Healthy Volunteers Clinical Trial
Official title:
A Phase 1, Pharmacokinetic Comparability Study of Intravenous and Subcutaneous Administration of Risankizumab in Healthy Subjects
Verified date | March 2022 |
Source | AbbVie |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objectives of this study are to assess the relative bioavailability of risankizumab in on-body delivery system (OBDS) versus the prefilled syringe (PFS) (Substudy 1) and to assess the relative bioavailability of risankizumab in the to-be-marketed Dose A liquid vial versus the Dose B liquid vial used in the Phase 3 studies (Substudy 2).
Status | Completed |
Enrollment | 394 |
Est. completion date | July 6, 2021 |
Est. primary completion date | July 6, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Body weight less than 100.00 kg at Screening and upon initial confinement. Exclusion Criteria: - Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment. |
Country | Name | City | State |
---|---|---|---|
United States | Anaheim Clinical Trials LLC /ID# 222821 | Anaheim | California |
United States | PPD Clinical Research Unit - Austin /ID# 222361 | Austin | Texas |
United States | Altasciences Clinical Los Angeles, Inc /ID# 222238 | Cypress | California |
United States | Acpru /Id# 222349 | Grayslake | Illinois |
United States | PPD Clinical Research Unit -Las Vegas /ID# 222363 | Las Vegas | Nevada |
United States | Clinical Pharmacology of Miami /ID# 225392 | Miami | Florida |
United States | PPD Clinical Research Unit /ID# 222362 | Orlando | Florida |
United States | Spaulding Clinical Research LLC /ID# 225405 | West Bend | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
AbbVie |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants Experiencing Adverse Events (AEs) | 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 140 days | |
Primary | Maximum Observed Serum Concentration (Cmax) | Maximum observed serum concentration (Cmax) of risankizumab. | Up to approximately 113 days | |
Primary | Time to Cmax (Tmax) | Time to Cmax of risankizumab. | Up to approximately 113 days | |
Primary | Apparent Terminal Phase Elimination Rate Constant (ß) | Apparent terminal phase elimination rate constant (ß) of risankizumab. | Up to approximately 113 days | |
Primary | Terminal Phase Elimination Hhalf-life (t1/2) | Terminal phase elimination half-life (t1/2) of risankizumab. | Up to approximately 113 days | |
Primary | Area Under Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) | AUCt of risankizumab. | Up to approximately 113 days | |
Primary | AUC From Time 0 to Infinity (AUCinf) | AUCinf of risankizumab. | Up to approximately 113 days |
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