Healthy Volunteers
Conditions
Keywords
Risankizumab
Brief summary
This study will assess how safe risankizumab is and how risankizumab moves through the body of adult healthy participants. Adverse Events will be assessed. Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease. Participants are randomly assigned to one of the 2 treatment groups. Approximately 198 adult healthy volunteers will be enrolled in at least 4 sites across the world. All participants will receive risankizumab as subcutaneous injections in one of the 2 different formulations. There may be higher burden for participants in this trial. Participants will be confined for 10 days and followed up for 140 days. Adverse Events and blood tests will be collected.
Interventions
DRUGRisankizumab Dose A
Prefilled Syringe
DRUGRisankizumab Dose B
Prefilled Syringe
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
\- Body weight greater than 40 kg and less than 100 kg at screening and upon initial confinement.
Exclusion criteria
* Previous exposure to any anti-interleukin-12/23 or anti-interleukin-23 treatment. * Intention to perform strenuous exercise to which the participant is unaccustomed within one week prior to administration of study drug or during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Approximately up to 113 days | Maximum Observed Plasma Concentration (Cmax) |
| Time to Maximum Observed Plasma Concentration (Tmax) | Approximately up to 113 days | Time to Maximum Observed Plasma Concentration (Tmax) |
| Apparent Terminal Phase Elimination Rate Constant (β) | Approximately up to 113 days | Apparent Terminal Phase Elimination Rate Constant (β) |
| The Terminal Phase Elimination Half-Life (t1/2) | Approximately up to 113 days | The Terminal Phase Elimination Half-Life (t1/2) |
| The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt) | Approximately up to 113 days | The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt) |
| The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞) | Approximately up to 113 days | The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞) |
| Number of Participants with Adverse Events | Approximately up to 140 days | 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. The investigator assesses the relationship of each event to the use of study. |
Countries
United States
Outcome results
None listed