Healthy VolunteersPhase 1NCT05567029
Study to Evaluate the Relative Bioavailability of Two Risankizumab Drug Product Presentations in Healthy Volunteers.
A Phase 1 study testing Risankizumab Dose A and Risankizumab Dose B in people with Healthy Volunteers, run by AbbVie at 5 sites in United States.
Trial summary
This study will assess how safe risankizumab is and how risankizumab moves through the body of adult healthy participants. Adverse Events will be assessed. Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease. Participants are randomly assigned to one of the 2 treatment groups. 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 Dose A and Risankizumab Dose B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 5 sitesUnited States
- Study dates
- 28 Sep 2022to 20 Apr 2023
- 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 greater than 40 kg and less than 100 kg at screening and upon initial confinement.
Who cannot join
- Previous exposure to any anti-interleukin-12/23 or anti-interleukin-23 treatment.
- Intention to perform strenuous exercise to which the participant is unaccustomed within one week prior to administration of study drug or during the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Anaheim Clinical Trials LLC /ID# 250098
Anaheim, California, 92801-2658
PPD Clinical Research Unit - Austin /ID# 250672
Austin, Texas, 78744
Acpru /Id# 249681
Grayslake, Illinois, 60030
Clinical Pharmacology of Miami /ID# 250099
Miami, Florida, 33014
Bio-Kinetic Clinical Applications, LLC /ID# 250181
Springfield, Missouri, 65802
About this study
Official title: A Phase 1 Study in Healthy Subjects to Evaluate the Bioavailability of Risankizumab 150mg/mL Formulation in the 180 mg Prefilled Syringe Relative to 90mg/mL Formulation in the 90 mg Prefilled Syringe
This study will assess how safe risankizumab is and how risankizumab moves through the body of adult healthy participants. Adverse Events will be assessed.
Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease. Participants are randomly assigned to one of the 2 treatment groups. Approximately 198 adult healthy volunteers will be enrolled in at least 4 sites across the world.
Read more
All participants will receive risankizumab as subcutaneous injections in one of the 2 different formulations.
There may be higher burden for participants in this trial. Participants will be confined for 10 days and followed up for 140 days. Adverse Events and blood tests will be collected.
- Conditions
- Healthy Volunteers
- Being tested
- Risankizumab Dose A, Risankizumab Dose B
- Keywords
- Risankizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risankizumab Dose ADrug
Prefilled Syringe
Risankizumab Dose BDrug
Prefilled Syringe
| Study group | Role | What they receive |
|---|---|---|
| Risankizumab Dose A | Experimental | Participants will receive subcutaneous dose of risankizumab dose A. Receives: Drug: Risankizumab Dose A |
| Risankizumab Dose B | Experimental | Participants will receive subcutaneous dose of risankizumab dose B. Receives: Drug: Risankizumab Dose B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
Maximum Observed Plasma Concentration (Cmax)
Measured: Approximately up to 113 days
Time to Maximum Observed Plasma Concentration (Tmax)
Time to Maximum Observed Plasma Concentration (Tmax)
Measured: Approximately up to 113 days
Apparent Terminal Phase Elimination Rate Constant (β)
Apparent Terminal Phase Elimination Rate Constant (β)
Measured: Approximately up to 113 days
The Terminal Phase Elimination Half-Life (t1/2)
The Terminal Phase Elimination Half-Life (t1/2)
Measured: Approximately up to 113 days
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
Measured: Approximately up to 113 days
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)
Measured: Approximately up to 113 days
Number of Participants with Adverse Events
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: Approximately up to 140 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start28 Sep 2022
- Primary completion20 Apr 2023
- Study completion20 Apr 2023
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
- 198 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
- NCT05567029
- Sponsor's protocol ID
- M23-522
- Status last verified
- Apr 2023
- First submitted
- 3 Oct 2022
- Last updated
- 28 Apr 2023
- 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 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study in Healthy Subjects to Evaluate the Bioavailability of Risankizumab 150mg/mL Formulation in the 180 mg Prefilled Syringe Relative to 90mg/mL Formulation in the 90 mg Prefilled Syringe
- ClinicalTrials.gov ID
- NCT05567029
- Acronym / sponsor ID
- M23-522
- Conditions
- Healthy Volunteers
- Keywords
- Risankizumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 5 Oct 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.
This study will assess how safe risankizumab is and how risankizumab moves through the body of adult healthy participants. Adverse Events will be assessed.
Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease. Participants are randomly assigned to one of the 2 treatment groups. Approximately 198 adult healthy volunteers will be enrolled in at least 4 sites across the world.
All participants will receive risankizumab as subcutaneous injections in one of the 2 different formulations.
There may be higher burden for participants in this trial. Participants will be confined for 10 days and followed up for 140 days. Adverse Events and blood tests will be collected.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risankizumab Dose A | Experimental | Drug: Risankizumab Dose AParticipants will receive subcutaneous dose of risankizumab dose A. |
| Risankizumab Dose B | Experimental | Drug: Risankizumab Dose BParticipants will receive subcutaneous dose of risankizumab dose B. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body weight greater than 40 kg and less than 100 kg at screening and upon initial confinement.
Key exclusion criteria (2 listed)
- Previous exposure to any anti-interleukin-12/23 or anti-interleukin-23 treatment.
- Intention to perform strenuous exercise to which the participant 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 |
|---|---|---|
| Risankizumab Dose APrefilled Syringe | Drug | Risankizumab Dose A |
| Risankizumab Dose BPrefilled Syringe | Drug | Risankizumab Dose B |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: Approximately up to 113 days
Maximum Observed Plasma Concentration (Cmax)
Time to Maximum Observed Plasma Concentration (Tmax)
Time frame: Approximately up to 113 days
Time to Maximum Observed Plasma Concentration (Tmax)
Apparent Terminal Phase Elimination Rate Constant (β)
Time frame: Approximately up to 113 days
Apparent Terminal Phase Elimination Rate Constant (β)
The Terminal Phase Elimination Half-Life (t1/2)
Time frame: Approximately up to 113 days
The Terminal Phase Elimination Half-Life (t1/2)
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
Time frame: Approximately up to 113 days
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)
Time frame: Approximately up to 113 days
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)
Number of Participants with Adverse Events
Time frame: Approximately up to 140 days
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.
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 28 Apr 2023.
- 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
5 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 Dose A and Risankizumab Dose B in people with Healthy Volunteers, run by AbbVie at 5 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 1 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 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Maximum Observed Plasma Concentration (Cmax) (time frame: Approximately up to 113 days). The study lists 7 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 28 Apr 2023; AzTrials last refreshed its copy on 26 Oct 2026.