Trial Outcomes & Findings for Pharmacokinetics, Safety, and Tolerability Study of the Pen and PFS of SB5 in Healthy Subjects (NCT NCT02326233)
NCT ID: NCT02326233
Last Updated: 2019-03-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
190 participants
Primary outcome timeframe
0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose
Results posted on
2019-03-18
Participant Flow
Participant milestones
| Measure |
Pen of SB5
Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug)
Pen of SB5
|
PFS of SB5
PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug)
PFS of SB5
|
|---|---|---|
|
Overall Study
STARTED
|
95
|
95
|
|
Overall Study
COMPLETED
|
95
|
94
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics, Safety, and Tolerability Study of the Pen and PFS of SB5 in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Pen of SB5
n=95 Participants
Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug)
Pen of SB5
|
PFS of SB5
n=95 Participants
PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug)
PFS of SB5
|
Total
n=190 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.2 years
STANDARD_DEVIATION 10.58 • n=5 Participants
|
30.5 years
STANDARD_DEVIATION 11.41 • n=7 Participants
|
30.8 years
STANDARD_DEVIATION 10.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
90 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
78 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Height (cm)
|
177.63 cm
STANDARD_DEVIATION 7.753 • n=5 Participants
|
177.89 cm
STANDARD_DEVIATION 7.814 • n=7 Participants
|
177.76 cm
STANDARD_DEVIATION 7.764 • n=5 Participants
|
PRIMARY outcome
Timeframe: 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdoseOutcome measures
| Measure |
Pen of SB5
n=94 Participants
Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug)
Pen of SB5
|
PFS of SB5
n=94 Participants
PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug)
PFS of SB5
|
|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
|
2743.2 h·μg/mL
Standard Deviation 1081.76
|
2503.3 h·μg/mL
Standard Deviation 1043.69
|
PRIMARY outcome
Timeframe: 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdoseOutcome measures
| Measure |
Pen of SB5
n=94 Participants
Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug)
Pen of SB5
|
PFS of SB5
n=94 Participants
PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug)
PFS of SB5
|
|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
|
2329.2 h·μg/mL
Standard Deviation 733.30
|
2182.2 h·μg/mL
Standard Deviation 724.98
|
PRIMARY outcome
Timeframe: 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdoseOutcome measures
| Measure |
Pen of SB5
n=94 Participants
Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug)
Pen of SB5
|
PFS of SB5
n=94 Participants
PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug)
PFS of SB5
|
|---|---|---|
|
Maximum Serum Concentration (Cmax)
|
3.803 μg/mL
Standard Deviation 1.0697
|
3.673 μg/mL
Standard Deviation 0.8810
|
SECONDARY outcome
Timeframe: 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdoseOutcome measures
| Measure |
Pen of SB5
n=94 Participants
Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug)
Pen of SB5
|
PFS of SB5
n=94 Participants
PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug)
PFS of SB5
|
|---|---|---|
|
Time to Reach Cmax (Tmax)
|
168.000 h
Interval 24.0 to 504.12
|
168.000 h
Interval 48.0 to 408.0
|
Adverse Events
Pen of SB5
Serious events: 1 serious events
Other events: 39 other events
Deaths: 0 deaths
PFS of SB5
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pen of SB5
n=95 participants at risk
Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug)
Pen of SB5
|
PFS of SB5
n=94 participants at risk
PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug)
PFS of SB5
|
|---|---|---|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/95
|
1.1%
1/94 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/95
|
1.1%
1/94 • Number of events 1
|
|
Psychiatric disorders
Schizophrenia
|
1.1%
1/95 • Number of events 1
|
0.00%
0/94
|
Other adverse events
| Measure |
Pen of SB5
n=95 participants at risk
Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug)
Pen of SB5
|
PFS of SB5
n=94 participants at risk
PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug)
PFS of SB5
|
|---|---|---|
|
General disorders
Fatigue
|
7.4%
7/95 • Number of events 7
|
1.1%
1/94 • Number of events 1
|
|
General disorders
Vessel puncture site bruise
|
5.3%
5/95 • Number of events 5
|
0.00%
0/94
|
|
Infections and infestations
Upper respiratory tract infection
|
15.8%
15/95 • Number of events 15
|
19.1%
18/94 • Number of events 19
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.3%
6/95 • Number of events 7
|
1.1%
1/94 • Number of events 1
|
|
Nervous system disorders
Headache
|
6.3%
6/95 • Number of events 6
|
8.5%
8/94 • Number of events 10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place