Phase 1
N=24
A Study of TAK-881 in Healthy Adults
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT05059977 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Number of Participants With Tolerability Events Related to Infusion of TAK-881 Per Infusion Site — 8; 8; 8; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- TAK-881 (Biological)
- Age
- Adult · 19+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Tolerability Events Related to Infusion of TAK-881 Per Infusion Site |
8; 8; 8; 4; 7 | — |
| SECONDARY Number of Participants With TEAEs |
8; 8; 8 | — |
| SECONDARY Number of Participants With Positive Binding Anti-Drug Antibodies (ADA) and Neutralizing Antibodies to rHuPH20 |
0; 0; 0 | — |
| SECONDARY Number of Participants Who Achieved Maximum Tolerable Infusion Rate Per Infusion Site |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Total Volume Infused Per Infusion Site for rHuPH20 and IGSC |
14.3; 29.3; 29.4; 10.0; 7.3; 141.3 | — |
| SECONDARY Time to Deliver the Total Infused Volume Per Infusion Site |
63.5; 99.5; 102.0; 53.0; 41.0 | — |
Summary
The main aims of this study are to check for side effects from TAK-881 in healthy adults and to learn how much TAK-881 they can receive without getting side effects from it.
During the study, participants will receive one infusion of TAK-881 under the skin (subcutaneous infusion) on Day 1 at a lower dose level followed by participants receiving one infusion of higher dose levels with ongoing safety monitored by the doctor to ensure optimal tolerability and safety.
Participants will stay in the clinic for 4 days and will come back after 4 weeks. A follow up visit will take place 12 weeks after the TAK-881 infusion.
Eligibility Criteria
Inclusion Criteria
- An understanding, ability, and willingness to fully comply with study procedures and restrictions.
- Ability to voluntarily provide written, signed, and dated (personally or via a legally-authorized representative) informed consent as applicable to participate in the study.
- Age 19-50 years inclusive at the time of consent. The date of signature of the informed consent is defined as the beginning of the screening period. This inclusion criterion will only be assessed at the first screening visit.
- Male, or non-pregnant, non-breastfeeding female who agrees to comply with any applicable contraceptive requirements of the protocol, or female of non-childbearing potential.
- Must be considered "healthy." Healthy as determined by the investigator on the basis of screening evaluations. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, and urinalysis.
- Body mass index (BMI) between 18.0 and 30.0 kilogram per square meter (kg/m^2) inclusive.
Exclusion Criteria
- Any current or relevant history of medical (e.g., any hematological, hepatic, respiratory, cardiovascular, renal, or neurological) or psychiatric conditions, which by judgment of the investigator might compromise the safety of the participant or integrity of the study, interfere with the participants participation in the trial and compromise the trial objectives, or any condition that presents an undue risk from the IP or procedures.
Note: Participants on stable dose of hormone replacements (e.g., thyroid hormone replacement) or oral contraceptives are permitted.
- Clinically significant cardiac conditions including but not limited to uncontrolled hypertension, myocardial infarction, unstable coronary artery disease and clinically significant arrhythmias and conduction disorders.
- Known or suspected intolerance or hypersensitivity to the IP(s), closely related compounds, or any of the stated ingredients (e.g., human immune globulin (IG), hyaluronidase, albumin).
- Known history of hypersensitivity or severe allergic reactions (e.g., urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following administration of blood or blood components.
- Known allergy to hyaluronidase of human (including recombinant human hyaluronidase) or animal origin (such as bee or wasp venom).
- Significant illness, as judged by the investigator, within 30 days of the first dose of IP.
- Known history of alcohol or other substance abuse within the last year.
- Donation of blood within 60 days, or blood products (e.g., plasma or platelets) within 2 weeks prior receiving the first dose of IP.
- Participants will be excluded if abnormal hematology, chemistry, and other laboratory values are greater than (>)10% above the upper limit of normal (ULN) or >10% below the lower limit of normal (LLN) except for liver function tests and absolute neutrophils. Participants will be excluded if any of the following laboratory parameters meet the criteria below:
- Absolute neutrophil count less than ( =) 1.5* ULN, aspartate aminotransferase (AST) >=1.5* ULN, alkaline phosphatase (ALP) >=1.5* ULN, or total bilirubin >=1.5 milligram per deciliter (mg/dL)
- Participants will be excluded if any other laboratory values are outside the reference range and are clinically significant per investigator's judgment.
- Participants who, within 30 days prior to the first dose of IP:
- Have participated in another clinical study involving IG products within 12 months of screening.
- Have used an IP (or 5 half-lives, whichever is longer).
- Have been enrolled in a clinical study (including vaccine studies or has been vaccinated with approved product) that, in the investigator's opinion, may impact this study. Participants who have received any vaccine (including live attenuated vaccines and
Data sourced from ClinicalTrials.gov (NCT05059977). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.