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CompletedNCT04578535Updated Dec 14, 2023Results posted

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

A Phase 1 interventional study of HYQVIA and HYQVIA in Healthy Volunteers, sponsored by Baxalta now part of Shire. Completed at 1 site in United States. Open to participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-14.

Sponsored by Baxalta now part of Shire · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
19 Years to 50 Years
Sex
All
01

Study summary

The purpose of the study is to assess the tolerability, safety, and pharmacokinetics of HYQVIA with ramp-up and no ramp-up dosing in healthy adult participants.

Read the detailed description

This study will comprise of Part 1 and Part 2. Each study part will consist of three treatment arms (Part 1 [approximately 24 participants]: Treatment Arms 1-3 and Part 2 [approximately 24 participants]: Treatment Arms 4-6). Treatment arms will be initiated in parallel within each study part. Each participant will participate in only one treatment arm. After participants in Treatment Arms 1-3 (Study Part 1) will complete Week 9, the tolerability and, safety data through Week 9 will be reviewed by a safety review team. (Participants in arms 1-3 will continue in the study as the safety review is being completed.) Once the safety review for Arms 1-3 (Study part 1) will be completed and approved, Treatment Arms 4-6 (Study Part 2) will begin.

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Baxalta now part of Shire is the lead sponsor of 110 studies on the registry; none are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • An understanding, ability, and willingness to fully comply with study procedures and restrictions
  • Ability to voluntarily provide written, signed, and dated (personally or via a legally authorized representative) informed consent to participate in the study
  • Age 19-50 years inclusive at the time of consent. The date of signature of the informed consent is defined as the beginning of the screening period. This inclusion criterion will only be assessed at the first screening visit
  • Male, or non-pregnant, non-breastfeeding female who agrees to comply with any applicable contraceptive requirements of the protocol, or females of non-childbearing potential
  • Must be considered "healthy". Healthy as determined by the investigator on the basis of screening evaluations and healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electro cardiogram (ECG), hematology, blood chemistry, and urinalysis
  • Body mass index (BMI) between 18.0 and 30.0 kilogram per square meter (kg/m\^2) inclusive

Exclusion criteria

Exclusion Criteria:

  • Any current or relevant history of medical (e.g. any hematological, hepatic, respiratory, cardiovascular, renal or neurological) or psychiatric conditions, which by judgment of the investigator might compromise the safety of the participant or integrity of the study, interfere with the participant's participations in the trial and compromise the trial objectives or any condition that presents undue risk from the investigational product or procedures Note: Participants on stable dose of hormone replacements (i.e. thyroid hormone replacement) or oral contraceptives are permitted
  • Clinically significant cardiac conditions including but not limited to uncontrolled hypertension, myocardial infarction, unstable coronary artery disease and clinically significant arrhythmias and conduction disorders
  • Known or suspected intolerance or hypersensitivity to the investigational product(s), closely related compounds, or any of the stated ingredients (e.g. human IG, hyaluronidase, albumin)
  • Known history of hypersensitivity or severe allergic reactions (e.g. urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following administration of blood or blood components
  • Significant illness, as judged by the investigator, within 30 days of the first dose of investigational product
  • Known history of alcohol or other substance abuse within the last year
  • Donation of blood within 60 days, or blood products (e.g., plasma or platelets) within 2 weeks prior receiving the first dose of investigational product
  • Participants will be excluded if any of the following laboratory parameters meet the criteria below:
  • Hemoglobin less than (\<) 11 gram per deciliter (g/dL). Absolute neutrophil count less than or equal to (\< or =) 1500/ cubic millimeter (mm\^3) and platelet count less than or equal to (\< or =) 100,000/mm\^3 Liver function: alanine aminotransferase (ALT) greater than or equal to > or =2.5 × upper limit normal (ULN), aspartate aminotransferase (AST) > or =2.5 × upper limit normal (ULN), alkaline phosphatase > or =1.5 × ULN or total bilirubin > or =1.5 milligram per deciliter (mg/dL) Renal function: creatinine clearance \<or= 60 milliliter per minute (mL/min) based on Cockcroft-Gault equation Coagulation tests: activated partial thromboplastin time (aPTT) >1.2 X ULN; international normalized ratio (INR) >1.2 Participants will be excluded if any other laboratory values are outside the reference range and are clinically significant per investigator's judgment.

  • Within 30 days prior to the first dose of investigational product:

    • Has participated in another clinical study involving immunoglobulin products within 12 months of screening.
    • Have used an investigational product (or 5 half-lives, whichever is longer).
    • Have been enrolled in a clinical study (including vaccine studies or has been vaccinated with approved product) that, in the investigator's opinion, may impact this study. Participants who have received any vaccine (including live attenuated vaccines) during the last 30 days before dosing will be excluded. No live attenuated virus vaccines are allowed during the study until the end of the follow up period
    • Have had any substantial changes in eating habits, as assessed by the investigator.
  • Confirmed systolic blood pressure >139 mmHg or \<89 mmHg and diastolic blood pressure >89 mmHg or \<49 millimeters of Mercury (mmHg)
  • A positive screen for alcohol or drugs of abuse at screening or D-1
  • A positive human immunodeficiency virus (HIV), hepatitis C virus (HCV), or ongoing/active hepatitis B infection at screening. Participants with immunity to hepatitis B from either active vaccination or from previous natural infection are eligible to participate in the study.
  • Smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during confinement in the CRU
  • Severe dermatitis or anatomical abnormality that would interfere with HYQVIA administration or endpoint assessments Note: the skin at the administration site should not be covered by tattoos.
  • Current use of any herbal, or homeopathic preparations are not permitted
  • Unable or unwilling to discontinue antihistamines or medications with antihistamine properties, sedatives, anxiolytics, systemic steroids, or topical steroids or antibiotics on any area below the chest for a minimum of 48 hours prior to each infusion visit and through 72 hours post last infusion
  • Current or relevant history of hypercoagulable conditions (e.g. Protein C, Protein S, and antithrombin III deficiency), thrombotic/thromboembolic events or venous thrombosis
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    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.

    Drug: HYQVIA

  • Experimental
    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.

    Drug: HYQVIA

  • Experimental
    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.

    Drug: HYQVIA

  • Experimental
    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.

    Drug: HYQVIA

  • Experimental
    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.

    Drug: HYQVIA

  • Experimental
    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.

    Drug: HYQVIA

Interventions

  • DrugHYQVIA

    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.

    Also known as: IGI 10% with rHuPH20, Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase

  • DrugHYQVIA

    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.

    Also known as: IGI 10% with rHuPH20, Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase

  • DrugHYQVIA

    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.

    Also known as: IGI 10% with rHuPH20, Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase

  • DrugHYQVIA

    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.

    Also known as: IGI 10% with rHuPH20, Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase

  • DrugHYQVIA

    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.

    Also known as: IGI 10% with rHuPH20, Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase

  • DrugHYQVIA

    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.

    Also known as: IGI 10% with rHuPH20, Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase

06

What researchers measure

Primary outcomes

  1. Number of Participants Who Tolerated All Initiated HYQVIA Infusion

    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.

    Time frame: From start of the study drug administration up to Week 9

Secondary outcomes

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    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.

    Time frame: From start of the study drug administration up to Week 25

  2. Number of Participants Who Developed Binding and Neutralizing Antibodies to Recombinant Human Hyaluronidase PH20 (rHuPH20)

    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.

    Time frame: From start of the study drug administration up to Week 25

  3. Time of Maximum Observed Serum Concentration (Tmax) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)

    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.

    Time frame: 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 6

  4. Maximum Observed Serum Concentration (Cmax) Sampled During a Dosing Interval of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)

    Cmax was a measure of the maximum amount of drug in the serum after the dose is given. Summarized baseline corrected data was reported.

    Time frame: 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 6

  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)

    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.

    Time frame: 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 6

  6. Terminal Half-Life (T1/2) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)

    T1/2 was the time required for a given drug concentration in the plasma to decrease by 50%. Summarized baseline corrected data was reported.

    Time frame: 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 6

  7. Apparent Total Clearance After Extravascular Administration (CL/F) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)

    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.

    Time frame: 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 6

  8. Apparent Volume of Distribution Associated With the Terminal Slope Following Extravascular Administration (Vz/F) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)

    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.

    Time frame: 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 6

07

Results

Posted Dec 14, 2023

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).

Participant flow — Overall Study
MilestonePart 1 Schedule A: TA 1 (Low TDL HYQVIA)Part 2 Schedule A: TA 4 (High TDL HYQVIA)Part 1 Schedule B: TA 2 (Low TDL HYQVIA)Part 2 Schedule B: TA 5 (High TDL HYQVIA)Part 1 Schedule C: TA 3 (Low TDL HYQVIA)Part 2 Schedule C: TA 6 (High TDL HYQVIA)
Started8889810
Completed688763
Not completed200227
Withdrew: Lost to follow-up100102
Withdrew: Pregnancy100000
Withdrew: Withdrawal by subject000115
Withdrew: Non-compliance with study procedures000010

Outcome measures

PrimaryNumber of Participants Who Tolerated All Initiated HYQVIA Infusion

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.

Time frame:
From start of the study drug administration up to Week 9
Reported as:
Count of participants · Participants
Number of Participants Who Tolerated All Initiated HYQVIA Infusion
ParticipantsPart 1 Schedule A: TA 1 (Low TDL HYQVIA)Part 2 Schedule A: TA 4 (High TDL HYQVIA)Part 1 Schedule B: TA 2 (Low TDL HYQVIA)Part 2 Schedule B: TA 5 (High TDL HYQVIA)Part 1 Schedule C: TA 3 (Low TDL HYQVIA)Part 2 Schedule C: TA 6 (High TDL HYQVIA)
Number of Participants Who Tolerated All Initiated HYQVIA Infusion7889810
SecondaryNumber of Participants With Treatment-Emergent Adverse Events (TEAEs)

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.

Time frame:
From start of the study drug administration up to Week 25
Reported as:
Count of participants · Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
ParticipantsPart 1 Schedule A: TA 1 (Low TDL HYQVIA)Part 2 Schedule A: TA 4 (High TDL HYQVIA)Part 1 Schedule B: TA 2 (Low TDL HYQVIA)Part 2 Schedule B: TA 5 (High TDL HYQVIA)Part 1 Schedule C: TA 3 (Low TDL HYQVIA)Part 2 Schedule C: TA 6 (High TDL HYQVIA)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)8889810
SecondaryNumber of Participants Who Developed Binding and Neutralizing Antibodies to Recombinant Human Hyaluronidase PH20 (rHuPH20)

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.

Time frame:
From start of the study drug administration up to Week 25
Reported as:
Count of participants · Participants
Number of Participants Who Developed Binding and Neutralizing Antibodies to Recombinant Human Hyaluronidase PH20 (rHuPH20)
ParticipantsPart 1 Schedule A: TA 1 (Low TDL HYQVIA)Part 2 Schedule A: TA 4 (High TDL HYQVIA)Part 1 Schedule B: TA 2 (Low TDL HYQVIA)Part 2 Schedule B: TA 5 (High TDL HYQVIA)Part 1 Schedule C: TA 3 (Low TDL HYQVIA)Part 2 Schedule C: TA 6 (High TDL HYQVIA)
Binding ADA (Anti-Drug Antibodies)232112
Neutralizing ADA000000
SecondaryTime of Maximum Observed Serum Concentration (Tmax) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)

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.

Time frame:
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 6
Reported as:
Median · days
Time of Maximum Observed Serum Concentration (Tmax) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)
daysPart 1 Schedule A: TA 1 (Low TDL HYQVIA)Part 2 Schedule A: TA 4 (High TDL HYQVIA)Part 1 Schedule B: TA 2 (Low TDL HYQVIA)Part 2 Schedule B: TA 5 (High TDL HYQVIA)Part 1 Schedule C: TA 3 (Low TDL HYQVIA)Part 2 Schedule C: TA 6 (High TDL HYQVIA)
Total IgG5.0 (2.0 to 8.0)4.0 (2.0 to 8.0)8.0 (6.0 to 16.0)6.0 (4.0 to 16.1)4.0 (4.0 to 15.0)6.0 (4.0 to 8.0)
Baseline corrected IgG15.0 (4.0 to 6.0)5.0 (4.0 to 8.0)7.0 (4.0 to 15.0)7.0 (6.0 to 8.0)6.0 (6.0 to 8.0)6.0 (4.0 to 8.0)
Baseline corrected IgG26.0 (2.0 to 8.0)7.0 (2.0 to 8.0)8.0 (4.0 to 15.0)6.0 (4.0 to 8.0)7.0 (4.0 to 16.1)7.0 (4.0 to 15.0)
Baseline corrected IgG35.0 (4.0 to 6.0)8.0 (6.0 to 16.0)8.0 (4.0 to 15.0)4.0 (4.0 to 8.0)7.0 (2.0 to 16.1)5.0 (4.0 to 8.0)
Baseline corrected IgG44.0 (4.0 to 4.0)8.0 (2.0 to 8.0)8.0 (4.0 to 15.0)8.0 (4.0 to 8.0)7.0 (4.0 to 8.0)6.0 (4.0 to 8.0)
SecondaryMaximum Observed Serum Concentration (Cmax) Sampled During a Dosing Interval of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)

Cmax was a measure of the maximum amount of drug in the serum after the dose is given. Summarized baseline corrected data was reported.

Time frame:
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 6
Reported as:
Geometric mean · grams per liter (g/L)
Maximum Observed Serum Concentration (Cmax) Sampled During a Dosing Interval of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)
grams per liter (g/L)Part 1 Schedule A: TA 1 (Low TDL HYQVIA)Part 2 Schedule A: TA 4 (High TDL HYQVIA)Part 1 Schedule B: TA 2 (Low TDL HYQVIA)Part 2 Schedule B: TA 5 (High TDL HYQVIA)Part 1 Schedule C: TA 3 (Low TDL HYQVIA)Part 2 Schedule C: TA 6 (High TDL HYQVIA)
Total IgG2.70 ± 116.83.17 ± 66.83.10 ± 37.15.71 ± 41.05.34 ± 51.912.75 ± 16.2
Baseline corrected IgG10.38 ± 58.51.51 ± 43.62.08 ± 25.11.11 ± 57.52.96 ± 36.25.88 ± 16.7
Baseline corrected IgG20.48 ± 52.80.96 ± 52.61.33 ± 19.61.18 ± 74.81.98 ± 48.83.99 ± 41.9
Baseline corrected IgG30.07 ± 5.70.03 ± 101.90.07 ± 26.40.04 ± 38.70.10 ± 67.60.19 ± 20.5
Baseline corrected IgG40.020.08 ± 19.00.12 ± 46.80.13 ± 182.80.18 ± 32.70.29 ± 25.5
SecondaryArea 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)

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.

Time frame:
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 6
Reported as:
Geometric mean · day*gram per liter (day*g/L)
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)
day*gram per liter (day*g/L)Part 1 Schedule A: TA 1 (Low TDL HYQVIA)Part 2 Schedule A: TA 4 (High TDL HYQVIA)Part 1 Schedule B: TA 2 (Low TDL HYQVIA)Part 2 Schedule B: TA 5 (High TDL HYQVIA)Part 1 Schedule C: TA 3 (Low TDL HYQVIA)Part 2 Schedule C: TA 6 (High TDL HYQVIA)
Total IgG9.63 ± 411.19.49 ± 39.031.60 ± 16.142.48 ± 43.370.39 ± 87.9117.69 ± 65.5
Baseline corrected IgG11.29 ± 46.611.37 ± 94.920.71 ± 60.14.30 ± 59.525.36 ± 51.660.04 ± 60.6
Baseline corrected IgG21.66 ± 42.56.59 ± 102.117.36 ± 43.94.37 ± 49.717.77 ± 75.442.27 ± 86.3
Baseline corrected IgG30.27 ± 27.40.22 ± 31.30.54 ± 79.00.17 ± 55.50.62 ± 90.51.33 ± 49.7
Baseline corrected IgG40.060.40 ± 50.61.04 ± 45.80.39 ± 119.71.27 ± 75.32.43 ± 61.3
SecondaryTerminal Half-Life (T1/2) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)

T1/2 was the time required for a given drug concentration in the plasma to decrease by 50%. Summarized baseline corrected data was reported.

Time frame:
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 6
Reported as:
Median · days
Terminal Half-Life (T1/2) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)
daysPart 1 Schedule A: TA 1 (Low TDL HYQVIA)Part 2 Schedule A: TA 4 (High TDL HYQVIA)Part 1 Schedule B: TA 2 (Low TDL HYQVIA)Part 2 Schedule B: TA 5 (High TDL HYQVIA)Part 1 Schedule C: TA 3 (Low TDL HYQVIA)Part 2 Schedule C: TA 6 (High TDL HYQVIA)
Total IgG————8.1 (5.9 to 10.3)—
SecondaryApparent Total Clearance After Extravascular Administration (CL/F) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)

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.

Time frame:
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 6
Reported as:
Geometric mean · liters per day per kilograms (L/day/kg)
Apparent Total Clearance After Extravascular Administration (CL/F) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)
liters per day per kilograms (L/day/kg)Part 1 Schedule A: TA 1 (Low TDL HYQVIA)Part 2 Schedule A: TA 4 (High TDL HYQVIA)Part 1 Schedule B: TA 2 (Low TDL HYQVIA)Part 2 Schedule B: TA 5 (High TDL HYQVIA)Part 1 Schedule C: TA 3 (Low TDL HYQVIA)Part 2 Schedule C: TA 6 (High TDL HYQVIA)
Total IgG————0.01 ± 19.3—
SecondaryApparent Volume of Distribution Associated With the Terminal Slope Following Extravascular Administration (Vz/F) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)

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.

Time frame:
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 6
Reported as:
Geometric mean · Liter per kilogram (L/Kg)
Apparent Volume of Distribution Associated With the Terminal Slope Following Extravascular Administration (Vz/F) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)
Liter per kilogram (L/Kg)Part 1 Schedule A: TA 1 (Low TDL HYQVIA)Part 2 Schedule A: TA 4 (High TDL HYQVIA)Part 1 Schedule B: TA 2 (Low TDL HYQVIA)Part 2 Schedule B: TA 5 (High TDL HYQVIA)Part 1 Schedule C: TA 3 (Low TDL HYQVIA)Part 2 Schedule C: TA 6 (High TDL HYQVIA)
Total IgG————0.07 ± 20.6—

Adverse events

Collected over From start of the study drug administration up to Week 25. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Part 1 Schedule A: TA 1 (Low TDL HYQVIA)0/8 (0%)0/8 (0%)8/8 (100%)
Part 2 Schedule A: TA 4 (High TDL HYQVIA)0/8 (0%)0/8 (0%)8/8 (100%)
Part 1 Schedule B: TA 2 (Low TDL HYQVIA)0/8 (0%)0/8 (0%)8/8 (100%)
Part 2 Schedule B: TA 5 (High TDL HYQVIA)0/9 (0%)0/9 (0%)9/9 (100%)
Part 1 Schedule C: TA 3 (Low TDL HYQVIA)0/8 (0%)0/8 (0%)8/8 (100%)
Part 2 Schedule C: TA 6 (High TDL HYQVIA)0/10 (0%)0/10 (0%)10/10 (100%)
Most frequent other events
Showing 10 of 15
Most frequent other events
EventPart 1 Schedule A: TA 1 (Low TDL HYQVIA)Part 2 Schedule A: TA 4 (High TDL HYQVIA)Part 1 Schedule B: TA 2 (Low TDL HYQVIA)Part 2 Schedule B: TA 5 (High TDL HYQVIA)Part 1 Schedule C: TA 3 (Low TDL HYQVIA)Part 2 Schedule C: TA 6 (High TDL HYQVIA)
Infusion site erythemaGeneral disorders5/86/85/89/96/810/10
Infusion site painGeneral disorders3/85/86/89/95/87/10
Infusion site swellingGeneral disorders8/88/88/89/98/810/10
Infusion site pruritusGeneral disorders4/83/87/85/93/85/10
PyrexiaGeneral disorders0/80/80/80/90/83/10
HeadacheNervous system disorders1/80/81/80/92/82/10
HypotensionVascular disorders0/80/80/80/90/82/10
Blood pressure systolic decreasedInvestigations0/81/80/80/90/80/10
ChillsGeneral disorders1/80/80/80/90/80/10
DizzinessNervous system disorders0/80/81/80/90/81/10

Baseline characteristics

The safety set included all enrolled participants who received at least 1 dose of HYQVIA.

Age, Continuous
Age, Continuous(years)Part 1 Schedule A: TA 1 (Low TDL HYQVIA)Part 2 Schedule A: TA 4 (High TDL HYQVIA)Part 1 Schedule B: TA 2 (Low TDL HYQVIA)Part 2 Schedule B: TA 5 (High TDL HYQVIA)Part 1 Schedule C: TA 3 (Low TDL HYQVIA)Part 2 Schedule C: TA 6 (High TDL HYQVIA)Total
Mean28.9 ± 8.0434.4 ± 6.4440.4 ± 5.0136.4 ± 7.8836.8 ± 8.5834.0 ± 10.0735.1 ± 8.28
Sex: Female, Male
Sex: Female, Male(Participants)Part 1 Schedule A: TA 1 (Low TDL HYQVIA)Part 2 Schedule A: TA 4 (High TDL HYQVIA)Part 1 Schedule B: TA 2 (Low TDL HYQVIA)Part 2 Schedule B: TA 5 (High TDL HYQVIA)Part 1 Schedule C: TA 3 (Low TDL HYQVIA)Part 2 Schedule C: TA 6 (High TDL HYQVIA)Total
Female75454429
Male13444622
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Part 1 Schedule A: TA 1 (Low TDL HYQVIA)Part 2 Schedule A: TA 4 (High TDL HYQVIA)Part 1 Schedule B: TA 2 (Low TDL HYQVIA)Part 2 Schedule B: TA 5 (High TDL HYQVIA)Part 1 Schedule C: TA 3 (Low TDL HYQVIA)Part 2 Schedule C: TA 6 (High TDL HYQVIA)Total
Hispanic or Latino886961047
Not Hispanic or Latino0020204
Unknown or Not Reported0000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Part 1 Schedule A: TA 1 (Low TDL HYQVIA)Part 2 Schedule A: TA 4 (High TDL HYQVIA)Part 1 Schedule B: TA 2 (Low TDL HYQVIA)Part 2 Schedule B: TA 5 (High TDL HYQVIA)Part 1 Schedule C: TA 3 (Low TDL HYQVIA)Part 2 Schedule C: TA 6 (High TDL HYQVIA)Total
American Indian or Alaska Native0000000
Asian0000000
Native Hawaiian or Other Pacific Islander0000000
Black or African American42432217
White46466834
More than one race0000000
Unknown or Not Reported0000000
08

Study locations

1 site
  • Clinical Pharmacology of Miami, Inc
    Hialeah, Florida 33014, United States
09

References and documents

Study documents

  • Study protocol · Jun 30, 2020
  • Statistical analysis plan · Apr 22, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Supporting information: Study protocol, Sap, Icf, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04578535
Lead sponsor
Baxalta now part of Shire
Collaborators
Baxalta Innovations GmbH, now part of Shire
Responsible party
Sponsor
First posted
Oct 8, 2020
Start date
Oct 27, 2020
Primary completion
Mar 2, 2022
Completion
Mar 2, 2022
Results posted
Dec 14, 2023
Last update
Dec 14, 2023

Study contacts

Study Director
study director · Shire

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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