NCT05274100

Brief Summary

The primary objectives of this study are to assess the relative bioavailability of risankizumab in on-body delivery system (OBDS) versus the prefilled syringe (PFS) (Substudy 1) and to assess the relative bioavailability of risankizumab in the to-be-marketed Dose A liquid vial versus the Dose B liquid vial used in the Phase 3 studies (Substudy 2).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
394

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Sep 2020

Typical duration for phase_1 healthy-volunteers

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 10, 2022

Completed
Last Updated

March 10, 2022

Status Verified

March 1, 2022

Enrollment Period

10 months

First QC Date

March 8, 2022

Last Update Submit

March 8, 2022

Conditions

Healthy Volunteers

Keywords

RisankizumabSKYRIZI

Outcome Measures

Primary Outcomes (7)

  • Percentage of Participants Experiencing Adverse Events (AEs)

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.

    Up to approximately 140 days

  • Maximum Observed Serum Concentration (Cmax)

    Maximum observed serum concentration (Cmax) of risankizumab.

    Up to approximately 113 days

  • Time to Cmax (Tmax)

    Time to Cmax of risankizumab.

    Up to approximately 113 days

  • Apparent Terminal Phase Elimination Rate Constant (β)

    Apparent terminal phase elimination rate constant (β) of risankizumab.

    Up to approximately 113 days

  • Terminal Phase Elimination Hhalf-life (t1/2)

    Terminal phase elimination half-life (t1/2) of risankizumab.

    Up to approximately 113 days

  • Area Under Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt)

    AUCt of risankizumab.

    Up to approximately 113 days

  • AUC From Time 0 to Infinity (AUCinf)

    AUCinf of risankizumab.

    Up to approximately 113 days

Study Arms (5)

Group 1: Risankizumab Dose A

EXPERIMENTAL

Participants will receive risankizumab dose A.

Drug: Risankizumab

Group 2: Risankizumab Dose B

EXPERIMENTAL

Participants will receive risankizumab dose B.

Drug: Risankizumab

Group 3: Risankizumab Dose C

EXPERIMENTAL

Participants will receive risankizumab dose C.

Drug: Risankizumab

Group 4: Risankizumab Dose D

EXPERIMENTAL

Participants will receive risankizumab dose D.

Drug: Risankizumab

Group 5: Risankizumab Dose D

EXPERIMENTAL

Participants will receive risankizumab dose D.

Drug: Risankizumab

Interventions

RisankizumabDRUG

Subcutaneous Injection via prefilled syringe (PFS)

Also known as: SKYRIZI
Group 1: Risankizumab Dose A

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Body weight less than 100.00 kg at Screening and upon initial confinement.

You may not qualify if:

  • \- Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Anaheim Clinical Trials LLC /ID# 222821

Anaheim, California, 92801-2658, United States

Location

Altasciences Clinical Los Angeles, Inc /ID# 222238

Cypress, California, 90630, United States

Location

Clinical Pharmacology of Miami /ID# 225392

Miami, Florida, 33014, United States

Location

PPD Clinical Research Unit /ID# 222362

Orlando, Florida, 32806-1044, United States

Location

Acpru /Id# 222349

Grayslake, Illinois, 60030, United States

Location

PPD Clinical Research Unit -Las Vegas /ID# 222363

Las Vegas, Nevada, 89113-2235, United States

Location

PPD Clinical Research Unit - Austin /ID# 222361

Austin, Texas, 78744, United States

Location

Spaulding Clinical Research LLC /ID# 225405

West Bend, Wisconsin, 53095, United States

Location

MeSH Terms

Interventions

risankizumab

Study Officials

  • ABBVIE INC.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2022

First Posted

March 10, 2022

Study Start

September 1, 2020

Primary Completion

July 6, 2021

Study Completion

July 6, 2021

Last Updated

March 10, 2022

Record last verified: 2022-03

Locations

US(8)