TAK-881 and HyQvia for Healthy Adults

Overseen By Takeda Contact

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Takeda

Must not be taking: Biologics, Vaccines, others

Disqualifiers: Blood disorders, Liver, Heart, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 17

Duration: 1 day

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, you will need to stop taking prescription and non-prescription medications, herbal remedies, homeopathic preparations, or vitamin supplements to participate in this trial.

What is the purpose of this trial?

The main aim of this study is to understand how the body absorbs, processes, and removes (known as pharmacokinetics or PK) TAK-881 and HyQvia, after they are given as a single injection under the skin in healthy adults. Study participants will receive a single dose of TAK-881 or HyQvia on Day 1. During the study, participants will need to stay at the clinic for 8 days followed by 8 ambulatory follow up visits till Day 85.

Research Team

Study Director

Principal Investigator

Takeda

Eligibility Criteria

This trial is for healthy adults who can stay at the clinic for 8 days and commit to follow-up visits until Day 85. Specific eligibility details are not provided, but typically participants must meet certain health standards.

Inclusion Criteria

Must be medically healthy

Must follow protocol-specified contraception guidance

Must be a non-smoker, with no use of nicotine or tobacco products

Exclusion Criteria

Pregnant or breastfeeding

Recently donated blood or blood products

History of alcohol or drug abuse within 2 years before dosing

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of TAK-881 or HyQvia on Day 1

1 day

1 visit (in-person)

In-clinic Observation

Participants stay at the clinic for observation after receiving the dose

8 days

8 days (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

77 days

8 visits (ambulatory)

Treatment Details

Interventions

• HyQvia
• TAK-881

Trial Overview The study is testing how TAK-881 and HyQvia are absorbed and processed by the body when given as a single under-the-skin injection. Participants will receive one dose on Day 1 and be monitored over an extended period.

Participant Groups

Group I: TAK-881 1.0 g/kg Experimental Treatment 2 Interventions

Participants will receive TAK-881, 1.0 gram per Kilogram (g/kg), single subcutaneous (SC) injection using investigational needle sets on Day 1.

Group II: HyQvia 1g/kg Experimental Treatment 2 Interventions

Participants will receive HyQvia, 1.0 g/kg, single SC injection using investigational needle sets on Day 1.

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier