Healthy VolunteersPhase 1NCT05274100
Study of Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants
A Phase 1 study testing Risankizumab in people with Healthy Volunteers, run by AbbVie at 8 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Risankizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 Sep 2020to 6 Jul 2021
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body weight less than 100.00 kg at Screening and upon initial confinement.
Who cannot join
- Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Anaheim Clinical Trials LLC /ID# 222821
Anaheim, California, 92801-2658
PPD Clinical Research Unit - Austin /ID# 222361
Austin, Texas, 78744
Altasciences Clinical Los Angeles, Inc /ID# 222238
Cypress, California, 90630
Acpru /Id# 222349
Grayslake, Illinois, 60030
PPD Clinical Research Unit -Las Vegas /ID# 222363
Las Vegas, Nevada, 89113-2235
Clinical Pharmacology of Miami /ID# 225392
Miami, Florida, 33014
PPD Clinical Research Unit /ID# 222362
Orlando, Florida, 32806-1044
Spaulding Clinical Research LLC /ID# 225405
West Bend, Wisconsin, 53095
About this study
Official title: A Phase 1, Pharmacokinetic Comparability Study of Intravenous and Subcutaneous Administration of Risankizumab in Healthy Subjects
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).
- Conditions
- Healthy Volunteers
- Being tested
- Risankizumab
- Keywords
- Risankizumab, SKYRIZI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisankizumabDrug
Also called SKYRIZI
Subcutaneous Injection via prefilled syringe (PFS)
RisankizumabDrug
Also called SKYRIZI
Intravenous Infusion
RisankizumabDrug
Also called SKYRIZI
Subcutaneous Injection via on-body delivery system (OBDS)
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Risankizumab Dose A | Experimental | Participants will receive risankizumab dose A. Receives: Drug: Risankizumab |
| Group 2: Risankizumab Dose B | Experimental | Participants will receive risankizumab dose B. Receives: Drug: Risankizumab |
| Group 3: Risankizumab Dose C | Experimental | Participants will receive risankizumab dose C. Receives: Drug: Risankizumab |
| Group 4: Risankizumab Dose D | Experimental | Participants will receive risankizumab dose D. Receives: Drug: Risankizumab |
| Group 5: Risankizumab Dose D | Experimental | Participants will receive risankizumab dose D. Receives: Drug: Risankizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 140 days
Maximum Observed Serum Concentration (Cmax)
Maximum observed serum concentration (Cmax) of risankizumab.
Measured: Up to approximately 113 days
Time to Cmax (Tmax)
Time to Cmax of risankizumab.
Measured: Up to approximately 113 days
Apparent Terminal Phase Elimination Rate Constant (β)
Apparent terminal phase elimination rate constant (β) of risankizumab.
Measured: Up to approximately 113 days
Terminal Phase Elimination Hhalf-life (t1/2)
Terminal phase elimination half-life (t1/2) of risankizumab.
Measured: 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.
Measured: Up to approximately 113 days
AUC From Time 0 to Infinity (AUCinf)
AUCinf of risankizumab.
Measured: Up to approximately 113 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start1 Sep 2020
- Primary completion6 Jul 2021
- Study completion6 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 394 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274100
- Sponsor's protocol ID
- M19-128
- Status last verified
- Mar 2022
- First submitted
- 8 Mar 2022
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No