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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Risankizumab

• Registration Number: NCT05268068
• Lead Sponsor: AbbVie

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-27
• Primary Completion: 2020-04-26
• Study Completion: 2020-04-26
• Status Verified: 2022-03
• Study First Submitted: 2022-03-03
• Study First Submitted QC: 2022-03-03
• Last Update Submitted: 2022-03-03
• Study First Posted: 2022-03-07
• Last Update Posted: 2022-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose C of Risankizumab for Intravenous (IV) Infusion	Risankizumab	Participants will receive IV infusion of risankizumab at dose C and then followed for 140 days.
Dose A of Risankizumab for Subcutaneous (SC) Injection	Risankizumab	Participants will receive SC injections of risankizumab at dose A and then followed for 140 days.
Dose B of Risankizumab for Subcutaneous (SC) Injection	Risankizumab	Participants will receive SC injections of risankizumab at dose B and then followed for 140 days.

Primary Outcome Measures

Name	Time	Method
Apparent Clearance (CL/F) for Subcutaneous (SC) dosing	Up to Approximately 140 Days	CL/F for SC dosing.
Clearance (CL) for Intravenous (IV) Dosing	Up to Approximately 140 Days	CL for IV dosing.
Number of Participants with Adverse Events (AE)	Up to Approximately 140 Days	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.
Time to Cmax (Tmax)	Up to Approximately 140 Days	Time to Cmax.
Terminal Phase Elimination Half-life (t1/2)	Up to Approximately 140 Days	Terminal phase elimination half-life.
Maximum Observed Concentration (Cmax)	Up to Approximately 140 Days	Maximum observed concentration.
Terminal Phase Elimination Rate Constant (β)	Up to Approximately 140 Days	Terminal phase elimination rate constant.
Area Under the Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)	Up to Approximately 140 Days	AUC from time 0 to time of the last measurable concentration (AUCt).
AUC from Time 0 to Infinity (AUCinf)	Up to Approximately 140 Days	AUC from time 0 to infinity (AUCinf).
Number of Anti-drug antibody (ADA) Titers	Up to Approximately 140 Days	ADA titers will be tabulated for each participant at the respective study visits.

Trial Locations

Locations (1)

Shanghai Xuhui Central Hospital /ID# 212830; 🇨🇳 Shanghai, Shanghai, China