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
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