Healthy VolunteersPhase 1NCT05059977
A Study of TAK-881 in Healthy Adults
A Phase 1 study testing TAK-881 in people with Healthy Volunteers, run by Takeda at 1 site in United States.
Trial summary
The main aims of this study are to check for side effects from TAK-881 in healthy adults and to learn how much TAK-881 they can receive without getting side effects from it. During the study, participants will receive one infusion of TAK-881 under the skin (subcutaneous infusion) on Day 1 at a lower dose level… 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?
- TAK-881
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2021to 12 Apr 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 as applicable 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 female of non-childbearing potential.
- Must be considered "healthy." Healthy as determined by the investigator on the basis of screening evaluations. 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 electrocardiogram (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 participants participation in the trial and compromise the trial objectives, or any condition that presents an undue risk from the IP or procedures.
- Note: Participants on stable dose of hormone replacements (e.g., 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 IP(s), closely related compounds, or any of the stated ingredients (e.g., human immune globulin (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.
- Known allergy to hyaluronidase of human (including recombinant human hyaluronidase) or animal origin (such as bee or wasp venom).
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- Significant illness, as judged by the investigator, within 30 days of the first dose of IP.
- 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 IP.
- Participants will be excluded if abnormal hematology, chemistry, and other laboratory values are greater than (>)10% above the upper limit of normal (ULN) or >10% below the lower limit of normal (LLN) except for liver function tests and absolute neutrophils. Participants will be excluded if any of the following laboratory parameters meet the criteria below:
- Absolute neutrophil count less than (<) 1.5* 10^9 cells/liter
- Liver function: alanine aminotransferase (ALT) greater than or equal to (>=) 1.5* ULN, aspartate aminotransferase (AST) >=1.5* ULN, alkaline phosphatase (ALP) >=1.5* ULN, or total bilirubin >=1.5 milligram per deciliter (mg/dL)
- Participants will be excluded if any other laboratory values are outside the reference range and are clinically significant per investigator's judgment.
- Participants who, within 30 days prior to the first dose of IP:
- Have participated in another clinical study involving IG products within 12 months of screening.
- Have used an IP (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 and COVID-19 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 millimeter of mercury (mmHg) or <89 mmHg and diastolic blood pressure >89 mmHg or <49 mmHg.
- A positive screen for alcohol or drugs of abuse at screening or Day -1 (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 clinical research center (CRC).
- Severe dermatitis or anatomical abnormality that would interfere with TAK-881 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 is 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 infusion visit and through 72 hours post 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
Hialeah, Florida, 33014
About this study
Official title: A Phase 1, Single-Dose, Single-Center, Open-Label, Three-Arm Study to Assess the Tolerability and Safety of Immune Globulin Subcutaneous (Human), 20% Solution With Recombinant Human Hyaluronidase (TAK-881) at Various Infusion Rates in Healthy Adult Subject
The main aims of this study are to check for side effects from TAK-881 in healthy adults and to learn how much TAK-881 they can receive without getting side effects from it.
During the study, participants will receive one infusion of TAK-881 under the skin (subcutaneous infusion) on Day 1 at a lower dose level followed by participants receiving one infusion of higher dose levels with ongoing safety monitored by the doctor to ensure optimal tolerability and safety.
Participants will stay in the clinic for 4 days and will come back after 4 weeks. A follow up visit will take place 12 weeks after the TAK-881 infusion.
- Conditions
- Healthy Volunteers
- Being tested
- TAK-881
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-881Biological
Also called Immune Globulin Subcutaneous (Human), 20% Solution with Recombinant Human Hyaluronidase.
Participants will receive subcutaneous infusion of TAK-881 on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| TAK-881 0.4 g/kg (in-line warmed) | Experimental | Participants will receive a single dose of TAK-881 comprising of 0.4 gram per kilogram (g/kg) (in-line warmed) Immune Globulin Subcutaneous (IGSC), 20 percent (%) at progressively increased infusion rates and Recombinant Human Hyaluronidase (rHuPH20) dose of 80 unit per gram (U/g) immunoglobulin G (IgG) on Day 1 of the study treatment period. Receives: Biological: TAK-881 |
| TAK-881 1.0 g/kg (in-line warmed) | Experimental | Participants will receive a single dose of TAK-881 comprising of 1.0 g/kg (in-line warmed) IGSC, 20% at progressively increased infusion rates and rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period. Receives: Biological: TAK-881 |
| TAK-881 1.0 g/kg (un-warmed) | Experimental | Participants will receive a single dose of TAK-881 comprising of 1.0 g/kg (un-warmed) IGSC, 20% at progressively increased infusion rates and rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period. Receives: Biological: TAK-881 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Tolerability Events Related to Infusion of TAK-881 Per Infusion Site
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 any treatment-emergent adverse event (TEAE) related to TAK-881. Number of participants with tolerability events related to infusion of TAK-881 per infusion sites (1 and 2) were reported.
Measured: Up to Day 4
Secondary outcomes (5)
Number of Participants With TEAEs
A TEAE was defined as any event emerged or manifested at or after the initiation of treatment with an Investigational product (IP) or medicinal product or any existing event that worsened in either intensity or frequency following exposure to the IP or medicinal product. Any clinically significant treatment-emergent changes in clinical laboratory measurements and vital signs were recorded as TEAEs. Number of participants with TEAEs were reported.
Measured: From the start of study drug administration up to Week 13
Number of Participants With Positive Binding Anti-Drug Antibodies (ADA) and Neutralizing Antibodies to rHuPH20
Positive binding ADA was defined as titer greater than or equal to (>=) 1:160. Neutralizing antibodies were only tested if binding ADA titer was >= 1:160. Number of participants with positive binding ADA and neutralizing antibodies to rHuPH20 were reported.
Measured: Baseline up to Week 13
Number of Participants Who Achieved Maximum Tolerable Infusion Rate Per Infusion Site
The maximum tolerable infusion rate achieved referred to the administration of IGSC, 20% at progressively increasing infusion rates and was defined as the highest infusion rate achieved at which the infusion was tolerable (i.e., no stopping, interruption, or infusion rate reduction due to a TAK-881-related TEAE). The maximum tolerable infusion rate for Infusion Site 2 depended on the planned volume according to the stepwise infusion rate escalation regimen. Number of participants who achieved maximum tolerable infusion rate per infusion sites (1 and 2) for each infusion rate (30, 60, 120, 180, and 300 milliliter per hour [mL/hour]) were reported.
Measured: Day 1 up to Day 4
Total Volume Infused Per Infusion Site for rHuPH20 and IGSC
Total volume infused per infusion sites (1 and 2) for rHuPH20 and IGSC were reported.
Measured: At Day 1
Time to Deliver the Total Infused Volume Per Infusion Site
Time to deliver (in minutes) the total infused volume was calculated as (stop date/time of IGSC 20% administration) - (start date/time of rHuPH20 administration). Time to deliver the total infused volume per infusion sites (1 and 2) were reported.
Measured: At Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start12 Oct 2021
- Primary completion12 Apr 2022
- Study completion12 Apr 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Takeda Development Center Americas, Inc., Baxalta Innovations GmbH, now part of Shire
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059977
- Sponsor's protocol ID
- TAK-881-1001
- Status last verified
- Apr 2023
- First submitted
- 27 Aug 2021
- Last updated
- 12 Jan 2024
- 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.
Publications
Nagy A, Duff K, Bauer A, Okonneh F, Rondon JC, Yel L, Li Z. A Phase 1 Open-Label Study to Assess the Tolerability, Safety, and Immunogenicity of Hyaluronidase-Facilitated Subcutaneous Immunoglobulin 20% in Healthy Adults. J Clin Immunol. 2023 Dec 22;44(1):28. doi: 10.1007/s10875-023-01632-2.
PubMed 38129731
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Dose, Single-Center, Open-Label, Three-Arm Study to Assess the Tolerability and Safety of Immune Globulin Subcutaneous (Human), 20% Solution With Recombinant Human Hyaluronidase (TAK-881) at Various Infusion Rates in Healthy Adult Subject
- ClinicalTrials.gov ID
- NCT05059977
- Acronym / sponsor ID
- TAK-881-1001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Collaborators
- Takeda Development Center Americas, Inc., Baxalta Innovations GmbH, now part of Shire
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 12 Apr 2022 (actual)
- Study completion
- 12 Apr 2022 (actual)
- First posted
- 28 Sep 2021 (actual)
- Results
- Posted 12 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aims of this study are to check for side effects from TAK-881 in healthy adults and to learn how much TAK-881 they can receive without getting side effects from it.
During the study, participants will receive one infusion of TAK-881 under the skin (subcutaneous infusion) on Day 1 at a lower dose level followed by participants receiving one infusion of higher dose levels with ongoing safety monitored by the doctor to ensure optimal tolerability and safety.
Participants will stay in the clinic for 4 days and will come back after 4 weeks. A follow up visit will take place 12 weeks after the TAK-881 infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TAK-881 0.4 g/kg (in-line warmed) | Experimental | Biological: TAK-881Participants will receive a single dose of TAK-881 comprising of 0.4 gram per kilogram (g/kg) (in-line warmed) Immune Globulin Subcutaneous (IGSC), 20 percent (%) at progressively increased infusion rates and Recombinant Human Hyaluronidase (rHuPH20) dose of 80 unit per gram (U/g) immunoglobulin G (IgG) on Day 1 of the study treatment period. |
| TAK-881 1.0 g/kg (in-line warmed) | Experimental | Biological: TAK-881Participants will receive a single dose of TAK-881 comprising of 1.0 g/kg (in-line warmed) IGSC, 20% at progressively increased infusion rates and rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period. |
| TAK-881 1.0 g/kg (un-warmed) | Experimental | Biological: TAK-881Participants will receive a single dose of TAK-881 comprising of 1.0 g/kg (un-warmed) IGSC, 20% at progressively increased infusion rates and rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period. |
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 as applicable 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 female of non-childbearing potential.
- Must be considered "healthy." Healthy as determined by the investigator on the basis of screening evaluations. 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 electrocardiogram (ECG), hematology, blood chemistry, and urinalysis.
Key exclusion criteria (26 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 participants participation in the trial and compromise the trial objectives, or any condition that presents an undue risk from the IP or procedures.
- Note: Participants on stable dose of hormone replacements (e.g., 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 IP(s), closely related compounds, or any of the stated ingredients (e.g., human immune globulin (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.
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 |
|---|---|---|
| TAK-881Also: Immune Globulin Subcutaneous (Human), 20% Solution with Recombinant Human Hyaluronidase.Participants will receive subcutaneous infusion of TAK-881 on Day 1. | Biological | TAK-881 0.4 g/kg (in-line warmed), TAK-881 1.0 g/kg (in-line warmed), TAK-881 1.0 g/kg (un-warmed) |
Primary outcome
Number of Participants With Tolerability Events Related to Infusion of TAK-881 Per Infusion Site
Time frame: Up to Day 4
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 any treatment-emergent adverse event (TEAE) related to TAK-881. Number of participants with tolerability events related to infusion of TAK-881 per infusion sites (1 and 2) were reported.
5 secondary outcomes
Number of Participants With TEAEs
Time frame: From the start of study drug administration up to Week 13
Number of Participants With Positive Binding Anti-Drug Antibodies (ADA) and Neutralizing Antibodies to rHuPH20
Time frame: Baseline up to Week 13
Number of Participants Who Achieved Maximum Tolerable Infusion Rate Per Infusion Site
Time frame: Day 1 up to Day 4
Total Volume Infused Per Infusion Site for rHuPH20 and IGSC
Time frame: At Day 1
Time to Deliver the Total Infused Volume Per Infusion Site
Time frame: At Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38129731Nagy A, Duff K, Bauer A, Okonneh F, Rondon JC, Yel L, Li Z. A Phase 1 Open-Label Study to Assess the Tolerability, Safety, and Immunogenicity of Hyaluronidase-Facilitated Subcutaneous Immunoglobulin 20% in Healthy Adults. J Clin Immunol. 2023 Dec 22;44(1):28. doi: 10.1007/s10875-023-01632-2.
- 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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Screening Protocol
Pain
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
Takeda
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 TAK-881 in people with Healthy Volunteers, run by Takeda 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 26 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 12 Jan 2024. 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 12 Jan 2024). 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 With Tolerability Events Related to Infusion of TAK-881 Per Infusion Site (time frame: Up to Day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05059977, which also lists 1 linked publication.
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 12 Jan 2024.