A Study of TAK-881 in Healthy Adults

NCT05059977 | Completed Phase 1 Results FDA Drug

• 1 other identifier: TAK-881-1001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to Day 4

Secondary Outcomes (5)

• Number of Participants With TEAEs

  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

  Baseline up to Week 13

• Number of Participants Who Achieved Maximum Tolerable Infusion Rate Per Infusion Site

  Day 1 up to Day 4

• Total Volume Infused Per Infusion Site for rHuPH20 and IGSC

  At Day 1

• Time to Deliver the Total Infused Volume Per Infusion Site

  At Day 1

Study Arms (3)

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.

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.

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.

Biological: TAK-881

Interventions

TAK-881 BIOLOGICAL

Participants will receive subcutaneous infusion of TAK-881 on Day 1.

Also known as: Immune Globulin Subcutaneous (Human), 20% Solution with Recombinant Human Hyaluronidase.

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)

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• \- 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).
• 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.

Sponsors & Collaborators

• Takeda: lead
• Takeda Development Center Americas, Inc.: collaborator
• Baxalta Innovations GmbH, now part of Shire: collaborator

Study Sites (1)

Clinical Pharmacology of Miami

Hialeah, Florida, 33014, United States

Location

Related Publications (1)

• 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.

  PMID: 38129731 DERIVED

MeSH Terms

Interventions

gamma-Globulins; Solutions

Intervention Hierarchy (Ancestors)

Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pharmaceutical Preparations

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 28, 2021
• Study Start: October 12, 2021
• Primary Completion: April 12, 2022
• Study Completion: April 12, 2022
• Last Updated: January 12, 2024
• Results First Posted: January 12, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (1)