Healthy VolunteersPhase 1NCT04578535
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 study testing HYQVIA in people with Healthy Volunteers, run by Baxalta now part of Shire at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- HYQVIA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2020to 2 Mar 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Pharmacology of Miami, Inc
Hialeah, Florida, 33014
About this study
Official title: A Phase 1, Open-Label, Randomized 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 Subjects
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.
- Conditions
- Healthy Volunteers
- Being tested
- HYQVIA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HYQVIADrug
Also called IGI 10% with rHuPH20, Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase
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.
HYQVIADrug
Also called IGI 10% with rHuPH20, Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase
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.
HYQVIADrug
Also called IGI 10% with rHuPH20, Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase
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.
HYQVIADrug
Also called IGI 10% with rHuPH20, Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase
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.
HYQVIADrug
Also called IGI 10% with rHuPH20, Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase
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.
HYQVIADrug
Also called IGI 10% with rHuPH20, Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase
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.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Schedule A: TA 1 (Low TDL HYQVIA) | Experimental | 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. Receives: Drug: HYQVIA |
| Part 2 Schedule A: TA 4 (High TDL HYQVIA) | Experimental | 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. Receives: Drug: HYQVIA |
| Part 1 Schedule B: TA 2 (Low TDL HYQVIA) | Experimental | 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. Receives: Drug: HYQVIA |
| Part 2 Schedule B: TA 5 (High TDL HYQVIA) | Experimental | 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. Receives: Drug: HYQVIA |
| Part 1 Schedule C: TA 3 (Low TDL HYQVIA) | Experimental | 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. Receives: Drug: HYQVIA |
| Part 2 Schedule C: TA 6 (High TDL HYQVIA) | Experimental | 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. Receives: Drug: HYQVIA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From start of the study drug administration up to Week 9
Secondary outcomes (8)
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.
Measured: From start of the study drug administration up to Week 25
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.
Measured: From start of the study drug administration up to Week 25
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start27 Oct 2020
- Primary completion2 Mar 2022
- Study completion2 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxalta now part of Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baxalta Innovations GmbH, now part of Shire
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Shire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578535
- Sponsor's protocol ID
- TAK-771-1001
- Status last verified
- Feb 2023
- First submitted
- 7 Jul 2020
- Last updated
- 14 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Randomized 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 Subjects
- ClinicalTrials.gov ID
- NCT04578535
- Acronym / sponsor ID
- TAK-771-1001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Baxalta now part of ShireIndustry (pharma, biotech, devices)
- Collaborators
- Baxalta Innovations GmbH, now part of Shire
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 2 Mar 2022 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Posted 14 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1 Schedule A: TA 1 (Low TDL HYQVIA) | Experimental | Drug: HYQVIAParticipants 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) | Experimental | Drug: HYQVIAParticipants 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) | Experimental | Drug: HYQVIAParticipants 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) | Experimental | Drug: HYQVIAParticipants 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) | Experimental | Drug: HYQVIAParticipants 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) | Experimental | Drug: HYQVIAParticipants 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. |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HYQVIAAlso: IGI 10% with rHuPH20, Immune Globulin Infusion 10% (Human) with Recombinant Human HyaluronidaseParticipants 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. | Drug | Part 1 Schedule A: TA 1 (Low TDL HYQVIA) |
| HYQVIAAlso: IGI 10% with rHuPH20, Immune Globulin Infusion 10% (Human) with Recombinant Human HyaluronidaseParticipants 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 | Part 2 Schedule A: TA 4 (High TDL HYQVIA) |
| HYQVIAAlso: IGI 10% with rHuPH20, Immune Globulin Infusion 10% (Human) with Recombinant Human HyaluronidaseParticipants 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 | Part 1 Schedule B: TA 2 (Low TDL HYQVIA) |
| HYQVIAAlso: IGI 10% with rHuPH20, Immune Globulin Infusion 10% (Human) with Recombinant Human HyaluronidaseParticipants 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 | Part 2 Schedule B: TA 5 (High TDL HYQVIA) |
| HYQVIAAlso: IGI 10% with rHuPH20, Immune Globulin Infusion 10% (Human) with Recombinant Human HyaluronidaseParticipants 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 | Part 1 Schedule C: TA 3 (Low TDL HYQVIA) |
| HYQVIAAlso: IGI 10% with rHuPH20, Immune Globulin Infusion 10% (Human) with Recombinant Human HyaluronidaseParticipants 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 | Part 2 Schedule C: TA 6 (High TDL HYQVIA) |
Primary outcome
Number of Participants Who Tolerated All Initiated HYQVIA Infusion
Time frame: From start of the study drug administration up to Week 9
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.
8 secondary outcomes
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From start of the study drug administration up to Week 25
Number of Participants Who Developed Binding and Neutralizing Antibodies to Recombinant Human Hyaluronidase PH20 (rHuPH20)
Time frame: From start of the study drug administration up to Week 25
Time of Maximum Observed Serum Concentration (Tmax) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)
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
Maximum Observed Serum Concentration (Cmax) Sampled During a Dosing Interval of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)
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
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)
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
Terminal Half-Life (T1/2) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)
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
Apparent Total Clearance After Extravascular Administration (CL/F) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)
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
Apparent Volume of Distribution Associated With the Terminal Slope Following Extravascular Administration (Vz/F) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Shire
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HYQVIA in people with Healthy Volunteers, run by Baxalta now part of Shire at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Tolerated All Initiated HYQVIA Infusion (time frame: From start of the study drug administration up to Week 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.