A Study to Compare the Bioavailability of Intravenously Infused Risankizumab Manufactured by Two Different Processes in Healthy Adults

Part of paid clinical trials in Anaheim, California.

Sponsor
AbbVie
Study ID
NCT06054425
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The objective of this study is to assess the bioavailability of risankizumab liquid vial manufactured with the new process (CMC3) relative to the current process (CMC2).

Key Dates

Start date
Nov 20, 2023
Status verified
May 2024
Primary completion
May 6, 2024
Completion
May 6, 2024

Study Design

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

Arms

  • Experimental: Arm 1
    Participants will receive risankizumab manufactured with using the current process (CMC2).
  • Active Comparator: Arm 2
    Participants will receive risankizumab manufactured with using the new process (CMC3).

Primary Outcome Measure

Maximum Observed Serum Concentration (Cmax) [ Time Frame: Up to Day 131 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Anaheim Clinical Trials LLC /ID# 260740AnaheimCalifornia92801-2658-
Clinical Pharmacology of Miami /ID# 260800MiamiFlorida33014-
Acpru /Id# 260864GrayslakeIllinois60030-

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Anaheim Clinical Trials LLC· Anaheim, CAClinical Pharmacology of Miami· Miami, FLAcpru· Grayslake, IL

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