A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-157 in Healthy Volunteers and in Participants With Chronic Plaque Psoriasis
NCT03922607 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 65
Last updated 2021-05-11
Summary
This is a study to evaluate pharmacokinetics (PK), safety and tolerability of ABBV-157 in healthy volunteers and in participants with chronic plaque psoriasis, and to evaluate the efficacy of ABBV-157 in the participants with psoriasis. This study consists of two substudies. Substudy 1 is a randomized, double-blind, placebo-controlled evaluation of multiple ascending oral doses of ABBV-157 in healthy adult volunteers. Substudy 2 is a randomized, double-blind, placebo-controlled study in which participants with moderate to severe chronic plaque psoriasis will be administered multiple oral doses of ABBV-157.
Conditions
Interventions
- DRUG
-
ABBV-157
ABBV-157 will be administered orally as capsule
- DRUG
-
Placebo for ABBV-157
Placebo for ABBV-157 will be administered orally as capsule
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
ABBVIE INC. · AbbVie
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-06-11
- Primary Completion
- 2021-04-13
- Completion
- 2021-04-13
- FDA Drug
- Yes
Countries
- United States
Study Locations
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