Trial Outcomes & Findings for A Study of TAK-881 and HyQvia in Healthy Adults (NCT NCT06895967)
NCT ID: NCT06895967
Last Updated: 2026-05-11
Results Overview
Baseline-corrected AUC Day 1-29 based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Day 1 up to Day 29
Results posted on
2026-05-11
Participant Flow
This study was conducted at single center in the United States from 24 March 2025 to 8 August 2025.
A total of 30 participants were enrolled and received study treatment.
Participant milestones
| Measure |
TAK-881 1.0 g/kg
Healthy participants received a single dose of TAK-881, 1.0 gram per kilogram (g/kg) subcutaneously (SC) using an investigational needle set on Day 1 and were followed through Day 85.
|
HyQvia 1.0 g/kg
Healthy participants received a single dose of HyQvia 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
Pharmacokinetic Per-protocol Analysis Set (PKPPAS)
|
13
|
15
|
|
Overall Study
COMPLETED
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
TAK-881 1.0 g/kg
Healthy participants received a single dose of TAK-881, 1.0 gram per kilogram (g/kg) subcutaneously (SC) using an investigational needle set on Day 1 and were followed through Day 85.
|
HyQvia 1.0 g/kg
Healthy participants received a single dose of HyQvia 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
|---|---|---|
|
Overall Study
Failed Drug/Alcohol Laboratory
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
A Study of TAK-881 and HyQvia in Healthy Adults
Baseline characteristics by cohort
| Measure |
TAK-881 1.0 g/kg
n=15 Participants
Healthy participants received a single dose of TAK-881, 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
HyQvia 1.0 g/kg
n=15 Participants
Healthy participants received a single dose of HyQvia 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.9 years
STANDARD_DEVIATION 9.14 • n=44 Participants
|
38.3 years
STANDARD_DEVIATION 6.98 • n=10 Participants
|
36.6 years
STANDARD_DEVIATION 8.18 • n=30 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=44 Participants
|
10 Participants
n=10 Participants
|
22 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=44 Participants
|
5 Participants
n=10 Participants
|
8 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=44 Participants
|
15 Participants
n=10 Participants
|
29 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=44 Participants
|
15 Participants
n=10 Participants
|
26 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 29Population: The PKPPAS included all participants who had no protocol violations that affect the reliability of the total IgG pharmacokinetic (PK) profiles.
Baseline-corrected AUC Day 1-29 based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration.
Outcome measures
| Measure |
TAK-881 1.0 g/kg
n=13 Participants
Healthy participants received a single dose of TAK-881, 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
HyQvia 1.0 g/kg
n=15 Participants
Healthy participants received a single dose of HyQvia 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
|---|---|---|
|
Baseline-corrected Area Under the Concentration-time Curve (AUC) From Day 1 to Day 29 (AUC Day 1-29) Based on Serum Total Immunoglobulin G (IgG) Levels
|
2993 gram*hour per liter (g*h/L)
Geometric Coefficient of Variation 13.6
|
3190 gram*hour per liter (g*h/L)
Geometric Coefficient of Variation 25.4
|
SECONDARY outcome
Timeframe: Day 1 up to Day 85Population: The PKPPAS included all participants who had no protocol violations that affect the reliability of the total IgG PK profiles.
Baseline-uncorrected Cmax based on serum total IgG levels was reported for TAK-881 and HyQvia.
Outcome measures
| Measure |
TAK-881 1.0 g/kg
n=13 Participants
Healthy participants received a single dose of TAK-881, 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
HyQvia 1.0 g/kg
n=15 Participants
Healthy participants received a single dose of HyQvia 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
|---|---|---|
|
Baseline-uncorrected Maximum Observed Concentration (Cmax) Based on Serum Total IgG Levels
|
19.84 gram per liter (g/L)
Geometric Coefficient of Variation 15.9
|
20.70 gram per liter (g/L)
Geometric Coefficient of Variation 13.0
|
SECONDARY outcome
Timeframe: Day 1 up to Day 85Population: The PKPPAS included all participants who had no protocol violations that affect the reliability of the total IgG PK profiles.
Baseline-uncorrected Tmax based on serum total IgG levels was reported for TAK-881 and HyQvia.
Outcome measures
| Measure |
TAK-881 1.0 g/kg
n=13 Participants
Healthy participants received a single dose of TAK-881, 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
HyQvia 1.0 g/kg
n=15 Participants
Healthy participants received a single dose of HyQvia 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
|---|---|---|
|
Baseline-uncorrected Time to Maximum Concentration (Tmax) Based on Serum Total IgG Levels
|
167.741 hours
Interval 119.75 to 167.86
|
143.829 hours
Interval 118.94 to 671.8
|
SECONDARY outcome
Timeframe: Day 1 up to Day 29Population: The PKPPAS included all participants who had no protocol violations that affect the reliability of the total IgG PK profiles.
Baseline-uncorrected AUC Day1-29 based on serum total IgG levels was reported for TAK-881 and HyQvia.
Outcome measures
| Measure |
TAK-881 1.0 g/kg
n=13 Participants
Healthy participants received a single dose of TAK-881, 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
HyQvia 1.0 g/kg
n=15 Participants
Healthy participants received a single dose of HyQvia 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
|---|---|---|
|
Baseline-uncorrected AUC Day1-29 Based on Serum Total IgG Levels
|
10310 g*h/L
Geometric Coefficient of Variation 13.8
|
10720 g*h/L
Geometric Coefficient of Variation 10.5
|
SECONDARY outcome
Timeframe: Day 1 up to Day 85Population: The PKPPAS included all participants who had no protocol violations that affect the reliability of the total IgG PK profiles. Here, "Overall number analyzed" signifies participants who were evaluable for this outcome measure.
Baseline-corrected AUCinf based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration.
Outcome measures
| Measure |
TAK-881 1.0 g/kg
n=11 Participants
Healthy participants received a single dose of TAK-881, 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
HyQvia 1.0 g/kg
n=12 Participants
Healthy participants received a single dose of HyQvia 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
|---|---|---|
|
Baseline-corrected AUC From Day 1 to Infinity (AUCinf) Based on Serum Total IgG Levels
|
4556 g*h/L
Geometric Coefficient of Variation 18.4
|
5425 g*h/L
Geometric Coefficient of Variation 41.4
|
SECONDARY outcome
Timeframe: Day 1 up to Day 85Population: The PKPPAS included all participants who had no protocol violations that affect the reliability of the total IgG PK profiles.
Baseline-corrected AUClast based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration.
Outcome measures
| Measure |
TAK-881 1.0 g/kg
n=13 Participants
Healthy participants received a single dose of TAK-881, 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
HyQvia 1.0 g/kg
n=15 Participants
Healthy participants received a single dose of HyQvia 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
|---|---|---|
|
Baseline-corrected AUC From Day 1 to Time of the Last Measurable Concentration (AUClast) Based on Serum Total IgG Levels
|
4240 g*h/L
Geometric Coefficient of Variation 21.0
|
4591 g*h/L
Geometric Coefficient of Variation 43.2
|
SECONDARY outcome
Timeframe: Day 1 up to Day 85Population: The PKPPAS included all participants who had no protocol violations that affect the reliability of the total IgG PK profiles.
Baseline-corrected Cmax based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration.
Outcome measures
| Measure |
TAK-881 1.0 g/kg
n=13 Participants
Healthy participants received a single dose of TAK-881, 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
HyQvia 1.0 g/kg
n=15 Participants
Healthy participants received a single dose of HyQvia 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
|---|---|---|
|
Baseline-corrected Cmax Based on Serum Total IgG Levels
|
8.875 g/L
Geometric Coefficient of Variation 21.2
|
9.486 g/L
Geometric Coefficient of Variation 21.8
|
SECONDARY outcome
Timeframe: Day 1 up to Day 85Population: The PKPPAS included all participants who had no protocol violations that affect the reliability of the total IgG PK profiles.
Baseline-corrected Tmax based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration.
Outcome measures
| Measure |
TAK-881 1.0 g/kg
n=13 Participants
Healthy participants received a single dose of TAK-881, 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
HyQvia 1.0 g/kg
n=15 Participants
Healthy participants received a single dose of HyQvia 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
|---|---|---|
|
Baseline-corrected Tmax Based on Serum Total IgG Levels
|
167.741 hours
Interval 119.75 to 167.86
|
143.829 hours
Interval 118.94 to 671.8
|
SECONDARY outcome
Timeframe: From Day 1 up to Day 85Population: The PKPPAS included all participants who had no protocol violations that affect the reliability of the total IgG PK profiles.
Baseline-corrected Tlast based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration.
Outcome measures
| Measure |
TAK-881 1.0 g/kg
n=13 Participants
Healthy participants received a single dose of TAK-881, 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
HyQvia 1.0 g/kg
n=15 Participants
Healthy participants received a single dose of HyQvia 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
|---|---|---|
|
Baseline-corrected Time of Last Measurable Concentration (Tlast) Based on Serum Total IgG Levels
|
2015.748 hours
Interval 575.93 to 2015.84
|
2015.705 hours
Interval 504.11 to 2016.97
|
SECONDARY outcome
Timeframe: Day 1 up to Day 85Population: The PKPPAS included all participants who had no protocol violations that affect the reliability of the total IgG PK profiles. Here, "Overall number analyzed" signifies participants who were evaluable for this outcome measure.
Baseline-corrected t1/2z based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration.
Outcome measures
| Measure |
TAK-881 1.0 g/kg
n=11 Participants
Healthy participants received a single dose of TAK-881, 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
HyQvia 1.0 g/kg
n=12 Participants
Healthy participants received a single dose of HyQvia 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
|---|---|---|
|
Baseline-corrected Terminal Half-life (t1/2z) Based on Serum Total IgG Levels
|
146.613 hours
Interval 42.28 to 454.04
|
165.913 hours
Interval 37.83 to 951.45
|
SECONDARY outcome
Timeframe: Day 1 up to Day 85Population: The PKPPAS included all participants who had no protocol violations that affect the reliability of the total IgG PK profiles. Here, "Overall number analyzed" signifies participants who were evaluable for this outcome measure.
Baseline-corrected CL/F based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration.
Outcome measures
| Measure |
TAK-881 1.0 g/kg
n=11 Participants
Healthy participants received a single dose of TAK-881, 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
HyQvia 1.0 g/kg
n=12 Participants
Healthy participants received a single dose of HyQvia 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
|---|---|---|
|
Baseline-corrected Apparent Clearance (CL/F) Based on Serum Total IgG Levels
|
0.01579 liter per hour (L/h)
Standard Deviation 0.0029847
|
0.01429 liter per hour (L/h)
Standard Deviation 0.0050489
|
SECONDARY outcome
Timeframe: Day 1 up to Day 85Population: The PKPPAS included all participants who had no protocol violations that affect the reliability of the total IgG PK profiles. Here, "Overall number analyzed" signifies participants who were evaluable for this outcome measure.
Baseline-corrected Vz/F based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration.
Outcome measures
| Measure |
TAK-881 1.0 g/kg
n=11 Participants
Healthy participants received a single dose of TAK-881, 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
HyQvia 1.0 g/kg
n=12 Participants
Healthy participants received a single dose of HyQvia 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
|---|---|---|
|
Baseline-corrected Apparent Volume of Distribution (Vz/F) Based on Serum Total IgG Levels
|
4.169 Liters (L)
Standard Deviation 2.7106
|
3.823 Liters (L)
Standard Deviation 2.7628
|
SECONDARY outcome
Timeframe: From start of study drug up to end of trial (up to Day 85)Population: Safety analysis set included all participants who received any amount of TAK-881 or HyQvia.
An Adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE was defined as any AE that was starting or worsening at the time of or after dosing of investigational product (IP).
Outcome measures
| Measure |
TAK-881 1.0 g/kg
n=15 Participants
Healthy participants received a single dose of TAK-881, 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
HyQvia 1.0 g/kg
n=15 Participants
Healthy participants received a single dose of HyQvia 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
15 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: On Day 1 (day of the first and only infusion)Population: Safety analysis set included all participants who received any amount of TAK-881 or HyQvia.
The number of participants with infusion withdrawals, interruptions, and infusion rate reductions due to TAK-881 or HyQvia related TEAEs were reported.
Outcome measures
| Measure |
TAK-881 1.0 g/kg
n=15 Participants
Healthy participants received a single dose of TAK-881, 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
HyQvia 1.0 g/kg
n=15 Participants
Healthy participants received a single dose of HyQvia 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
|---|---|---|
|
Number of Participants With Infusion Withdrawals, Interruptions, and Infusion Rate Reductions
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Days -1, 29, and 85Population: Safety analysis set included all participants who received any amount of TAK-881 or HyQvia.
Number of participants with positive binding antibodies to recombinant human hyaluronidase (rHuPH20) with titer greater than or equal to (\>=) 1:160 were reported.
Outcome measures
| Measure |
TAK-881 1.0 g/kg
n=15 Participants
Healthy participants received a single dose of TAK-881, 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
HyQvia 1.0 g/kg
n=15 Participants
Healthy participants received a single dose of HyQvia 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
|---|---|---|
|
Number of Participants With Positive Binding Antibodies to rHuPH20
At Day -1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Binding Antibodies to rHuPH20
At Day 29
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Binding Antibodies to rHuPH20
At Day 85
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Days -1, 29, and 85Population: Safety analysis set included all participants who received any amount of TAK-881 or HyQvia.
Number of participants with neutralizing antibodies to rHuPH20 were reported.
Outcome measures
| Measure |
TAK-881 1.0 g/kg
n=15 Participants
Healthy participants received a single dose of TAK-881, 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
HyQvia 1.0 g/kg
n=15 Participants
Healthy participants received a single dose of HyQvia 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
|---|---|---|
|
Number of Participants With Neutralizing Antibodies to rHuPH20
At Day -1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Neutralizing Antibodies to rHuPH20
At Day 29
|
0 Participants
|
0 Participants
|
|
Number of Participants With Neutralizing Antibodies to rHuPH20
At Day 85
|
0 Participants
|
0 Participants
|
Adverse Events
TAK-881 1.0 g/kg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
HyQvia 1.0 g/kg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TAK-881 1.0 g/kg
n=15 participants at risk
Healthy participants received a single dose of TAK-881, 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
HyQvia 1.0 g/kg
n=15 participants at risk
Healthy participants received a single dose of HyQvia 1.0 g/kg SC using an investigational needle set on Day 1 and were followed through Day 85.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
|
General disorders
Fatigue
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
|
General disorders
Feeling cold
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
|
General disorders
Feeling hot
|
26.7%
4/15 • From start of study drug up to end of trial (up to Day 85)
|
33.3%
5/15 • From start of study drug up to end of trial (up to Day 85)
|
|
General disorders
Generalised oedema
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
|
Nervous system disorders
Headache
|
60.0%
9/15 • From start of study drug up to end of trial (up to Day 85)
|
60.0%
9/15 • From start of study drug up to end of trial (up to Day 85)
|
|
Vascular disorders
Hot flush
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
26.7%
4/15 • From start of study drug up to end of trial (up to Day 85)
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
|
General disorders
Infusion site discolouration
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
|
General disorders
Infusion site discomfort
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
26.7%
4/15 • From start of study drug up to end of trial (up to Day 85)
|
|
General disorders
Infusion site erythema
|
93.3%
14/15 • From start of study drug up to end of trial (up to Day 85)
|
100.0%
15/15 • From start of study drug up to end of trial (up to Day 85)
|
|
General disorders
Infusion site hypoaesthesia
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
|
General disorders
Infusion site induration
|
13.3%
2/15 • From start of study drug up to end of trial (up to Day 85)
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
|
General disorders
Infusion site pain
|
53.3%
8/15 • From start of study drug up to end of trial (up to Day 85)
|
60.0%
9/15 • From start of study drug up to end of trial (up to Day 85)
|
|
General disorders
Infusion site pallor
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
|
General disorders
Infusion site papule
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
|
General disorders
Infusion site pruritus
|
53.3%
8/15 • From start of study drug up to end of trial (up to Day 85)
|
73.3%
11/15 • From start of study drug up to end of trial (up to Day 85)
|
|
General disorders
Infusion site swelling
|
100.0%
15/15 • From start of study drug up to end of trial (up to Day 85)
|
93.3%
14/15 • From start of study drug up to end of trial (up to Day 85)
|
|
General disorders
Infusion site warmth
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
|
General disorders
Malaise
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
13.3%
2/15 • From start of study drug up to end of trial (up to Day 85)
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • From start of study drug up to end of trial (up to Day 85)
|
20.0%
3/15 • From start of study drug up to end of trial (up to Day 85)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
|
General disorders
Pain
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
13.3%
2/15 • From start of study drug up to end of trial (up to Day 85)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
|
Vascular disorders
Pallor
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
|
Eye disorders
Photophobia
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
|
Renal and urinary disorders
Pollakiuria
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
|
Nervous system disorders
Presyncope
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
|
General disorders
Pyrexia
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
|
Reproductive system and breast disorders
Vaginal discharge
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
|
Eye disorders
Vision blurred
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
2/15 • From start of study drug up to end of trial (up to Day 85)
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
|
Eye disorders
Eyelid function disorder
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
|
General disorders
Asthenia
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
|
Infections and infestations
Cellulitis
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
|
Gastrointestinal disorders
Cheilitis
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
|
General disorders
Chest discomfort
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
|
General disorders
Chills
|
20.0%
3/15 • From start of study drug up to end of trial (up to Day 85)
|
13.3%
2/15 • From start of study drug up to end of trial (up to Day 85)
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/15 • From start of study drug up to end of trial (up to Day 85)
|
6.7%
1/15 • From start of study drug up to end of trial (up to Day 85)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place