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

NCT05268068 | Completed Phase 1

• 1 other identifier: M17-381
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers; Risankizumab; ABBV-066; SKYRIZI

Outcome Measures

Primary Outcomes (10)

• 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

• Maximum Observed Concentration (Cmax)

  Maximum observed concentration.

  Up to Approximately 140 Days

• Time to Cmax (Tmax)

  Time to Cmax.

  Up to Approximately 140 Days

• Terminal Phase Elimination Rate Constant (β)

  Terminal phase elimination rate constant.

  Up to Approximately 140 Days

• Terminal Phase Elimination Half-life (t1/2)

  Terminal phase elimination half-life.

  Up to Approximately 140 Days

• 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

• AUC from Time 0 to Infinity (AUCinf)

  AUC from time 0 to infinity (AUCinf).

  Up to Approximately 140 Days

• Apparent Clearance (CL/F) for Subcutaneous (SC) dosing

  CL/F for SC dosing.

  Up to Approximately 140 Days

• Clearance (CL) for Intravenous (IV) Dosing

  CL for IV dosing.

  Up to Approximately 140 Days

• 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

Study Arms (3)

Dose A of Risankizumab for Subcutaneous (SC) Injection

EXPERIMENTAL

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

Drug: Risankizumab

Dose B of Risankizumab for Subcutaneous (SC) Injection

EXPERIMENTAL

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

Drug: Risankizumab

Dose C of Risankizumab for Intravenous (IV) Infusion

EXPERIMENTAL

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

Drug: Risankizumab

Interventions

Risankizumab DRUG

Intravenous (IV) Infusion

Also known as: ABBV-066, SKYRIZI

Dose C of Risankizumab for Intravenous (IV) Infusion

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Shanghai Xuhui Central Hospital /ID# 212830

Shanghai, Shanghai Municipality, 200031, China

Location

MeSH Terms

Interventions

risankizumab

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 7, 2022
• Study Start: June 27, 2019
• Primary Completion: April 26, 2020
• Study Completion: April 26, 2020
• Last Updated: March 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)