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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-27

Study Completion Date

2020-04-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Dose A of Risankizumab for Subcutaneous (SC) Injection

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

Group Type EXPERIMENTAL

Risankizumab

Intervention Type DRUG

Subcutaneous (SC) Injection

Dose B of Risankizumab for Subcutaneous (SC) Injection

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

Group Type EXPERIMENTAL

Risankizumab

Intervention Type DRUG

Subcutaneous (SC) Injection

Dose C of Risankizumab for Intravenous (IV) Infusion

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

Group Type EXPERIMENTAL

Risankizumab

Intervention Type DRUG

Intravenous (IV) Infusion

Interventions

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Risankizumab

Intravenous (IV) Infusion

Intervention Type DRUG

Risankizumab

Subcutaneous (SC) Injection

Intervention Type DRUG

Other Intervention Names

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ABBV-066 SKYRIZI ABBV-066 SKYRIZI

Eligibility Criteria

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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.