Healthy VolunteersPhase 1NCT06571266
A Study to Assess the Relative Bioavailability of Two Formulations of Risankizumab Following Subcutaneous Administration With Prefilled Syringes in Healthy Adult Participants
A Phase 1 study testing Risankizumab in people with Healthy Volunteers, run by AbbVie at 3 sites in United States.
Trial summary
This study will assess the pharmacokinetics, relative bioavailability and tolerability of two formulations of risankizumab following subcutaneous (SC) administration in healthy adult participants. 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
- 231 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Sep 2024to 16 Apr 2025
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body weight 40 kg to 100 kg, inclusive, at screening and upon initial confinement
- Body Mass Index (BMI) is > = 18.0 to < = 32.0 kg/m2 after rounded to the tenths decimal, at Screening and upon confinement.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.
Who cannot join
- Participant with exposure to any anti-interleukin-12/23 or anti-interleukin-23 treatment for at least one year prior to Screening.
- Participant with intention to perform strenuous exercise within at least one week prior to administration of study drug or during the study.
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cenexel Act /ID# 270310
Anaheim, California, 92801
Acpru /Id# 270152
Grayslake, Illinois, 60030
Collaborative Neuroscience Research CNS /ID# 270286
Los Alamitos, California, 90720
About this study
Official title: A Phase 1 Pharmacokinetic Study in Healthy Subjects to Evaluate the Relative Bioavailability of Two Formulations of Risankizumab Following Subcutaneous Administration With Prefilled Syringes
This study will assess the pharmacokinetics, relative bioavailability and tolerability of two formulations of risankizumab following subcutaneous (SC) administration in healthy adult participants.
- Conditions
- Healthy Volunteers
- Being tested
- Risankizumab
- Keywords
- Healthy Volunteers, Risankizumab, ABBV-066
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
| Study group | Role | What they receive |
|---|---|---|
| Risankizumab Formulation 1 | Experimental | Participants will receive a single dose of Risankizumab formulation 1 on day 1. Receives: Drug: Risankizumab |
| Risankizumab Formulation 2 | Experimental | Participants will receive a single dose of Risankizumab formulation 2 on day 1. Receives: Drug: Risankizumab |
| Risankizumab Formulation 3 | Experimental | Participants will receive a single dose of Risankizumab formulation 3 on day 1. 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 (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.
Measured: Up to day 140
Maximum Observed Serum Concentration (Cmax) of Risankizumab
Cmax will be assessed of Risankizumab
Measured: Up to Day 140
Time to Cmax (Tmax) of Risankizumab
Tmax will be assessed of Risankizumab
Measured: Up to Day 140
Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab
Apparent terminal phase elimination rate constant (β) will be assessed of Risankizumab
Measured: Up to Day 140
Terminal Phase Elimination Half-life (t1/2) of Risankizumab
Terminal phase elimination half-life (t1/2) will be assessed of Risankizumab
Measured: Up to Day 140
Area Under the Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUC0-t)
AUC0-t will be assessed
Measured: Up to Day 140
AUC from Time 0 to Infinity (AUC0-inf) of Risankizumab
AUC0-inf will be assessed of Risankizumab
Measured: Up to Day 140
Number of Anti-drug antibody (ADA) Titers
Incidence and concentration of anti-drug antibodies
Measured: Up to Day 140
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start11 Sep 2024
- Primary completion16 Apr 2025
- Study completion16 Apr 2025
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
- 231 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
- NCT06571266
- Sponsor's protocol ID
- M24-342
- Status last verified
- May 2025
- First submitted
- 23 Aug 2024
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Pharmacokinetic Study in Healthy Subjects to Evaluate the Relative Bioavailability of Two Formulations of Risankizumab Following Subcutaneous Administration With Prefilled Syringes
- ClinicalTrials.gov ID
- NCT06571266
- Acronym / sponsor ID
- M24-342
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers, Risankizumab, ABBV-066
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- 16 Apr 2025 (actual)
- Study completion
- 16 Apr 2025 (actual)
- First posted
- 26 Aug 2024 (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.
This study will assess the pharmacokinetics, relative bioavailability and tolerability of two formulations of risankizumab following subcutaneous (SC) administration in healthy adult participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Risankizumab Formulation 1 | Experimental | Drug: RisankizumabParticipants will receive a single dose of Risankizumab formulation 1 on day 1. |
| Risankizumab Formulation 2 | Experimental | Drug: RisankizumabParticipants will receive a single dose of Risankizumab formulation 2 on day 1. |
| Risankizumab Formulation 3 | Experimental | Drug: RisankizumabParticipants will receive a single dose of Risankizumab formulation 3 on day 1. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body weight 40 kg to 100 kg, inclusive, at screening and upon initial confinement
- Body Mass Index (BMI) is > = 18.0 to < = 32.0 kg/m2 after rounded to the tenths decimal, at Screening and upon confinement.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.
Key exclusion criteria (3 listed)
- Participant with exposure to any anti-interleukin-12/23 or anti-interleukin-23 treatment for at least one year prior to Screening.
- Participant with intention to perform strenuous exercise within at least one week prior to administration of study drug or during the study.
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
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, SKYRIZI• Subcutaneous Injection via prefilled syringe | Drug | Risankizumab Formulation 1, Risankizumab Formulation 2, Risankizumab Formulation 3 |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Up to day 140
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.
Maximum Observed Serum Concentration (Cmax) of Risankizumab
Time frame: Up to Day 140
Cmax will be assessed of Risankizumab
Time to Cmax (Tmax) of Risankizumab
Time frame: Up to Day 140
Tmax will be assessed of Risankizumab
Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab
Time frame: Up to Day 140
Apparent terminal phase elimination rate constant (β) will be assessed of Risankizumab
Terminal Phase Elimination Half-life (t1/2) of Risankizumab
Time frame: Up to Day 140
Terminal phase elimination half-life (t1/2) will be assessed of Risankizumab
Area Under the Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUC0-t)
Time frame: Up to Day 140
AUC0-t will be assessed
AUC from Time 0 to Infinity (AUC0-inf) of Risankizumab
Time frame: Up to Day 140
AUC0-inf will be assessed of Risankizumab
Number of Anti-drug antibody (ADA) Titers
Time frame: Up to Day 140
Incidence and concentration 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 16 May 2025.
- Individual participant dataSharing planned: No
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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
3 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 3 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 3 inclusion and 3 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 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 (AEs) (time frame: Up to day 140). 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 16 May 2025.