Clinical trial NCT06895967: A Study of TAK-881 and HyQvia in Healthy Adults
Official title: A Phase 1, Randomized, Open-Label, Pharmacokinetic Trial of TAK-881 and HyQvia in Healthy Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2025-03-26
Enrollment: 30
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 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.


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.

Primary outcomes:
measure: Baseline-corrected Area Under the Concentration-time Curve (AUC) From Day 1 to Day 29 (AUC Day1-29) Based on Serum Total Immunoglobulin G (IgG) Levels
timeFrame: Day 1 up to Day 29
Secondary outcomes:
measure: Baseline-Uncorrected Maximum Observed Concentration (Cmax) Based on Serum Total IgG Levels
timeFrame: From Screening up to Day 85
measure: Baseline-Uncorrected Time to Maximum Concentration (Tmax) Based on Serum Total IgG Levels
timeFrame: From Screening up to Day 85
measure: Baseline-Uncorrected AUC Day1-29 Based on Serum Total IgG Levels
timeFrame: Day 1 up to Day 29
measure: Baseline-corrected AUC from Day 1 to infinity (AUCinf) Based on Serum Total IgG Levels
timeFrame: From Day 1 up to Day 85
measure: Baseline-corrected AUC from Day 1 to Time of the Last Measurable Concentration (AUClast) Based on Serum Total IgG Levels
timeFrame: From Day 1 up to Day 85
measure: Baseline-corrected Cmax Based on Serum Total IgG Levels
timeFrame: From Day 1 up to Day 85
measure: Baseline-corrected Tmax Based on Serum Total IgG Levels
timeFrame: From Day 1 up to Day 85
measure: Baseline-corrected Time of last measurable concentration (Tlast) Based on Serum Total IgG Levels
timeFrame: From Day 1 up to Day 85
measure: Baseline-corrected Terminal Half-life (t1/2z) Based on Serum Total IgG Levels
timeFrame: From Day 1 up to Day 85
measure: Baseline-corrected Apparent Clearance (CL/F) Based on Serum Total IgG Levels
timeFrame: From Day 1 up to Day 85
measure: Baseline-corrected Apparent Volume of Distribution (Vz/F) Based on Serum Total IgG Levels
timeFrame: From Day up to Day 85
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From first dose of study drug up to Day 85
measure: Number of Participants With Infusion Withdrawals, Interruptions, and Infusion Rate Reductions
timeFrame: From first dose of study drug up to Day 85
measure: Number of Participants With Positive Binding Antibodies to rHuPH20
timeFrame: From first dose of study drug up to Day 85
measure: Number of Participants With Neutralizing Antibodies to rHuPH20
timeFrame: From first dose of study drug up to Day 85
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion
state: Arizona
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: