7
Change From Baseline to Each Measured Time Point Post-dose in Morning Serum Cortisol Day 8	-29.8 nmol/L Interval -50.1 to -1.1	-37.4 nmol/L Interval -53.2 to -16.1	-61.7 nmol/L Interval -72.2 to -47.4	-8.6 nmol/L Interval -35.1 to 28.8
Change From Baseline to Each Measured Time Point Post-dose in Morning Serum Cortisol Day 14	-7.6 nmol/L Interval -37.7 to 37.1	-35.5 nmol/L Interval -53.4 to -10.7	-40.4 nmol/L Interval -55.8 to -19.6	-27.3 nmol/L Interval -48.9 to 3.4
Change From Baseline to Each Measured Time Point Post-dose in Morning Serum Cortisol Day 15	-24.4 nmol/L Interval -48.2 to 10.4	-28.1 nmol/L Interval -47.9 to -0.7	-46.4 nmol/L Interval -61.2 to -26.0	-8.3 nmol/L Interval -37.2 to 34.0
Change From Baseline to Each Measured Time Point Post-dose in Morning Serum Cortisol Day 22	3.3 nmol/L Interval -26.6 to 45.2	-28.5 nmol/L Interval -46.5 to -4.4	-14.4 nmol/L Interval -36.0 to 14.6	-11.3 nmol/L Interval -36.9 to 24.9
Change From Baseline to Each Measured Time Point Post-dose in Morning Serum Cortisol Day 29	-4.5 nmol/L Interval -26.8 to 24.5	-21.1 nmol/L Interval -37.1 to -1.1	-6.3 nmol/L Interval -25.3 to 17.5	0.8 nmol/L Interval -22.7 to 31.5
Change From Baseline to Each Measured Time Point Post-dose in Morning Serum Cortisol Day 36	-6.4 nmol/L Interval -33.5 to 31.7	-19.5 nmol/L Interval -39.8 to 7.7	-3.0 nmol/L Interval -27.6 to 29.8	11.7 nmol/L Interval -20.7 to 57.2
Change From Baseline to Each Measured Time Point Post-dose in Morning Serum Cortisol Day 42	-18.3 nmol/L Interval -47.8 to 27.7	-27.0 nmol/L Interval -49.5 to 5.4	-19.1 nmol/L Interval -42.4 to 13.6	-21.4 nmol/L Interval -47.3 to 17.1
Change From Baseline to Each Measured Time Point Post-dose in Morning Serum Cortisol Day 43	-22.1 nmol/L Interval -39.1 to -0.3	-14.9 nmol/L Interval -32.2 to 6.8	-13.4 nmol/L Interval -29.8 to 6.9	3.0 nmol/L Interval -19.5 to 31.9

Adverse Events

FX006 10mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

FX006 40mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

FX006 60 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

TCA IR 40 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Scott Kelley, Chief Medical Officer

Flexion Therapeutics

Phone: 781-305-7142

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Measure	FX006 10mg n=5 participants at risk Single 3 mL IA injection	FX006 40mg n=7 participants at risk Single 3 mL IA injection	FX006 60 mg n=7 participants at risk Single 3 mL IA injection	TCA IR 40 mg n=5 participants at risk Single 1 mL IA injection of commercially available triamcinolone acetonide
Cardiac disorders Palpitations	20.0% 1/5 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.
Gastrointestinal disorders Dental caries	20.0% 1/5 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.
Gastrointestinal disorders Diarrhoea	20.0% 1/5 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.
Gastrointestinal disorders Nausea	20.0% 1/5 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.
Gastrointestinal disorders Vomiting	20.0% 1/5 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.
General disorders Adverse drug reaction	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.	14.3% 1/7 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.
General disorders Catheter site haematoma	20.0% 1/5 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	14.3% 1/7 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	14.3% 1/7 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	40.0% 2/5 • Number of events 2 • Adverse Events were collected from post injection on Day 1 through Day 43.
General disorders Catheter site related reaction	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.
General disorders Feeling hot	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.	14.3% 1/7 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.
General disorders Injection site erythema	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.	14.3% 1/7 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.
General disorders Injection site pain	20.0% 1/5 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	14.3% 1/7 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.
General disorders Vessel puncture site haematoma	40.0% 2/5 • Number of events 2 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	14.3% 1/7 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.
Infections and infestations Nasopharyngitis	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.
Infections and infestations Sinusitis	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.	14.3% 1/7 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.
Infections and infestations Upper respiratory tract infection	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.	14.3% 1/7 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	14.3% 1/7 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.
Injury, poisoning and procedural complications Contusion	20.0% 1/5 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	28.6% 2/7 • Number of events 2 • Adverse Events were collected from post injection on Day 1 through Day 43.	28.6% 2/7 • Number of events 2 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.
Injury, poisoning and procedural complications Joint injury	20.0% 1/5 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.
Injury, poisoning and procedural complications Joint sprain	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	14.3% 1/7 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.
Injury, poisoning and procedural complications Laceration	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	14.3% 1/7 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.
Injury, poisoning and procedural complications Post-traumatic pain	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.	28.6% 2/7 • Number of events 2 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.
Investigations Blood pressure increased	20.0% 1/5 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.
Musculoskeletal and connective tissue disorders Arthralgia	20.0% 1/5 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	42.9% 3/7 • Number of events 3 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.
Musculoskeletal and connective tissue disorders Joint stiffness	20.0% 1/5 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	14.3% 1/7 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.	14.3% 1/7 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	28.6% 2/7 • Number of events 2 • Adverse Events were collected from post injection on Day 1 through Day 43.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	14.3% 1/7 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	14.3% 1/7 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	14.3% 1/7 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.
Nervous system disorders Dizziness	20.0% 1/5 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.
Nervous system disorders Headache	20.0% 1/5 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	42.9% 3/7 • Number of events 3 • Adverse Events were collected from post injection on Day 1 through Day 43.	42.9% 3/7 • Number of events 3 • Adverse Events were collected from post injection on Day 1 through Day 43.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.
Nervous system disorders Lethargy	20.0% 1/5 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.
Nervous system disorders Syncope	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.	14.3% 1/7 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.
Psychiatric disorders Anxiety	20.0% 1/5 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.
Psychiatric disorders Insomnia	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.
Psychiatric disorders Libido decreased	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	14.3% 1/7 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.	14.3% 1/7 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	20.0% 1/5 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	14.3% 1/7 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.
Skin and subcutaneous tissue disorders Night Sweats	20.0% 1/5 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	14.3% 1/7 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.	14.3% 1/7 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.
Vascular disorders Flushing	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.	14.3% 1/7 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.
Vascular disorders Hypertension	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/7 • Adverse Events were collected from post injection on Day 1 through Day 43.	14.3% 1/7 • Number of events 1 • Adverse Events were collected from post injection on Day 1 through Day 43.	0.00% 0/5 • Adverse Events were collected from post injection on Day 1 through Day 43.