A Study of Intravenously (IV) Infused or Subcutaneously (SC) Injected Risankizumab in Healthy Adult Participants in China

Healthy Volunteers Clinical Trial

Official title:

A Phase 1 Study in Healthy Chinese Subjects to Assess the Pharmacokinetics, Safety and Tolerability After a Single Dose of Risankizumab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05268068
• Other study ID #: M17-381
• Status: Completed
• Phase: Phase 1
• Start date: June 27, 2019
• Est. completion date: April 26, 2020

Study information

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

Clinical Trial Summary

The objective of this study to assess the pharmacokinetics, safety, tolerability and immunogenicity following a single subcutaneous (SC) or intravenous (IV) dose of risankizumab in healthy Chinese participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 26, 2020
• Est. primary completion date: April 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Body Mass Index (BMI) is >= 19.0 to <= 26.0 kg/m2 after rounding to the nearest tenth. BMI is calculated as weight in kg divided by the square of height measured in meters.

Exclusion Criteria:

• Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Risankizumab
Intravenous (IV) Infusion
• Risankizumab
Subcutaneous (SC) Injection

Locations

Country	Name	City	State
China	Shanghai Xuhui Central Hospital /ID# 212830	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events (AE)	An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.	Up to Approximately 140 Days
Primary	Maximum Observed Concentration (Cmax)	Maximum observed concentration.	Up to Approximately 140 Days
Primary	Time to Cmax (Tmax)	Time to Cmax.	Up to Approximately 140 Days
Primary	Terminal Phase Elimination Rate Constant (ß)	Terminal phase elimination rate constant.	Up to Approximately 140 Days
Primary	Terminal Phase Elimination Half-life (t1/2)	Terminal phase elimination half-life.	Up to Approximately 140 Days
Primary	Area Under the Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)	AUC from time 0 to time of the last measurable concentration (AUCt).	Up to Approximately 140 Days
Primary	AUC from Time 0 to Infinity (AUCinf)	AUC from time 0 to infinity (AUCinf).	Up to Approximately 140 Days
Primary	Apparent Clearance (CL/F) for Subcutaneous (SC) dosing	CL/F for SC dosing.	Up to Approximately 140 Days
Primary	Clearance (CL) for Intravenous (IV) Dosing	CL for IV dosing.	Up to Approximately 140 Days
Primary	Number of Anti-drug antibody (ADA) Titers	ADA titers will be tabulated for each participant at the respective study visits.	Up to Approximately 140 Days