A Study in Healthy Japanese and Caucasian Subjects to Assess the Pharmacokinetics, Safety and Tolerability of Risankizumab

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Placebo; Drug: 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

Study Timeline

• Study Start: 2017-10-23
• Primary Completion: 2018-06-15
• Study Completion: 2018-06-15
• Status Verified: 2022-03
• Study First Submitted: 2022-03-23
• Study First Submitted QC: 2022-03-23
• Last Update Submitted: 2022-03-23
• Study First Posted: 2022-03-31
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 17

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

Trial Locations

Locations (1)

Altasciences Clinical Los Angeles, Inc /ID# 164197; 🇺🇸 Cypress, California, United States