A Study in Healthy Japanese and Caucasian Subjects to Assess the Pharmacokinetics, Safety and Tolerability of Risankizumab
- Registration Number
- NCT05305222
- Lead Sponsor
- AbbVie
- Brief Summary
The main objective of this study is to assess the pharmacokinetics, safety, tolerability and immunogenicity following a single intravenous (IV) infusion of risankizumab in healthy Japanese and Caucasian participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 17
- Must be first or second generation Japanese of full parentage residing outside of Japan for less than 10 years. First generation participants will have been born to two parents and four grandparents also born in Japan of full Japanese descent. Second generation participants born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent. All participants must maintain a typical Japanese lifestyle, including consuming a typical Japanese diet or participants must be Caucasian and not of Hispanic ethnicity.
- Body Mass Index (BMI) is >= 18.5 and <= 29.9 kg/m2 (after rounding to the tenths decimal) at Screening. BMI is calculated as weight in kilograms (kg) divided by the square of height measured in meters (m).
- Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Japanese Participants Receiving Placebo Placebo Participants will receive single dose of placebo. Caucasian Participants Receiving Placebo Placebo Participants will receive single dose of placebo. Japanese Participants Receiving Risankizumab Risankizumab Participants will receive single dose of risankizumab. Caucasian Participants Receiving Risankizumab Risankizumab Participants will receive single dose of risankizumab.
- Primary Outcome Measures
Name Time Method Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab Up to approximately 137 days Apparent terminal phase elimination rate constant (β) of Risankizumab.
Terminal Phase Elimination Half-life (t1/2) of Risankizumab Up to approximately 137 days Terminal phase elimination half-life (t1/2) of Risankizumab.
Maximum Observed Plasma Concentration (Cmax) of Risankizumab Up to approximately 137 days Maximum observed plasma concentration (Cmax) of Risankizumab.
Time to Cmax (Cmax) of Risankizumab Up to approximately 137 days Tmax of Risankizumab.
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Last Measurable Concentration (AUCt) of Risankizumab Up to approximately 137 days AUCt of Risankizumab.
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCinf) of Risankizumab Up to approximately 137 days AUCinf of Risankizumab.
Number of Participants Experiencing Adverse Events Up to approximately 137 days An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Altasciences Clinical Los Angeles, Inc /ID# 164197
🇺🇸Cypress, California, United States