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A Study of TAK-881 With and Without Ramp-Up Dosing in Healthy Adults

NCT06935266 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-11-03

No results posted yet for this study

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 \[EOT\]).

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

TAK-881

TAK-881 SC injection.

DEVICE

SC Investigational Needle Sets

The single-use only SC needle set will be used to administer TAK-881 to the target depth below the skin surface. One needle set (single or bifurcated) will be used per infusion.

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-22
Primary Completion
2025-09-22
Completion
2025-09-22
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06935266 on ClinicalTrials.gov