A Study to Evaluate the Bioavailability of Risankizumab Following Subcutaneous Dosing in Healthy Male Participants

Part of paid clinical trials in Grayslake, Illinois.

Sponsor
AbbVie
Study ID
NCT05283694
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • risankizumab — DRUG
    Subcutaneous Injection via prepared syringe
  • risankizumab — DRUG
    Subcutaneous Injection via syringe pump

Study Details

The objective of this study is to evaluate the bioavailability, safety and tolerability of risankizumab following subcutaneous injections in healthy male participants.

Key Dates

Start date
Sep 11, 2017
Status verified
Mar 2022
Primary completion
Jun 12, 2018
Completion
Jun 12, 2018

Study Design

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

Arms

  • Experimental: Risankizumab Dose A
    Participants will receive 3 Subcutaneous (SC) injections of risankizumab Dose A administered via prepared syringe at Day 1 and followed for 140 days.
  • Experimental: Risankizumab Dose B
    Participants will receive 1 SC injection of risankizumab Dose B administered via syringe pump at Day 1 and followed for 140 days.
  • Experimental: Risankizumab Dose C
    Participants will receive 1 SC injection of risankizumab Dose C administered via syringe pump at Day 1 and followed for 140 days.
  • Experimental: Risankizumab Dose D
    Participants will receive 1 SC injection of risankizumab Dose D administered via prepared syringe at Day 1 and followed for 140 days.

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Up to 140 Days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Acpru /Id# 165737GrayslakeIllinois60030-

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Acpru· Grayslake, IL

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