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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05305222
• Other study ID #: M16-533
• Status: Completed
• Phase: Phase 1
• Start date: October 23, 2017
• Est. completion date: June 15, 2018

Study information

• Verified date: March 2022
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 15, 2018
• Est. primary completion date: June 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Risankizumab
Intravenous (IV) Infusion
• Placebo
Intravenous (IV) Infusion

Locations

Country	Name	City	State
United States	Altasciences Clinical Los Angeles, Inc /ID# 164197	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing Adverse Events	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.	Up to approximately 137 days
Primary	Maximum Observed Plasma Concentration (Cmax) of Risankizumab	Maximum observed plasma concentration (Cmax) of Risankizumab.	Up to approximately 137 days
Primary	Time to Cmax (Cmax) of Risankizumab	Tmax of Risankizumab.	Up to approximately 137 days
Primary	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Last Measurable Concentration (AUCt) of Risankizumab	AUCt of Risankizumab.	Up to approximately 137 days
Primary	Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCinf) of Risankizumab	AUCinf of Risankizumab.	Up to approximately 137 days
Primary	Apparent Terminal Phase Elimination Rate Constant (ß) of Risankizumab	Apparent terminal phase elimination rate constant (ß) of Risankizumab.	Up to approximately 137 days
Primary	Terminal Phase Elimination Half-life (t1/2) of Risankizumab	Terminal phase elimination half-life (t1/2) of Risankizumab.	Up to approximately 137 days