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 — DRUGIntravenous (IV) Infusion
- Placebo — DRUGIntravenous (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 RisankizumabParticipants will receive single dose of risankizumab.
- Experimental: Japanese Participants Receiving PlaceboParticipants will receive single dose of placebo.
- Experimental: Caucasian Participants Receiving RisankizumabParticipants will receive single dose of risankizumab.
- Experimental: Caucasian Participants Receiving PlaceboParticipants will receive single dose of placebo.
Primary Outcome Measure
Number of Participants Experiencing Adverse Events [ Time Frame: Up to approximately 137 days ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Altasciences Clinical Los Angeles, Inc /ID# 164197 | Cypress | California | 90630 | - |
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