Trial Outcomes & Findings for A Study to Assess the Tolerability, Safety, and Pharmacokinetics of Subcutaneous Immune Globulin Infusion 10% (Human) With Recombinant Human Hyaluronidase (HYQVIA/HyQvia) With Ramp-up and No Ramp-up Dosing in Healthy Adult Participants (NCT NCT04578535)
NCT ID: NCT04578535
Last Updated: 2023-12-14
Results Overview
A tolerability event was considered to have occurred if an infusion was tolerable. An infusion was considered tolerable if the infusion rate was not reduced, or the infusion was not interrupted or stopped, due to an adverse event (AE) related to HYQVIA infusion. Tolerability was measured in terms of the number of participants for which the infusions was tolerable. Number of participants who tolerated all initiated HYQVIA Infusion were reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
51 participants
Primary outcome timeframe
From start of the study drug administration up to Week 9
Results posted on
2023-12-14
Participant Flow
A total of 51 participants were enrolled in the study, 33 participants into the Ramp-Up dosing group (treatment arms \[TA\] 1, 2, 4, and 5) and 18 participants into the No Ramp-Up dosing group (TA 3 and TA 6).
This study was conducted in 2 parts with a target dose level (TDL) of either 0.4 grams/kilograms (g/kg) (Part 1) or 1.0 g/kg (Part 2) through dose Ramp-Up or No Ramp-Up (direct administration of TDL). Each study part consisted of 3 TA (Part 1: TA 1 to 3 and Part 2: TA 4 to 6. TA 1 and 4 followed Schedule A (1/4 of the TDL to the full TDL) and TA 2 and 5 followed Schedule B (1/2 of TDL to full TDL) and TA 3 and 6 followed no ramp up (Schedule C).
Participant milestones
| Measure |
Part 1 Schedule A: TA 1 (Low TDL HYQVIA)
Participants received a subcutaneous (SC) infusion of HYQVIA 0.1 g/kg (1/4 of TDL) on Day 1 and 8, 0.2 g/kg (1/2 of TDL) on Day 15, 0.3 g/kg (3/4 of TDL) on Day 29 followed by 0.4 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner.
|
Part 2 Schedule A: TA 4 (High TDL HYQVIA)
Participants received a SC infusion of HYQVIA 0.25 g/kg (1/4 of TDL) on Day 1 and 8, 0.5 g/kg (1/2 of TDL) on Day 15, 0.75 g/kg (3/4 of TDL) on Day 29 followed by 1.0 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner.
|
Part 1 Schedule B: TA 2 (Low TDL HYQVIA)
Participants received a SC infusion of HYQVIA 0.2 g/kg (1/2 of TDL) on Day 1 and 15, followed by 0.4 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner.
|
Part 2 Schedule B: TA 5 (High TDL HYQVIA)
Participants received a SC infusion of HYQVIA 0.5 g/kg (1/2 of TDL) on Day 1 and 15, followed by 1.0 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner.
|
Part 1 Schedule C: TA 3 (Low TDL HYQVIA)
Participants received a SC infusion of HYQVIA 0.4 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner.
|
Part 2 Schedule C: TA 6 (High TDL HYQVIA)
Participants received a SC infusion of HYQVIA 1.0 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
9
|
8
|
10
|
|
Overall Study
COMPLETED
|
6
|
8
|
8
|
7
|
6
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
2
|
2
|
7
|
Reasons for withdrawal
| Measure |
Part 1 Schedule A: TA 1 (Low TDL HYQVIA)
Participants received a subcutaneous (SC) infusion of HYQVIA 0.1 g/kg (1/4 of TDL) on Day 1 and 8, 0.2 g/kg (1/2 of TDL) on Day 15, 0.3 g/kg (3/4 of TDL) on Day 29 followed by 0.4 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner.
|
Part 2 Schedule A: TA 4 (High TDL HYQVIA)
Participants received a SC infusion of HYQVIA 0.25 g/kg (1/4 of TDL) on Day 1 and 8, 0.5 g/kg (1/2 of TDL) on Day 15, 0.75 g/kg (3/4 of TDL) on Day 29 followed by 1.0 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner.
|
Part 1 Schedule B: TA 2 (Low TDL HYQVIA)
Participants received a SC infusion of HYQVIA 0.2 g/kg (1/2 of TDL) on Day 1 and 15, followed by 0.4 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner.
|
Part 2 Schedule B: TA 5 (High TDL HYQVIA)
Participants received a SC infusion of HYQVIA 0.5 g/kg (1/2 of TDL) on Day 1 and 15, followed by 1.0 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner.
|
Part 1 Schedule C: TA 3 (Low TDL HYQVIA)
Participants received a SC infusion of HYQVIA 0.4 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner.
|
Part 2 Schedule C: TA 6 (High TDL HYQVIA)
Participants received a SC infusion of HYQVIA 1.0 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner.
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
1
|
0
|
2
|
|
Overall Study
Pregnancy
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
1
|
5
|
|
Overall Study
Non-Compliance with Study Procedures
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Assess the Tolerability, Safety, and Pharmacokinetics of Subcutaneous Immune Globulin Infusion 10% (Human) With Recombinant Human Hyaluronidase (HYQVIA/HyQvia) With Ramp-up and No Ramp-up Dosing in Healthy Adult Participants
Baseline characteristics by cohort
| Measure |
Part 1 Schedule A: TA 1 (Low TDL HYQVIA)
n=8 Participants
Participants received a SC infusion of HYQVIA 0.1 g/kg (1/4 of TDL) on Day 1 and 8, 0.2 g/kg (1/2 of TDL) on Day 15, 0.3 g/kg (3/4 of TDL) on Day 29 followed by 0.4 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner.
|
Part 2 Schedule A: TA 4 (High TDL HYQVIA)
n=8 Participants
Participants received a SC infusion of HYQVIA 0.25 g/kg (1/4 of TDL) on Day 1 and 8, 0.5 g/kg (1/2 of TDL) on Day 15, 0.75 g/kg (3/4 of TDL) on Day 29 followed by 1.0 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner.
|
Part 1 Schedule B: TA 2 (Low TDL HYQVIA)
n=8 Participants
Participants received a SC infusion of HYQVIA 0.2 g/kg (1/2 of TDL) on Day 1 and 15, followed by 0.4 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner.
|
Part 2 Schedule B: TA 5 (High TDL HYQVIA)
n=9 Participants
Participants received a SC infusion of HYQVIA 0.5 g/kg (1/2 of TDL) on Day 1 and 15, followed by 1.0 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner.
|
Part 1 Schedule C: TA 3 (Low TDL HYQVIA)
n=8 Participants
Participants received a SC infusion of HYQVIA 0.4 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner.
|
Part 2 Schedule C: TA 6 (High TDL HYQVIA)
n=10 Participants
Participants received a SC infusion of HYQVIA 1.0 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
28.9 years
STANDARD_DEVIATION 8.04 • n=5 Participants
|
34.4 years
STANDARD_DEVIATION 6.44 • n=7 Participants
|
40.4 years
STANDARD_DEVIATION 5.01 • n=5 Participants
|
36.4 years
STANDARD_DEVIATION 7.88 • n=4 Participants
|
36.8 years
STANDARD_DEVIATION 8.58 • n=21 Participants
|
34.0 years
STANDARD_DEVIATION 10.07 • n=10 Participants
|
35.1 years
STANDARD_DEVIATION 8.28 • n=115 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
29 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
22 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
47 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
34 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: From start of the study drug administration up to Week 9Population: The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
A tolerability event was considered to have occurred if an infusion was tolerable. An infusion was considered tolerable if the infusion rate was not reduced, or the infusion was not interrupted or stopped, due to an adverse event (AE) related to HYQVIA infusion. Tolerability was measured in terms of the number of participants for which the infusions was tolerable. Number of participants who tolerated all initiated HYQVIA Infusion were reported.
Outcome measures
| Measure |
Part 1 Schedule A: TA 1 (Low TDL HYQVIA)
n=8 Participants
Participants received a SC infusion of HYQVIA 0.1 g/kg (1/4 of TDL) on Day 1 and 8, 0.2 g/kg (1/2 of TDL) on Day 15, 0.3 g/kg (3/4 of TDL) on Day 29 followed by 0.4 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner.
|
Part 2 Schedule A: TA 4 (High TDL HYQVIA)
n=8 Participants
Participants received a SC infusion of HYQVIA 0.25 g/kg (1/4 of TDL) on Day 1 and 8, 0.5 g/kg (1/2 of TDL) on Day 15, 0.75 g/kg (3/4 of TDL) on Day 29 followed by 1.0 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner.
|
Part 1 Schedule B: TA 2 (Low TDL HYQVIA)
n=8 Participants
Participants received a SC infusion of HYQVIA 0.2 g/kg (1/2 of TDL) on Day 1 and 15, followed by 0.4 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner.
|
Part 2 Schedule B: TA 5 (High TDL HYQVIA)
n=9 Participants
Participants received a SC infusion of HYQVIA 0.5 g/kg (1/2 of TDL) on Day 1 and 15, followed by 1.0 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner.
|
Part 1 Schedule C: TA 3 (Low TDL HYQVIA)
n=8 Participants
Participants received a SC infusion of HYQVIA 0.4 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner.
|
Part 2 Schedule C: TA 6 (High TDL HYQVIA)
n=10 Participants
Participants received a SC infusion of HYQVIA 1.0 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Tolerated All Initiated HYQVIA Infusion
|
7 Participants
|
8 Participants
|
8 Participants
|
9 Participants
|
8 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: From start of the study drug administration up to Week 25Population: The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
Treatment-emergent adverse events (TEAE) were defined as any event not present prior to the initiation of the treatments or any event already present that worsened in either intensity or frequency following exposure to the treatments. Number of participants with TEAEs was reported.
Outcome measures
| Measure |
Part 1 Schedule A: TA 1 (Low TDL HYQVIA)
n=8 Participants
Participants received a SC infusion of HYQVIA 0.1 g/kg (1/4 of TDL) on Day 1 and 8, 0.2 g/kg (1/2 of TDL) on Day 15, 0.3 g/kg (3/4 of TDL) on Day 29 followed by 0.4 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner.
|
Part 2 Schedule A: TA 4 (High TDL HYQVIA)
n=8 Participants
Participants received a SC infusion of HYQVIA 0.25 g/kg (1/4 of TDL) on Day 1 and 8, 0.5 g/kg (1/2 of TDL) on Day 15, 0.75 g/kg (3/4 of TDL) on Day 29 followed by 1.0 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner.
|
Part 1 Schedule B: TA 2 (Low TDL HYQVIA)
n=8 Participants
Participants received a SC infusion of HYQVIA 0.2 g/kg (1/2 of TDL) on Day 1 and 15, followed by 0.4 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner.
|
Part 2 Schedule B: TA 5 (High TDL HYQVIA)
n=9 Participants
Participants received a SC infusion of HYQVIA 0.5 g/kg (1/2 of TDL) on Day 1 and 15, followed by 1.0 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner.
|
Part 1 Schedule C: TA 3 (Low TDL HYQVIA)
n=8 Participants
Participants received a SC infusion of HYQVIA 0.4 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner.
|
Part 2 Schedule C: TA 6 (High TDL HYQVIA)
n=10 Participants
Participants received a SC infusion of HYQVIA 1.0 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
8 Participants
|
8 Participants
|
8 Participants
|
9 Participants
|
8 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: From start of the study drug administration up to Week 25Population: The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
Binding antibodies are responsible for binding to a pathogen and alerting the immune system to its presence so white blood cells can be sent to destroy it. The antibody level (titer) in the blood tells health care provider whether or not participant been exposed to an antigen, or something that the body thinks is foreign. A neutralizing antibody (NAb) is an antibody that is responsible for defending cells from pathogens, which are organisms that cause disease. The number of participants who developed binding and neutralizing antibodies to rHuPH20 were reported.
Outcome measures
| Measure |
Part 1 Schedule A: TA 1 (Low TDL HYQVIA)
n=8 Participants
Participants received a SC infusion of HYQVIA 0.1 g/kg (1/4 of TDL) on Day 1 and 8, 0.2 g/kg (1/2 of TDL) on Day 15, 0.3 g/kg (3/4 of TDL) on Day 29 followed by 0.4 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner.
|
Part 2 Schedule A: TA 4 (High TDL HYQVIA)
n=8 Participants
Participants received a SC infusion of HYQVIA 0.25 g/kg (1/4 of TDL) on Day 1 and 8, 0.5 g/kg (1/2 of TDL) on Day 15, 0.75 g/kg (3/4 of TDL) on Day 29 followed by 1.0 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner.
|
Part 1 Schedule B: TA 2 (Low TDL HYQVIA)
n=8 Participants
Participants received a SC infusion of HYQVIA 0.2 g/kg (1/2 of TDL) on Day 1 and 15, followed by 0.4 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner.
|
Part 2 Schedule B: TA 5 (High TDL HYQVIA)
n=9 Participants
Participants received a SC infusion of HYQVIA 0.5 g/kg (1/2 of TDL) on Day 1 and 15, followed by 1.0 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner.
|
Part 1 Schedule C: TA 3 (Low TDL HYQVIA)
n=8 Participants
Participants received a SC infusion of HYQVIA 0.4 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner.
|
Part 2 Schedule C: TA 6 (High TDL HYQVIA)
n=10 Participants
Participants received a SC infusion of HYQVIA 1.0 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Developed Binding and Neutralizing Antibodies to Recombinant Human Hyaluronidase PH20 (rHuPH20)
Binding ADA (Anti-Drug Antibodies)
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Who Developed Binding and Neutralizing Antibodies to Recombinant Human Hyaluronidase PH20 (rHuPH20)
Neutralizing ADA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1), and 48, 96, 144 and 192 hours post-dose for all treatment arms; 360 hours post-dose for treatment arms 2 and 5; 360 and 696 hours post-dose for treatment arms 3 and 6Population: PK Set included all enrolled participants received at least 1 dose of HYQVIA and had at least 1 evaluable post-dose serum concentration for total IgG or IgG subclasses. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number analyzed" signifies those participants who were evaluable at the specified categories.
Tmax was a measure of the time to reach the maximum concentration in the plasma after the drug dose. Summarized baseline corrected data was reported.
Outcome measures
| Measure |
Part 1 Schedule A: TA 1 (Low TDL HYQVIA)
n=5 Participants
Participants received a SC infusion of HYQVIA 0.1 g/kg (1/4 of TDL) on Day 1 and 8, 0.2 g/kg (1/2 of TDL) on Day 15, 0.3 g/kg (3/4 of TDL) on Day 29 followed by 0.4 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner.
|
Part 2 Schedule A: TA 4 (High TDL HYQVIA)
n=8 Participants
Participants received a SC infusion of HYQVIA 0.25 g/kg (1/4 of TDL) on Day 1 and 8, 0.5 g/kg (1/2 of TDL) on Day 15, 0.75 g/kg (3/4 of TDL) on Day 29 followed by 1.0 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner.
|
Part 1 Schedule B: TA 2 (Low TDL HYQVIA)
n=8 Participants
Participants received a SC infusion of HYQVIA 0.2 g/kg (1/2 of TDL) on Day 1 and 15, followed by 0.4 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner.
|
Part 2 Schedule B: TA 5 (High TDL HYQVIA)
n=9 Participants
Participants received a SC infusion of HYQVIA 0.5 g/kg (1/2 of TDL) on Day 1 and 15, followed by 1.0 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner.
|
Part 1 Schedule C: TA 3 (Low TDL HYQVIA)
n=9 Participants
Participants received a SC infusion of HYQVIA 0.4 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner.
|
Part 2 Schedule C: TA 6 (High TDL HYQVIA)
n=10 Participants
Participants received a SC infusion of HYQVIA 1.0 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner.
|
|---|---|---|---|---|---|---|
|
Time of Maximum Observed Serum Concentration (Tmax) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)
Total IgG
|
5.0 days
Interval 2.0 to 8.0
|
4.0 days
Interval 2.0 to 8.0
|
8.0 days
Interval 6.0 to 16.0
|
6.0 days
Interval 4.0 to 16.1
|
4.0 days
Interval 4.0 to 15.0
|
6.0 days
Interval 4.0 to 8.0
|
|
Time of Maximum Observed Serum Concentration (Tmax) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)
Baseline corrected IgG1
|
5.0 days
Interval 4.0 to 6.0
|
5.0 days
Interval 4.0 to 8.0
|
7.0 days
Interval 4.0 to 15.0
|
7.0 days
Interval 6.0 to 8.0
|
6.0 days
Interval 6.0 to 8.0
|
6.0 days
Interval 4.0 to 8.0
|
|
Time of Maximum Observed Serum Concentration (Tmax) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)
Baseline corrected IgG2
|
6.0 days
Interval 2.0 to 8.0
|
7.0 days
Interval 2.0 to 8.0
|
8.0 days
Interval 4.0 to 15.0
|
6.0 days
Interval 4.0 to 8.0
|
7.0 days
Interval 4.0 to 16.1
|
7.0 days
Interval 4.0 to 15.0
|
|
Time of Maximum Observed Serum Concentration (Tmax) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)
Baseline corrected IgG3
|
5.0 days
Interval 4.0 to 6.0
|
8.0 days
Interval 6.0 to 16.0
|
8.0 days
Interval 4.0 to 15.0
|
4.0 days
Interval 4.0 to 8.0
|
7.0 days
Interval 2.0 to 16.1
|
5.0 days
Interval 4.0 to 8.0
|
|
Time of Maximum Observed Serum Concentration (Tmax) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)
Baseline corrected IgG4
|
4.0 days
Interval 4.0 to 4.0
|
8.0 days
Interval 2.0 to 8.0
|
8.0 days
Interval 4.0 to 15.0
|
8.0 days
Interval 4.0 to 8.0
|
7.0 days
Interval 4.0 to 8.0
|
6.0 days
Interval 4.0 to 8.0
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1), and 48, 96, 144 and 192 hours post-dose for all treatment arms; 360 hours post-dose for treatment arms 2 and 5; 360 and 696 hours post-dose for treatment arms 3 and 6Population: PK Set included all enrolled participants received at least 1 dose of HYQVIA and had at least 1 evaluable post-dose serum concentration for total IgG or IgG subclasses. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number analyzed" signifies those participants who were evaluable at the specified categories.
Cmax was a measure of the maximum amount of drug in the serum after the dose is given. Summarized baseline corrected data was reported.
Outcome measures
| Measure |
Part 1 Schedule A: TA 1 (Low TDL HYQVIA)
n=5 Participants
Participants received a SC infusion of HYQVIA 0.1 g/kg (1/4 of TDL) on Day 1 and 8, 0.2 g/kg (1/2 of TDL) on Day 15, 0.3 g/kg (3/4 of TDL) on Day 29 followed by 0.4 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner.
|
Part 2 Schedule A: TA 4 (High TDL HYQVIA)
n=8 Participants
Participants received a SC infusion of HYQVIA 0.25 g/kg (1/4 of TDL) on Day 1 and 8, 0.5 g/kg (1/2 of TDL) on Day 15, 0.75 g/kg (3/4 of TDL) on Day 29 followed by 1.0 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner.
|
Part 1 Schedule B: TA 2 (Low TDL HYQVIA)
n=8 Participants
Participants received a SC infusion of HYQVIA 0.2 g/kg (1/2 of TDL) on Day 1 and 15, followed by 0.4 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner.
|
Part 2 Schedule B: TA 5 (High TDL HYQVIA)
n=9 Participants
Participants received a SC infusion of HYQVIA 0.5 g/kg (1/2 of TDL) on Day 1 and 15, followed by 1.0 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner.
|
Part 1 Schedule C: TA 3 (Low TDL HYQVIA)
n=9 Participants
Participants received a SC infusion of HYQVIA 0.4 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner.
|
Part 2 Schedule C: TA 6 (High TDL HYQVIA)
n=10 Participants
Participants received a SC infusion of HYQVIA 1.0 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner.
|
|---|---|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) Sampled During a Dosing Interval of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)
Baseline corrected IgG4
|
0.02 grams per liter (g/L)
|
0.08 grams per liter (g/L)
Geometric Coefficient of Variation 19.0
|
0.12 grams per liter (g/L)
Geometric Coefficient of Variation 46.8
|
0.13 grams per liter (g/L)
Geometric Coefficient of Variation 182.8
|
0.18 grams per liter (g/L)
Geometric Coefficient of Variation 32.7
|
0.29 grams per liter (g/L)
Geometric Coefficient of Variation 25.5
|
|
Maximum Observed Serum Concentration (Cmax) Sampled During a Dosing Interval of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)
Total IgG
|
2.70 grams per liter (g/L)
Geometric Coefficient of Variation 116.8
|
3.17 grams per liter (g/L)
Geometric Coefficient of Variation 66.8
|
3.10 grams per liter (g/L)
Geometric Coefficient of Variation 37.1
|
5.71 grams per liter (g/L)
Geometric Coefficient of Variation 41.0
|
5.34 grams per liter (g/L)
Geometric Coefficient of Variation 51.9
|
12.75 grams per liter (g/L)
Geometric Coefficient of Variation 16.2
|
|
Maximum Observed Serum Concentration (Cmax) Sampled During a Dosing Interval of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)
Baseline corrected IgG1
|
0.38 grams per liter (g/L)
Geometric Coefficient of Variation 58.5
|
1.51 grams per liter (g/L)
Geometric Coefficient of Variation 43.6
|
2.08 grams per liter (g/L)
Geometric Coefficient of Variation 25.1
|
1.11 grams per liter (g/L)
Geometric Coefficient of Variation 57.5
|
2.96 grams per liter (g/L)
Geometric Coefficient of Variation 36.2
|
5.88 grams per liter (g/L)
Geometric Coefficient of Variation 16.7
|
|
Maximum Observed Serum Concentration (Cmax) Sampled During a Dosing Interval of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)
Baseline corrected IgG2
|
0.48 grams per liter (g/L)
Geometric Coefficient of Variation 52.8
|
0.96 grams per liter (g/L)
Geometric Coefficient of Variation 52.6
|
1.33 grams per liter (g/L)
Geometric Coefficient of Variation 19.6
|
1.18 grams per liter (g/L)
Geometric Coefficient of Variation 74.8
|
1.98 grams per liter (g/L)
Geometric Coefficient of Variation 48.8
|
3.99 grams per liter (g/L)
Geometric Coefficient of Variation 41.9
|
|
Maximum Observed Serum Concentration (Cmax) Sampled During a Dosing Interval of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)
Baseline corrected IgG3
|
0.07 grams per liter (g/L)
Geometric Coefficient of Variation 5.7
|
0.03 grams per liter (g/L)
Geometric Coefficient of Variation 101.9
|
0.07 grams per liter (g/L)
Geometric Coefficient of Variation 26.4
|
0.04 grams per liter (g/L)
Geometric Coefficient of Variation 38.7
|
0.10 grams per liter (g/L)
Geometric Coefficient of Variation 67.6
|
0.19 grams per liter (g/L)
Geometric Coefficient of Variation 20.5
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1), and 48, 96, 144 and 192 hours post-dose for all treatment arms; 360 hours post-dose for treatment arms 2 and 5; 360 and 696 hours post-dose for treatment arms 3 and 6Population: PK Set included all enrolled participants received at least 1 dose of HYQVIA and had at least 1 evaluable post-dose serum concentration for total IgG or IgG subclasses. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number analyzed" signifies those participants who were evaluable at the specified categories.
AUClast was a measure of the total amount of drug in the plasma from time zero to time of the last measurable concentration. Summarized baseline corrected data was reported.
Outcome measures
| Measure |
Part 1 Schedule A: TA 1 (Low TDL HYQVIA)
n=5 Participants
Participants received a SC infusion of HYQVIA 0.1 g/kg (1/4 of TDL) on Day 1 and 8, 0.2 g/kg (1/2 of TDL) on Day 15, 0.3 g/kg (3/4 of TDL) on Day 29 followed by 0.4 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner.
|
Part 2 Schedule A: TA 4 (High TDL HYQVIA)
n=8 Participants
Participants received a SC infusion of HYQVIA 0.25 g/kg (1/4 of TDL) on Day 1 and 8, 0.5 g/kg (1/2 of TDL) on Day 15, 0.75 g/kg (3/4 of TDL) on Day 29 followed by 1.0 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner.
|
Part 1 Schedule B: TA 2 (Low TDL HYQVIA)
n=8 Participants
Participants received a SC infusion of HYQVIA 0.2 g/kg (1/2 of TDL) on Day 1 and 15, followed by 0.4 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner.
|
Part 2 Schedule B: TA 5 (High TDL HYQVIA)
n=9 Participants
Participants received a SC infusion of HYQVIA 0.5 g/kg (1/2 of TDL) on Day 1 and 15, followed by 1.0 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner.
|
Part 1 Schedule C: TA 3 (Low TDL HYQVIA)
n=8 Participants
Participants received a SC infusion of HYQVIA 0.4 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner.
|
Part 2 Schedule C: TA 6 (High TDL HYQVIA)
n=10 Participants
Participants received a SC infusion of HYQVIA 1.0 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner.
|
|---|---|---|---|---|---|---|
|
Area Under the Curve From the Time of Dosing to the Last Time Point With Measurable Concentration (AUClast) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)
Baseline corrected IgG3
|
0.27 day*gram per liter (day*g/L)
Geometric Coefficient of Variation 27.4
|
0.22 day*gram per liter (day*g/L)
Geometric Coefficient of Variation 31.3
|
0.54 day*gram per liter (day*g/L)
Geometric Coefficient of Variation 79.0
|
0.17 day*gram per liter (day*g/L)
Geometric Coefficient of Variation 55.5
|
0.62 day*gram per liter (day*g/L)
Geometric Coefficient of Variation 90.5
|
1.33 day*gram per liter (day*g/L)
Geometric Coefficient of Variation 49.7
|
|
Area Under the Curve From the Time of Dosing to the Last Time Point With Measurable Concentration (AUClast) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)
Total IgG
|
9.63 day*gram per liter (day*g/L)
Geometric Coefficient of Variation 411.1
|
9.49 day*gram per liter (day*g/L)
Geometric Coefficient of Variation 39.0
|
31.60 day*gram per liter (day*g/L)
Geometric Coefficient of Variation 16.1
|
42.48 day*gram per liter (day*g/L)
Geometric Coefficient of Variation 43.3
|
70.39 day*gram per liter (day*g/L)
Geometric Coefficient of Variation 87.9
|
117.69 day*gram per liter (day*g/L)
Geometric Coefficient of Variation 65.5
|
|
Area Under the Curve From the Time of Dosing to the Last Time Point With Measurable Concentration (AUClast) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)
Baseline corrected IgG1
|
1.29 day*gram per liter (day*g/L)
Geometric Coefficient of Variation 46.6
|
11.37 day*gram per liter (day*g/L)
Geometric Coefficient of Variation 94.9
|
20.71 day*gram per liter (day*g/L)
Geometric Coefficient of Variation 60.1
|
4.30 day*gram per liter (day*g/L)
Geometric Coefficient of Variation 59.5
|
25.36 day*gram per liter (day*g/L)
Geometric Coefficient of Variation 51.6
|
60.04 day*gram per liter (day*g/L)
Geometric Coefficient of Variation 60.6
|
|
Area Under the Curve From the Time of Dosing to the Last Time Point With Measurable Concentration (AUClast) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)
Baseline corrected IgG2
|
1.66 day*gram per liter (day*g/L)
Geometric Coefficient of Variation 42.5
|
6.59 day*gram per liter (day*g/L)
Geometric Coefficient of Variation 102.1
|
17.36 day*gram per liter (day*g/L)
Geometric Coefficient of Variation 43.9
|
4.37 day*gram per liter (day*g/L)
Geometric Coefficient of Variation 49.7
|
17.77 day*gram per liter (day*g/L)
Geometric Coefficient of Variation 75.4
|
42.27 day*gram per liter (day*g/L)
Geometric Coefficient of Variation 86.3
|
|
Area Under the Curve From the Time of Dosing to the Last Time Point With Measurable Concentration (AUClast) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)
Baseline corrected IgG4
|
0.06 day*gram per liter (day*g/L)
|
0.40 day*gram per liter (day*g/L)
Geometric Coefficient of Variation 50.6
|
1.04 day*gram per liter (day*g/L)
Geometric Coefficient of Variation 45.8
|
0.39 day*gram per liter (day*g/L)
Geometric Coefficient of Variation 119.7
|
1.27 day*gram per liter (day*g/L)
Geometric Coefficient of Variation 75.3
|
2.43 day*gram per liter (day*g/L)
Geometric Coefficient of Variation 61.3
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1), and 48, 96, 144 and 192 hours post-dose for all treatment arms; 360 hours post-dose for treatment arms 2 and 5; 360 and 696 hours post-dose for treatment arms 3 and 6Population: PK Set included all enrolled participants received at least 1 dose of HYQVIA and had at least 1 evaluable post-dose serum concentration for total IgG or IgG subclasses. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number analyzed" signifies those participants who were evaluable at the specified categories. "0" in analyzed field signifies that none of the participants had evaluable data at specified timepoint.
T1/2 was the time required for a given drug concentration in the plasma to decrease by 50%. Summarized baseline corrected data was reported.
Outcome measures
| Measure |
Part 1 Schedule A: TA 1 (Low TDL HYQVIA)
Participants received a SC infusion of HYQVIA 0.1 g/kg (1/4 of TDL) on Day 1 and 8, 0.2 g/kg (1/2 of TDL) on Day 15, 0.3 g/kg (3/4 of TDL) on Day 29 followed by 0.4 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner.
|
Part 2 Schedule A: TA 4 (High TDL HYQVIA)
Participants received a SC infusion of HYQVIA 0.25 g/kg (1/4 of TDL) on Day 1 and 8, 0.5 g/kg (1/2 of TDL) on Day 15, 0.75 g/kg (3/4 of TDL) on Day 29 followed by 1.0 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner.
|
Part 1 Schedule B: TA 2 (Low TDL HYQVIA)
Participants received a SC infusion of HYQVIA 0.2 g/kg (1/2 of TDL) on Day 1 and 15, followed by 0.4 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner.
|
Part 2 Schedule B: TA 5 (High TDL HYQVIA)
Participants received a SC infusion of HYQVIA 0.5 g/kg (1/2 of TDL) on Day 1 and 15, followed by 1.0 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner.
|
Part 1 Schedule C: TA 3 (Low TDL HYQVIA)
n=2 Participants
Participants received a SC infusion of HYQVIA 0.4 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner.
|
Part 2 Schedule C: TA 6 (High TDL HYQVIA)
Participants received a SC infusion of HYQVIA 1.0 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner.
|
|---|---|---|---|---|---|---|
|
Terminal Half-Life (T1/2) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)
Total IgG
|
—
|
—
|
—
|
—
|
8.1 days
Interval 5.9 to 10.3
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1), and 48, 96, 144 and 192 hours post-dose for all treatment arms; 360 hours post-dose for treatment arms 2 and 5; 360 and 696 hours post-dose for treatment arms 3 and 6Population: PK Set included all enrolled participants received at least 1 dose of HYQVIA and had at least 1 evaluable post-dose serum concentration for total IgG or IgG subclasses. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "0" in analyzed field signifies that none of the participants had evaluable data at specified timepoint.
Apparent clearance was a calculation of the rate at which a drug is removed from plasma after oral administration via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes). Summarized baseline corrected data was reported.
Outcome measures
| Measure |
Part 1 Schedule A: TA 1 (Low TDL HYQVIA)
Participants received a SC infusion of HYQVIA 0.1 g/kg (1/4 of TDL) on Day 1 and 8, 0.2 g/kg (1/2 of TDL) on Day 15, 0.3 g/kg (3/4 of TDL) on Day 29 followed by 0.4 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner.
|
Part 2 Schedule A: TA 4 (High TDL HYQVIA)
Participants received a SC infusion of HYQVIA 0.25 g/kg (1/4 of TDL) on Day 1 and 8, 0.5 g/kg (1/2 of TDL) on Day 15, 0.75 g/kg (3/4 of TDL) on Day 29 followed by 1.0 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner.
|
Part 1 Schedule B: TA 2 (Low TDL HYQVIA)
Participants received a SC infusion of HYQVIA 0.2 g/kg (1/2 of TDL) on Day 1 and 15, followed by 0.4 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner.
|
Part 2 Schedule B: TA 5 (High TDL HYQVIA)
Participants received a SC infusion of HYQVIA 0.5 g/kg (1/2 of TDL) on Day 1 and 15, followed by 1.0 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner.
|
Part 1 Schedule C: TA 3 (Low TDL HYQVIA)
n=2 Participants
Participants received a SC infusion of HYQVIA 0.4 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner.
|
Part 2 Schedule C: TA 6 (High TDL HYQVIA)
Participants received a SC infusion of HYQVIA 1.0 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner.
|
|---|---|---|---|---|---|---|
|
Apparent Total Clearance After Extravascular Administration (CL/F) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)
Total IgG
|
—
|
—
|
—
|
—
|
0.01 liters per day per kilograms (L/day/kg)
Geometric Coefficient of Variation 19.3
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1), and 48, 96, 144 and 192 hours post-dose for all treatment arms; 360 hours post-dose for treatment arms 2 and 5; 360 and 696 hours post-dose for treatment arms 3 and 6Population: PK Set included all enrolled participants received at least 1 dose of HYQVIA and had at least 1 evaluable post-dose serum concentration for total IgG or IgG subclasses. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "0" in analyzed field signifies that none of the participants had evaluable data at specified timepoint.
Volume of distribution (Vz/F) was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose is influenced by the fraction absorbed. Summarized baseline corrected data was reported.
Outcome measures
| Measure |
Part 1 Schedule A: TA 1 (Low TDL HYQVIA)
Participants received a SC infusion of HYQVIA 0.1 g/kg (1/4 of TDL) on Day 1 and 8, 0.2 g/kg (1/2 of TDL) on Day 15, 0.3 g/kg (3/4 of TDL) on Day 29 followed by 0.4 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner.
|
Part 2 Schedule A: TA 4 (High TDL HYQVIA)
Participants received a SC infusion of HYQVIA 0.25 g/kg (1/4 of TDL) on Day 1 and 8, 0.5 g/kg (1/2 of TDL) on Day 15, 0.75 g/kg (3/4 of TDL) on Day 29 followed by 1.0 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner.
|
Part 1 Schedule B: TA 2 (Low TDL HYQVIA)
Participants received a SC infusion of HYQVIA 0.2 g/kg (1/2 of TDL) on Day 1 and 15, followed by 0.4 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner.
|
Part 2 Schedule B: TA 5 (High TDL HYQVIA)
Participants received a SC infusion of HYQVIA 0.5 g/kg (1/2 of TDL) on Day 1 and 15, followed by 1.0 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner.
|
Part 1 Schedule C: TA 3 (Low TDL HYQVIA)
n=2 Participants
Participants received a SC infusion of HYQVIA 0.4 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner.
|
Part 2 Schedule C: TA 6 (High TDL HYQVIA)
Participants received a SC infusion of HYQVIA 1.0 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner.
|
|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution Associated With the Terminal Slope Following Extravascular Administration (Vz/F) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)
Total IgG
|
—
|
—
|
—
|
—
|
0.07 Liter per kilogram (L/Kg)
Geometric Coefficient of Variation 20.6
|
—
|
Adverse Events
Part 1 Schedule A: TA 1 (Low TDL HYQVIA)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part 2 Schedule A: TA 4 (High TDL HYQVIA)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part 1 Schedule B: TA 2 (Low TDL HYQVIA)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part 2 Schedule B: TA 5 (High TDL HYQVIA)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Part 1 Schedule C: TA 3 (Low TDL HYQVIA)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part 2 Schedule C: TA 6 (High TDL HYQVIA)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1 Schedule A: TA 1 (Low TDL HYQVIA)
n=8 participants at risk
Participants received a subcutaneous (SC) infusion of HYQVIA 0.1 g/kg (1/4 of TDL) on Day 1 and 8, 0.2 g/kg (1/2 of TDL) on Day 15, 0.3 g/kg (3/4 of TDL) on Day 29 followed by 0.4 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner.
|
Part 2 Schedule A: TA 4 (High TDL HYQVIA)
n=8 participants at risk
Participants received a SC infusion of HYQVIA 0.25 g/kg (1/4 of TDL) on Day 1 and 8, 0.5 g/kg (1/2 of TDL) on Day 15, 0.75 g/kg (3/4 of TDL) on Day 29 followed by 1.0 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner.
|
Part 1 Schedule B: TA 2 (Low TDL HYQVIA)
n=8 participants at risk
Participants received a SC infusion of HYQVIA 0.2 g/kg (1/2 of TDL) on Day 1 and 15, followed by 0.4 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner.
|
Part 2 Schedule B: TA 5 (High TDL HYQVIA)
n=9 participants at risk
Participants received a SC infusion of HYQVIA 0.5 g/kg (1/2 of TDL) on Day 1 and 15, followed by 1.0 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner.
|
Part 1 Schedule C: TA 3 (Low TDL HYQVIA)
n=8 participants at risk
Participants received a SC infusion of HYQVIA 0.4 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner.
|
Part 2 Schedule C: TA 6 (High TDL HYQVIA)
n=10 participants at risk
Participants received a SC infusion of HYQVIA 1.0 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner,
|
|---|---|---|---|---|---|---|
|
Investigations
Blood pressure systolic decreased
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
12.5%
1/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/9 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/10 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
|
General disorders
Chills
|
12.5%
1/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/9 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/10 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/9 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
10.0%
1/10 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
12.5%
1/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/9 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
10.0%
1/10 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
12.5%
1/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/9 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
25.0%
2/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
20.0%
2/10 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
|
Vascular disorders
Hypotension
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/9 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
20.0%
2/10 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
|
General disorders
Infusion site erythema
|
62.5%
5/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
75.0%
6/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
62.5%
5/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
100.0%
9/9 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
75.0%
6/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
100.0%
10/10 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
11.1%
1/9 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/10 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
|
General disorders
Infusion site pain
|
37.5%
3/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
62.5%
5/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
75.0%
6/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
100.0%
9/9 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
62.5%
5/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
70.0%
7/10 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
|
General disorders
Infusion site pruritus
|
50.0%
4/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
37.5%
3/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
87.5%
7/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
55.6%
5/9 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
37.5%
3/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
50.0%
5/10 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
|
General disorders
Infusion site swelling
|
100.0%
8/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
100.0%
8/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
100.0%
8/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
100.0%
9/9 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
100.0%
8/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
100.0%
10/10 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
11.1%
1/9 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/10 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
|
General disorders
Pain
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/9 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
10.0%
1/10 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
|
General disorders
Pyrexia
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/9 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
30.0%
3/10 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/9 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
0.00%
0/8 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
10.0%
1/10 • From start of the study drug administration up to Week 25
The safety set included all enrolled participants who received at least 1 dose of HYQVIA.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER