NCT06935266

Brief Summary

The main aim of this study is to check how well healthy adults can tolerate TAK-881 with different dosing schedules. During the study, participants will receive one infusion of TAK-881 under the skin (subcutaneous \[SC\] infusion) on Day 1 at a lower dose level followed by participants receiving multiple infusion of higher dose levels. Participants will be in the study for approximately 19 weeks including screening period and follow-up (End of Treatment \[EOT\]).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 20, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

April 22, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2025

Completed
Last Updated

November 3, 2025

Status Verified

October 1, 2025

Enrollment Period

5 months

First QC Date

April 11, 2025

Last Update Submit

October 31, 2025

Conditions

Healthy Volunteers

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With Tolerable Infusions of TAK-881

    A tolerable infusion is considered to have occurred if an infusion is completed without interruption (discontinuing the infusion, or infusion rate reduction) due to any treatment-emergent adverse events (TEAEs) related to TAK-881.

    From start of the study drug administration up to Day 57

  • Number of Tolerable Infusions

    A tolerable infusion is considered to have occurred if an infusion is completed without interruption (discontinuing the infusion, or infusion rate reduction) due to any TEAEs related to TAK-881.

    From start of the study drug administration up to Day 57

Secondary Outcomes (5)

  • Number of Participants With TEAEs

    From start of the study drug administration up to Week 16

  • Number of Participants With Clinically Significant Changes in Clinical Laboratory Values

    Up to Week 16

  • Number of Participants With Clinically Significant Changes in Vital Sign Values

    Up to Week 16

  • Number of Participants With Positive Binding Antibodies (Titer Greater Than or Equal to [>=] 1:160)

    Up to Week 16

  • Number of Participants With Neutralizing Antibodies to rHuPH20

    Up to Week 16

Study Arms (8)

Cohort 1, Schedule B, Treatment Arm 1: TAK-881

EXPERIMENTAL

Participants will receive TAK-881, subcutaneous (SC) injection, 0.15 grams per kilogram (g/kg) on Day 1, 0.3 g/kg on Day 8, 0.6 g/kg on Days 22 and 50 in ramp-up dosing manner.

Biological: TAK-881Device: SC Investigational Needle Sets

Cohort 1, Schedule C, Treatment Arm 2: TAK-881

EXPERIMENTAL

Participants will receive TAK-881, SC injection, 0.6 g/kg on Days 1, 29 and 57 in no ramp-up dosing manner.

Biological: TAK-881Device: SC Investigational Needle Sets

Cohort 2, Schedule A, Treatment Arm 3: TAK-881

EXPERIMENTAL

Participants will receive TAK-881, SC injection, 0.25 g/kg on Days 1 and 8, 0.5 g/kg on Day 15, 0.75 g/kg on Day 29 and 1.0 g/kg on Day 50 in ramp-up dosing manner.

Biological: TAK-881Device: SC Investigational Needle Sets

Cohort 2, Schedule B: Treatment Arm 4: TAK-881

EXPERIMENTAL

Participants will receive TAK-881, SC injection, 0.25 g/kg on Day 1, 0.5 g/kg on Day 8, 1.0 g/kg on Days 22 and 50 in ramp-up dosing manner.

Biological: TAK-881Device: SC Investigational Needle Sets

Cohort 2, Schedule C: Treatment Arm 5: TAK-881

EXPERIMENTAL

Participants will receive TAK-881, SC injection, 1.0 g/kg on Days 1, 29 and 57 in no ramp-up dosing manner.

Biological: TAK-881Device: SC Investigational Needle Sets

Cohort 3, Schedule A: Treatment Arm 6: TAK-881

EXPERIMENTAL

Participants will receive TAK-881, SC injection, 0.5 g/kg on Days 1 and 8, 1.0 g/kg on Day 15, 1.5 g/kg on Day 29 and 2.0 g/kg on Day 50 in ramp-up dosing manner.

Biological: TAK-881Device: SC Investigational Needle Sets

Cohort 3, Schedule B: Treatment Arm 7: TAK-881

EXPERIMENTAL

Participants will receive TAK-881, SC injection, 0.5 g/kg on Day 1, 1.0 g/kg on Day 8, 2.0 g/kg on Days 22 and 50 in ramp-up dosing manner.

Biological: TAK-881Device: SC Investigational Needle Sets

Cohort 3, Schedule C: Treatment Arm 8: TAK-881

EXPERIMENTAL

Participants will receive TAK-881, SC injection, 2.0 g/kg, on Days 1, 29 and 57 in no ramp-up dosing manner.

Biological: TAK-881Device: SC Investigational Needle Sets

Interventions

TAK-881BIOLOGICAL

TAK-881 SC injection.

Also known as: Immune Globulin Subcutaneous (Human), 20% Solution with Recombinant Human Hyaluronidase (rHuPH20), 20% Solution with Recombinant Human Hyaluronidase (rHuPH20)
Cohort 1, Schedule B, Treatment Arm 1: TAK-881Cohort 1, Schedule C, Treatment Arm 2: TAK-881Cohort 2, Schedule A, Treatment Arm 3: TAK-881Cohort 2, Schedule B: Treatment Arm 4: TAK-881Cohort 2, Schedule C: Treatment Arm 5: TAK-881Cohort 3, Schedule A: Treatment Arm 6: TAK-881Cohort 3, Schedule B: Treatment Arm 7: TAK-881Cohort 3, Schedule C: Treatment Arm 8: TAK-881
SC Investigational Needle SetsDEVICE

The single-use only SC needle set will be used to administer TAK-881 to the target depth below the skin surface. One needle set (single or bifurcated) will be used per infusion.

Cohort 1, Schedule B, Treatment Arm 1: TAK-881Cohort 1, Schedule C, Treatment Arm 2: TAK-881Cohort 2, Schedule A, Treatment Arm 3: TAK-881Cohort 2, Schedule B: Treatment Arm 4: TAK-881Cohort 2, Schedule C: Treatment Arm 5: TAK-881Cohort 3, Schedule A: Treatment Arm 6: TAK-881Cohort 3, Schedule B: Treatment Arm 7: TAK-881Cohort 3, Schedule C: Treatment Arm 8: TAK-881

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men and Women between 18 and 50 years can participate.
  • Must be a non-smoker, with no use of nicotine or tobacco products for at least 3 months prior to the first dosing.
  • Must have Body Mass Index (BMI) between 18.0 and 30.0 kilograms per square meter (kg/m\^2).
  • Must be medically healthy.
  • Must follow protocol-specified contraception guidance.

You may not qualify if:

  • Any current or past medical history of blood/clotting disorder, liver, lung, heart, kidney, immune, skin, or brain or psychiatric condition.
  • History of alcohol or drug abuse within 2 years before dosing.
  • History or presence of hypersensitivity or severe allergic reactions to blood or blood components.
  • History or presence of thrombotic/thromboembolic events, or venous thrombosis.
  • Pregnant or breastfeeding.
  • Unable to refrain from taking prescription and non-prescription medications, herbal remedies, homeopathic preparations, or vitamin supplements.
  • Recently donated blood or blood products.
  • Participated in another clinical trial involving immunoglobulin products within 12 months of screening.
  • Has taken biologic agents within 12 weeks of screening.
  • Has used an investigational product within 30 days or 5 half-lives, whichever is longer, prior to screening.
  • Has received any vaccine (including live attenuated vaccines and coronavirus disease 2019 \[COVID-19\] vaccines) during the last 30 days before dosing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

Related Links

MeSH Terms

Interventions

gamma-GlobulinsSolutions

Intervention Hierarchy (Ancestors)

ImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPharmaceutical Preparations

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2025

First Posted

April 20, 2025

Study Start

April 22, 2025

Primary Completion

September 22, 2025

Study Completion

September 22, 2025

Last Updated

November 3, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
More information

Locations

US(1)