Understanding how TAK-881 and HyQvia are processed in healthy adults

A Phase 1, Randomized, Open-Label, Pharmacokinetic Trial of TAK-881 and HyQvia in Healthy Adults

This study tests how healthy adults' bodies handle a new drug called TAK-881 and a treatment called HyQvia after a single injection to see how safe and effective they are.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Takeda (Industry-sponsored)
• Locations: 1 site (Tempe, Arizona)
• Trial ID: NCT06895967 on ClinicalTrials.gov

What this trial studies

This study aims to investigate the pharmacokinetics of TAK-881 and HyQvia by administering a single subcutaneous injection to healthy adult volunteers. Participants will be monitored for 8 days in a clinical setting, followed by 8 additional follow-up visits over a period of 85 days. The study focuses on how the body absorbs, processes, and eliminates these drugs, providing valuable data on their safety and efficacy. The findings could inform future therapeutic applications of these treatments.

Who should consider this trial

Good fit: Ideal candidates are healthy men and women aged 18 to 50 with a BMI between 18.0 and 30.0.

Not a fit: Patients with a history of significant medical conditions or those currently taking medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of drug absorption and processing, leading to improved therapeutic strategies.

How similar studies have performed: While pharmacokinetic studies are common, the specific combination of TAK-881 and HyQvia in this context is novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Tempe, Arizona

• Celerion — Tempe, Arizona, United States (Recruiting)

Study contacts

• Study coordinator: Takeda Contact

Conditions Healthy Volunteers; Drug Therapy