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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05283681
- Acronym / sponsor ID
- M15-990
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 11 Nov 2019 (actual)
- Study completion
- 11 Nov 2019 (actual)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Risankizumab Dose A | Experimental | Drug: RisankizumabParticipants will receive 1 Subcutaneous (SC) injection of risankizumab Dose A administered via Prefilled Syringe (PFS) at Day 1 and followed for 140 days |
| Risankizumab Dose B | Experimental | Drug: RisankizumabParticipants will receive SC injections of risankizumab Dose B administered via PFS at Day 1 and followed for 140 days |
| Risankizumab Dose C | Experimental | Drug: RisankizumabParticipants will receive 1 SC injection of risankizumab Dose C administered via Auto-Injector (AI) at Day 1 and followed for 140 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male and female healthy volunteers between 18 and 55 years of age.
- Body weight less than 110.00 kg inclusive at Screening.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RisankizumabAlso: ABBV-066, SKYRIZISubcutaneous Injection via Prefilled Syringe (PFS) | Drug | Risankizumab Dose A, Risankizumab Dose B |
| RisankizumabAlso: ABBV-066, SKYRIZISubcutaneous Injection via Auto-Injector (AI) | Drug | Risankizumab Dose C |
Primary outcome
Number of Participants with Adverse Events
Time frame: Up to 140 Days
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.
Maximum observed serum concentration (Cmax)
Time frame: Up to 113 Days
Maximum observed serum concentration
Time to Cmax (Tmax)
Time frame: Up to 113 Days
Time to Cmax
Terminal phase elimination rate constant (β)
Time frame: Up to 113 Days
Terminal phase elimination rate constant
Terminal phase elimination half-life (t1/2)
Time frame: Up to 113 Days
Terminal phase elimination half-life
Area under the concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt)
Time frame: Up to 113 Days
AUC from 0 to time of last measurable concentration
AUC from time 0 to infinity (AUCinf)
Time frame: Up to 113 Days
AUC from time 0 to infinity
Number of Anti-drug antibody (ADA) Titers
Time frame: Up to 113 Days
Incidence of anti-drug antibodies
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
RecruitingEarly Phase 1
Study Brain Mechanisms of Frustration With Magnetoencephalography in Healthy Volunteers
Irritability
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Risankizumab in people with Healthy Volunteers, run by AbbVie at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (time frame: Up to 140 Days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.