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TAK-881 for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 up to day 4
Awards & highlights

Summary

This trial tests TAK-881, a new drug, in healthy adults to check for side effects and determine the safe dosage. Participants receive increasing doses while being monitored for safety.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 up to day 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to day 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Tolerability Events Related to Infusion of TAK-881 Per Infusion Site
Secondary outcome measures
Number of Participants Who Achieved Maximum Tolerable Infusion Rate Per Infusion Site
Number of Participants With Positive Binding Anti-Drug Antibodies (ADA) and Neutralizing Antibodies to rHuPH20
Number of Participants With TEAEs
+2 more

Side effects data

From 2022 Phase 1 trial • 24 Patients • NCT05059977
100%
Infusion site erythema
88%
Infusion site swelling
50%
Infusion site pain
38%
Infusion site pruritus
13%
Diarrhoea
13%
Headache
13%
Infusion site extravasation
13%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
TAK-881 0.4 g/kg Warmed
TAK-881 1.0 g/kg Warmed
TAK-881 1.0 g/kg Un-warmed

Trial Design

3Treatment groups
Experimental Treatment
Group I: TAK-881 1.0 g/kg (un-warmed)Experimental Treatment1 Intervention
Participants will receive a single dose of TAK-881 comprising of 1.0 g/kg (un-warmed) IGSC, 20% at progressively increased infusion rates and rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period.
Group II: TAK-881 1.0 g/kg (in-line warmed)Experimental Treatment1 Intervention
Participants will receive a single dose of TAK-881 comprising of 1.0 g/kg (in-line warmed) IGSC, 20% at progressively increased infusion rates and rHuPH20 dose of 80 U/g IgG on Day 1 of the study treatment period.
Group III: TAK-881 0.4 g/kg (in-line warmed)Experimental Treatment1 Intervention
Participants will receive a single dose of TAK-881 comprising of 0.4 gram per kilogram (g/kg) (in-line warmed) Immune Globulin Subcutaneous (IGSC), 20 percent (%) at progressively increased infusion rates and Recombinant Human Hyaluronidase (rHuPH20) dose of 80 unit per gram (U/g) immunoglobulin G (IgG) on Day 1 of the study treatment period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAK-881
2021
Completed Phase 1
~30

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Baxalta Innovations GmbH, now part of ShireIndustry Sponsor
18 Previous Clinical Trials
7,992 Total Patients Enrolled
Takeda Development Center Americas, Inc.Industry Sponsor
56 Previous Clinical Trials
12,016 Total Patients Enrolled
TakedaLead Sponsor
1,213 Previous Clinical Trials
4,187,129 Total Patients Enrolled
~6 spots leftby Sep 2025
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