A Study to Evaluate the Bioavailability of Risankizumab Following Subcutaneous Dosing in Healthy Male Participants

Healthy Volunteers Clinical Trial

Official title:

A Randomized Open-Label Single Dose Study to Evaluate the Effect of Rate and Volume of Administration on the Bioavailability of Risankizumab Following Subcutaneous (SC) Dosing in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05283694
• Other study ID #: M16-324
• Status: Completed
• Phase: Phase 1
• Start date: September 11, 2017
• Est. completion date: June 12, 2018

Study information

• Verified date: March 2022
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the bioavailability, safety and tolerability of risankizumab following subcutaneous injections in healthy male participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 12, 2018
• Est. primary completion date: June 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Body weight less than 100.00 kg inclusive at Screening and Check-In Day.

• Body Mass Index (BMI) is = 18.0 to = 29.9 kg/m2 after rounded to the tenths decimal, at Screening and upon confinement.

Exclusion Criteria:

• Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.

• History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• risankizumab
Subcutaneous Injection via prepared syringe
• risankizumab
Subcutaneous Injection via syringe pump

Locations

Country	Name	City	State
United States	Acpru /Id# 165737	Grayslake	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax)	Maximum Observed Plasma Concentration	Up to 140 Days
Primary	Time to maximum observed plasma concentration (Tmax)	Time to maximum observed plasma concentration	Up to 140 Days
Primary	Area under the plasma concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUCt)	AUC from time 0 to the time of last measurable concentration	Up to 140 Days
Primary	AUC from time 0 to infinity (AUCinf)	AUC from time 0 to infinity	Up to 140 Days
Primary	Terminal phase elimination rate constant (ß)	Terminal phase elimination rate constant	Up to 140 Days
Primary	Terminal phase elimination half-life (t1/2).	Terminal phase elimination half-life	Up to 140 Days
Primary	Number of Anti-drug antibody (ADA) Titers	Incidence of anti-drug antibodies	Up to 140 Days
Primary	Number of Participants with Adverse Events	An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.	Up to 140 Days