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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05274100
Other study ID # M19-128
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 1, 2020
Est. completion date July 6, 2021

Study information

Verified date March 2022
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 394
Est. completion date July 6, 2021
Est. primary completion date July 6, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Body weight less than 100.00 kg at Screening and upon initial confinement. Exclusion Criteria: - Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Risankizumab
Subcutaneous Injection via prefilled syringe (PFS)
Risankizumab
Intravenous Infusion
Risankizumab
Subcutaneous Injection via on-body delivery system (OBDS)

Locations

Country Name City State
United States Anaheim Clinical Trials LLC /ID# 222821 Anaheim California
United States PPD Clinical Research Unit - Austin /ID# 222361 Austin Texas
United States Altasciences Clinical Los Angeles, Inc /ID# 222238 Cypress California
United States Acpru /Id# 222349 Grayslake Illinois
United States PPD Clinical Research Unit -Las Vegas /ID# 222363 Las Vegas Nevada
United States Clinical Pharmacology of Miami /ID# 225392 Miami Florida
United States PPD Clinical Research Unit /ID# 222362 Orlando Florida
United States Spaulding Clinical Research LLC /ID# 225405 West Bend Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants Experiencing Adverse Events (AEs) An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. Up to approximately 140 days
Primary Maximum Observed Serum Concentration (Cmax) Maximum observed serum concentration (Cmax) of risankizumab. Up to approximately 113 days
Primary Time to Cmax (Tmax) Time to Cmax of risankizumab. Up to approximately 113 days
Primary Apparent Terminal Phase Elimination Rate Constant (ß) Apparent terminal phase elimination rate constant (ß) of risankizumab. Up to approximately 113 days
Primary Terminal Phase Elimination Hhalf-life (t1/2) Terminal phase elimination half-life (t1/2) of risankizumab. Up to approximately 113 days
Primary Area Under Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) AUCt of risankizumab. Up to approximately 113 days
Primary AUC From Time 0 to Infinity (AUCinf) AUCinf of risankizumab. Up to approximately 113 days
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