A Phase 1 Study in Healthy Subjects to Assess Pharmacokinetics Following Intravenous and Subcutaneous Administration of Risankizumab

AbbVie

Summary

The purpose of this study is to compare how the drug moves through the body following risankizumab subcutaneous (SC) and risankizumab intravenous (IV) doses.

Eligibility

Age range: 18–65 years
Sex: All
Healthy volunteers: Yes

Detailed criteria

Inclusion Criteria: * Body weight between 40 kg and 100 kg inclusive at screening and upon initial confinement. * BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters. * A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG. Exclusion Criteria: * Exposure to any anti-interleukin-12/23 or anti interleukin-23 treatment for at least one year prior to Screening. * Intention to perform s…

Interventions

Drug
Risankizumab
Intravenous (IV)
Drug
Risankizumab
Subcutaneous (SC) Injections

Locations (2)

CenExel ACT- Anaheim Clinical Trials /ID# 281821
Anaheim, California
Cpmi /Id# 281783
Miami, Florida

A Phase 1 Study in Healthy Subjects to Assess Pharmacokinetics Following Intravenous and Subcutaneous Administration of Risankizumab

Summary

Eligibility

Interventions

Locations (2)

Run this study?

Details

Conditions