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Study to Evaluate the Relative Bioavailability of Two Risankizumab Drug Product Presentations in Healthy Volunteers.

NCT05567029 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2023-04-28

No results posted yet for this study

Summary

This study will assess how safe risankizumab is and how risankizumab moves through the body of adult healthy participants. Adverse Events will be assessed.

Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease. Participants are randomly assigned to one of the 2 treatment groups. Approximately 198 adult healthy volunteers will be enrolled in at least 4 sites across the world.

All participants will receive risankizumab as subcutaneous injections in one of the 2 different formulations.

There may be higher burden for participants in this trial. Participants will be confined for 10 days and followed up for 140 days. Adverse Events and blood tests will be collected.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Risankizumab Dose A

Prefilled Syringe

DRUG

Risankizumab Dose B

Prefilled Syringe

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
2022-09-28
Primary Completion
2023-04-20
Completion
2023-04-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05567029 on ClinicalTrials.gov