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

Healthy Volunteers Clinical Trial

Official title:

A Phase 1 Pharmacokinetic Comparability Study in Healthy Subjects to Evaluate the Relative Bioavailability of Risankizumab in Vials Manufactured by Two Different Processes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06054425
• Other study ID #: M24-696
• Status: Completed
• Phase: Phase 1
• Start date: November 20, 2023
• Est. completion date: May 6, 2024

Study information

• Verified date: May 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 6, 2024
• Est. primary completion date: May 6, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Risankizumab
Infusion; intravenous

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials LLC /ID# 260740	Anaheim	California
United States	Acpru /Id# 260864	Grayslake	Illinois
United States	Clinical Pharmacology of Miami /ID# 260800	Miami	Florida

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 Serum Concentration (Cmax)	Cmax will be assessed.	Up to Day 131
Primary	Time to Cmax (Tmax)	Tmax will be assessed.	Up to Day 131
Primary	Apparent Terminal Phase Elimination Rate Constant (ß)	Apparent terminal phase elimination rate constant (ß) will be assessed.	Up to Day 131
Primary	Terminal Phase Elimination Half-life (t1/2)	Terminal phase elimination half-life (t1/2) will be assessed.	Up to Day 131
Primary	Area Under the Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUC0-t)	AUC0-t will be assessed.	Up to Day 131
Primary	AUC from Time 0 to Infinity (AUC0-inf)	AUC0-inf will be assessed.	Up to Day 131
Primary	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.	Baseline to Day 141

External Links

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