Trial Outcomes & Findings for A Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of the Fixed-Dose Combination of Pertuzumab and Trastuzumab Administered Subcutaneously Using a Handheld Syringe or Using the On-Body Delivery System (NCT NCT05275010)
NCT ID: NCT05275010
Last Updated: 2024-09-23
Results Overview
For the analysis of AUC0-62days, participants in the Per Protocol Pharmacokinetics (PK) Analysis Population (PAP) with missing Day 63 PK pertuzumab concentration data or with a Day 63 PK sample time deviation outside a +/-120-hour window of planned sampling time were excluded. Participants were excluded from the PAP for the following reasons: 1. The participant violates inclusion or exclusion criteria regarding body mass index (BMI), use of prohibited medications and concomitant subcutaneous, intravenous (IV), or any parenteral drugs, participation in an investigational drug or device study, current chronic daily treatment with corticosteroids, and receipt of IV antibiotics for infection. 2. An SC injection site other than thigh is used; 3. Any participant whose injection is not successfully performed.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
151 participants
Primary outcome timeframe
Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63
Results posted on
2024-09-23
Participant Flow
Participant milestones
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
|---|---|---|
|
Overall Study
STARTED
|
76
|
75
|
|
Overall Study
Received the Single Dose of Study Treatment
|
72
|
74
|
|
Overall Study
Entered Follow-Up
|
71
|
74
|
|
Overall Study
COMPLETED
|
71
|
73
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
|---|---|---|
|
Overall Study
Reason Not Specified
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
A Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of the Fixed-Dose Combination of Pertuzumab and Trastuzumab Administered Subcutaneously Using a Handheld Syringe or Using the On-Body Delivery System
Baseline characteristics by cohort
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
n=76 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
n=75 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.0 Years
n=5 Participants
|
29.0 Years
n=7 Participants
|
29.0 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
68 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Number of Participants by Weight Category (>75 kg vs. ≤75 kg)
>75 kg
|
55 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Number of Participants by Weight Category (>75 kg vs. ≤75 kg)
≤75 kg
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63Population: Per Protocol PK Analysis Population for Pertuzumab AUC0-62 (PPAP1): includes all randomized participants who were treated and adhered to the pre-specified protocol criteria for general PK analysis and for pertuzumab AUC0-62 analysis specifically.
For the analysis of AUC0-62days, participants in the Per Protocol Pharmacokinetics (PK) Analysis Population (PAP) with missing Day 63 PK pertuzumab concentration data or with a Day 63 PK sample time deviation outside a +/-120-hour window of planned sampling time were excluded. Participants were excluded from the PAP for the following reasons: 1. The participant violates inclusion or exclusion criteria regarding body mass index (BMI), use of prohibited medications and concomitant subcutaneous, intravenous (IV), or any parenteral drugs, participation in an investigational drug or device study, current chronic daily treatment with corticosteroids, and receipt of IV antibiotics for infection. 2. An SC injection site other than thigh is used; 3. Any participant whose injection is not successfully performed.
Outcome measures
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
n=68 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
n=73 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
|---|---|---|
|
Area Under the Time-Concentration Curve From the Start of Dosing to 63 Days (AUC0-62) for Serum Pertuzumab
|
1671.2 μg*day/mL
Geometric Coefficient of Variation 27.5
|
1674.6 μg*day/mL
Geometric Coefficient of Variation 23.2
|
PRIMARY outcome
Timeframe: Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63Population: Per Protocol PK Analysis Population for Trastuzumab AUC0-62 (TPAP1): includes all randomized participants who were treated and adhered to the pre-specified protocol criteria for general PK analysis and for trastuzumab AUC0-62 analysis specifically.
For the analysis of AUC0-62days, participants in the Per Protocol Pharmacokinetics (PK) Analysis Population (PAP) with missing Day 63 PK trastuzumab concentration data or with a Day 63 PK sample time deviation outside a +/-120-hour window of planned sampling time were excluded. Participants were excluded from the PAP for the following reasons: 1. The participant violates inclusion or exclusion criteria regarding body mass index (BMI), use of prohibited medications and concomitant subcutaneous, intravenous (IV), or any parenteral drugs, participation in an investigational drug or device study, current chronic daily treatment with corticosteroids, and receipt of IV antibiotics for infection. 2. An SC injection site other than thigh is used; 3. Any participant whose injection is not successfully performed.
Outcome measures
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
n=68 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
n=73 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
|---|---|---|
|
Area Under the Time-Concentration Curve From the Start of Dosing to 63 Days (AUC0-62) for Serum Trastuzumab
|
1341.2 μg*day/mL
Geometric Coefficient of Variation 31.4
|
1347.1 μg*day/mL
Geometric Coefficient of Variation 23.6
|
PRIMARY outcome
Timeframe: Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63Population: Per Protocol PK Analysis Population for Pertuzumab Cmax (PPAP2): includes all randomized participants who were treated and adhered to the pre-specified protocol criteria for general PK analysis and for pertuzumab Cmax analysis specifically.
For analysis of Cmax, participants from the Per Protocol PK Analysis Population (PAP) with two or more missing PK pertuzumab concentration data on any of Days 3, 5, 7, 9 or 11 were excluded. Participants were excluded from the PAP for the following reasons: 1. The participant violates inclusion or exclusion criteria regarding body mass index (BMI), use of prohibited medications and concomitant subcutaneous, intravenous (IV), or any parenteral drugs, participation in an investigational drug or device study, current chronic daily treatment with corticosteroids, and receipt of IV antibiotics for infection. 2. An SC injection site other than thigh is used; 3. Any participant whose injection is not successfully performed.
Outcome measures
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
n=68 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
n=74 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
|---|---|---|
|
Maximum Serum Concentration (Cmax) of Pertuzumab
|
63.4 microgram per millilitre (μg/mL)
Geometric Coefficient of Variation 32.2
|
65.8 microgram per millilitre (μg/mL)
Geometric Coefficient of Variation 24.7
|
PRIMARY outcome
Timeframe: Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63Population: Per Protocol PK Analysis Population for Trastuzumab Cmax (TPAP2): includes all randomized participants who were treated and adhered to the pre-specified protocol criteria for general PK analysis and for trastuzumab Cmax analysis specifically.
For analysis of Cmax, participants from the Per Protocol PK Analysis Population (PAP) with two or more missing PK trastuzumab concentration data on any of Days 3, 5, 7, 9 or 11 were excluded. Participants were excluded from the PAP for the following reasons: 1. The participant violates inclusion or exclusion criteria regarding body mass index (BMI), use of prohibited medications and concomitant subcutaneous, intravenous (IV), or any parenteral drugs, participation in an investigational drug or device study, current chronic daily treatment with corticosteroids, and receipt of IV antibiotics for infection. 2. An SC injection site other than thigh is used; 3. Any participant whose injection is not successfully performed.
Outcome measures
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
n=68 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
n=74 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
|---|---|---|
|
Maximum Serum Concentration (Cmax) of Trastuzumab
|
59.8 microgram per millilitre (μg/mL)
Geometric Coefficient of Variation 33.8
|
62.0 microgram per millilitre (μg/mL)
Geometric Coefficient of Variation 25.2
|
SECONDARY outcome
Timeframe: Day 22Population: The Per Protocol PK Population (PAP) includes all randomized participants who were treated and adhered to the pre-specified protocol criteria. Only participants who provided PK samples on Day 22 were included in this analysis.
Outcome measures
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
n=69 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
n=73 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
|---|---|---|
|
Observed Serum Concentration of Pertuzumab on Day 22
|
34.2 microgram per millilitre (μg/mL)
Standard Deviation 10.6
|
34.6 microgram per millilitre (μg/mL)
Standard Deviation 8.79
|
SECONDARY outcome
Timeframe: Day 22Population: The Per Protocol PK Population (PAP) includes all randomized participants who were treated and adhered to the pre-specified protocol criteria. Only participants who provided PK samples on Day 22 were included in this analysis.
Outcome measures
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
n=69 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
n=73 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
|---|---|---|
|
Observed Serum Concentration of Trastuzumab on Day 22
|
29.9 microgram per millilitre (μg/mL)
Standard Deviation 10.7
|
29.5 microgram per millilitre (μg/mL)
Standard Deviation 6.72
|
SECONDARY outcome
Timeframe: Day 63Population: The Per Protocol PK Population (PAP) includes all randomized participants who were treated and adhered to the pre-specified protocol criteria. Only participants who provided PK samples on Day 63 were included in this analysis.
Outcome measures
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
n=69 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
n=74 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
|---|---|---|
|
Observed Serum Concentration of Pertuzumab on Day 63
|
6.23 microgram per millilitre (μg/mL)
Standard Deviation 3.64
|
6.23 microgram per millilitre (μg/mL)
Standard Deviation 5.42
|
SECONDARY outcome
Timeframe: Day 63Population: The Per Protocol PK Population (PAP) includes all randomized participants who were treated and adhered to the pre-specified protocol criteria. Only participants who provided PK samples on Day 63 were included in this analysis.
Outcome measures
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
n=69 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
n=74 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
|---|---|---|
|
Observed Serum Concentration of Trastuzumab on Day 63
|
1.00 microgram per millilitre (μg/mL)
Interval to 6.82
The values for the majority of participant samples (n = 63) were lower than reportable (i.e., below the minimum quantifiable concentration of 1 ug/mL); thus, the lower limit of the full range could not be calculated.
|
1.00 microgram per millilitre (μg/mL)
Interval to 35.2
The values for the majority of participant samples (n = 55) were lower than reportable (i.e., below the minimum quantifiable concentration of 1 ug/mL); thus, the lower limit of the full range could not be calculated.
|
SECONDARY outcome
Timeframe: Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63Population: The Per Protocol PK Population (PAP) includes all randomized participants who were treated and adhered to the pre-specified protocol criteria. The number analyzed includes participants in the PAP with adequate concentration profiles, which allowed for individual PK parameters to be estimated.
Outcome measures
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
n=70 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
n=74 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
|---|---|---|
|
Area Under the Time-Concentration Curve From the Start of Dosing Extrapolated to Infinity (AUC0-∞) for Serum Pertuzumab
|
1930 μg*day/mL
Standard Deviation 593
|
1860 μg*day/mL
Standard Deviation 454
|
SECONDARY outcome
Timeframe: Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63Population: The Per Protocol PK Population (PAP) includes all randomized participants who were treated and adhered to the pre-specified protocol criteria. The number analyzed includes participants in the PAP with adequate concentration profiles, which allowed for individual PK parameters to be estimated.
Outcome measures
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
n=70 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
n=74 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
|---|---|---|
|
Area Under the Time-Concentration Curve From the Start of Dosing Extrapolated to Infinity (AUC0-∞) for Serum Trastuzumab
|
1440 μg*day/mL
Standard Deviation 453
|
1410 μg*day/mL
Standard Deviation 331
|
SECONDARY outcome
Timeframe: Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63Population: The Per Protocol PK Population (PAP) includes all randomized participants who were treated and adhered to the pre-specified protocol criteria. The number analyzed includes participants in the PAP with adequate concentration profiles, which allowed for individual PK parameters to be estimated.
Outcome measures
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
n=70 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
n=74 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
|---|---|---|
|
Observed Time to Maximum Serum Concentration (Tmax) of Pertuzumab
|
4.00 Days
Interval 1.94 to 21.01
|
4.00 Days
Interval 1.99 to 21.02
|
SECONDARY outcome
Timeframe: Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63Population: The Per Protocol PK Population (PAP) includes all randomized participants who were treated and adhered to the pre-specified protocol criteria. The number analyzed includes participants in the PAP with adequate concentration profiles, which allowed for individual PK parameters to be estimated.
Outcome measures
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
n=70 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
n=74 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
|---|---|---|
|
Observed Time to Maximum Serum Concentration (Tmax) of Trastuzumab
|
4.01 Days
Interval 1.94 to 10.08
|
4.00 Days
Interval 1.99 to 13.91
|
SECONDARY outcome
Timeframe: Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63Population: The Per Protocol PK Population (PAP) includes all randomized participants who were treated and adhered to the pre-specified protocol criteria. The number analyzed includes participants in the PAP with adequate concentration profiles, which allowed for individual PK parameters to be estimated.
Outcome measures
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
n=70 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
n=74 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
|---|---|---|
|
Terminal Elimination Half-Life (t1/2) of Pertuzumab
|
15.6 Days
Interval 6.85 to 56.4
|
15.1 Days
Interval 7.86 to 24.6
|
SECONDARY outcome
Timeframe: Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63Population: The Per Protocol PK Population (PAP) includes all randomized participants who were treated and adhered to the pre-specified protocol criteria. The number analyzed includes participants in the PAP with adequate concentration profiles, which allowed for individual PK parameters to be estimated.
Outcome measures
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
n=70 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
n=74 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
|---|---|---|
|
Terminal Elimination Half-Life (t1/2) of Trastuzumab
|
8.93 Days
Interval 5.88 to 26.8
|
8.43 Days
Interval 5.89 to 19.0
|
SECONDARY outcome
Timeframe: Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63Population: The Per Protocol PK Population (PAP) includes all randomized participants who were treated and adhered to the pre-specified protocol criteria. The number analyzed includes participants in the PAP with adequate concentration profiles, which allowed for individual PK parameters to be estimated.
Outcome measures
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
n=70 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
n=74 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
|---|---|---|
|
Apparent Drug Clearance (CL/F) of Pertuzumab
|
347 millilitres per day (mL/day)
Standard Deviation 124
|
361 millilitres per day (mL/day)
Standard Deviation 102
|
SECONDARY outcome
Timeframe: Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63Population: The Per Protocol PK Population (PAP) includes all randomized participants who were treated and adhered to the pre-specified protocol criteria. The number analyzed includes participants in the PAP with adequate concentration profiles, which allowed for individual PK parameters to be estimated.
Outcome measures
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
n=70 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
n=74 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
|---|---|---|
|
Apparent Drug Clearance (CL/F) of Trastuzumab
|
469 millilitres per day (mL/day)
Standard Deviation 172
|
481 millilitres per day (mL/day)
Standard Deviation 122
|
SECONDARY outcome
Timeframe: Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63Population: The Per Protocol PK Population (PAP) includes all randomized participants who were treated and adhered to the pre-specified protocol criteria. The number analyzed includes participants in the PAP with adequate concentration profiles, which allowed for individual PK parameters to be estimated.
Outcome measures
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
n=70 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
n=74 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
|---|---|---|
|
Apparent Volume of Distribution (Vd/F) of Pertuzumab
|
7670 millilitres (mL)
Standard Deviation 2030
|
7730 millilitres (mL)
Standard Deviation 2250
|
SECONDARY outcome
Timeframe: Predose (0 hour) and 2, 6, and 12 hours postdose on Day 1, and postdose on Days 2, 3, 5, 7, 9, 11, 15, 22, 35, 49, and 63Population: The Per Protocol PK Population (PAP) includes all randomized participants who were treated and adhered to the pre-specified protocol criteria. The number analyzed includes participants in the PAP with adequate concentration profiles, which allowed for individual PK parameters to be estimated.
Outcome measures
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
n=70 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
n=74 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
|---|---|---|
|
Apparent Volume of Distribution (Vd/F) of Trastuzumab
|
6320 millilitres (mL)
Standard Deviation 2890
|
6030 millilitres (mL)
Standard Deviation 1980
|
SECONDARY outcome
Timeframe: From study drug dose until safety follow-up visit (up to 7 months)Population: Safety population: all participants who received the single dose of study treatment.
The adverse event (AE) severity grading scale NCI CTCAE v5.0 was used for assessing AE severity. Any AEs for which the NCI CTCAE v5.0 did not provide a grading scale, the standard four-point scale from 1 to 4 (mild, moderate, severe, life-threatening) was used. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade. AEs to monitor included administration-related reactions, hypersensitivity and anaphylaxis, diarrhoea, rash, cardiac dysfunction, neutropenia or febrile neutropenia, mucositis, and interstitial lung disease.
Outcome measures
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
n=72 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
n=74 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
|---|---|---|
|
Summary of the Number of Participants With at Least One Adverse Event, With Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
Any Adverse Event (AE)
|
70 Participants
|
71 Participants
|
|
Summary of the Number of Participants With at Least One Adverse Event, With Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
AE with Fatal Outcome
|
0 Participants
|
0 Participants
|
|
Summary of the Number of Participants With at Least One Adverse Event, With Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
Serious AE
|
1 Participants
|
0 Participants
|
|
Summary of the Number of Participants With at Least One Adverse Event, With Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
Related Serious AE
|
0 Participants
|
0 Participants
|
|
Summary of the Number of Participants With at Least One Adverse Event, With Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
Grade 3 to 4 AE
|
1 Participants
|
0 Participants
|
|
Summary of the Number of Participants With at Least One Adverse Event, With Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
AE Leading to Drug Interruption
|
0 Participants
|
0 Participants
|
|
Summary of the Number of Participants With at Least One Adverse Event, With Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
Device Related AE
|
0 Participants
|
0 Participants
|
|
Summary of the Number of Participants With at Least One Adverse Event, With Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
Any AE to Monitor
|
63 Participants
|
59 Participants
|
|
Summary of the Number of Participants With at Least One Adverse Event, With Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
AE to Monitor: Anaphylaxis and Hypersensitivity, Any Grade
|
48 Participants
|
36 Participants
|
|
Summary of the Number of Participants With at Least One Adverse Event, With Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
AE to Monitor: Anaphylaxis and Hypersensitivity, Grade ≥3
|
0 Participants
|
0 Participants
|
|
Summary of the Number of Participants With at Least One Adverse Event, With Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
AE to Monitor: Infusion/Admin. Related Reactions Within 24 hours, Any Grade
|
62 Participants
|
55 Participants
|
|
Summary of the Number of Participants With at Least One Adverse Event, With Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
AE to Monitor: Infusion/Admin. Related Reactions Within 24 hours, Grade ≥3
|
0 Participants
|
0 Participants
|
|
Summary of the Number of Participants With at Least One Adverse Event, With Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
AE to Monitor: Rash/Skin Reactions, Any Grade
|
0 Participants
|
0 Participants
|
|
Summary of the Number of Participants With at Least One Adverse Event, With Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
AE to Monitor: Diarrhoea, Any Grade
|
17 Participants
|
9 Participants
|
|
Summary of the Number of Participants With at Least One Adverse Event, With Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
AE to Monitor: Diarrhoea, Grade ≥3
|
0 Participants
|
0 Participants
|
|
Summary of the Number of Participants With at Least One Adverse Event, With Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
AE to Monitor: Cardiac Dysfunction, Any Grade
|
0 Participants
|
0 Participants
|
|
Summary of the Number of Participants With at Least One Adverse Event, With Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
AE to Monitor: Interstitial Lung Disease, Any Grade
|
0 Participants
|
0 Participants
|
|
Summary of the Number of Participants With at Least One Adverse Event, With Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
AE to Monitor: Neutropenia/Febrile Neutropenia, Any Grade
|
0 Participants
|
1 Participants
|
|
Summary of the Number of Participants With at Least One Adverse Event, With Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
AE to Monitor: Neutropenia/Febrile Neutropenia, Grade ≥3
|
0 Participants
|
0 Participants
|
|
Summary of the Number of Participants With at Least One Adverse Event, With Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
AE to Monitor: Serious Mucositis, Any Grade
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, once between Days 20 and 35, and once between Days 56 and 63Population: Safety population: all participants who received the single dose of study treatment. The number analyzed represents all participants with available data at a given timepoint.
Echocardiography was used to assess left ventricular ejection fraction (LVEF) values. The screening LVEF assessment had to be performed within ≤28 days prior to randomization and the LVEF value must have been ≥55% to be eligible for the study.
Outcome measures
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
n=72 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
n=74 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
|---|---|---|
|
Change From Baseline Left Ventricular Ejection Fraction (LVEF) Over Time
Baseline (BL) - Value at Visit
|
61.55 Percentage points of LVEF
Standard Deviation 3.56
|
60.99 Percentage points of LVEF
Standard Deviation 3.82
|
|
Change From Baseline Left Ventricular Ejection Fraction (LVEF) Over Time
Change from BL - Day 20 to 35
|
0.10 Percentage points of LVEF
Standard Deviation 4.88
|
-0.94 Percentage points of LVEF
Standard Deviation 4.06
|
|
Change From Baseline Left Ventricular Ejection Fraction (LVEF) Over Time
Change from BL - Day 56 to 63
|
-0.87 Percentage points of LVEF
Standard Deviation 5.04
|
-0.20 Percentage points of LVEF
Standard Deviation 4.29
|
|
Change From Baseline Left Ventricular Ejection Fraction (LVEF) Over Time
Change from BL - Minimum Value at Anytime
|
-2.09 Percentage points of LVEF
Standard Deviation 4.39
|
-2.36 Percentage points of LVEF
Standard Deviation 3.84
|
|
Change From Baseline Left Ventricular Ejection Fraction (LVEF) Over Time
Change from BL - Maximum Value at Anytime
|
1.32 Percentage points of LVEF
Standard Deviation 5.01
|
1.23 Percentage points of LVEF
Standard Deviation 3.70
|
SECONDARY outcome
Timeframe: Baseline, Days 2, 7, 22, and 63Population: Safety population: all participants who received the single dose of study treatment. The number analyzed represents all participants with available data at a given timepoint.
Vital sign measurements were taken after the participant had remained resting in a semi-supine position for at least 5 minutes. The minimum and maximum values are, respectively, the smallest and largest values obtained at any point after baseline, including any repeat and unscheduled measurements.
Outcome measures
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
n=72 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
n=74 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
|---|---|---|
|
Change From Baseline Pulse Rate Over Time
Baseline (BL) - Value at Visit
|
58.24 beats per minute
Standard Deviation 9.30
|
59.30 beats per minute
Standard Deviation 10.89
|
|
Change From Baseline Pulse Rate Over Time
Change from BL at Day 2
|
7.04 beats per minute
Standard Deviation 8.51
|
6.51 beats per minute
Standard Deviation 10.86
|
|
Change From Baseline Pulse Rate Over Time
Change from BL at Day 7
|
1.80 beats per minute
Standard Deviation 8.63
|
4.34 beats per minute
Standard Deviation 11.39
|
|
Change From Baseline Pulse Rate Over Time
Change from BL at Day 22
|
5.40 beats per minute
Standard Deviation 11.52
|
5.14 beats per minute
Standard Deviation 11.91
|
|
Change From Baseline Pulse Rate Over Time
Change from BL at Day 63
|
2.47 beats per minute
Standard Deviation 8.64
|
4.16 beats per minute
Standard Deviation 10.87
|
|
Change From Baseline Pulse Rate Over Time
Change from BL - Minimum Value at Anytime
|
-2.49 beats per minute
Standard Deviation 7.67
|
-1.78 beats per minute
Standard Deviation 9.17
|
|
Change From Baseline Pulse Rate Over Time
Change from BL - Maximum Value at Anytime
|
14.79 beats per minute
Standard Deviation 15.06
|
13.19 beats per minute
Standard Deviation 12.09
|
SECONDARY outcome
Timeframe: Baseline, Days 2, 7, 22, and 63Population: Safety population: all participants who received the single dose of study treatment. The number analyzed represents all participants with available data at a given timepoint.
Vital sign measurements were taken after the participant had remained resting in a semi-supine position for at least 5 minutes. The minimum and maximum values are, respectively, the smallest and largest values obtained at any point after baseline, including any repeat and unscheduled measurements.
Outcome measures
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
n=72 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
n=74 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
|---|---|---|
|
Change From Baseline Respiratory Rate Over Time
Baseline (BL) - Value at Visit
|
15.71 breaths per minute
Standard Deviation 1.61
|
15.50 breaths per minute
Standard Deviation 1.49
|
|
Change From Baseline Respiratory Rate Over Time
Change from BL at Day 2
|
-0.22 breaths per minute
Standard Deviation 2.22
|
-0.03 breaths per minute
Standard Deviation 2.39
|
|
Change From Baseline Respiratory Rate Over Time
Change from BL at Day 7
|
0.00 breaths per minute
Standard Deviation 2.31
|
0.04 breaths per minute
Standard Deviation 2.10
|
|
Change From Baseline Respiratory Rate Over Time
Change from BL at Day 22
|
-0.34 breaths per minute
Standard Deviation 1.68
|
0.53 breaths per minute
Standard Deviation 2.04
|
|
Change From Baseline Respiratory Rate Over Time
Change from BL at Day 63
|
-0.19 breaths per minute
Standard Deviation 2.30
|
0.15 breaths per minute
Standard Deviation 2.61
|
|
Change From Baseline Respiratory Rate Over Time
Change from BL - Minimum Value at Anytime
|
-1.86 breaths per minute
Standard Deviation 1.69
|
-1.64 breaths per minute
Standard Deviation 2.00
|
|
Change From Baseline Respiratory Rate Over Time
Change from BL - Maximum Value at Anytime
|
1.44 breaths per minute
Standard Deviation 1.96
|
1.93 breaths per minute
Standard Deviation 2.08
|
SECONDARY outcome
Timeframe: Baseline, Days 2, 7, 22, and 63Population: Safety population: all participants who received the single dose of study treatment. The number analyzed represents all participants with available data at a given timepoint.
Vital sign measurements were taken after the participant had remained resting in a semi-supine position for at least 5 minutes. The minimum and maximum values are, respectively, the smallest and largest values obtained at any point after baseline, including any repeat and unscheduled measurements.
Outcome measures
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
n=72 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
n=74 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
|---|---|---|
|
Change From Baseline Systolic Blood Pressure Over Time
Baseline (BL) - Value at Visit
|
118.33 beats per minute
Standard Deviation 9.19
|
116.09 beats per minute
Standard Deviation 9.68
|
|
Change From Baseline Systolic Blood Pressure Over Time
Change from BL at Day 2
|
-1.44 beats per minute
Standard Deviation 7.90
|
0.61 beats per minute
Standard Deviation 9.02
|
|
Change From Baseline Systolic Blood Pressure Over Time
Change from BL at Day 7
|
4.55 beats per minute
Standard Deviation 7.14
|
4.99 beats per minute
Standard Deviation 9.20
|
|
Change From Baseline Systolic Blood Pressure Over Time
Change from BL at Day 22
|
3.60 beats per minute
Standard Deviation 10.76
|
5.23 beats per minute
Standard Deviation 10.70
|
|
Change From Baseline Systolic Blood Pressure Over Time
Change from BL at Day 63
|
4.70 beats per minute
Standard Deviation 9.51
|
5.53 beats per minute
Standard Deviation 9.64
|
|
Change From Baseline Systolic Blood Pressure Over Time
Change from BL - Minimum Value at Anytime
|
-4.68 beats per minute
Standard Deviation 7.97
|
-3.51 beats per minute
Standard Deviation 8.00
|
|
Change From Baseline Systolic Blood Pressure Over Time
Change from BL - Maximum Value at Anytime
|
11.17 beats per minute
Standard Deviation 9.96
|
12.78 beats per minute
Standard Deviation 11.13
|
SECONDARY outcome
Timeframe: Baseline, Days 2, 7, 22, and 63Population: Safety population: all participants who received the single dose of study treatment. The number analyzed represents all participants with available data at a given timepoint.
Vital sign measurements were taken after the participant had remained resting in a semi-supine position for at least 5 minutes. The minimum and maximum values are, respectively, the smallest and largest values obtained at any point after baseline, including any repeat and unscheduled measurements.
Outcome measures
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
n=72 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
n=74 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
|---|---|---|
|
Change From Baseline Diastolic Blood Pressure Over Time
Baseline (BL) - Value at Visit
|
70.50 beats per minute
Standard Deviation 7.55
|
70.38 beats per minute
Standard Deviation 7.20
|
|
Change From Baseline Diastolic Blood Pressure Over Time
Change from BL at Day 2
|
-1.99 beats per minute
Standard Deviation 6.86
|
-2.12 beats per minute
Standard Deviation 6.49
|
|
Change From Baseline Diastolic Blood Pressure Over Time
Change from BL at Day 7
|
3.04 beats per minute
Standard Deviation 6.82
|
2.62 beats per minute
Standard Deviation 7.04
|
|
Change From Baseline Diastolic Blood Pressure Over Time
Change from BL at Day 22
|
3.43 beats per minute
Standard Deviation 7.13
|
4.16 beats per minute
Standard Deviation 7.67
|
|
Change From Baseline Diastolic Blood Pressure Over Time
Change from BL at Day 63
|
3.96 beats per minute
Standard Deviation 7.86
|
3.64 beats per minute
Standard Deviation 8.36
|
|
Change From Baseline Diastolic Blood Pressure Over Time
Change from BL - Minimum Value at Anytime
|
-4.58 beats per minute
Standard Deviation 7.16
|
-4.30 beats per minute
Standard Deviation 6.13
|
|
Change From Baseline Diastolic Blood Pressure Over Time
Change from BL - Maximum Value at Anytime
|
8.13 beats per minute
Standard Deviation 7.11
|
8.65 beats per minute
Standard Deviation 7.13
|
SECONDARY outcome
Timeframe: At Baseline (predose) and Post-Baseline (postdose Days 2, 7, 22, and 63)Population: Safety population: all participants who received the single dose of study treatment. The number analyzed represents all participants with available data at baseline and at least at one post-baseline timepoint.
For safety monitoring purposes, the investigator was required to review, sign, and date all electrocardiogram (ECG) reports. Any morphologic waveform changes or other ECG abnormalities were documented by the investigator. Post-baseline, if all examinations were normal, then it was categorized as 'Normal'. If any abnormality was reported, then it was categorized as 'Abnormal'. 'Clinically significant' is a subset of the abnormal category.
Outcome measures
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
n=72 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
n=74 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
|---|---|---|
|
Number of Participants With Normal or Abnormal Electrocardiogram Results at Baseline and Post-Baseline Anytime, as Determined by the Investigator
Baseline: Normal ECG
|
48 Participants
|
42 Participants
|
|
Number of Participants With Normal or Abnormal Electrocardiogram Results at Baseline and Post-Baseline Anytime, as Determined by the Investigator
Baseline: Abnormal ECG
|
24 Participants
|
32 Participants
|
|
Number of Participants With Normal or Abnormal Electrocardiogram Results at Baseline and Post-Baseline Anytime, as Determined by the Investigator
Baseline: Abnormal and Clinically Significant ECG
|
0 Participants
|
0 Participants
|
|
Number of Participants With Normal or Abnormal Electrocardiogram Results at Baseline and Post-Baseline Anytime, as Determined by the Investigator
Post-Baseline: Normal ECG
|
42 Participants
|
35 Participants
|
|
Number of Participants With Normal or Abnormal Electrocardiogram Results at Baseline and Post-Baseline Anytime, as Determined by the Investigator
Post-Baseline: Abnormal ECG
|
30 Participants
|
39 Participants
|
|
Number of Participants With Normal or Abnormal Electrocardiogram Results at Baseline and Post-Baseline Anytime, as Determined by the Investigator
Post-Baseline: Abnormal and Clinically Significant ECG
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline until Day 63Population: Safety population: all participants who received the single dose of study treatment.
Not every laboratory abnormality qualified as an adverse event. A laboratory test result had to be reported as an adverse event if it met any of the following criteria: was accompanied by clinical symptoms; resulted in a change in study treatment; resulted in a medical intervention or a change in concomitant therapy; was clinically significant in the investigator's judgment.
Outcome measures
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
n=72 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
n=74 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
|---|---|---|
|
Number of Participants With Adverse Events Based on Laboratory Test Abnormalities
Alanine aminotransferase increased
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events Based on Laboratory Test Abnormalities
Hepatic enzyme increased
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events Based on Laboratory Test Abnormalities
Transaminases increased
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Based on Laboratory Test Abnormalities
Anaemia
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events Based on Laboratory Test Abnormalities
Neutropenia
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1: pre-dose, during drug injection, after drug injection while removing the device or syringe, and 2 hours after drug injectionPopulation: Safety population: all participants who received the single dose of study treatment. The number analyzed indicates all participants who responded to the questionnaire at a given timepoint.
Pain intensity scores were assessed by the participants using the Visual Analog Scale (VAS) on a line measuring between 0 mm ('no pain') and 100 mm ('unbearable pain'). The VAS was completed in both study arms to assess the level of pain experienced by the participant in relation to the injection of Phesgo. On Day 1, pain assessments were performed prior to, during, and immediately after injection of Phesgo when the needle or device was removed, and 2 hours after injection.
Outcome measures
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
n=72 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
n=74 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
|---|---|---|
|
Pain Score at the Injection Site, Assessed by the Participant Using the 100-millimetre (mm) Visual Analog Scale
Immediately Post-Injection
|
8.56 score on a scale
Standard Deviation 12.62
|
5.04 score on a scale
Standard Deviation 7.82
|
|
Pain Score at the Injection Site, Assessed by the Participant Using the 100-millimetre (mm) Visual Analog Scale
Prior to Injection
|
0.68 score on a scale
Standard Deviation 1.45
|
0.50 score on a scale
Standard Deviation 1.52
|
|
Pain Score at the Injection Site, Assessed by the Participant Using the 100-millimetre (mm) Visual Analog Scale
During Injection
|
6.85 score on a scale
Standard Deviation 8.79
|
8.95 score on a scale
Standard Deviation 10.28
|
|
Pain Score at the Injection Site, Assessed by the Participant Using the 100-millimetre (mm) Visual Analog Scale
2 Hours After Injection
|
3.11 score on a scale
Standard Deviation 5.29
|
1.62 score on a scale
Standard Deviation 5.97
|
SECONDARY outcome
Timeframe: Prior to injection and after injection on Day 1Population: The analysis only included healthcare professionals that treated participants in Arm 2: PH FDC SC Using OBDS who received the single dose of study treatment.
Skin irritation and sensitization reactions at the site of injection caused by the adhesion of the OBDS to the skin were assessed by the study staff using the device monitoring questionnaire in the eCRF. Dermal effects were reported on a scale from 0 (no evidence or irritation) to 7 (strong reaction spreading beyond test site). Other effects were reported on a separate scale from 0 (no evidence) to 7 (small petechial eruptions or scabs).
Outcome measures
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
n=74 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
|---|---|---|
|
Number of Participants With Skin Irritation and Sensitization Reactions at the Injection Site, as Reported by Investigators in the Device Monitoring Questionnaire
Prior to Injection, Dermal Effects: 0 - No Evidence or Irritation
|
74 Participants
|
—
|
|
Number of Participants With Skin Irritation and Sensitization Reactions at the Injection Site, as Reported by Investigators in the Device Monitoring Questionnaire
After Injection, Dermal Effects: 0 - No Evidence or Irritation
|
62 Participants
|
—
|
|
Number of Participants With Skin Irritation and Sensitization Reactions at the Injection Site, as Reported by Investigators in the Device Monitoring Questionnaire
After Injection, Dermal Effects: 1 - Minimal Erythema
|
12 Participants
|
—
|
|
Number of Participants With Skin Irritation and Sensitization Reactions at the Injection Site, as Reported by Investigators in the Device Monitoring Questionnaire
Prior to Injection, Other Effects: 0 - No Evidence or Irritation
|
74 Participants
|
—
|
|
Number of Participants With Skin Irritation and Sensitization Reactions at the Injection Site, as Reported by Investigators in the Device Monitoring Questionnaire
After Injection, Other Effects: 0 - No Evidence or Irritation
|
73 Participants
|
—
|
|
Number of Participants With Skin Irritation and Sensitization Reactions at the Injection Site, as Reported by Investigators in the Device Monitoring Questionnaire
After Injection, Other Effects: 1 - Slight Glazed Appearance
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: The analysis only included participants in Arm 2: PH FDC SC Using OBDS who received the single dose of study treatment.
Participants in the Phesgo OBDS arm completed the device monitoring questionnaire the injection with the OBDS. The questionnaire assessed the following criteria: ease of device attachment, attachment during the injection, ease of device removal, and overall wearing comfort, which were each rated on a three-point scale as "Good", "Acceptable", or "Poor".
Outcome measures
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
n=74 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
|---|---|---|
|
Number of Participants by Their Ratings of the Comfort of Wearing the On-Body Delivery System Device, as Reported in the Device Monitoring Questionnaire
Ease of Device Attachment · Good
|
74 Participants
|
—
|
|
Number of Participants by Their Ratings of the Comfort of Wearing the On-Body Delivery System Device, as Reported in the Device Monitoring Questionnaire
Ease of Device Attachment · Acceptable
|
0 Participants
|
—
|
|
Number of Participants by Their Ratings of the Comfort of Wearing the On-Body Delivery System Device, as Reported in the Device Monitoring Questionnaire
Ease of Device Attachment · Poor
|
0 Participants
|
—
|
|
Number of Participants by Their Ratings of the Comfort of Wearing the On-Body Delivery System Device, as Reported in the Device Monitoring Questionnaire
Attachment of Device During Injection · Good
|
73 Participants
|
—
|
|
Number of Participants by Their Ratings of the Comfort of Wearing the On-Body Delivery System Device, as Reported in the Device Monitoring Questionnaire
Attachment of Device During Injection · Acceptable
|
1 Participants
|
—
|
|
Number of Participants by Their Ratings of the Comfort of Wearing the On-Body Delivery System Device, as Reported in the Device Monitoring Questionnaire
Attachment of Device During Injection · Poor
|
0 Participants
|
—
|
|
Number of Participants by Their Ratings of the Comfort of Wearing the On-Body Delivery System Device, as Reported in the Device Monitoring Questionnaire
Ease of Device Removal · Good
|
67 Participants
|
—
|
|
Number of Participants by Their Ratings of the Comfort of Wearing the On-Body Delivery System Device, as Reported in the Device Monitoring Questionnaire
Ease of Device Removal · Acceptable
|
6 Participants
|
—
|
|
Number of Participants by Their Ratings of the Comfort of Wearing the On-Body Delivery System Device, as Reported in the Device Monitoring Questionnaire
Ease of Device Removal · Poor
|
1 Participants
|
—
|
|
Number of Participants by Their Ratings of the Comfort of Wearing the On-Body Delivery System Device, as Reported in the Device Monitoring Questionnaire
Overall Wearing Comfort · Good
|
67 Participants
|
—
|
|
Number of Participants by Their Ratings of the Comfort of Wearing the On-Body Delivery System Device, as Reported in the Device Monitoring Questionnaire
Overall Wearing Comfort · Acceptable
|
7 Participants
|
—
|
|
Number of Participants by Their Ratings of the Comfort of Wearing the On-Body Delivery System Device, as Reported in the Device Monitoring Questionnaire
Overall Wearing Comfort · Poor
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: The analysis only included healthcare professionals that treated participants in Arm 2: PH FDC SC Using OBDS who received the single dose of study treatment.
Details of performance and ease of use of the on-body delivery system (OBDS) were reported by site staff, using the device monitoring questionnaire in the eCRF. This included the following: Preparation of the injection site, Preparation of the OBDS, Prefilled cartridge inspection before insertion in the OBDS, Positioning and attachment of the OBDS on the anterior thigh, Drug delivery, and OBDS administration failures.
Outcome measures
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
n=74 Participants
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
|---|---|---|
|
Number of Healthcare Professionals by Their Responses to the Device Monitoring Questionnaire Regarding Use of the On-Body Delivery System Device
Was the Injection Site Prepared as per Protocol? · Yes
|
74 Participants
|
—
|
|
Number of Healthcare Professionals by Their Responses to the Device Monitoring Questionnaire Regarding Use of the On-Body Delivery System Device
Was the Injection Site Prepared as per Protocol? · No
|
0 Participants
|
—
|
|
Number of Healthcare Professionals by Their Responses to the Device Monitoring Questionnaire Regarding Use of the On-Body Delivery System Device
Was the Injection Device Prepared as per Protocol? · Yes
|
74 Participants
|
—
|
|
Number of Healthcare Professionals by Their Responses to the Device Monitoring Questionnaire Regarding Use of the On-Body Delivery System Device
Was the Injection Device Prepared as per Protocol? · No
|
0 Participants
|
—
|
|
Number of Healthcare Professionals by Their Responses to the Device Monitoring Questionnaire Regarding Use of the On-Body Delivery System Device
Was the Body Positioning of the Device Compliant with Protocol? · Yes
|
74 Participants
|
—
|
|
Number of Healthcare Professionals by Their Responses to the Device Monitoring Questionnaire Regarding Use of the On-Body Delivery System Device
Was the Body Positioning of the Device Compliant with Protocol? · No
|
0 Participants
|
—
|
|
Number of Healthcare Professionals by Their Responses to the Device Monitoring Questionnaire Regarding Use of the On-Body Delivery System Device
Were There any Findings from the Cartridge Inspection? · Yes
|
0 Participants
|
—
|
|
Number of Healthcare Professionals by Their Responses to the Device Monitoring Questionnaire Regarding Use of the On-Body Delivery System Device
Were There any Findings from the Cartridge Inspection? · No
|
74 Participants
|
—
|
|
Number of Healthcare Professionals by Their Responses to the Device Monitoring Questionnaire Regarding Use of the On-Body Delivery System Device
Were There any Issues with the Attachment of the Device to the Body? · Yes
|
0 Participants
|
—
|
|
Number of Healthcare Professionals by Their Responses to the Device Monitoring Questionnaire Regarding Use of the On-Body Delivery System Device
Were There any Issues with the Attachment of the Device to the Body? · No
|
74 Participants
|
—
|
|
Number of Healthcare Professionals by Their Responses to the Device Monitoring Questionnaire Regarding Use of the On-Body Delivery System Device
Did you Experience any Device Failure? · Yes
|
0 Participants
|
—
|
|
Number of Healthcare Professionals by Their Responses to the Device Monitoring Questionnaire Regarding Use of the On-Body Delivery System Device
Did you Experience any Device Failure? · No
|
74 Participants
|
—
|
|
Number of Healthcare Professionals by Their Responses to the Device Monitoring Questionnaire Regarding Use of the On-Body Delivery System Device
Has Needle Been Inserted? · Yes
|
74 Participants
|
—
|
|
Number of Healthcare Professionals by Their Responses to the Device Monitoring Questionnaire Regarding Use of the On-Body Delivery System Device
Has Needle Been Inserted? · No
|
0 Participants
|
—
|
|
Number of Healthcare Professionals by Their Responses to the Device Monitoring Questionnaire Regarding Use of the On-Body Delivery System Device
Has Another Device Been Used? · Yes
|
0 Participants
|
—
|
|
Number of Healthcare Professionals by Their Responses to the Device Monitoring Questionnaire Regarding Use of the On-Body Delivery System Device
Has Another Device Been Used? · No
|
74 Participants
|
—
|
Adverse Events
Arm 1: PH FDC SC Using a Handheld Syringe
Serious events: 1 serious events
Other events: 70 other events
Deaths: 0 deaths
Arm 2: PH FDC SC Using the OBDS
Serious events: 0 serious events
Other events: 69 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
n=72 participants at risk
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
n=74 participants at risk
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
|---|---|---|
|
Injury, poisoning and procedural complications
Foot fracture
|
1.4%
1/72 • Number of events 1 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
0.00%
0/74 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.4%
1/72 • Number of events 1 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
0.00%
0/74 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.4%
1/72 • Number of events 1 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
0.00%
0/74 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
Other adverse events
| Measure |
Arm 1: PH FDC SC Using a Handheld Syringe
n=72 participants at risk
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.
|
Arm 2: PH FDC SC Using the OBDS
n=74 participants at risk
A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) was administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).
|
|---|---|---|
|
Injury, poisoning and procedural complications
Injection related reaction
|
66.7%
48/72 • Number of events 48 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
48.6%
36/74 • Number of events 36 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
|
General disorders
Injection site reaction
|
23.6%
17/72 • Number of events 17 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
24.3%
18/74 • Number of events 19 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
|
General disorders
Fatigue
|
5.6%
4/72 • Number of events 4 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
8.1%
6/74 • Number of events 6 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
|
General disorders
Injection site bruising
|
4.2%
3/72 • Number of events 3 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
6.8%
5/74 • Number of events 5 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
12/72 • Number of events 13 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
20.3%
15/74 • Number of events 15 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
|
Infections and infestations
COVID-19
|
8.3%
6/72 • Number of events 6 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
5.4%
4/74 • Number of events 4 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
|
Gastrointestinal disorders
Diarrhoea
|
23.6%
17/72 • Number of events 18 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
12.2%
9/74 • Number of events 9 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
|
Gastrointestinal disorders
Nausea
|
1.4%
1/72 • Number of events 1 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
6.8%
5/74 • Number of events 5 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
|
Nervous system disorders
Headache
|
25.0%
18/72 • Number of events 21 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
23.0%
17/74 • Number of events 19 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
9.7%
7/72 • Number of events 8 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
10.8%
8/74 • Number of events 8 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
|
Skin and subcutaneous tissue disorders
Acne
|
6.9%
5/72 • Number of events 5 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
5.4%
4/74 • Number of events 4 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.2%
3/72 • Number of events 3 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
6.8%
5/74 • Number of events 5 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.9%
5/72 • Number of events 9 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
6.8%
5/74 • Number of events 5 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.9%
5/72 • Number of events 5 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
1.4%
1/74 • Number of events 1 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.4%
1/72 • Number of events 1 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
5.4%
4/74 • Number of events 4 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
|
Immune system disorders
Seasonal allergy
|
8.3%
6/72 • Number of events 6 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
5.4%
4/74 • Number of events 4 • From study drug dose until safety follow-up visit (up to 7 months)
All adverse events were to be reported until Day 63 after the single dose of study drug. After this point only death, serious adverse events, adverse events, or adverse event of special interest that were related to study drug were reported until the 7-month safety follow-up visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER