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

NCT05274087 | Completed Phase 1 FDA Drug

• 1 other identifier: M20-200
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

Risankizumab

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

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

  Up to approximately 15 days

Study Arms (3)

Group 1

EXPERIMENTAL

Participants will receive Regimen A (15-minute autoinjector (AI) warm-up time) in Period 1, Regimen B (30-minute AI warm-up time) in Period 2 followed by Regimen C (45-minute AI warm-up time) in Period 3.

Drug: Risankizumab

Group 2

EXPERIMENTAL

Participants will receive Regimen B in Period 1, Regimen C in Period 2 followed by Regimen A in Period 3.

Drug: Risankizumab

Group 3

EXPERIMENTAL

Participants will receive Regimen C in Period 1, Regimen A in Period 2 followed by Regimen B in Period 3.

Drug: Risankizumab

Interventions

Risankizumab DRUG

Subcutaneous autoinjector

Also known as: SKYRIZI

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Body mass index (BMI) is \>= 18.0 to \<= 30.0 kg/m2.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Acpru /Id# 223662

Grayslake, Illinois, 60030, United States

Location

MeSH Terms

Interventions

risankizumab

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 10, 2022
• Study Start: September 15, 2020
• Primary Completion: April 7, 2021
• Study Completion: April 7, 2021
• Last Updated: March 10, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)