Study to Evaluate the Effect of Different Warm-Up Times of Risankizumab Autoinjector (AI) on the Injection Pain Experiences in Healthy Volunteers

AbbVie30 enrolled

Overview

The objective of this study is to assess the impact of different warm-up times of risankizumab autoinjector (AI) on the participant injection site pain experience in healthy adult volunteers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Volunteers

Interventions

RisankizumabDRUG

Subcutaneous autoinjector

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: \- Body mass index (BMI) is \>= 18.0 to \<= 30.0 kg/m2. Exclusion Criteria: * Any findings in the medical examination that are deviating from normal and judged as clinically relevant by the investigator. * Any laboratory value outside the reference range that the investigator considers to be of clinical relevance. * Any evidence of a concomitant disease judged as clinically relevant by the investigator. * History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, or psychiatric disease or disorder, or any other uncontrolled medical illness.

Locations (1)

Acpru /Id# 223662

Grayslake, Illinois, United States

Outcomes

Primary Outcomes

Change in Injection Site Pain Assessed Using Visual Analog Scale

Injection site-related pain assessments will be recorded directly by the participant using a VAS after the injection is complete (within approximately 5 minutes and 1 hour post-dose).

Time frame: Up to approximately 15 days

Percentage of Participants Experiencing Adverse Events

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.

Time frame: Up to approximately 155 days

Secondary Outcomes

Participant Rated Acceptability Assessed as Change in Self-Injection Assessment Questionnaire (SIAQ)

SIAQ is an electronic patient-reported outcomes (ePRO) device assessing participant acceptability with scores ranging from 0 (worst experience) to 10 (best experience).

Time frame: Up to approximately 15 days

Data from ClinicalTrials.gov

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