Healthy VolunteersPhase 1NCT05283681
A Study to Evaluate the Bioavailability of Risankizumab in Pre-filled Syringe or Auto-injector in Healthy Adult Participants
A Phase 1 study testing Risankizumab in people with Healthy Volunteers, run by AbbVie at 2 sites in United States.
Trial summary
The objective of this study is to evaluate the bioavailability of risankizumab new formulation in prefilled syringe (PFS) relative to the 90 mg/mL formulation in PFS in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 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
- 226 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Apr 2019to 11 Nov 2019
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female healthy volunteers between 18 and 55 years of age.
- Body weight less than 110.00 kg inclusive at Screening.
Who cannot join
- Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.
- Intention to perform strenuous exercise to which the subject is unaccustomed within one week prior to administration of study drug or during the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
PPD Clinical Research Unit - Austin /ID# 211456
Austin, Texas, 78744
Acpru /Id# 210844
Grayslake, Illinois, 60030
About this study
Official title: A Phase 1 Study in Healthy Volunteers to Evaluate the Bioavailability of Risankizumab New Formulation in Pre-filled Syringe Relative to 90 mg/mL Formulation in Pre-filled Syringe and Characterization of Risankizumab Pharmacokinetics Using New Formulation in Auto-injector
The objective of this study is to evaluate the bioavailability of risankizumab new formulation in prefilled syringe (PFS) relative to the 90 mg/mL formulation in PFS in healthy volunteers. The study will also evaluate the bioavailability of risankizumab new formulation in auto-injector (AI) relative to PFS in healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- Risankizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisankizumabDrug
Also called ABBV-066, SKYRIZI
Subcutaneous Injection via Prefilled Syringe (PFS)
RisankizumabDrug
Also called ABBV-066, SKYRIZI
Subcutaneous Injection via Auto-Injector (AI)
| Study group | Role | What they receive |
|---|---|---|
| Risankizumab Dose A | Experimental | Participants will receive 1 Subcutaneous (SC) injection of risankizumab Dose A administered via Prefilled Syringe (PFS) at Day 1 and followed for 140 days Receives: Drug: Risankizumab |
| Risankizumab Dose B | Experimental | Participants will receive SC injections of risankizumab Dose B administered via PFS at Day 1 and followed for 140 days Receives: Drug: Risankizumab |
| Risankizumab Dose C | Experimental | Participants will receive 1 SC injection of risankizumab Dose C administered via Auto-Injector (AI) at Day 1 and followed for 140 days. Receives: Drug: Risankizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
Measured: Up to 140 Days
Maximum observed serum concentration (Cmax)
Maximum observed serum concentration
Measured: Up to 113 Days
Time to Cmax (Tmax)
Time to Cmax
Measured: Up to 113 Days
Terminal phase elimination rate constant (β)
Terminal phase elimination rate constant
Measured: Up to 113 Days
Terminal phase elimination half-life (t1/2)
Terminal phase elimination half-life
Measured: Up to 113 Days
Area under the concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt)
AUC from 0 to time of last measurable concentration
Measured: Up to 113 Days
AUC from time 0 to infinity (AUCinf)
AUC from time 0 to infinity
Measured: Up to 113 Days
Number of Anti-drug antibody (ADA) Titers
Incidence of anti-drug antibodies
Measured: Up to 113 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start2 Apr 2019
- Primary completion11 Nov 2019
- Study completion11 Nov 2019
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
- 226 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
- NCT05283681
- Sponsor's protocol ID
- M15-990
- Status last verified
- Mar 2022
- First submitted
- 9 Mar 2022
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No