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

AbbVie

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Risankizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05268068

M17-381

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Dose A of Risankizumab for Subcutaneous (SC) Injection

Experimental group

Description:

Participants will receive SC injections of risankizumab at dose A and then followed for 140 days.

Treatment:

Drug: Risankizumab

Drug: Risankizumab

Dose B of Risankizumab for Subcutaneous (SC) Injection

Experimental group

Description:

Participants will receive SC injections of risankizumab at dose B and then followed for 140 days.

Treatment:

Drug: Risankizumab

Drug: Risankizumab

Dose C of Risankizumab for Intravenous (IV) Infusion

Experimental group

Description:

Participants will receive IV infusion of risankizumab at dose C and then followed for 140 days.

Treatment:

Drug: Risankizumab

Drug: Risankizumab