Healthy VolunteersPhase 1NCT05283694
A Study to Evaluate the Bioavailability of Risankizumab Following Subcutaneous Dosing in Healthy Male Participants
A Phase 1 study testing risankizumab in people with Healthy Volunteers, run by AbbVie at 1 site in United States.
Trial summary
The objective of this study is to evaluate the bioavailability, safety and tolerability of risankizumab following subcutaneous injections in healthy male participants. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy 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
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2017to 12 Jun 2018
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body weight less than 100.00 kg inclusive at Screening and Check-In Day.
- Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2 after rounded to the tenths decimal, at Screening and upon confinement.
Who cannot join
- Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Open-Label Single Dose Study to Evaluate the Effect of Rate and Volume of Administration on the Bioavailability of Risankizumab Following Subcutaneous (SC) Dosing in Healthy Volunteers
The objective of this study is to evaluate the bioavailability, safety and tolerability of risankizumab following subcutaneous injections in healthy male participants.
- 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 prepared syringe
risankizumabDrug
Also called ABBV-066, SKYRIZI
Subcutaneous Injection via syringe pump
| Study group | Role | What they receive |
|---|---|---|
| Risankizumab Dose A | Experimental | Participants will receive 3 Subcutaneous (SC) injections of risankizumab Dose A administered via prepared syringe at Day 1 and followed for 140 days. Receives: Drug: risankizumab |
| Risankizumab Dose B | Experimental | Participants will receive 1 SC injection of risankizumab Dose B administered via syringe pump 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 syringe pump at Day 1 and followed for 140 days. Receives: Drug: risankizumab |
| Risankizumab Dose D | Experimental | Participants will receive 1 SC injection of risankizumab Dose D administered via prepared syringe 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.
Maximum Observed Plasma Concentration (Cmax)
Maximum Observed Plasma Concentration
Measured: Up to 140 Days
Time to maximum observed plasma concentration (Tmax)
Time to maximum observed plasma concentration
Measured: Up to 140 Days
Area under the plasma concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUCt)
AUC from time 0 to the time of last measurable concentration
Measured: Up to 140 Days
AUC from time 0 to infinity (AUCinf)
AUC from time 0 to infinity
Measured: Up to 140 Days
Terminal phase elimination rate constant (β)
Terminal phase elimination rate constant
Measured: Up to 140 Days
Terminal phase elimination half-life (t1/2).
Terminal phase elimination half-life
Measured: Up to 140 Days
Number of Anti-drug antibody (ADA) Titers
Incidence of anti-drug antibodies
Measured: Up to 140 Days
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
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 start11 Sep 2017
- Primary completion12 Jun 2018
- Study completion12 Jun 2018
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
- 48 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
- NCT05283694
- Sponsor's protocol ID
- M16-324
- 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 Randomized Open-Label Single Dose Study to Evaluate the Effect of Rate and Volume of Administration on the Bioavailability of Risankizumab Following Subcutaneous (SC) Dosing in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05283694
- Acronym / sponsor ID
- M16-324
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 12 Jun 2018 (actual)
- Study completion
- 12 Jun 2018 (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, safety and tolerability of risankizumab following subcutaneous injections in healthy male participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Risankizumab Dose A | Experimental | Drug: risankizumabParticipants will receive 3 Subcutaneous (SC) injections of risankizumab Dose A administered via prepared syringe at Day 1 and followed for 140 days. |
| Risankizumab Dose B | Experimental | Drug: risankizumabParticipants will receive 1 SC injection of risankizumab Dose B administered via syringe pump 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 syringe pump at Day 1 and followed for 140 days. |
| Risankizumab Dose D | Experimental | Drug: risankizumabParticipants will receive 1 SC injection of risankizumab Dose D administered via prepared syringe at Day 1 and followed for 140 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body weight less than 100.00 kg inclusive at Screening and Check-In Day.
- Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2 after rounded to the tenths decimal, at Screening and upon confinement.
Key exclusion criteria (2 listed)
- Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), 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, SKYRIZISubcutaneous Injection via prepared syringe | Drug | Risankizumab Dose A, Risankizumab Dose D |
| risankizumabAlso: ABBV-066, SKYRIZISubcutaneous Injection via syringe pump | Drug | Risankizumab Dose B, Risankizumab Dose C |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to 140 Days
Maximum Observed Plasma Concentration
Time to maximum observed plasma concentration (Tmax)
Time frame: Up to 140 Days
Time to maximum observed plasma concentration
Area under the plasma concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUCt)
Time frame: Up to 140 Days
AUC from time 0 to the time of last measurable concentration
AUC from time 0 to infinity (AUCinf)
Time frame: Up to 140 Days
AUC from time 0 to infinity
Terminal phase elimination rate constant (β)
Time frame: Up to 140 Days
Terminal phase elimination rate constant
Terminal phase elimination half-life (t1/2).
Time frame: Up to 140 Days
Terminal phase elimination half-life
Number of Anti-drug antibody (ADA) Titers
Time frame: Up to 140 Days
Incidence of anti-drug antibodies
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.
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
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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
1 site 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 1 site 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 1 site 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: 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.