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OpenTrials
Completed

NCT Number: NCT05268068

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

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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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai Xuhui Central Hospital /ID# 212830

Shanghai, Shanghai Municipality, 200031, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Risankizumab

Drug

Intravenous (IV) Infusion

Other names: ABBV-066, SKYRIZI

Primary outcomes

  1. Number of Participants with Adverse Events (AE)

    Time frame: 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.

  2. Maximum Observed Concentration (Cmax)

    Time frame: Up to Approximately 140 Days

    Maximum observed concentration.

  3. Time to Cmax (Tmax)

    Time frame: Up to Approximately 140 Days

    Time to Cmax.

  4. Terminal Phase Elimination Rate Constant (β)

    Time frame: Up to Approximately 140 Days

    Terminal phase elimination rate constant.

  5. Terminal Phase Elimination Half-life (t1/2)

    Time frame: Up to Approximately 140 Days

    Terminal phase elimination half-life.

  6. Area Under the Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)

    Time frame: Up to Approximately 140 Days

    AUC from time 0 to time of the last measurable concentration (AUCt).

  7. AUC from Time 0 to Infinity (AUCinf)

    Time frame: Up to Approximately 140 Days

    AUC from time 0 to infinity (AUCinf).

  8. Apparent Clearance (CL/F) for Subcutaneous (SC) dosing

    Time frame: Up to Approximately 140 Days

    CL/F for SC dosing.

  9. Clearance (CL) for Intravenous (IV) Dosing

    Time frame: Up to Approximately 140 Days

    CL for IV dosing.

  10. Number of Anti-drug antibody (ADA) Titers

    Time frame: Up to Approximately 140 Days

    ADA titers will be tabulated for each participant at the respective study visits.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 7, 2022
Registry last updated
Mar 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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