Healthy VolunteersPhase 1NCT05268068
A Study of Intravenously (IV) Infused or Subcutaneously (SC) Injected Risankizumab in Healthy Adult Participants in China
A Phase 1 study testing Risankizumab in people with Healthy Volunteers, run by AbbVie at 1 site in China.
Trial summary
The objective of this study to assess the pharmacokinetics, safety, tolerability and immunogenicity following a single subcutaneous (SC) or intravenous (IV) dose of risankizumab in healthy Chinese participants. Read more about this study
- Who is it for?
- Ages 18 to 45 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
- 30 participants
- Where
- 1 siteChina
- Study dates
- 27 Jun 2019to 26 Apr 2020
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index (BMI) is >= 19.0 to <= 26.0 kg/m2 after rounding to the nearest tenth. BMI is calculated as weight in kg divided by the square of height measured in meters.
Who cannot join
- Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Xuhui Central Hospital /ID# 212830
Shanghai, Shanghai Municipality, 200031
About this study
Official title: A Phase 1 Study in Healthy Chinese Subjects to Assess the Pharmacokinetics, Safety and Tolerability After a Single Dose of Risankizumab
The objective of this study to assess the pharmacokinetics, safety, tolerability and immunogenicity following a single subcutaneous (SC) or intravenous (IV) dose of risankizumab in healthy Chinese participants.
- Conditions
- Healthy Volunteers
- Being tested
- Risankizumab
- Keywords
- Healthy Volunteers, Risankizumab, ABBV-066, SKYRIZI
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
Intravenous (IV) Infusion
RisankizumabDrug
Also called ABBV-066, SKYRIZI
Subcutaneous (SC) Injection
| Study group | Role | What they receive |
|---|---|---|
| Dose A of Risankizumab for Subcutaneous (SC) Injection | Experimental | Participants will receive SC injections of risankizumab at dose A and then followed for 140 days. Receives: Drug: Risankizumab |
| Dose B of Risankizumab for Subcutaneous (SC) Injection | Experimental | Participants will receive SC injections of risankizumab at dose B and then followed for 140 days. Receives: Drug: Risankizumab |
| Dose C of Risankizumab for Intravenous (IV) Infusion | Experimental | Participants will receive IV infusion of risankizumab at dose C and then 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 (AE)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Measured: Up to Approximately 140 Days
Maximum Observed Concentration (Cmax)
Maximum observed concentration.
Measured: Up to Approximately 140 Days
Time to Cmax (Tmax)
Time to Cmax.
Measured: Up to Approximately 140 Days
Terminal Phase Elimination Rate Constant (β)
Terminal phase elimination rate constant.
Measured: Up to Approximately 140 Days
Terminal Phase Elimination Half-life (t1/2)
Terminal phase elimination half-life.
Measured: Up to Approximately 140 Days
Area Under the Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
AUC from time 0 to time of the last measurable concentration (AUCt).
Measured: Up to Approximately 140 Days
AUC from Time 0 to Infinity (AUCinf)
AUC from time 0 to infinity (AUCinf).
Measured: Up to Approximately 140 Days
Apparent Clearance (CL/F) for Subcutaneous (SC) dosing
CL/F for SC dosing.
Measured: Up to Approximately 140 Days
Clearance (CL) for Intravenous (IV) Dosing
CL for IV dosing.
Measured: Up to Approximately 140 Days
Number of Anti-drug antibody (ADA) Titers
ADA titers will be tabulated for each participant at the respective study visits.
Measured: Up to Approximately 140 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start27 Jun 2019
- Primary completion26 Apr 2020
- Study completion26 Apr 2020
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
- 30 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
- NCT05268068
- Sponsor's protocol ID
- M17-381
- Status last verified
- Mar 2022
- First submitted
- 3 Mar 2022
- Last updated
- 7 Mar 2022
- 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 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study in Healthy Chinese Subjects to Assess the Pharmacokinetics, Safety and Tolerability After a Single Dose of Risankizumab
- ClinicalTrials.gov ID
- NCT05268068
- Acronym / sponsor ID
- M17-381
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers, Risankizumab, ABBV-066, SKYRIZI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- 26 Apr 2020 (actual)
- Study completion
- 26 Apr 2020 (actual)
- First posted
- 7 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 to assess the pharmacokinetics, safety, tolerability and immunogenicity following a single subcutaneous (SC) or intravenous (IV) dose of risankizumab in healthy Chinese participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose A of Risankizumab for Subcutaneous (SC) Injection | Experimental | Drug: RisankizumabParticipants will receive SC injections of risankizumab at dose A and then followed for 140 days. |
| Dose B of Risankizumab for Subcutaneous (SC) Injection | Experimental | Drug: RisankizumabParticipants will receive SC injections of risankizumab at dose B and then followed for 140 days. |
| Dose C of Risankizumab for Intravenous (IV) Infusion | Experimental | Drug: RisankizumabParticipants will receive IV infusion of risankizumab at dose C and then followed for 140 days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body Mass Index (BMI) is >= 19.0 to <= 26.0 kg/m2 after rounding to the nearest tenth. BMI is calculated as weight in kg divided by the square of height measured in meters.
Key exclusion criteria (1 listed)
- Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.
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, SKYRIZIIntravenous (IV) Infusion | Drug | Dose C of Risankizumab for Intravenous (IV) Infusion |
| RisankizumabAlso: ABBV-066, SKYRIZISubcutaneous (SC) Injection | Drug | Dose A of Risankizumab for Subcutaneous (SC) Injection, Dose B of Risankizumab for Subcutaneous (SC) Injection |
Primary outcome
Number of Participants with Adverse Events (AE)
Time frame: Up to Approximately 140 Days
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Maximum Observed Concentration (Cmax)
Time frame: Up to Approximately 140 Days
Maximum observed concentration.
Time to Cmax (Tmax)
Time frame: Up to Approximately 140 Days
Time to Cmax.
Terminal Phase Elimination Rate Constant (β)
Time frame: Up to Approximately 140 Days
Terminal phase elimination rate constant.
Terminal Phase Elimination Half-life (t1/2)
Time frame: Up to Approximately 140 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 Approximately 140 Days
AUC from time 0 to time of the last measurable concentration (AUCt).
AUC from Time 0 to Infinity (AUCinf)
Time frame: Up to Approximately 140 Days
AUC from time 0 to infinity (AUCinf).
Apparent Clearance (CL/F) for Subcutaneous (SC) dosing
Time frame: Up to Approximately 140 Days
CL/F for SC dosing.
Clearance (CL) for Intravenous (IV) Dosing
Time frame: Up to Approximately 140 Days
CL for IV dosing.
Number of Anti-drug antibody (ADA) Titers
Time frame: Up to Approximately 140 Days
ADA titers will be tabulated for each participant at the respective study visits.
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 7 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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 China.
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 1 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 7 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 China. 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 (AE) (time frame: Up to Approximately 140 Days). The study lists 10 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 7 Mar 2022.