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Study of Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants

NCT05274100 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 394

Last updated 2022-03-10

No results posted yet for this study

Summary

The primary objectives of this study are to assess the relative bioavailability of risankizumab in on-body delivery system (OBDS) versus the prefilled syringe (PFS) (Substudy 1) and to assess the relative bioavailability of risankizumab in the to-be-marketed Dose A liquid vial versus the Dose B liquid vial used in the Phase 3 studies (Substudy 2).

Conditions

  • Healthy Volunteers

Interventions

DRUG

Risankizumab

Subcutaneous Injection via prefilled syringe (PFS)

DRUG

Risankizumab

Intravenous Infusion

DRUG

Risankizumab

Subcutaneous Injection via on-body delivery system (OBDS)

Sponsors & Collaborators

Principal Investigators

  • ABBVIE INC. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2021-07-06
Completion
2021-07-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT05274100 on ClinicalTrials.gov