A Study to Compare the Bioavailability of Intravenously Infused Risankizumab Manufactured by Two Different Processes in Healthy Adults

AbbVie48 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

RisankizumabDRUG

Infusion; intravenous

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (3)

Anaheim Clinical Trials LLC /ID# 260740

Anaheim, California, United States

Clinical Pharmacology of Miami /ID# 260800

Miami, Florida, United States

Acpru /Id# 260864

Grayslake, Illinois, United States

Outcomes

Primary Outcomes

Maximum Observed Serum Concentration (Cmax)

Cmax will be assessed.

Time frame: Up to Day 131

Time to Cmax (Tmax)

Tmax will be assessed.

Time frame: Up to Day 131

Apparent Terminal Phase Elimination Rate Constant (β)

Apparent terminal phase elimination rate constant (β) will be assessed.

Time frame: Up to Day 131

Terminal Phase Elimination Half-life (t1/2)

Terminal phase elimination half-life (t1/2) will be assessed.

Time frame: 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.

Time frame: Up to Day 131

AUC from Time 0 to Infinity (AUC0-inf)

AUC0-inf will be assessed.

Time frame: 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.

Time frame: Baseline to Day 141

Data from ClinicalTrials.gov

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