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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Group 2 | Experimental | Participants will receive Regimen B in Period 1, Regimen C in Period 2 followed by Regimen A in Period 3. |
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| Group 3 | Experimental | Participants will receive Regimen C in Period 1, Regimen A in Period 2 followed by Regimen B in Period 3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risankizumab | Drug | Subcutaneous autoinjector |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Rated Acceptability Assessed as Change in Self-Injection Assessment Questionnaire (SIAQ) | SIAQ is an electronic patient-reported outcomes (ePRO) device assessing participant acceptability with scores ranging from 0 (worst experience) to 10 (best experience). | Up to approximately 15 days |
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Inclusion Criteria:
- Body mass index (BMI) is >= 18.0 to <= 30.0 kg/m2.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acpru /Id# 223662 | Grayslake | Illinois | 60030 | United States |
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| ID | Term |
|---|---|
| C000601773 | risankizumab |
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