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

Part of paid clinical trials in Grayslake, Illinois.

Sponsor
AbbVie
Study ID
NCT05274087
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 15, 2020
Status verified
Mar 2022
Primary completion
Apr 7, 2021
Completion
Apr 7, 2021

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

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

Primary Outcome Measure

Change in Injection Site Pain Assessed Using Visual Analog Scale [ Time Frame: Up to approximately 15 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Acpru /Id# 223662GrayslakeIllinois60030-

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Acpru· Grayslake, IL

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