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

NCT06054425 | Completed Phase 1

• 1 other identifier: M24-696
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Healthy Volunteers

Keywords

Risankizumab

Outcome Measures

Primary Outcomes (7)

• Maximum Observed Serum Concentration (Cmax)

  Cmax will be assessed.

  Up to Day 131

• Time to Cmax (Tmax)

  Tmax will be assessed.

  Up to Day 131

• Apparent Terminal Phase Elimination Rate Constant (β)

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

  Up to Day 131

• Terminal Phase Elimination Half-life (t1/2)

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

  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.

  Up to Day 131

• AUC from Time 0 to Infinity (AUC0-inf)

  AUC0-inf will be assessed.

  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.

  Baseline to Day 141

Study Arms (2)

Arm 1

EXPERIMENTAL

Participants will receive risankizumab manufactured with using the current process (CMC2).

Drug: Risankizumab

Arm 2

ACTIVE COMPARATOR

Participants will receive risankizumab manufactured with using the new process (CMC3).

Drug: Risankizumab

Interventions

Risankizumab DRUG

Infusion; intravenous

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (3)

Anaheim Clinical Trials LLC /ID# 260740

Anaheim, California, 92801-2658, United States

Location

Clinical Pharmacology of Miami /ID# 260800

Miami, Florida, 33014, United States

Location

Acpru /Id# 260864

Grayslake, Illinois, 60030, United States

Location

Related Links

• Related Info

MeSH Terms

Interventions

risankizumab

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: September 26, 2023
• Study Start: November 20, 2023
• Primary Completion: May 6, 2024
• Study Completion: May 6, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)