A Study in Healthy Japanese and Caucasian Subjects to Assess the Pharmacokinetics, Safety and Tolerability of Risankizumab

Part of paid clinical trials in Cypress, California.

Sponsor
AbbVie
Study ID
NCT05305222
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Risankizumab — DRUG
    Intravenous (IV) Infusion
  • Placebo — DRUG
    Intravenous (IV) Infusion

Study Details

The main objective of this study is to assess the pharmacokinetics, safety, tolerability and immunogenicity following a single intravenous (IV) infusion of risankizumab in healthy Japanese and Caucasian participants.

Key Dates

Start date
Oct 23, 2017
Status verified
Mar 2022
Primary completion
Jun 15, 2018
Completion
Jun 15, 2018

Study Design

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

Arms

  • Experimental: Japanese Participants Receiving Risankizumab
    Participants will receive single dose of risankizumab.
  • Experimental: Japanese Participants Receiving Placebo
    Participants will receive single dose of placebo.
  • Experimental: Caucasian Participants Receiving Risankizumab
    Participants will receive single dose of risankizumab.
  • Experimental: Caucasian Participants Receiving Placebo
    Participants will receive single dose of placebo.

Primary Outcome Measure

Number of Participants Experiencing Adverse Events [ Time Frame: Up to approximately 137 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Altasciences Clinical Los Angeles, Inc /ID# 164197CypressCalifornia90630-

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