Healthy VolunteersPhase 1NCT06487572
A Study to Assess Pharmacokinetic Exposures Following Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants
A Phase 1 study testing Risankizumab in people with Healthy Volunteers, run by AbbVie at 2 sites in United States.
Trial summary
The objective of this study is to compare pharmacokinetic exposures following intravenous and subcutaneous administration of Risankizumab. Read more about this study
- Who is it for?
- Ages 18 to 65 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
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Jul 2024to 7 Feb 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) ≥ 18.0 to ≤ 32.0 kg/m^2 after rounding to the tenths decimal at the time of screening and upon initial confinement. BMI is calculated as weight in kg divided by the square of height measured in meters.
- Body weight greater than 40 kg and less than 100 kg at screening and upon initial 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
- Previous exposure to any anti-interleukin-12/23 or anti interleukin-23 treatment for at least one year prior to Screening.
- Intention to perform strenuous exercise to which the particpant is unaccustomed within one week prior to administration of first dose of study drug and during the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Acpru /Id# 267057
Grayslake, Illinois, 60030
Clinical Pharmacology Of Miami /ID# 268219
Miami, Florida, 33014
About this study
Official title: A Phase 1, Open-label Study to Assess PK Exposures Following Intravenous and Subcutaneous Administration of Risankizumab in Healthy Subjects
The objective of this study is to compare pharmacokinetic exposures following intravenous and subcutaneous administration of Risankizumab.
- 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
Intravenous (IV) Infusion
RisankizumabDrug
Also called ABBV-066, SKYRIZI
Subcutaneous (SC) Injection
| Study group | Role | What they receive |
|---|---|---|
| Risankizumab Dose A for Intravenous (IV) Infusion | Experimental | Participants will receive IV infusion of risankizumab at dose A and then followed for 140 days. Receives: Drug: Risankizumab |
| Risankizumab Dose B for Subcutaneous (SC) Injection | Experimental | Participants will receive SC injections of risankizumab at dose B 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 Experiencing Adverse Events
An adverse event is defined as any untoward medical occurrence in a patient 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 Serum Concentration (Cmax) of Risankizumab
Cmax of Risankizumab.
Measured: Up to approximately 140 days
Time to Cmax (Tmax) of Risankizumab
Tmax of Risankizumab.
Measured: Up to approximately 140 days
Area Under the Serum Concentration-Time Curve (AUC) of Risankizumab
AUCt of Risankizumab.
Measured: Up to approximately Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start23 Jul 2024
- Primary completion7 Feb 2025
- Study completion7 Feb 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
- 60 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
- NCT06487572
- Sponsor's protocol ID
- M24-460
- Status last verified
- Feb 2025
- First submitted
- 28 Jun 2024
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No