Study of Intravenous and Subcutaneous Administration of R... | NCT05274100 | Trialant

Study of Intravenous and Subcutaneous Administration of R... | NCT05274100 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1: Risankizumab Dose A	Experimental	Participants will receive risankizumab dose A.	Drug: Risankizumab
Group 2: Risankizumab Dose B	Experimental	Participants will receive risankizumab dose B.	Drug: Risankizumab
Group 3: Risankizumab Dose C	Experimental	Participants will receive risankizumab dose C.	Drug: Risankizumab
Group 4: Risankizumab Dose D	Experimental	Participants will receive risankizumab dose D.	Drug: Risankizumab
Group 5: Risankizumab Dose D	Experimental	Participants will receive risankizumab dose D.	Drug: Risankizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Experiencing 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. The investigator assesses the relationship of each event to the use of study.	Up to approximately 140 days
Maximum Observed Serum Concentration (Cmax)	Maximum observed serum concentration (Cmax) of risankizumab.	Up to approximately 113 days
Time to Cmax (Tmax)	Time to Cmax of risankizumab.	Up to approximately 113 days
Apparent Terminal Phase Elimination Rate Constant (β)	Apparent terminal phase elimination rate constant (β) of risankizumab.	Up to approximately 113 days
Terminal Phase Elimination Hhalf-life (t1/2)	Terminal phase elimination half-life (t1/2) of risankizumab.	Up to approximately 113 days
Area Under Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt)	AUCt of risankizumab.	Up to approximately 113 days
AUC From Time 0 to Infinity (AUCinf)	AUCinf of risankizumab.	Up to approximately 113 days

Contacts/Locations Module