Clinical trial NCT06935266: A Study of TAK-881 With and Without Ramp-Up Dosing in Healthy Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2025-04-20
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The main aim of this study is to check how well healthy adults can tolerate TAK-881 with different dosing schedules.

During the study, participants will receive one infusion of TAK-881 under the skin (subcutaneous \[SC\] infusion) on Day 1 at a lower dose level followed by participants receiving multiple infusion of higher dose levels.

Participants will be in the study for approximately 19 weeks including screening period and follow-up (End of Treatment \[EOT\]).


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.

Primary outcomes:
measure: Number of Participants With Tolerable Infusions of TAK-881
timeFrame: From start of the study drug administration up to Day 57
measure: Number of Tolerable Infusions
timeFrame: From start of the study drug administration up to Day 57
Secondary outcomes:
measure: Number of Participants With TEAEs
timeFrame: From start of the study drug administration up to Week 16
measure: Number of Participants With Clinically Significant Changes in Clinical Laboratory Values
timeFrame: Up to Week 16
measure: Number of Participants With Clinically Significant Changes in Vital Sign Values
timeFrame: Up to Week 16
measure: Number of Participants With Positive Binding Antibodies (Titer Greater Than or Equal to [>=] 1:160)
timeFrame: Up to Week 16
measure: Number of Participants With Neutralizing Antibodies to rHuPH20
timeFrame: Up to Week 16
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion
state: Arizona
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: