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

AbbVie

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: risankizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05283694

M16-324

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 4 patient groups

Risankizumab Dose A

Experimental group

Description:

Participants will receive 3 Subcutaneous (SC) injections of risankizumab Dose A administered via prepared syringe at Day 1 and followed for 140 days.

Treatment:

Drug: risankizumab

Drug: risankizumab

Risankizumab Dose B

Experimental group

Description:

Participants will receive 1 SC injection of risankizumab Dose B administered via syringe pump at Day 1 and followed for 140 days.

Treatment:

Drug: risankizumab

Drug: risankizumab

Risankizumab Dose C

Experimental group

Description:

Participants will receive 1 SC injection of risankizumab Dose C administered via syringe pump at Day 1 and followed for 140 days.

Treatment:

Drug: risankizumab

Drug: risankizumab

Risankizumab Dose D

Experimental group

Description:

Participants will receive 1 SC injection of risankizumab Dose D administered via prepared syringe at Day 1 and followed for 140 days.

Treatment:

Drug: risankizumab

Drug: risankizumab