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

AbbVie

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Risankizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05274087

M20-200

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 3 patient groups

Group 1

Experimental group

Description:

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.

Treatment:

Drug: Risankizumab

Group 2

Experimental group

Description:

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

Treatment:

Drug: Risankizumab

Group 3

Experimental group

Description:

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

Treatment:

Drug: Risankizumab