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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 up to day 4

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Tolerability Events Related to Infusion of TAK-881 Per Infusion Site

Secondary study objectives

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%

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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