Study of Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Risankizumab

• Registration Number: NCT05274100
• Lead Sponsor: AbbVie

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-01
• Primary Completion: 2021-07-06
• Study Completion: 2021-07-06
• Status Verified: 2022-03
• Study First Submitted: 2022-03-08
• Study First Submitted QC: 2022-03-08
• Last Update Submitted: 2022-03-08
• Study First Posted: 2022-03-10
• Last Update Posted: 2022-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 394

Inclusion Criteria

• Body weight less than 100.00 kg at Screening and upon initial confinement.

Read More

Exclusion Criteria

• Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: Risankizumab Dose B	Risankizumab	Participants will receive risankizumab dose B.
Group 3: Risankizumab Dose C	Risankizumab	Participants will receive risankizumab dose C.
Group 1: Risankizumab Dose A	Risankizumab	Participants will receive risankizumab dose A.
Group 4: Risankizumab Dose D	Risankizumab	Participants will receive risankizumab dose D.
Group 5: Risankizumab Dose D	Risankizumab	Participants will receive risankizumab dose D.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Experiencing Adverse Events (AEs)	Up to approximately 140 days	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.
Maximum Observed Serum Concentration (Cmax)	Up to approximately 113 days	Maximum observed serum concentration (Cmax) of risankizumab.
Area Under Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt)	Up to approximately 113 days	AUCt of risankizumab.
AUC From Time 0 to Infinity (AUCinf)	Up to approximately 113 days	AUCinf of risankizumab.
Time to Cmax (Tmax)	Up to approximately 113 days	Time to Cmax of risankizumab.
Apparent Terminal Phase Elimination Rate Constant (β)	Up to approximately 113 days	Apparent terminal phase elimination rate constant (β) of risankizumab.
Terminal Phase Elimination Hhalf-life (t1/2)	Up to approximately 113 days	Terminal phase elimination half-life (t1/2) of risankizumab.

Trial Locations

Locations (8)

PPD Clinical Research Unit - Austin /ID# 222361; 🇺🇸 Austin, Texas, United States

Altasciences Clinical Los Angeles, Inc /ID# 222238; 🇺🇸 Cypress, California, United States

Anaheim Clinical Trials LLC /ID# 222821; 🇺🇸 Anaheim, California, United States

Clinical Pharmacology of Miami /ID# 225392; 🇺🇸 Miami, Florida, United States

PPD Clinical Research Unit /ID# 222362; 🇺🇸 Orlando, Florida, United States

Acpru /Id# 222349; 🇺🇸 Grayslake, Illinois, United States

PPD Clinical Research Unit -Las Vegas /ID# 222363; 🇺🇸 Las Vegas, Nevada, United States

Spaulding Clinical Research LLC /ID# 225405; 🇺🇸 West Bend, Wisconsin, United States