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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-15

Study Completion Date

2021-04-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Risankizumab

Intervention Type DRUG

Subcutaneous autoinjector

Group 2

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

Group Type EXPERIMENTAL

Risankizumab

Intervention Type DRUG

Subcutaneous autoinjector

Group 3

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

Group Type EXPERIMENTAL

Risankizumab

Intervention Type DRUG

Subcutaneous autoinjector

Interventions

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Risankizumab

Subcutaneous autoinjector

Intervention Type DRUG

Other Intervention Names

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SKYRIZI

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes