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

Healthy Volunteers Clinical Trial

Official title:

A Randomized, Double-Blind, Three-Period Crossover Study to Evaluate the Effect of Different Warm-Up Times of Risankizumab Autoinjector (AI) on the Injection Pain Experiences in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05274087
• Other study ID #: M20-200
• Status: Completed
• Phase: Phase 1
• Start date: September 15, 2020
• Est. completion date: April 7, 2021

Study information

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

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 7, 2021
• Est. primary completion date: April 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Risankizumab
Subcutaneous autoinjector

Locations

Country	Name	City	State
United States	Acpru /Id# 223662	Grayslake	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Up to approximately 15 days
Primary	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.	Up to approximately 155 days
Secondary	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).	Up to approximately 15 days