A Study of TAK-881 and HyQvia in Healthy Adults

Takeda

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Biological: TAK-881; Biological: HyQvia; Device: SC Investigational Needle Sets

Study type: Interventional

Funder types: Industry

Identifiers

NCT06895967

TAK-881-1002

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Men and Women between 18 and 50 years can participate.
2. Must be a non-smoker, with no use of nicotine or tobacco products.
3. Must have Body Mass Index (BMI) between 18.0 and 30.0, and body weight under 120 kilograms (kg).
4. Must be medically healthy.
5. Must follow protocol-specified contraception guidance.

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

TAK-881 1.0 g/kg

Experimental group

Description:

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

Treatment:

Device: SC Investigational Needle Sets

Biological: TAK-881

Device: SC Investigational Needle Sets

HyQvia 1g/kg

Experimental group

Description:

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

Treatment:

Device: SC Investigational Needle Sets

Biological: HyQvia

Device: SC Investigational Needle Sets