Healthy VolunteersPhase 1NCT06054425
A Study to Compare the Bioavailability of Intravenously Infused Risankizumab Manufactured by Two Different Processes in Healthy Adults
A Phase 1 study testing Risankizumab in people with Healthy Volunteers, run by AbbVie at 3 sites in United States.
Trial summary
The objective of this study is to assess the bioavailability of risankizumab liquid vial manufactured with the new process (CMC3) relative to the current process (CMC2). 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Nov 2023to 6 May 2024
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index (BMI) >= 18.0 to <= 32.0 kg/m2 after rounding to the tenths decimal at the time of 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 electrocardiogram (ECG).
- Body weight less than 100.00 kg at Screening and upon initial confinement.
Who cannot join
- History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
- Previous exposure to any anti-interleukin (IL)-12/23 or anti-IL-23 treatment for at least one year prior to Screening.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Anaheim Clinical Trials LLC /ID# 260740
Anaheim, California, 92801-2658
Acpru /Id# 260864
Grayslake, Illinois, 60030
Clinical Pharmacology of Miami /ID# 260800
Miami, Florida, 33014
About this study
Official title: A Phase 1 Pharmacokinetic Comparability Study in Healthy Subjects to Evaluate the Relative Bioavailability of Risankizumab in Vials Manufactured by Two Different Processes
The objective of this study is to assess the bioavailability of risankizumab liquid vial manufactured with the new process (CMC3) relative to the current process (CMC2).
- Conditions
- Healthy Volunteers
- Being tested
- Risankizumab
- Keywords
- Risankizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisankizumabDrug
Infusion; intravenous
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Participants will receive risankizumab manufactured with using the current process (CMC2). Receives: Drug: Risankizumab |
| Arm 2 | Active comparator | Participants will receive risankizumab manufactured with using the new process (CMC3). Receives: Drug: Risankizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Serum Concentration (Cmax)
Cmax will be assessed.
Measured: Up to Day 131
Time to Cmax (Tmax)
Tmax will be assessed.
Measured: Up to Day 131
Apparent Terminal Phase Elimination Rate Constant (β)
Apparent terminal phase elimination rate constant (β) will be assessed.
Measured: Up to Day 131
Terminal Phase Elimination Half-life (t1/2)
Terminal phase elimination half-life (t1/2) will be assessed.
Measured: Up to Day 131
Area Under the Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUC0-t)
AUC0-t will be assessed.
Measured: Up to Day 131
AUC from Time 0 to Infinity (AUC0-inf)
AUC0-inf will be assessed.
Measured: Up to Day 131
Number of Participants with Adverse Events (AEs)
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.
Measured: Baseline to Day 141
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start20 Nov 2023
- Primary completion6 May 2024
- Study completion6 May 2024
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
- NCT06054425
- Sponsor's protocol ID
- M24-696
- Status last verified
- May 2024
- First submitted
- 20 Sep 2023
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No