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

Sponsor
AbbVie
Study ID
NCT05268068
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 27, 2019
Status verified
Mar 2022
Primary completion
Apr 26, 2020
Completion
Apr 26, 2020

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

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

Primary Outcome Measure

Number of Participants with Adverse Events (AE) [ Time Frame: Up to Approximately 140 Days ]

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