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

AbbVie48 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

risankizumabDRUG

Subcutaneous Injection via prepared syringe

risankizumabDRUG

Subcutaneous Injection via syringe pump

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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. 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.

Locations (1)

Acpru /Id# 165737

Grayslake, Illinois, United States

Outcomes

Primary Outcomes

Maximum Observed Plasma Concentration (Cmax)

Maximum Observed Plasma Concentration

Time frame: Up to 140 Days

Time to maximum observed plasma concentration (Tmax)

Time to maximum observed plasma concentration

Time frame: Up to 140 Days

Area under the plasma concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUCt)

AUC from time 0 to the time of last measurable concentration

Time frame: Up to 140 Days

AUC from time 0 to infinity (AUCinf)

AUC from time 0 to infinity

Time frame: Up to 140 Days

Terminal phase elimination rate constant (β)

Terminal phase elimination rate constant

Time frame: Up to 140 Days

Terminal phase elimination half-life (t1/2).

Terminal phase elimination half-life

Time frame: Up to 140 Days

Number of Anti-drug antibody (ADA) Titers

Incidence of anti-drug antibodies

Time frame: Up to 140 Days

Number of Participants with Adverse Events

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.

Time frame: Up to 140 Days

Data from ClinicalTrials.gov

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