ClinicalTrials.Veeva

Menu

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

AbbVie logo

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

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems