A Study to Evaluate the Bioavailability of Risankizumab Following Subcutaneous Dosing in Healthy Male Participants

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: risankizumab

• Registration Number: NCT05283694
• Lead Sponsor: AbbVie

Brief Summary

The objective of this study is to evaluate the bioavailability, safety and tolerability of risankizumab following subcutaneous injections in healthy male participants.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-11
• Primary Completion: 2018-06-12
• Study Completion: 2018-06-12
• Status Verified: 2022-03
• Study First Submitted: 2022-03-09
• Study First Submitted QC: 2022-03-09
• Last Update Submitted: 2022-03-09
• Study First Posted: 2022-03-17
• Last Update Posted: 2022-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

Inclusion Criteria

• Body weight less than 100.00 kg inclusive at Screening and Check-In Day.
• Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2 after rounded to the tenths decimal, at Screening and upon confinement.

Read More

Exclusion Criteria

• Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.
• History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Risankizumab Dose A	risankizumab	Participants will receive 3 Subcutaneous (SC) injections of risankizumab Dose A administered via prepared syringe at Day 1 and followed for 140 days.
Risankizumab Dose B	risankizumab	Participants will receive 1 SC injection of risankizumab Dose B administered via syringe pump at Day 1 and followed for 140 days.
Risankizumab Dose C	risankizumab	Participants will receive 1 SC injection of risankizumab Dose C administered via syringe pump at Day 1 and followed for 140 days.
Risankizumab Dose D	risankizumab	Participants will receive 1 SC injection of risankizumab Dose D administered via prepared syringe at Day 1 and followed for 140 days.

Primary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax)	Up to 140 Days	Maximum Observed Plasma Concentration
Time to maximum observed plasma concentration (Tmax)	Up to 140 Days	Time to maximum observed plasma concentration
Terminal phase elimination rate constant (β)	Up to 140 Days	Terminal phase elimination rate constant
AUC from time 0 to infinity (AUCinf)	Up to 140 Days	AUC from time 0 to infinity
Terminal phase elimination half-life (t1/2).	Up to 140 Days	Terminal phase elimination half-life
Area under the plasma concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUCt)	Up to 140 Days	AUC from time 0 to the time of last measurable concentration
Number of Anti-drug antibody (ADA) Titers	Up to 140 Days	Incidence of anti-drug antibodies
Number of Participants with Adverse Events	Up to 140 Days	An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.

Trial Locations

Locations (1)

Acpru /Id# 165737; 🇺🇸 Grayslake, Illinois, United States