Testing the drug TAK-881 in healthy adults with different dosing schedules

A Phase 1, Open-Label, Within-Dose-Level Randomized Trial to Assess the Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous 20% (Human) With Recombinant Human Hyaluronidase (TAK-881) With Ramp-Up and No Ramp-Up Dosing in Healthy Adult Participants

This study is testing how well healthy adults can tolerate the drug TAK-881 when given in different doses over about 19 weeks.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Takeda (Industry-sponsored)
• Locations: 1 site (Tempe, Arizona)
• Trial ID: NCT06935266 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the tolerance of healthy adults to the drug TAK-881 through various dosing schedules. Participants will receive a subcutaneous infusion of TAK-881 starting at a lower dose on Day 1, followed by multiple infusions at higher dose levels. The study will last approximately 19 weeks, including a screening period and follow-up after treatment. The focus is on understanding how well the drug is tolerated in a healthy population.

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 kg/m².

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 provide insights into the safety and tolerability of TAK-881, paving the way for its use in future treatments.

How similar studies have performed: Other studies evaluating drug tolerability in healthy volunteers have shown success, indicating that this approach is well-established.

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 for at least 3 months prior to the first dosing.
3. Must have Body Mass Index (BMI) between 18.0 and 30.0 kilograms per square meter (kg/m\^2).
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 coronavirus disease 2019 \[COVID-19\] 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